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Methasol-N
Betamethasone + Neomycin Sulphate (E/E)
Methasol-N
Betamethasone + Neomycin Sulphate (E/E)
Indications
Uveitis
Indication detailsView
Eye: Inflammatory conditions (eg. uveitis, marginal keratitis, allergic conjunctivitis, blepharitis and episcleritis) where development of bacterial infection is likely.
Ear: Otitis externa and other inflammatory conditions where bacterial infection is present or suspected.
Nose: Inflammatory conditions where infection is present or suspected.
Ear: Otitis externa and other inflammatory conditions where bacterial infection is present or suspected.
Nose: Inflammatory conditions where infection is present or suspected.
Therapeutic classView
Ophthalmic steroid - antibiotic combined preparations
PharmacologyView
Betamethasone is a corticosteroid which is effective in inflammatory dermatoses. It is also effective in less responsive conditions such as psoriasis. Betamethasone has a 16β-methyl group that enhances the anti-inflammatory action of the molecule and reduces the sodium and water retaining properties of the fluorine atom bound at carbon 9.
Neomycin sulfate is bactericidal against many bacteria which are commonly associated with skin infections. Neomycin is a broad spectrum antibiotic which actively transported across the bacterial cell membrane, binds to a specific receptor protein on the 30s subunit of bacterial ribosomes, and interferes with an initiation complex between mRNA (messenger RNA) and the 30s subunit, inhibiting protein synthesis. DNA may be misread, thus producing nonfunctional proteins; polyribosomes are split apart and are unable to synthesize protein.
Neomycin sulfate is bactericidal against many bacteria which are commonly associated with skin infections. Neomycin is a broad spectrum antibiotic which actively transported across the bacterial cell membrane, binds to a specific receptor protein on the 30s subunit of bacterial ribosomes, and interferes with an initiation complex between mRNA (messenger RNA) and the 30s subunit, inhibiting protein synthesis. DNA may be misread, thus producing nonfunctional proteins; polyribosomes are split apart and are unable to synthesize protein.
DosageView
Drops:
- Eye: 1 drop instilled into the eye every one or two hours until control is achieved, when the frequency may be reduced.
- Ear: 2 or 3 drops instilled into the ear, every two or three hours until control is achieved, when the frequency can be reduced.
- Nose: 2 or 3 drops instilled into each nostril two or three times daily.
Side effectsView
Acute sensitization to neomycin is a rare event but can occur after topical application to the eye. Eye drops containing corticosteroids cause a serious rise in intra-ocular pressure in a small percentage of the population, including most of those with a family history of glaucoma. A milder rise may be experienced by a larger proportion of subjects if treatment is continued for longer than a few weeks. Thinning of the cornea leading to perforation has occurred with use of topical corticosteroids. Cataract is reported to have occurred after unduly prolonged treatment of eye conditions with topical corticosteroids.
ContraindicationsView
Viral, fungal, tuberculous or purulent conditions. Use in the eye is contra-indicated if glaucoma is present or where herpetic keratitis (e.g. dendritic ulcer) is considered a possibility. Inadvertent use of topical steroids in the latter condition can lead to extension of the ulcer and marked visual deterioration. Preparations containing neomycin should not be used for treating otitis externa when the ear drum is perforated, because of the risk of ototoxicity.
PrecautionsView
Steroids should not be administered to "red eyes" until a definitive diagnosis has been made. Ophthalmological treatment with steroid preparations should not be repeated or prolonged without regular review to exclude raised intra-ocular pressure or unsuspected infections. The unnecessary topical use of neomycin containing products should be avoided in order to minimize the occurrence of neomycin-resistant organisms (and organism cross-resistant to other aminoglycosides).
Pregnancy & lactationView
Pregnancy Category-Not Classified. FDA has not yet classified the drug into a specified pregnancy category. Topical administration of corticosteroid to pregnant animals can cause abnormalities of fetal development. The relevance of this finding to human beings has not been established; however, topical steroids should not be used extensively in pregnancy, i.e. in large amounts or for prolonged periods.
StorageView
Store below 25° C
Methasol-N
Betamethasone + Neomycin Sulphate (E/E)
Methasol-N
Betamethasone + Neomycin Sulphate (E/E)
Indications
Uveitis
Indication detailsView
Eye: Inflammatory conditions (eg. uveitis, marginal keratitis, allergic conjunctivitis, blepharitis and episcleritis) where development of bacterial infection is likely.
Ear: Otitis externa and other inflammatory conditions where bacterial infection is present or suspected.
Nose: Inflammatory conditions where infection is present or suspected.
Ear: Otitis externa and other inflammatory conditions where bacterial infection is present or suspected.
Nose: Inflammatory conditions where infection is present or suspected.
Therapeutic classView
Ophthalmic steroid - antibiotic combined preparations
PharmacologyView
Betamethasone is a corticosteroid which is effective in inflammatory dermatoses. It is also effective in less responsive conditions such as psoriasis. Betamethasone has a 16β-methyl group that enhances the anti-inflammatory action of the molecule and reduces the sodium and water retaining properties of the fluorine atom bound at carbon 9.
Neomycin sulfate is bactericidal against many bacteria which are commonly associated with skin infections. Neomycin is a broad spectrum antibiotic which actively transported across the bacterial cell membrane, binds to a specific receptor protein on the 30s subunit of bacterial ribosomes, and interferes with an initiation complex between mRNA (messenger RNA) and the 30s subunit, inhibiting protein synthesis. DNA may be misread, thus producing nonfunctional proteins; polyribosomes are split apart and are unable to synthesize protein.
Neomycin sulfate is bactericidal against many bacteria which are commonly associated with skin infections. Neomycin is a broad spectrum antibiotic which actively transported across the bacterial cell membrane, binds to a specific receptor protein on the 30s subunit of bacterial ribosomes, and interferes with an initiation complex between mRNA (messenger RNA) and the 30s subunit, inhibiting protein synthesis. DNA may be misread, thus producing nonfunctional proteins; polyribosomes are split apart and are unable to synthesize protein.
DosageView
Drops:
- Eye: 1 drop instilled into the eye every one or two hours until control is achieved, when the frequency may be reduced.
- Ear: 2 or 3 drops instilled into the ear, every two or three hours until control is achieved, when the frequency can be reduced.
- Nose: 2 or 3 drops instilled into each nostril two or three times daily.
Side effectsView
Acute sensitization to neomycin is a rare event but can occur after topical application to the eye. Eye drops containing corticosteroids cause a serious rise in intra-ocular pressure in a small percentage of the population, including most of those with a family history of glaucoma. A milder rise may be experienced by a larger proportion of subjects if treatment is continued for longer than a few weeks. Thinning of the cornea leading to perforation has occurred with use of topical corticosteroids. Cataract is reported to have occurred after unduly prolonged treatment of eye conditions with topical corticosteroids.
ContraindicationsView
Viral, fungal, tuberculous or purulent conditions. Use in the eye is contra-indicated if glaucoma is present or where herpetic keratitis (e.g. dendritic ulcer) is considered a possibility. Inadvertent use of topical steroids in the latter condition can lead to extension of the ulcer and marked visual deterioration. Preparations containing neomycin should not be used for treating otitis externa when the ear drum is perforated, because of the risk of ototoxicity.
PrecautionsView
Steroids should not be administered to "red eyes" until a definitive diagnosis has been made. Ophthalmological treatment with steroid preparations should not be repeated or prolonged without regular review to exclude raised intra-ocular pressure or unsuspected infections. The unnecessary topical use of neomycin containing products should be avoided in order to minimize the occurrence of neomycin-resistant organisms (and organism cross-resistant to other aminoglycosides).
Pregnancy & lactationView
Pregnancy Category-Not Classified. FDA has not yet classified the drug into a specified pregnancy category. Topical administration of corticosteroid to pregnant animals can cause abnormalities of fetal development. The relevance of this finding to human beings has not been established; however, topical steroids should not be used extensively in pregnancy, i.e. in large amounts or for prolonged periods.
StorageView
Store below 25° C
Methebac
Methenamine Hippurate
Methebac
Methenamine Hippurate
Indications
Urinary tract infection
Indication detailsView
Methenamine is indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary. This drug should only be used after eradication of the infection by other appropriate antimicrobial agents. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Methenamine and other antibacterial drugs, Methenamine should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Therapeutic classView
Other genito-urinary preparations
PharmacologyView
Methenamine Hippurate has antibacterial activity because the methenamine component is hydrolyzed to formaldehyde in acid urine. Hippuric acid, the other component, has some antibacterial activity and also acts to keep the urine acid. The drug is generally active against E. coli, enterococci and staphylococci. Enterobacter aerogenes is generally resistant. The urine must be kept sufficiently acid for urea-splitting organisms such as Proteus and Pseudomonas to be inhibited.
Pharmacology: Within 1/2 hour after ingestion of a single 1-gram dose of Methenamine, antibacterial activity is demonstrable in the urine. Urine has continuous antibacterial activity when HIPREX is administered at the recommended dosage schedule of 1 gram twice daily. Over 90% of methenamine moiety is excreted in the urine within 24 hours after administration of a single 1-gram dose. Similarly, the hippurate moiety is rapidly absorbed and excreted, and it reaches the urine by both tubular secretion and glomerular filtration. This action may be important in older patients or in those with some degree of renal impairment.
Pharmacology: Within 1/2 hour after ingestion of a single 1-gram dose of Methenamine, antibacterial activity is demonstrable in the urine. Urine has continuous antibacterial activity when HIPREX is administered at the recommended dosage schedule of 1 gram twice daily. Over 90% of methenamine moiety is excreted in the urine within 24 hours after administration of a single 1-gram dose. Similarly, the hippurate moiety is rapidly absorbed and excreted, and it reaches the urine by both tubular secretion and glomerular filtration. This action may be important in older patients or in those with some degree of renal impairment.
DosageView
For adults and pediatric patients over 12 years of age: 1 tablet twice daily (morning and night).
For pediatric patients 6 to 12 years of age: ½ to 1 tablet twice daily (morning and night).
Since the antibacterial activity of Methenamine is greater in acid urine, restriction of alkalinizing foods and medications is desirable. If necessary, as indicated by urinary pH and clinical response, supplemental acidification of the urine should be instituted. The efficacy of therapy should be monitored by repeated urine cultures.
For pediatric patients 6 to 12 years of age: ½ to 1 tablet twice daily (morning and night).
Since the antibacterial activity of Methenamine is greater in acid urine, restriction of alkalinizing foods and medications is desirable. If necessary, as indicated by urinary pH and clinical response, supplemental acidification of the urine should be instituted. The efficacy of therapy should be monitored by repeated urine cultures.
ContraindicationsView
Methenamine Hippurate tablets USP is contraindicated in patients with renal insufficiency, severe hepatic insufficiency, or severe dehydration. Methenamine preparations should not be given to patients taking sulfonamides because some sulfonamides may form an insoluble precipitate with formaldehyde in the urine.
PrecautionsView
Prescribing Methenamine in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Care should be taken to maintain an acid pH of the urine, especially when treating infections due to urea-splitting organisms such as Proteus and strains of Pseudomonas.
In a few instances in one study, the serum transaminase levels were slightly elevated during treatment but returned to normal while the patients were still taking Methenamine. Because of this report, it is recommended that liver function studies be performed periodically on patients taking the drug, especially those with liver dysfunction.
Care should be taken to maintain an acid pH of the urine, especially when treating infections due to urea-splitting organisms such as Proteus and strains of Pseudomonas.
In a few instances in one study, the serum transaminase levels were slightly elevated during treatment but returned to normal while the patients were still taking Methenamine. Because of this report, it is recommended that liver function studies be performed periodically on patients taking the drug, especially those with liver dysfunction.
Pregnancy & lactationView
In early pregnancy the safe use of Methenamine is not established. In the last trimester, safety is suggested, but not definitely proved. No adverse effects on the fetus were seen in studies in pregnant rats and rabbits. Methenamine taken during pregnancy can interfere with laboratory tests of urine estriol (resulting in unmeasurably low values) when acid hydrolysis is used in the laboratory procedure. This interference is due to the presence in the urine of methenamine and/or formaldehyde. Enzymatic hydrolysis, in place of acid hydrolysis, will circumvent this problem.
Pediatric usageView
Geriatric Use: Clinical studies of Methenamine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Renal insufficiency and severe hepatic insufficiency: Methenamine is contraindicated in patients with renal insufficiency and severe hepatic insufficiency.
Renal insufficiency and severe hepatic insufficiency: Methenamine is contraindicated in patients with renal insufficiency and severe hepatic insufficiency.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Metherspan
Methylergonovine Maleate
Metherspan
Methylergonovine Maleate
Indications
Uterine hemorrhage
Indication detailsView
Following delivery of the placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.
Therapeutic classView
Drugs acting on the Uterus
PharmacologyView
Methylergonovine Maleate acts directly on the smooth muscle of the uterus and increases the tone, rate, and amplitude of rhythmic contractions. Thus, it induces a rapid and sustained tetanic uterotonic effect which shortens the third stage of labor and reduces blood loss. The onset of action after I.V. administration is immediate; after I.M. administration, 2-5 minutes, and after oral administration, 5-10 minutes.
DosageView
Intramuscularly: 1 ml/0.2 mg, after delivery of the anterior shoulder, after delivery of the placenta, or during the puerperium. May be repeated as required, at intervals of 2-4 hours.
Intravenously: 1 ml/0.2 mg, administered slowly over a period of no less than 60 seconds
Orally: One tablet, 0.2 mg, 3 or 4 times daily in the puerperium for a maximum of 1 week.
Intravenously: 1 ml/0.2 mg, administered slowly over a period of no less than 60 seconds
Orally: One tablet, 0.2 mg, 3 or 4 times daily in the puerperium for a maximum of 1 week.
Side effectsView
The most common adverse reaction is hypertension associated in several cases with seizure and/or headache. Hypotension has also been reported. Abdominal pain (caused by uterine contractions), nausea and vomiting have occurred occasionally. Rarely observed reactions have included: acute myocardial infarction, transient chest pains, vasoconstriction, vasospasm, coronary arterial spasm, bradycardia, tachycardia, dyspnea, hematuria, thrombophlebitis, water intoxication, hallucinations, leg cramps, dizziness, tinnitus, nasal congestion, diarrhea, diaphoresis, palpitation, rash, and foul taste. There have been rare isolated reports of anaphylaxis, without a proven causal relationship to the drug product.
ContraindicationsView
Hypertension; toxemia; pregnancy; and hypersensitivity.
PrecautionsView
Caution should be exercised in the presence of sepsis, obliterative vascular disease. Also use with caution during the second stage of labor. The necessity for manual removal of a retained placenta should occur only rarely with proper technique and adequate allowance of time for its spontaneous separation.
InteractionsView
There have been rare reports of serious adverse events in connection with the coadministration of certain ergot alkaloid drugs (e.g., dihydroergotamine and ergotamine) and potent CYP 3A4 inhibitors, resulting in vasospasm leading to cerebral ischemia and/or ischemia of the extremities. Although there have been no reports of such interactions with methylergonovine alone, potent CYP 3A4 inhibitors should not be coadministered with methylergonovine. Examples of some of the more potent CYP 3A4 inhibitors include macrolide antibiotics (e.g., erythromycin, troleandomycin, clarithromycin), HIV protease or reverse transcriptase inhibitors (e.g., ritonavir, indinavir, nelfinavir, delavirdine) or azole antifungals (e.g., ketoconazole, itraconazole, voriconazole). Less potent CYP 3A4 inhibitors should be administered with caution. Less potent inhibitors include saquinavir, nefazodone, fluconazole, grapefruit juice, fluoxetine, fluvoxamine, zileuton, and clotrimazole. These lists are not exhaustive, and the prescriber should consider the effects on CYP 3A4 of other agents being considered for concomitant use with methylergonovine.
Pregnancy & lactationView
Pregnancy Category C. Animal reproductive studies have not been conducted with Methylergonovine. It is also not known whether methylergonovine maleate can cause fetal harm or can affect reproductive capacity. Use of Methylergonovine is contraindicated during pregnancy because of its uterotonic effects.
Breast-feeding: Mothers should not breast-feed during treatment with Methylergonovine. Milk secreted during this period should be discarded. Methylergonovine may produce adverse effects in the breast-feeding infant. Methylergonovine may also reduce the yield of breast milk. Mothers should wait at least 12 hours after administration of the last dose of Methylergonovine before initiating or resuming breast feeding
Breast-feeding: Mothers should not breast-feed during treatment with Methylergonovine. Milk secreted during this period should be discarded. Methylergonovine may produce adverse effects in the breast-feeding infant. Methylergonovine may also reduce the yield of breast milk. Mothers should wait at least 12 hours after administration of the last dose of Methylergonovine before initiating or resuming breast feeding
Pediatric usageView
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Overdose effectsView
Symptoms of acute overdose may include: nausea, vomiting, oliquria, abdominal pain, numbness, tingling of the extremities, rise in blood pressure, in severe cases followed by hypotension, respiratory depression, hypothermia, convulsions, and coma.
StorageView
Store below 25°C; in tight, light-resistant container.
Metherspan
Methylergonovine Maleate
Metherspan
Methylergonovine Maleate
Indications
Uterine hemorrhage
Indication detailsView
Following delivery of the placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.
Therapeutic classView
Drugs acting on the Uterus
PharmacologyView
Methylergonovine Maleate acts directly on the smooth muscle of the uterus and increases the tone, rate, and amplitude of rhythmic contractions. Thus, it induces a rapid and sustained tetanic uterotonic effect which shortens the third stage of labor and reduces blood loss. The onset of action after I.V. administration is immediate; after I.M. administration, 2-5 minutes, and after oral administration, 5-10 minutes.
DosageView
Intramuscularly: 1 ml/0.2 mg, after delivery of the anterior shoulder, after delivery of the placenta, or during the puerperium. May be repeated as required, at intervals of 2-4 hours.
Intravenously: 1 ml/0.2 mg, administered slowly over a period of no less than 60 seconds
Orally: One tablet, 0.2 mg, 3 or 4 times daily in the puerperium for a maximum of 1 week.
Intravenously: 1 ml/0.2 mg, administered slowly over a period of no less than 60 seconds
Orally: One tablet, 0.2 mg, 3 or 4 times daily in the puerperium for a maximum of 1 week.
Side effectsView
The most common adverse reaction is hypertension associated in several cases with seizure and/or headache. Hypotension has also been reported. Abdominal pain (caused by uterine contractions), nausea and vomiting have occurred occasionally. Rarely observed reactions have included: acute myocardial infarction, transient chest pains, vasoconstriction, vasospasm, coronary arterial spasm, bradycardia, tachycardia, dyspnea, hematuria, thrombophlebitis, water intoxication, hallucinations, leg cramps, dizziness, tinnitus, nasal congestion, diarrhea, diaphoresis, palpitation, rash, and foul taste. There have been rare isolated reports of anaphylaxis, without a proven causal relationship to the drug product.
ContraindicationsView
Hypertension; toxemia; pregnancy; and hypersensitivity.
PrecautionsView
Caution should be exercised in the presence of sepsis, obliterative vascular disease. Also use with caution during the second stage of labor. The necessity for manual removal of a retained placenta should occur only rarely with proper technique and adequate allowance of time for its spontaneous separation.
InteractionsView
There have been rare reports of serious adverse events in connection with the coadministration of certain ergot alkaloid drugs (e.g., dihydroergotamine and ergotamine) and potent CYP 3A4 inhibitors, resulting in vasospasm leading to cerebral ischemia and/or ischemia of the extremities. Although there have been no reports of such interactions with methylergonovine alone, potent CYP 3A4 inhibitors should not be coadministered with methylergonovine. Examples of some of the more potent CYP 3A4 inhibitors include macrolide antibiotics (e.g., erythromycin, troleandomycin, clarithromycin), HIV protease or reverse transcriptase inhibitors (e.g., ritonavir, indinavir, nelfinavir, delavirdine) or azole antifungals (e.g., ketoconazole, itraconazole, voriconazole). Less potent CYP 3A4 inhibitors should be administered with caution. Less potent inhibitors include saquinavir, nefazodone, fluconazole, grapefruit juice, fluoxetine, fluvoxamine, zileuton, and clotrimazole. These lists are not exhaustive, and the prescriber should consider the effects on CYP 3A4 of other agents being considered for concomitant use with methylergonovine.
Pregnancy & lactationView
Pregnancy Category C. Animal reproductive studies have not been conducted with Methylergonovine. It is also not known whether methylergonovine maleate can cause fetal harm or can affect reproductive capacity. Use of Methylergonovine is contraindicated during pregnancy because of its uterotonic effects.
Breast-feeding: Mothers should not breast-feed during treatment with Methylergonovine. Milk secreted during this period should be discarded. Methylergonovine may produce adverse effects in the breast-feeding infant. Methylergonovine may also reduce the yield of breast milk. Mothers should wait at least 12 hours after administration of the last dose of Methylergonovine before initiating or resuming breast feeding
Breast-feeding: Mothers should not breast-feed during treatment with Methylergonovine. Milk secreted during this period should be discarded. Methylergonovine may produce adverse effects in the breast-feeding infant. Methylergonovine may also reduce the yield of breast milk. Mothers should wait at least 12 hours after administration of the last dose of Methylergonovine before initiating or resuming breast feeding
Pediatric usageView
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Overdose effectsView
Symptoms of acute overdose may include: nausea, vomiting, oliquria, abdominal pain, numbness, tingling of the extremities, rise in blood pressure, in severe cases followed by hypotension, respiratory depression, hypothermia, convulsions, and coma.
StorageView
Store below 25°C; in tight, light-resistant container.
Methicap
Silymarin [Milk thistle]
Methicap
Silymarin [Milk thistle]
Indications
Jaundice
Indication detailsView
Silymarin (Milk thistle) is indicated for the treatment and prevention of-
- Liver disease, (non-alcoholic & alcoholic)
- Liver cirrhosis, (non-alcoholic & alcoholic)
- Infectious hepatitis
- Drug-induced hepatitis
- Liver disease secondary to diabetes mellitus
- Toxicity of narcotics
- Fatty liver
- Jaundice
Therapeutic classView
Cholagogues, Cholelitholytics & Hepatic Protectors, Herbal and Nutraceuticals
PharmacologyView
Silymarin, a flavonoid complex of Silybum marianum or Milk thistle, is the biologically active component. It provides hepatocellular protection through toxin blockade at the membrane level, enhances protein synthesis, antioxidant activity, anti-fibrotic activity and possible anti-inflammatory or immunomodulating effects.
DosageView
1 capsule 2 to 3 times daily or as directed by a physician.
Side effectsView
Well tolerated in the recommended dose. Occasionally a mild laxative effect may observe.
ContraindicationsView
Contraindicated in patient with a known hypersensitivity to silymarin.
InteractionsView
Concomitant use of silymarin and butyrophenones or phenothiazines has resulted in the reduction of lipid peroxidation.
Pregnancy & lactationView
No experience is available about the use of Silymarin 70 mg or 140 mg during pregnancy and lactation. Therefore, if needed Silymarin 70 mg or 140 mg should be taken with caution according to the physician’s advice.
StorageView
Store in a cool & dry place, away from light & moisture. Keep out of reach of children.
Methicol
Mecobalamin
Methicol
Mecobalamin
Indications
Peripheral neuropathy
Indication detailsView
Mecobalamin is indicated in-
- Peripheral Neuropathies
- Diabetic Neuropathy
- Verteberal Syndrome
- Nerve Compression Syndrome
- Multiple sclerosis
- Amyotrophic lateral sclerosis
- Parkinson’s disease
- Alzheimer’s disease
- Diabetic retinopathy
- Entrapment neuropathy
- Drug induced neuropathy
- Megaloblastic anemia due to Vitamin B12 deficiency
Therapeutic classView
Drugs for Megaloblastic Anemia
PharmacologyView
Mecobalamin is the neurologically active form of vitamin B12 and occurs as a water-soluble vitamin in the body. It is a cofactor in the enzyme methionine synthase, which functions to transfer methyl groups for the regeneration of methionine from homocysteine. In anaemia, it increases erythrocyte production by promoting nucleic acid synthesis in the bone marrow and by promoting maturation and division of erythrocytes.
DosageView
Tablet: The usual adult dosage is 500 mcg tablet three times daily. The dosage should be adjusted according to the age of patient and the severity of symptoms.
Injection:
Injection:
- Peripheral neuropathies: The usual adult dosage is 500 mcg Mecobalamin administered intramuscularly or intravenously three times a week.The dosage should be adjusted according to the age of patient and the severity of symptoms.
- Megaloblastic anemia: The usual adult dosage is 500 mcg Mecobalamin administered intramuscularly or intravenously three times a week. After about two months of administration, dosage should be changed to one ampoule equivalent to 500 mcg of Mecobalamin every one to three months as maintenance therapy
Side effectsView
Generally Mecobalamin is well tolerated. However, a few side effects like GI discomfort (including anorexia, nausea or diarrhea) & rash may be seen after administration of Mecobalamin.
ContraindicationsView
Hypersensitivity to any component of this product.
PrecautionsView
The medicine should not be used for months if there is no response at all after its use for a certain period of time.
InteractionsView
Decreased GI tract absorption with neomycin, aminosalicylic acid, H2-blockers and colchicine. Reduced serum concentrations with oral contraceptives. Reduced effects in anaemia with parenteral chloramphenicol.
Pregnancy & lactationView
Not recommended during pregnancy & lactation.
Pediatric usageView
Use in children: Not recommended.
StorageView
Oral: Store at room temperature. Protect from moisture and light.
Parenteral: Store at room temperature. Do not expose to direct light.
Parenteral: Store at room temperature. Do not expose to direct light.
Methigic
Methylprednisolone
Methigic
Methylprednisolone
Indications
Rheumatic disorders
Indication detailsView
Endocrine Disorders: Primary or Secondary Adrenocortical Insufficiency, Congenital Adrenal Hyperplasia, Nonsuppurative Thyroiditis, Hypercalcemia associated with Cancer.
Rheumatic Disorders: Rheumatoid Arthritis. Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis, Acute and Subacute Bursitis, Synovitis of Osteoarthritis, Acute nonspecific Tenosynovitis, Post-traumatic Osteoarthritis, Psoriatic Arthritis, Epicondylitis, Acute Gouty Arthritis.
Collagen Diseases: Systemic lupus Erythematosus, Systemic Dermatomyositis and Acute Rheumatic Carditis.
Dermatologic Diseases: Bullous Dermatitis Herpetiformis, Severe Erythema Multiforme (Stevens-Johnson syndrome), Severe Seborrheic Dermatitis, Exfoliative Dermatitis, Mycosis Fungoides, Pemphigus, Severe Psoriasis.
Allergy: Seasonal or Perennial Allergic Rhinitis, Drug hypersensitivity reactions, Serum Sickness, Contact Dermatitis, Bronchial Asthma and Atopic Dermatitis;
Ophthalmic Diseases: Allergic Corneal Ulcers, Herpes Zoster Ophthalmicus, Anterior segment inflammation, Sympathetic Ophthalmia, Keratitis, Optic Neuritis, Allergic Conjunctivitis, Chorioretinitis, iritis end iridocyclitis.
Respiratory Diseases: Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, Aspiration Pneumonitis.
Hematological Disorders: Idiopathic Thrombocytopenic Purpura in adults, Secondary Thrombocytopenia in adults, Acquired (Autoimmune) Hemolytic Anemia, Erythroblastopenia, Congenital (Erythroid) Hypoplastic Anemia.
Neoplastic Diseases: For palliative management of Leukemias and Lymphomas in adults, Acute leukemia of childhood.
Edematous States: To induce a diuresis or remission of Proteinuria in the Nephrotic Syndrome, without Uremia, of the idiopathic type or that due to Lupus Erythematosus.
Gastrointestinal Disease: To tide the patient over a critical period of the disease in Ulcerative Colitis & Regional Enteritis.
CNS Disease: Acute Exacerbations of Multiple Sclerosis.
Rheumatic Disorders: Rheumatoid Arthritis. Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis, Acute and Subacute Bursitis, Synovitis of Osteoarthritis, Acute nonspecific Tenosynovitis, Post-traumatic Osteoarthritis, Psoriatic Arthritis, Epicondylitis, Acute Gouty Arthritis.
Collagen Diseases: Systemic lupus Erythematosus, Systemic Dermatomyositis and Acute Rheumatic Carditis.
Dermatologic Diseases: Bullous Dermatitis Herpetiformis, Severe Erythema Multiforme (Stevens-Johnson syndrome), Severe Seborrheic Dermatitis, Exfoliative Dermatitis, Mycosis Fungoides, Pemphigus, Severe Psoriasis.
Allergy: Seasonal or Perennial Allergic Rhinitis, Drug hypersensitivity reactions, Serum Sickness, Contact Dermatitis, Bronchial Asthma and Atopic Dermatitis;
Ophthalmic Diseases: Allergic Corneal Ulcers, Herpes Zoster Ophthalmicus, Anterior segment inflammation, Sympathetic Ophthalmia, Keratitis, Optic Neuritis, Allergic Conjunctivitis, Chorioretinitis, iritis end iridocyclitis.
Respiratory Diseases: Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, Aspiration Pneumonitis.
Hematological Disorders: Idiopathic Thrombocytopenic Purpura in adults, Secondary Thrombocytopenia in adults, Acquired (Autoimmune) Hemolytic Anemia, Erythroblastopenia, Congenital (Erythroid) Hypoplastic Anemia.
Neoplastic Diseases: For palliative management of Leukemias and Lymphomas in adults, Acute leukemia of childhood.
Edematous States: To induce a diuresis or remission of Proteinuria in the Nephrotic Syndrome, without Uremia, of the idiopathic type or that due to Lupus Erythematosus.
Gastrointestinal Disease: To tide the patient over a critical period of the disease in Ulcerative Colitis & Regional Enteritis.
CNS Disease: Acute Exacerbations of Multiple Sclerosis.
Therapeutic classView
Glucocorticoids
PharmacologyView
Pharmacodynamic properties: Methylprednisolone Is a potent anti-inflammatory agent with the capacity to profoundly inhibit the immune system. Glucocorticoids primarily bind to and activate intracellular glucocorticoid receptors that being activated bind to promoter regions of DMA (which may activate or suppress transcription) and activate transcription factors that result in inactivation of genes through deacetylation of histones. Methylprednisolone influences the kidney and fluid & electrolyte balance, lipid,
protein, and carbohydrate metabolism, skeletal muscle, the cardiovascular system, the immune system, the nervous system, and the endocrine system.
Pharmacokinetic properties: The absolute bioavailability of Methylprednisclone is generally high (82% to 89%) following oral administration and rapidly absorbed and the maximum plasma concentration is achieved around 1.5 to 2.3 hours across doses following oral administration in normal healthy adults. Methylprednisolone is widely distributed into the tissues and its volume of distribution is 41-61.5 liter. It crosses the Wood-brain barrier and the placental barrier and is secreted in breast milk. The plasma protein binding of Methylprednisolone in humans is approximately 77%. Methylprednisolone is metabolized in the liver to inactive metabolites. No dosing adjustments are necessary for renal failure. Methylprednisolone is haemodializable.
protein, and carbohydrate metabolism, skeletal muscle, the cardiovascular system, the immune system, the nervous system, and the endocrine system.
Pharmacokinetic properties: The absolute bioavailability of Methylprednisclone is generally high (82% to 89%) following oral administration and rapidly absorbed and the maximum plasma concentration is achieved around 1.5 to 2.3 hours across doses following oral administration in normal healthy adults. Methylprednisolone is widely distributed into the tissues and its volume of distribution is 41-61.5 liter. It crosses the Wood-brain barrier and the placental barrier and is secreted in breast milk. The plasma protein binding of Methylprednisolone in humans is approximately 77%. Methylprednisolone is metabolized in the liver to inactive metabolites. No dosing adjustments are necessary for renal failure. Methylprednisolone is haemodializable.
DosageView
The usual range is 2-48 mg daily in divided doses, depending on the specific disease being treated.
As anti-inflammatory or immunosuppressive initial dosage: As anti-inflammatory or immunosuppressive, the initial dosage of Methylprednisolone tablets may vary from 4-48 mg per day depending on the specific disease entity being treated, in situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory dirtied response, Methylprednisolone should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be Individualized on the basis of the disease under treatment and the response of the patient.
As anti-inflammatory or immunosuppressive maintenance dosage: After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis: In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of Methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.
Methylprednisolone 4 mg tablet can be used to treat and to control severe allergy end dermatitis following the guideline listed below to minimize the steroid withdrawal syndromes:
The following should be kept in mind when considering alternate-day therapy:
As anti-inflammatory or immunosuppressive initial dosage: As anti-inflammatory or immunosuppressive, the initial dosage of Methylprednisolone tablets may vary from 4-48 mg per day depending on the specific disease entity being treated, in situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory dirtied response, Methylprednisolone should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be Individualized on the basis of the disease under treatment and the response of the patient.
As anti-inflammatory or immunosuppressive maintenance dosage: After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis: In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of Methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.
Methylprednisolone 4 mg tablet can be used to treat and to control severe allergy end dermatitis following the guideline listed below to minimize the steroid withdrawal syndromes:
- Day 1: 2 tablets before breakfast + 1 tablet after lunch + 1 tablet after dinner + 2 tablets at bedtime
- Day 2: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet after dinner + 2 tablets at bedtime
- Day 3: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet after dinner + 1 tablet at bedtime
- Day 4: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet at bedtime
- Day 5: 1 tablet before breakfast + 1 tablet at bedtime
- Day 6: 1 tablet before breakfast
The following should be kept in mind when considering alternate-day therapy:
- Basic principles and indications for corticosteroid therapy should be applied.
- Alternate-day therapy is a therapeutic technique primarily designed for pefienis in whom long-term pharmacologic corticoid therapy is anticipated.
- In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate-day therapy. More severe disease state usually will require daily divided high dose therapy for initiai control of the disease process. The initial suppressive dose level should be continued until a satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases.
Side effectsView
Short courses of Methylprednisolone are usually well-tolerated with few, mild side effects. Long term, high doses of Methyiprednisoione may produce predictable and potentially serious side effects. Whenever possible, the lowest effective doses of Methylprednisolone should be used for the shortest length of time to minimize side effects. Alternate day dosing also can help reduce side effects. Side effects of Methylprednisolone and other corticosteroids range from mild annoyances to serious irreversible bodily damage. Side effects include fluid retention, weight gain, high blood pressure, potassium loss, headache, muscle weakness, hair growth on the face, glaucoma, cataracts, peptic ulceration, growth retardation in children, convulsions, and psychic disturbances including depression, euphoria, insomnia etc. Prolonged use of Methylprednisolone can depress the ability of the body's adrenal glands to produce corticosteroids. Abruptly stopping Methylprednisolone in these individuals can cause symptoms of corticosteroid insufficiency, with accompanying nausea, vomiting, and even shock. Therefore, withdrawal of Methylprednisolone usually is accomplished by gradually lowering the dose. Gradually tapering Methylprednisolone not only minimizes the symptoms of corticosteroid insufficiency, it also reduces the risk of an abrupt flare of the disease being treated.
ContraindicationsView
Systemic fungal infections arid known hypersensitivity to components.
PrecautionsView
Adrenocortical insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
InteractionsView
Erythromycin, Clarithromycin, Phenobarbital, Phenytoin, Rifampin and Ketoconazole inhibit the metabolism of Methylprednisolone. Estrogens, including With control pills, can increase the effect of corticosteroids by 50%. Cyclosporin reduces the metabolism of Methylprednisolone. while Methylprednisolone reduces the metabolism of Cyclosporin. Methylprednisolone may increase or decrease the effect of blood thinners (e.g. Warfarin). For all these Interactions, the dose of Methylprednisolone may need to be lowered.
Pregnancy & lactationView
Pregnancy category C. Dregs should be given only if the potential benefit justifies the potential risk te the foetus. Mefhyiprednisofone has not been adequately evaluated in nursing mothers.
Overdose effectsView
Report of acute toxicity and/or death following an overdose of glucocorticoid ere rare. No specific antidote is available; treatment is supportive and symptomatic. Serum electrolytes should be monitored.
StorageView
Store in a cool and dry place, away from light. Keep out of reach of children.
Methigic
Methylprednisolone
Methigic
Methylprednisolone
Indications
Rheumatic disorders
Indication detailsView
Endocrine Disorders: Primary or Secondary Adrenocortical Insufficiency, Congenital Adrenal Hyperplasia, Nonsuppurative Thyroiditis, Hypercalcemia associated with Cancer.
Rheumatic Disorders: Rheumatoid Arthritis. Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis, Acute and Subacute Bursitis, Synovitis of Osteoarthritis, Acute nonspecific Tenosynovitis, Post-traumatic Osteoarthritis, Psoriatic Arthritis, Epicondylitis, Acute Gouty Arthritis.
Collagen Diseases: Systemic lupus Erythematosus, Systemic Dermatomyositis and Acute Rheumatic Carditis.
Dermatologic Diseases: Bullous Dermatitis Herpetiformis, Severe Erythema Multiforme (Stevens-Johnson syndrome), Severe Seborrheic Dermatitis, Exfoliative Dermatitis, Mycosis Fungoides, Pemphigus, Severe Psoriasis.
Allergy: Seasonal or Perennial Allergic Rhinitis, Drug hypersensitivity reactions, Serum Sickness, Contact Dermatitis, Bronchial Asthma and Atopic Dermatitis;
Ophthalmic Diseases: Allergic Corneal Ulcers, Herpes Zoster Ophthalmicus, Anterior segment inflammation, Sympathetic Ophthalmia, Keratitis, Optic Neuritis, Allergic Conjunctivitis, Chorioretinitis, iritis end iridocyclitis.
Respiratory Diseases: Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, Aspiration Pneumonitis.
Hematological Disorders: Idiopathic Thrombocytopenic Purpura in adults, Secondary Thrombocytopenia in adults, Acquired (Autoimmune) Hemolytic Anemia, Erythroblastopenia, Congenital (Erythroid) Hypoplastic Anemia.
Neoplastic Diseases: For palliative management of Leukemias and Lymphomas in adults, Acute leukemia of childhood.
Edematous States: To induce a diuresis or remission of Proteinuria in the Nephrotic Syndrome, without Uremia, of the idiopathic type or that due to Lupus Erythematosus.
Gastrointestinal Disease: To tide the patient over a critical period of the disease in Ulcerative Colitis & Regional Enteritis.
CNS Disease: Acute Exacerbations of Multiple Sclerosis.
Rheumatic Disorders: Rheumatoid Arthritis. Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis, Acute and Subacute Bursitis, Synovitis of Osteoarthritis, Acute nonspecific Tenosynovitis, Post-traumatic Osteoarthritis, Psoriatic Arthritis, Epicondylitis, Acute Gouty Arthritis.
Collagen Diseases: Systemic lupus Erythematosus, Systemic Dermatomyositis and Acute Rheumatic Carditis.
Dermatologic Diseases: Bullous Dermatitis Herpetiformis, Severe Erythema Multiforme (Stevens-Johnson syndrome), Severe Seborrheic Dermatitis, Exfoliative Dermatitis, Mycosis Fungoides, Pemphigus, Severe Psoriasis.
Allergy: Seasonal or Perennial Allergic Rhinitis, Drug hypersensitivity reactions, Serum Sickness, Contact Dermatitis, Bronchial Asthma and Atopic Dermatitis;
Ophthalmic Diseases: Allergic Corneal Ulcers, Herpes Zoster Ophthalmicus, Anterior segment inflammation, Sympathetic Ophthalmia, Keratitis, Optic Neuritis, Allergic Conjunctivitis, Chorioretinitis, iritis end iridocyclitis.
Respiratory Diseases: Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, Aspiration Pneumonitis.
Hematological Disorders: Idiopathic Thrombocytopenic Purpura in adults, Secondary Thrombocytopenia in adults, Acquired (Autoimmune) Hemolytic Anemia, Erythroblastopenia, Congenital (Erythroid) Hypoplastic Anemia.
Neoplastic Diseases: For palliative management of Leukemias and Lymphomas in adults, Acute leukemia of childhood.
Edematous States: To induce a diuresis or remission of Proteinuria in the Nephrotic Syndrome, without Uremia, of the idiopathic type or that due to Lupus Erythematosus.
Gastrointestinal Disease: To tide the patient over a critical period of the disease in Ulcerative Colitis & Regional Enteritis.
CNS Disease: Acute Exacerbations of Multiple Sclerosis.
Therapeutic classView
Glucocorticoids
PharmacologyView
Pharmacodynamic properties: Methylprednisolone Is a potent anti-inflammatory agent with the capacity to profoundly inhibit the immune system. Glucocorticoids primarily bind to and activate intracellular glucocorticoid receptors that being activated bind to promoter regions of DMA (which may activate or suppress transcription) and activate transcription factors that result in inactivation of genes through deacetylation of histones. Methylprednisolone influences the kidney and fluid & electrolyte balance, lipid,
protein, and carbohydrate metabolism, skeletal muscle, the cardiovascular system, the immune system, the nervous system, and the endocrine system.
Pharmacokinetic properties: The absolute bioavailability of Methylprednisclone is generally high (82% to 89%) following oral administration and rapidly absorbed and the maximum plasma concentration is achieved around 1.5 to 2.3 hours across doses following oral administration in normal healthy adults. Methylprednisolone is widely distributed into the tissues and its volume of distribution is 41-61.5 liter. It crosses the Wood-brain barrier and the placental barrier and is secreted in breast milk. The plasma protein binding of Methylprednisolone in humans is approximately 77%. Methylprednisolone is metabolized in the liver to inactive metabolites. No dosing adjustments are necessary for renal failure. Methylprednisolone is haemodializable.
protein, and carbohydrate metabolism, skeletal muscle, the cardiovascular system, the immune system, the nervous system, and the endocrine system.
Pharmacokinetic properties: The absolute bioavailability of Methylprednisclone is generally high (82% to 89%) following oral administration and rapidly absorbed and the maximum plasma concentration is achieved around 1.5 to 2.3 hours across doses following oral administration in normal healthy adults. Methylprednisolone is widely distributed into the tissues and its volume of distribution is 41-61.5 liter. It crosses the Wood-brain barrier and the placental barrier and is secreted in breast milk. The plasma protein binding of Methylprednisolone in humans is approximately 77%. Methylprednisolone is metabolized in the liver to inactive metabolites. No dosing adjustments are necessary for renal failure. Methylprednisolone is haemodializable.
DosageView
The usual range is 2-48 mg daily in divided doses, depending on the specific disease being treated.
As anti-inflammatory or immunosuppressive initial dosage: As anti-inflammatory or immunosuppressive, the initial dosage of Methylprednisolone tablets may vary from 4-48 mg per day depending on the specific disease entity being treated, in situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory dirtied response, Methylprednisolone should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be Individualized on the basis of the disease under treatment and the response of the patient.
As anti-inflammatory or immunosuppressive maintenance dosage: After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis: In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of Methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.
Methylprednisolone 4 mg tablet can be used to treat and to control severe allergy end dermatitis following the guideline listed below to minimize the steroid withdrawal syndromes:
The following should be kept in mind when considering alternate-day therapy:
As anti-inflammatory or immunosuppressive initial dosage: As anti-inflammatory or immunosuppressive, the initial dosage of Methylprednisolone tablets may vary from 4-48 mg per day depending on the specific disease entity being treated, in situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory dirtied response, Methylprednisolone should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be Individualized on the basis of the disease under treatment and the response of the patient.
As anti-inflammatory or immunosuppressive maintenance dosage: After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis: In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of Methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.
Methylprednisolone 4 mg tablet can be used to treat and to control severe allergy end dermatitis following the guideline listed below to minimize the steroid withdrawal syndromes:
- Day 1: 2 tablets before breakfast + 1 tablet after lunch + 1 tablet after dinner + 2 tablets at bedtime
- Day 2: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet after dinner + 2 tablets at bedtime
- Day 3: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet after dinner + 1 tablet at bedtime
- Day 4: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet at bedtime
- Day 5: 1 tablet before breakfast + 1 tablet at bedtime
- Day 6: 1 tablet before breakfast
The following should be kept in mind when considering alternate-day therapy:
- Basic principles and indications for corticosteroid therapy should be applied.
- Alternate-day therapy is a therapeutic technique primarily designed for pefienis in whom long-term pharmacologic corticoid therapy is anticipated.
- In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate-day therapy. More severe disease state usually will require daily divided high dose therapy for initiai control of the disease process. The initial suppressive dose level should be continued until a satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases.
Side effectsView
Short courses of Methylprednisolone are usually well-tolerated with few, mild side effects. Long term, high doses of Methyiprednisoione may produce predictable and potentially serious side effects. Whenever possible, the lowest effective doses of Methylprednisolone should be used for the shortest length of time to minimize side effects. Alternate day dosing also can help reduce side effects. Side effects of Methylprednisolone and other corticosteroids range from mild annoyances to serious irreversible bodily damage. Side effects include fluid retention, weight gain, high blood pressure, potassium loss, headache, muscle weakness, hair growth on the face, glaucoma, cataracts, peptic ulceration, growth retardation in children, convulsions, and psychic disturbances including depression, euphoria, insomnia etc. Prolonged use of Methylprednisolone can depress the ability of the body's adrenal glands to produce corticosteroids. Abruptly stopping Methylprednisolone in these individuals can cause symptoms of corticosteroid insufficiency, with accompanying nausea, vomiting, and even shock. Therefore, withdrawal of Methylprednisolone usually is accomplished by gradually lowering the dose. Gradually tapering Methylprednisolone not only minimizes the symptoms of corticosteroid insufficiency, it also reduces the risk of an abrupt flare of the disease being treated.
ContraindicationsView
Systemic fungal infections arid known hypersensitivity to components.
PrecautionsView
Adrenocortical insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
InteractionsView
Erythromycin, Clarithromycin, Phenobarbital, Phenytoin, Rifampin and Ketoconazole inhibit the metabolism of Methylprednisolone. Estrogens, including With control pills, can increase the effect of corticosteroids by 50%. Cyclosporin reduces the metabolism of Methylprednisolone. while Methylprednisolone reduces the metabolism of Cyclosporin. Methylprednisolone may increase or decrease the effect of blood thinners (e.g. Warfarin). For all these Interactions, the dose of Methylprednisolone may need to be lowered.
Pregnancy & lactationView
Pregnancy category C. Dregs should be given only if the potential benefit justifies the potential risk te the foetus. Mefhyiprednisofone has not been adequately evaluated in nursing mothers.
Overdose effectsView
Report of acute toxicity and/or death following an overdose of glucocorticoid ere rare. No specific antidote is available; treatment is supportive and symptomatic. Serum electrolytes should be monitored.
StorageView
Store in a cool and dry place, away from light. Keep out of reach of children.
Methigic
Methylprednisolone
Methigic
Methylprednisolone
Indications
Rheumatic disorders
Indication detailsView
Endocrine Disorders: Primary or Secondary Adrenocortical Insufficiency, Congenital Adrenal Hyperplasia, Nonsuppurative Thyroiditis, Hypercalcemia associated with Cancer.
Rheumatic Disorders: Rheumatoid Arthritis. Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis, Acute and Subacute Bursitis, Synovitis of Osteoarthritis, Acute nonspecific Tenosynovitis, Post-traumatic Osteoarthritis, Psoriatic Arthritis, Epicondylitis, Acute Gouty Arthritis.
Collagen Diseases: Systemic lupus Erythematosus, Systemic Dermatomyositis and Acute Rheumatic Carditis.
Dermatologic Diseases: Bullous Dermatitis Herpetiformis, Severe Erythema Multiforme (Stevens-Johnson syndrome), Severe Seborrheic Dermatitis, Exfoliative Dermatitis, Mycosis Fungoides, Pemphigus, Severe Psoriasis.
Allergy: Seasonal or Perennial Allergic Rhinitis, Drug hypersensitivity reactions, Serum Sickness, Contact Dermatitis, Bronchial Asthma and Atopic Dermatitis;
Ophthalmic Diseases: Allergic Corneal Ulcers, Herpes Zoster Ophthalmicus, Anterior segment inflammation, Sympathetic Ophthalmia, Keratitis, Optic Neuritis, Allergic Conjunctivitis, Chorioretinitis, iritis end iridocyclitis.
Respiratory Diseases: Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, Aspiration Pneumonitis.
Hematological Disorders: Idiopathic Thrombocytopenic Purpura in adults, Secondary Thrombocytopenia in adults, Acquired (Autoimmune) Hemolytic Anemia, Erythroblastopenia, Congenital (Erythroid) Hypoplastic Anemia.
Neoplastic Diseases: For palliative management of Leukemias and Lymphomas in adults, Acute leukemia of childhood.
Edematous States: To induce a diuresis or remission of Proteinuria in the Nephrotic Syndrome, without Uremia, of the idiopathic type or that due to Lupus Erythematosus.
Gastrointestinal Disease: To tide the patient over a critical period of the disease in Ulcerative Colitis & Regional Enteritis.
CNS Disease: Acute Exacerbations of Multiple Sclerosis.
Rheumatic Disorders: Rheumatoid Arthritis. Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis, Acute and Subacute Bursitis, Synovitis of Osteoarthritis, Acute nonspecific Tenosynovitis, Post-traumatic Osteoarthritis, Psoriatic Arthritis, Epicondylitis, Acute Gouty Arthritis.
Collagen Diseases: Systemic lupus Erythematosus, Systemic Dermatomyositis and Acute Rheumatic Carditis.
Dermatologic Diseases: Bullous Dermatitis Herpetiformis, Severe Erythema Multiforme (Stevens-Johnson syndrome), Severe Seborrheic Dermatitis, Exfoliative Dermatitis, Mycosis Fungoides, Pemphigus, Severe Psoriasis.
Allergy: Seasonal or Perennial Allergic Rhinitis, Drug hypersensitivity reactions, Serum Sickness, Contact Dermatitis, Bronchial Asthma and Atopic Dermatitis;
Ophthalmic Diseases: Allergic Corneal Ulcers, Herpes Zoster Ophthalmicus, Anterior segment inflammation, Sympathetic Ophthalmia, Keratitis, Optic Neuritis, Allergic Conjunctivitis, Chorioretinitis, iritis end iridocyclitis.
Respiratory Diseases: Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, Aspiration Pneumonitis.
Hematological Disorders: Idiopathic Thrombocytopenic Purpura in adults, Secondary Thrombocytopenia in adults, Acquired (Autoimmune) Hemolytic Anemia, Erythroblastopenia, Congenital (Erythroid) Hypoplastic Anemia.
Neoplastic Diseases: For palliative management of Leukemias and Lymphomas in adults, Acute leukemia of childhood.
Edematous States: To induce a diuresis or remission of Proteinuria in the Nephrotic Syndrome, without Uremia, of the idiopathic type or that due to Lupus Erythematosus.
Gastrointestinal Disease: To tide the patient over a critical period of the disease in Ulcerative Colitis & Regional Enteritis.
CNS Disease: Acute Exacerbations of Multiple Sclerosis.
Therapeutic classView
Glucocorticoids
PharmacologyView
Pharmacodynamic properties: Methylprednisolone Is a potent anti-inflammatory agent with the capacity to profoundly inhibit the immune system. Glucocorticoids primarily bind to and activate intracellular glucocorticoid receptors that being activated bind to promoter regions of DMA (which may activate or suppress transcription) and activate transcription factors that result in inactivation of genes through deacetylation of histones. Methylprednisolone influences the kidney and fluid & electrolyte balance, lipid,
protein, and carbohydrate metabolism, skeletal muscle, the cardiovascular system, the immune system, the nervous system, and the endocrine system.
Pharmacokinetic properties: The absolute bioavailability of Methylprednisclone is generally high (82% to 89%) following oral administration and rapidly absorbed and the maximum plasma concentration is achieved around 1.5 to 2.3 hours across doses following oral administration in normal healthy adults. Methylprednisolone is widely distributed into the tissues and its volume of distribution is 41-61.5 liter. It crosses the Wood-brain barrier and the placental barrier and is secreted in breast milk. The plasma protein binding of Methylprednisolone in humans is approximately 77%. Methylprednisolone is metabolized in the liver to inactive metabolites. No dosing adjustments are necessary for renal failure. Methylprednisolone is haemodializable.
protein, and carbohydrate metabolism, skeletal muscle, the cardiovascular system, the immune system, the nervous system, and the endocrine system.
Pharmacokinetic properties: The absolute bioavailability of Methylprednisclone is generally high (82% to 89%) following oral administration and rapidly absorbed and the maximum plasma concentration is achieved around 1.5 to 2.3 hours across doses following oral administration in normal healthy adults. Methylprednisolone is widely distributed into the tissues and its volume of distribution is 41-61.5 liter. It crosses the Wood-brain barrier and the placental barrier and is secreted in breast milk. The plasma protein binding of Methylprednisolone in humans is approximately 77%. Methylprednisolone is metabolized in the liver to inactive metabolites. No dosing adjustments are necessary for renal failure. Methylprednisolone is haemodializable.
DosageView
The usual range is 2-48 mg daily in divided doses, depending on the specific disease being treated.
As anti-inflammatory or immunosuppressive initial dosage: As anti-inflammatory or immunosuppressive, the initial dosage of Methylprednisolone tablets may vary from 4-48 mg per day depending on the specific disease entity being treated, in situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory dirtied response, Methylprednisolone should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be Individualized on the basis of the disease under treatment and the response of the patient.
As anti-inflammatory or immunosuppressive maintenance dosage: After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis: In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of Methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.
Methylprednisolone 4 mg tablet can be used to treat and to control severe allergy end dermatitis following the guideline listed below to minimize the steroid withdrawal syndromes:
The following should be kept in mind when considering alternate-day therapy:
As anti-inflammatory or immunosuppressive initial dosage: As anti-inflammatory or immunosuppressive, the initial dosage of Methylprednisolone tablets may vary from 4-48 mg per day depending on the specific disease entity being treated, in situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory dirtied response, Methylprednisolone should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be Individualized on the basis of the disease under treatment and the response of the patient.
As anti-inflammatory or immunosuppressive maintenance dosage: After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis: In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of Methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.
Methylprednisolone 4 mg tablet can be used to treat and to control severe allergy end dermatitis following the guideline listed below to minimize the steroid withdrawal syndromes:
- Day 1: 2 tablets before breakfast + 1 tablet after lunch + 1 tablet after dinner + 2 tablets at bedtime
- Day 2: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet after dinner + 2 tablets at bedtime
- Day 3: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet after dinner + 1 tablet at bedtime
- Day 4: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet at bedtime
- Day 5: 1 tablet before breakfast + 1 tablet at bedtime
- Day 6: 1 tablet before breakfast
The following should be kept in mind when considering alternate-day therapy:
- Basic principles and indications for corticosteroid therapy should be applied.
- Alternate-day therapy is a therapeutic technique primarily designed for pefienis in whom long-term pharmacologic corticoid therapy is anticipated.
- In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate-day therapy. More severe disease state usually will require daily divided high dose therapy for initiai control of the disease process. The initial suppressive dose level should be continued until a satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases.
Side effectsView
Short courses of Methylprednisolone are usually well-tolerated with few, mild side effects. Long term, high doses of Methyiprednisoione may produce predictable and potentially serious side effects. Whenever possible, the lowest effective doses of Methylprednisolone should be used for the shortest length of time to minimize side effects. Alternate day dosing also can help reduce side effects. Side effects of Methylprednisolone and other corticosteroids range from mild annoyances to serious irreversible bodily damage. Side effects include fluid retention, weight gain, high blood pressure, potassium loss, headache, muscle weakness, hair growth on the face, glaucoma, cataracts, peptic ulceration, growth retardation in children, convulsions, and psychic disturbances including depression, euphoria, insomnia etc. Prolonged use of Methylprednisolone can depress the ability of the body's adrenal glands to produce corticosteroids. Abruptly stopping Methylprednisolone in these individuals can cause symptoms of corticosteroid insufficiency, with accompanying nausea, vomiting, and even shock. Therefore, withdrawal of Methylprednisolone usually is accomplished by gradually lowering the dose. Gradually tapering Methylprednisolone not only minimizes the symptoms of corticosteroid insufficiency, it also reduces the risk of an abrupt flare of the disease being treated.
ContraindicationsView
Systemic fungal infections arid known hypersensitivity to components.
PrecautionsView
Adrenocortical insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
InteractionsView
Erythromycin, Clarithromycin, Phenobarbital, Phenytoin, Rifampin and Ketoconazole inhibit the metabolism of Methylprednisolone. Estrogens, including With control pills, can increase the effect of corticosteroids by 50%. Cyclosporin reduces the metabolism of Methylprednisolone. while Methylprednisolone reduces the metabolism of Cyclosporin. Methylprednisolone may increase or decrease the effect of blood thinners (e.g. Warfarin). For all these Interactions, the dose of Methylprednisolone may need to be lowered.
Pregnancy & lactationView
Pregnancy category C. Dregs should be given only if the potential benefit justifies the potential risk te the foetus. Mefhyiprednisofone has not been adequately evaluated in nursing mothers.
Overdose effectsView
Report of acute toxicity and/or death following an overdose of glucocorticoid ere rare. No specific antidote is available; treatment is supportive and symptomatic. Serum electrolytes should be monitored.
StorageView
Store in a cool and dry place, away from light. Keep out of reach of children.
Methigic
Methylprednisolone
Methigic
Methylprednisolone
Indications
Rheumatic disorders
Indication detailsView
Endocrine Disorders: Primary or Secondary Adrenocortical Insufficiency, Congenital Adrenal Hyperplasia, Nonsuppurative Thyroiditis, Hypercalcemia associated with Cancer.
Rheumatic Disorders: Rheumatoid Arthritis. Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis, Acute and Subacute Bursitis, Synovitis of Osteoarthritis, Acute nonspecific Tenosynovitis, Post-traumatic Osteoarthritis, Psoriatic Arthritis, Epicondylitis, Acute Gouty Arthritis.
Collagen Diseases: Systemic lupus Erythematosus, Systemic Dermatomyositis and Acute Rheumatic Carditis.
Dermatologic Diseases: Bullous Dermatitis Herpetiformis, Severe Erythema Multiforme (Stevens-Johnson syndrome), Severe Seborrheic Dermatitis, Exfoliative Dermatitis, Mycosis Fungoides, Pemphigus, Severe Psoriasis.
Allergy: Seasonal or Perennial Allergic Rhinitis, Drug hypersensitivity reactions, Serum Sickness, Contact Dermatitis, Bronchial Asthma and Atopic Dermatitis;
Ophthalmic Diseases: Allergic Corneal Ulcers, Herpes Zoster Ophthalmicus, Anterior segment inflammation, Sympathetic Ophthalmia, Keratitis, Optic Neuritis, Allergic Conjunctivitis, Chorioretinitis, iritis end iridocyclitis.
Respiratory Diseases: Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, Aspiration Pneumonitis.
Hematological Disorders: Idiopathic Thrombocytopenic Purpura in adults, Secondary Thrombocytopenia in adults, Acquired (Autoimmune) Hemolytic Anemia, Erythroblastopenia, Congenital (Erythroid) Hypoplastic Anemia.
Neoplastic Diseases: For palliative management of Leukemias and Lymphomas in adults, Acute leukemia of childhood.
Edematous States: To induce a diuresis or remission of Proteinuria in the Nephrotic Syndrome, without Uremia, of the idiopathic type or that due to Lupus Erythematosus.
Gastrointestinal Disease: To tide the patient over a critical period of the disease in Ulcerative Colitis & Regional Enteritis.
CNS Disease: Acute Exacerbations of Multiple Sclerosis.
Rheumatic Disorders: Rheumatoid Arthritis. Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis, Acute and Subacute Bursitis, Synovitis of Osteoarthritis, Acute nonspecific Tenosynovitis, Post-traumatic Osteoarthritis, Psoriatic Arthritis, Epicondylitis, Acute Gouty Arthritis.
Collagen Diseases: Systemic lupus Erythematosus, Systemic Dermatomyositis and Acute Rheumatic Carditis.
Dermatologic Diseases: Bullous Dermatitis Herpetiformis, Severe Erythema Multiforme (Stevens-Johnson syndrome), Severe Seborrheic Dermatitis, Exfoliative Dermatitis, Mycosis Fungoides, Pemphigus, Severe Psoriasis.
Allergy: Seasonal or Perennial Allergic Rhinitis, Drug hypersensitivity reactions, Serum Sickness, Contact Dermatitis, Bronchial Asthma and Atopic Dermatitis;
Ophthalmic Diseases: Allergic Corneal Ulcers, Herpes Zoster Ophthalmicus, Anterior segment inflammation, Sympathetic Ophthalmia, Keratitis, Optic Neuritis, Allergic Conjunctivitis, Chorioretinitis, iritis end iridocyclitis.
Respiratory Diseases: Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, Aspiration Pneumonitis.
Hematological Disorders: Idiopathic Thrombocytopenic Purpura in adults, Secondary Thrombocytopenia in adults, Acquired (Autoimmune) Hemolytic Anemia, Erythroblastopenia, Congenital (Erythroid) Hypoplastic Anemia.
Neoplastic Diseases: For palliative management of Leukemias and Lymphomas in adults, Acute leukemia of childhood.
Edematous States: To induce a diuresis or remission of Proteinuria in the Nephrotic Syndrome, without Uremia, of the idiopathic type or that due to Lupus Erythematosus.
Gastrointestinal Disease: To tide the patient over a critical period of the disease in Ulcerative Colitis & Regional Enteritis.
CNS Disease: Acute Exacerbations of Multiple Sclerosis.
Therapeutic classView
Glucocorticoids
PharmacologyView
Pharmacodynamic properties: Methylprednisolone Is a potent anti-inflammatory agent with the capacity to profoundly inhibit the immune system. Glucocorticoids primarily bind to and activate intracellular glucocorticoid receptors that being activated bind to promoter regions of DMA (which may activate or suppress transcription) and activate transcription factors that result in inactivation of genes through deacetylation of histones. Methylprednisolone influences the kidney and fluid & electrolyte balance, lipid,
protein, and carbohydrate metabolism, skeletal muscle, the cardiovascular system, the immune system, the nervous system, and the endocrine system.
Pharmacokinetic properties: The absolute bioavailability of Methylprednisclone is generally high (82% to 89%) following oral administration and rapidly absorbed and the maximum plasma concentration is achieved around 1.5 to 2.3 hours across doses following oral administration in normal healthy adults. Methylprednisolone is widely distributed into the tissues and its volume of distribution is 41-61.5 liter. It crosses the Wood-brain barrier and the placental barrier and is secreted in breast milk. The plasma protein binding of Methylprednisolone in humans is approximately 77%. Methylprednisolone is metabolized in the liver to inactive metabolites. No dosing adjustments are necessary for renal failure. Methylprednisolone is haemodializable.
protein, and carbohydrate metabolism, skeletal muscle, the cardiovascular system, the immune system, the nervous system, and the endocrine system.
Pharmacokinetic properties: The absolute bioavailability of Methylprednisclone is generally high (82% to 89%) following oral administration and rapidly absorbed and the maximum plasma concentration is achieved around 1.5 to 2.3 hours across doses following oral administration in normal healthy adults. Methylprednisolone is widely distributed into the tissues and its volume of distribution is 41-61.5 liter. It crosses the Wood-brain barrier and the placental barrier and is secreted in breast milk. The plasma protein binding of Methylprednisolone in humans is approximately 77%. Methylprednisolone is metabolized in the liver to inactive metabolites. No dosing adjustments are necessary for renal failure. Methylprednisolone is haemodializable.
DosageView
The usual range is 2-48 mg daily in divided doses, depending on the specific disease being treated.
As anti-inflammatory or immunosuppressive initial dosage: As anti-inflammatory or immunosuppressive, the initial dosage of Methylprednisolone tablets may vary from 4-48 mg per day depending on the specific disease entity being treated, in situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory dirtied response, Methylprednisolone should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be Individualized on the basis of the disease under treatment and the response of the patient.
As anti-inflammatory or immunosuppressive maintenance dosage: After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis: In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of Methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.
Methylprednisolone 4 mg tablet can be used to treat and to control severe allergy end dermatitis following the guideline listed below to minimize the steroid withdrawal syndromes:
The following should be kept in mind when considering alternate-day therapy:
As anti-inflammatory or immunosuppressive initial dosage: As anti-inflammatory or immunosuppressive, the initial dosage of Methylprednisolone tablets may vary from 4-48 mg per day depending on the specific disease entity being treated, in situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory dirtied response, Methylprednisolone should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be Individualized on the basis of the disease under treatment and the response of the patient.
As anti-inflammatory or immunosuppressive maintenance dosage: After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis: In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of Methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.
Methylprednisolone 4 mg tablet can be used to treat and to control severe allergy end dermatitis following the guideline listed below to minimize the steroid withdrawal syndromes:
- Day 1: 2 tablets before breakfast + 1 tablet after lunch + 1 tablet after dinner + 2 tablets at bedtime
- Day 2: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet after dinner + 2 tablets at bedtime
- Day 3: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet after dinner + 1 tablet at bedtime
- Day 4: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet at bedtime
- Day 5: 1 tablet before breakfast + 1 tablet at bedtime
- Day 6: 1 tablet before breakfast
The following should be kept in mind when considering alternate-day therapy:
- Basic principles and indications for corticosteroid therapy should be applied.
- Alternate-day therapy is a therapeutic technique primarily designed for pefienis in whom long-term pharmacologic corticoid therapy is anticipated.
- In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate-day therapy. More severe disease state usually will require daily divided high dose therapy for initiai control of the disease process. The initial suppressive dose level should be continued until a satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases.
Side effectsView
Short courses of Methylprednisolone are usually well-tolerated with few, mild side effects. Long term, high doses of Methyiprednisoione may produce predictable and potentially serious side effects. Whenever possible, the lowest effective doses of Methylprednisolone should be used for the shortest length of time to minimize side effects. Alternate day dosing also can help reduce side effects. Side effects of Methylprednisolone and other corticosteroids range from mild annoyances to serious irreversible bodily damage. Side effects include fluid retention, weight gain, high blood pressure, potassium loss, headache, muscle weakness, hair growth on the face, glaucoma, cataracts, peptic ulceration, growth retardation in children, convulsions, and psychic disturbances including depression, euphoria, insomnia etc. Prolonged use of Methylprednisolone can depress the ability of the body's adrenal glands to produce corticosteroids. Abruptly stopping Methylprednisolone in these individuals can cause symptoms of corticosteroid insufficiency, with accompanying nausea, vomiting, and even shock. Therefore, withdrawal of Methylprednisolone usually is accomplished by gradually lowering the dose. Gradually tapering Methylprednisolone not only minimizes the symptoms of corticosteroid insufficiency, it also reduces the risk of an abrupt flare of the disease being treated.
ContraindicationsView
Systemic fungal infections arid known hypersensitivity to components.
PrecautionsView
Adrenocortical insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
InteractionsView
Erythromycin, Clarithromycin, Phenobarbital, Phenytoin, Rifampin and Ketoconazole inhibit the metabolism of Methylprednisolone. Estrogens, including With control pills, can increase the effect of corticosteroids by 50%. Cyclosporin reduces the metabolism of Methylprednisolone. while Methylprednisolone reduces the metabolism of Cyclosporin. Methylprednisolone may increase or decrease the effect of blood thinners (e.g. Warfarin). For all these Interactions, the dose of Methylprednisolone may need to be lowered.
Pregnancy & lactationView
Pregnancy category C. Dregs should be given only if the potential benefit justifies the potential risk te the foetus. Mefhyiprednisofone has not been adequately evaluated in nursing mothers.
Overdose effectsView
Report of acute toxicity and/or death following an overdose of glucocorticoid ere rare. No specific antidote is available; treatment is supportive and symptomatic. Serum electrolytes should be monitored.
StorageView
Store in a cool and dry place, away from light. Keep out of reach of children.
Methipred
Methylprednisolone
Methipred
Methylprednisolone
Indications
Rheumatic disorders
Indication detailsView
Endocrine Disorders: Primary or Secondary Adrenocortical Insufficiency, Congenital Adrenal Hyperplasia, Nonsuppurative Thyroiditis, Hypercalcemia associated with Cancer.
Rheumatic Disorders: Rheumatoid Arthritis. Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis, Acute and Subacute Bursitis, Synovitis of Osteoarthritis, Acute nonspecific Tenosynovitis, Post-traumatic Osteoarthritis, Psoriatic Arthritis, Epicondylitis, Acute Gouty Arthritis.
Collagen Diseases: Systemic lupus Erythematosus, Systemic Dermatomyositis and Acute Rheumatic Carditis.
Dermatologic Diseases: Bullous Dermatitis Herpetiformis, Severe Erythema Multiforme (Stevens-Johnson syndrome), Severe Seborrheic Dermatitis, Exfoliative Dermatitis, Mycosis Fungoides, Pemphigus, Severe Psoriasis.
Allergy: Seasonal or Perennial Allergic Rhinitis, Drug hypersensitivity reactions, Serum Sickness, Contact Dermatitis, Bronchial Asthma and Atopic Dermatitis;
Ophthalmic Diseases: Allergic Corneal Ulcers, Herpes Zoster Ophthalmicus, Anterior segment inflammation, Sympathetic Ophthalmia, Keratitis, Optic Neuritis, Allergic Conjunctivitis, Chorioretinitis, iritis end iridocyclitis.
Respiratory Diseases: Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, Aspiration Pneumonitis.
Hematological Disorders: Idiopathic Thrombocytopenic Purpura in adults, Secondary Thrombocytopenia in adults, Acquired (Autoimmune) Hemolytic Anemia, Erythroblastopenia, Congenital (Erythroid) Hypoplastic Anemia.
Neoplastic Diseases: For palliative management of Leukemias and Lymphomas in adults, Acute leukemia of childhood.
Edematous States: To induce a diuresis or remission of Proteinuria in the Nephrotic Syndrome, without Uremia, of the idiopathic type or that due to Lupus Erythematosus.
Gastrointestinal Disease: To tide the patient over a critical period of the disease in Ulcerative Colitis & Regional Enteritis.
CNS Disease: Acute Exacerbations of Multiple Sclerosis.
Rheumatic Disorders: Rheumatoid Arthritis. Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis, Acute and Subacute Bursitis, Synovitis of Osteoarthritis, Acute nonspecific Tenosynovitis, Post-traumatic Osteoarthritis, Psoriatic Arthritis, Epicondylitis, Acute Gouty Arthritis.
Collagen Diseases: Systemic lupus Erythematosus, Systemic Dermatomyositis and Acute Rheumatic Carditis.
Dermatologic Diseases: Bullous Dermatitis Herpetiformis, Severe Erythema Multiforme (Stevens-Johnson syndrome), Severe Seborrheic Dermatitis, Exfoliative Dermatitis, Mycosis Fungoides, Pemphigus, Severe Psoriasis.
Allergy: Seasonal or Perennial Allergic Rhinitis, Drug hypersensitivity reactions, Serum Sickness, Contact Dermatitis, Bronchial Asthma and Atopic Dermatitis;
Ophthalmic Diseases: Allergic Corneal Ulcers, Herpes Zoster Ophthalmicus, Anterior segment inflammation, Sympathetic Ophthalmia, Keratitis, Optic Neuritis, Allergic Conjunctivitis, Chorioretinitis, iritis end iridocyclitis.
Respiratory Diseases: Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, Aspiration Pneumonitis.
Hematological Disorders: Idiopathic Thrombocytopenic Purpura in adults, Secondary Thrombocytopenia in adults, Acquired (Autoimmune) Hemolytic Anemia, Erythroblastopenia, Congenital (Erythroid) Hypoplastic Anemia.
Neoplastic Diseases: For palliative management of Leukemias and Lymphomas in adults, Acute leukemia of childhood.
Edematous States: To induce a diuresis or remission of Proteinuria in the Nephrotic Syndrome, without Uremia, of the idiopathic type or that due to Lupus Erythematosus.
Gastrointestinal Disease: To tide the patient over a critical period of the disease in Ulcerative Colitis & Regional Enteritis.
CNS Disease: Acute Exacerbations of Multiple Sclerosis.
Therapeutic classView
Glucocorticoids
PharmacologyView
Pharmacodynamic properties: Methylprednisolone Is a potent anti-inflammatory agent with the capacity to profoundly inhibit the immune system. Glucocorticoids primarily bind to and activate intracellular glucocorticoid receptors that being activated bind to promoter regions of DMA (which may activate or suppress transcription) and activate transcription factors that result in inactivation of genes through deacetylation of histones. Methylprednisolone influences the kidney and fluid & electrolyte balance, lipid,
protein, and carbohydrate metabolism, skeletal muscle, the cardiovascular system, the immune system, the nervous system, and the endocrine system.
Pharmacokinetic properties: The absolute bioavailability of Methylprednisclone is generally high (82% to 89%) following oral administration and rapidly absorbed and the maximum plasma concentration is achieved around 1.5 to 2.3 hours across doses following oral administration in normal healthy adults. Methylprednisolone is widely distributed into the tissues and its volume of distribution is 41-61.5 liter. It crosses the Wood-brain barrier and the placental barrier and is secreted in breast milk. The plasma protein binding of Methylprednisolone in humans is approximately 77%. Methylprednisolone is metabolized in the liver to inactive metabolites. No dosing adjustments are necessary for renal failure. Methylprednisolone is haemodializable.
protein, and carbohydrate metabolism, skeletal muscle, the cardiovascular system, the immune system, the nervous system, and the endocrine system.
Pharmacokinetic properties: The absolute bioavailability of Methylprednisclone is generally high (82% to 89%) following oral administration and rapidly absorbed and the maximum plasma concentration is achieved around 1.5 to 2.3 hours across doses following oral administration in normal healthy adults. Methylprednisolone is widely distributed into the tissues and its volume of distribution is 41-61.5 liter. It crosses the Wood-brain barrier and the placental barrier and is secreted in breast milk. The plasma protein binding of Methylprednisolone in humans is approximately 77%. Methylprednisolone is metabolized in the liver to inactive metabolites. No dosing adjustments are necessary for renal failure. Methylprednisolone is haemodializable.
DosageView
The usual range is 2-48 mg daily in divided doses, depending on the specific disease being treated.
As anti-inflammatory or immunosuppressive initial dosage: As anti-inflammatory or immunosuppressive, the initial dosage of Methylprednisolone tablets may vary from 4-48 mg per day depending on the specific disease entity being treated, in situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory dirtied response, Methylprednisolone should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be Individualized on the basis of the disease under treatment and the response of the patient.
As anti-inflammatory or immunosuppressive maintenance dosage: After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis: In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of Methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.
Methylprednisolone 4 mg tablet can be used to treat and to control severe allergy end dermatitis following the guideline listed below to minimize the steroid withdrawal syndromes:
The following should be kept in mind when considering alternate-day therapy:
As anti-inflammatory or immunosuppressive initial dosage: As anti-inflammatory or immunosuppressive, the initial dosage of Methylprednisolone tablets may vary from 4-48 mg per day depending on the specific disease entity being treated, in situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory dirtied response, Methylprednisolone should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be Individualized on the basis of the disease under treatment and the response of the patient.
As anti-inflammatory or immunosuppressive maintenance dosage: After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis: In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of Methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.
Methylprednisolone 4 mg tablet can be used to treat and to control severe allergy end dermatitis following the guideline listed below to minimize the steroid withdrawal syndromes:
- Day 1: 2 tablets before breakfast + 1 tablet after lunch + 1 tablet after dinner + 2 tablets at bedtime
- Day 2: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet after dinner + 2 tablets at bedtime
- Day 3: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet after dinner + 1 tablet at bedtime
- Day 4: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet at bedtime
- Day 5: 1 tablet before breakfast + 1 tablet at bedtime
- Day 6: 1 tablet before breakfast
The following should be kept in mind when considering alternate-day therapy:
- Basic principles and indications for corticosteroid therapy should be applied.
- Alternate-day therapy is a therapeutic technique primarily designed for pefienis in whom long-term pharmacologic corticoid therapy is anticipated.
- In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate-day therapy. More severe disease state usually will require daily divided high dose therapy for initiai control of the disease process. The initial suppressive dose level should be continued until a satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases.
Side effectsView
Short courses of Methylprednisolone are usually well-tolerated with few, mild side effects. Long term, high doses of Methyiprednisoione may produce predictable and potentially serious side effects. Whenever possible, the lowest effective doses of Methylprednisolone should be used for the shortest length of time to minimize side effects. Alternate day dosing also can help reduce side effects. Side effects of Methylprednisolone and other corticosteroids range from mild annoyances to serious irreversible bodily damage. Side effects include fluid retention, weight gain, high blood pressure, potassium loss, headache, muscle weakness, hair growth on the face, glaucoma, cataracts, peptic ulceration, growth retardation in children, convulsions, and psychic disturbances including depression, euphoria, insomnia etc. Prolonged use of Methylprednisolone can depress the ability of the body's adrenal glands to produce corticosteroids. Abruptly stopping Methylprednisolone in these individuals can cause symptoms of corticosteroid insufficiency, with accompanying nausea, vomiting, and even shock. Therefore, withdrawal of Methylprednisolone usually is accomplished by gradually lowering the dose. Gradually tapering Methylprednisolone not only minimizes the symptoms of corticosteroid insufficiency, it also reduces the risk of an abrupt flare of the disease being treated.
ContraindicationsView
Systemic fungal infections arid known hypersensitivity to components.
PrecautionsView
Adrenocortical insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
InteractionsView
Erythromycin, Clarithromycin, Phenobarbital, Phenytoin, Rifampin and Ketoconazole inhibit the metabolism of Methylprednisolone. Estrogens, including With control pills, can increase the effect of corticosteroids by 50%. Cyclosporin reduces the metabolism of Methylprednisolone. while Methylprednisolone reduces the metabolism of Cyclosporin. Methylprednisolone may increase or decrease the effect of blood thinners (e.g. Warfarin). For all these Interactions, the dose of Methylprednisolone may need to be lowered.
Pregnancy & lactationView
Pregnancy category C. Dregs should be given only if the potential benefit justifies the potential risk te the foetus. Mefhyiprednisofone has not been adequately evaluated in nursing mothers.
Overdose effectsView
Report of acute toxicity and/or death following an overdose of glucocorticoid ere rare. No specific antidote is available; treatment is supportive and symptomatic. Serum electrolytes should be monitored.
StorageView
Store in a cool and dry place, away from light. Keep out of reach of children.
Methipred
Methylprednisolone
Methipred
Methylprednisolone
Indications
Rheumatic disorders
Indication detailsView
Endocrine Disorders: Primary or Secondary Adrenocortical Insufficiency, Congenital Adrenal Hyperplasia, Nonsuppurative Thyroiditis, Hypercalcemia associated with Cancer.
Rheumatic Disorders: Rheumatoid Arthritis. Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis, Acute and Subacute Bursitis, Synovitis of Osteoarthritis, Acute nonspecific Tenosynovitis, Post-traumatic Osteoarthritis, Psoriatic Arthritis, Epicondylitis, Acute Gouty Arthritis.
Collagen Diseases: Systemic lupus Erythematosus, Systemic Dermatomyositis and Acute Rheumatic Carditis.
Dermatologic Diseases: Bullous Dermatitis Herpetiformis, Severe Erythema Multiforme (Stevens-Johnson syndrome), Severe Seborrheic Dermatitis, Exfoliative Dermatitis, Mycosis Fungoides, Pemphigus, Severe Psoriasis.
Allergy: Seasonal or Perennial Allergic Rhinitis, Drug hypersensitivity reactions, Serum Sickness, Contact Dermatitis, Bronchial Asthma and Atopic Dermatitis;
Ophthalmic Diseases: Allergic Corneal Ulcers, Herpes Zoster Ophthalmicus, Anterior segment inflammation, Sympathetic Ophthalmia, Keratitis, Optic Neuritis, Allergic Conjunctivitis, Chorioretinitis, iritis end iridocyclitis.
Respiratory Diseases: Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, Aspiration Pneumonitis.
Hematological Disorders: Idiopathic Thrombocytopenic Purpura in adults, Secondary Thrombocytopenia in adults, Acquired (Autoimmune) Hemolytic Anemia, Erythroblastopenia, Congenital (Erythroid) Hypoplastic Anemia.
Neoplastic Diseases: For palliative management of Leukemias and Lymphomas in adults, Acute leukemia of childhood.
Edematous States: To induce a diuresis or remission of Proteinuria in the Nephrotic Syndrome, without Uremia, of the idiopathic type or that due to Lupus Erythematosus.
Gastrointestinal Disease: To tide the patient over a critical period of the disease in Ulcerative Colitis & Regional Enteritis.
CNS Disease: Acute Exacerbations of Multiple Sclerosis.
Rheumatic Disorders: Rheumatoid Arthritis. Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis, Acute and Subacute Bursitis, Synovitis of Osteoarthritis, Acute nonspecific Tenosynovitis, Post-traumatic Osteoarthritis, Psoriatic Arthritis, Epicondylitis, Acute Gouty Arthritis.
Collagen Diseases: Systemic lupus Erythematosus, Systemic Dermatomyositis and Acute Rheumatic Carditis.
Dermatologic Diseases: Bullous Dermatitis Herpetiformis, Severe Erythema Multiforme (Stevens-Johnson syndrome), Severe Seborrheic Dermatitis, Exfoliative Dermatitis, Mycosis Fungoides, Pemphigus, Severe Psoriasis.
Allergy: Seasonal or Perennial Allergic Rhinitis, Drug hypersensitivity reactions, Serum Sickness, Contact Dermatitis, Bronchial Asthma and Atopic Dermatitis;
Ophthalmic Diseases: Allergic Corneal Ulcers, Herpes Zoster Ophthalmicus, Anterior segment inflammation, Sympathetic Ophthalmia, Keratitis, Optic Neuritis, Allergic Conjunctivitis, Chorioretinitis, iritis end iridocyclitis.
Respiratory Diseases: Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, Aspiration Pneumonitis.
Hematological Disorders: Idiopathic Thrombocytopenic Purpura in adults, Secondary Thrombocytopenia in adults, Acquired (Autoimmune) Hemolytic Anemia, Erythroblastopenia, Congenital (Erythroid) Hypoplastic Anemia.
Neoplastic Diseases: For palliative management of Leukemias and Lymphomas in adults, Acute leukemia of childhood.
Edematous States: To induce a diuresis or remission of Proteinuria in the Nephrotic Syndrome, without Uremia, of the idiopathic type or that due to Lupus Erythematosus.
Gastrointestinal Disease: To tide the patient over a critical period of the disease in Ulcerative Colitis & Regional Enteritis.
CNS Disease: Acute Exacerbations of Multiple Sclerosis.
Therapeutic classView
Glucocorticoids
PharmacologyView
Pharmacodynamic properties: Methylprednisolone Is a potent anti-inflammatory agent with the capacity to profoundly inhibit the immune system. Glucocorticoids primarily bind to and activate intracellular glucocorticoid receptors that being activated bind to promoter regions of DMA (which may activate or suppress transcription) and activate transcription factors that result in inactivation of genes through deacetylation of histones. Methylprednisolone influences the kidney and fluid & electrolyte balance, lipid,
protein, and carbohydrate metabolism, skeletal muscle, the cardiovascular system, the immune system, the nervous system, and the endocrine system.
Pharmacokinetic properties: The absolute bioavailability of Methylprednisclone is generally high (82% to 89%) following oral administration and rapidly absorbed and the maximum plasma concentration is achieved around 1.5 to 2.3 hours across doses following oral administration in normal healthy adults. Methylprednisolone is widely distributed into the tissues and its volume of distribution is 41-61.5 liter. It crosses the Wood-brain barrier and the placental barrier and is secreted in breast milk. The plasma protein binding of Methylprednisolone in humans is approximately 77%. Methylprednisolone is metabolized in the liver to inactive metabolites. No dosing adjustments are necessary for renal failure. Methylprednisolone is haemodializable.
protein, and carbohydrate metabolism, skeletal muscle, the cardiovascular system, the immune system, the nervous system, and the endocrine system.
Pharmacokinetic properties: The absolute bioavailability of Methylprednisclone is generally high (82% to 89%) following oral administration and rapidly absorbed and the maximum plasma concentration is achieved around 1.5 to 2.3 hours across doses following oral administration in normal healthy adults. Methylprednisolone is widely distributed into the tissues and its volume of distribution is 41-61.5 liter. It crosses the Wood-brain barrier and the placental barrier and is secreted in breast milk. The plasma protein binding of Methylprednisolone in humans is approximately 77%. Methylprednisolone is metabolized in the liver to inactive metabolites. No dosing adjustments are necessary for renal failure. Methylprednisolone is haemodializable.
DosageView
The usual range is 2-48 mg daily in divided doses, depending on the specific disease being treated.
As anti-inflammatory or immunosuppressive initial dosage: As anti-inflammatory or immunosuppressive, the initial dosage of Methylprednisolone tablets may vary from 4-48 mg per day depending on the specific disease entity being treated, in situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory dirtied response, Methylprednisolone should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be Individualized on the basis of the disease under treatment and the response of the patient.
As anti-inflammatory or immunosuppressive maintenance dosage: After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis: In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of Methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.
Methylprednisolone 4 mg tablet can be used to treat and to control severe allergy end dermatitis following the guideline listed below to minimize the steroid withdrawal syndromes:
The following should be kept in mind when considering alternate-day therapy:
As anti-inflammatory or immunosuppressive initial dosage: As anti-inflammatory or immunosuppressive, the initial dosage of Methylprednisolone tablets may vary from 4-48 mg per day depending on the specific disease entity being treated, in situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory dirtied response, Methylprednisolone should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be Individualized on the basis of the disease under treatment and the response of the patient.
As anti-inflammatory or immunosuppressive maintenance dosage: After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis: In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of Methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.
Methylprednisolone 4 mg tablet can be used to treat and to control severe allergy end dermatitis following the guideline listed below to minimize the steroid withdrawal syndromes:
- Day 1: 2 tablets before breakfast + 1 tablet after lunch + 1 tablet after dinner + 2 tablets at bedtime
- Day 2: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet after dinner + 2 tablets at bedtime
- Day 3: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet after dinner + 1 tablet at bedtime
- Day 4: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet at bedtime
- Day 5: 1 tablet before breakfast + 1 tablet at bedtime
- Day 6: 1 tablet before breakfast
The following should be kept in mind when considering alternate-day therapy:
- Basic principles and indications for corticosteroid therapy should be applied.
- Alternate-day therapy is a therapeutic technique primarily designed for pefienis in whom long-term pharmacologic corticoid therapy is anticipated.
- In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate-day therapy. More severe disease state usually will require daily divided high dose therapy for initiai control of the disease process. The initial suppressive dose level should be continued until a satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases.
Side effectsView
Short courses of Methylprednisolone are usually well-tolerated with few, mild side effects. Long term, high doses of Methyiprednisoione may produce predictable and potentially serious side effects. Whenever possible, the lowest effective doses of Methylprednisolone should be used for the shortest length of time to minimize side effects. Alternate day dosing also can help reduce side effects. Side effects of Methylprednisolone and other corticosteroids range from mild annoyances to serious irreversible bodily damage. Side effects include fluid retention, weight gain, high blood pressure, potassium loss, headache, muscle weakness, hair growth on the face, glaucoma, cataracts, peptic ulceration, growth retardation in children, convulsions, and psychic disturbances including depression, euphoria, insomnia etc. Prolonged use of Methylprednisolone can depress the ability of the body's adrenal glands to produce corticosteroids. Abruptly stopping Methylprednisolone in these individuals can cause symptoms of corticosteroid insufficiency, with accompanying nausea, vomiting, and even shock. Therefore, withdrawal of Methylprednisolone usually is accomplished by gradually lowering the dose. Gradually tapering Methylprednisolone not only minimizes the symptoms of corticosteroid insufficiency, it also reduces the risk of an abrupt flare of the disease being treated.
ContraindicationsView
Systemic fungal infections arid known hypersensitivity to components.
PrecautionsView
Adrenocortical insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
InteractionsView
Erythromycin, Clarithromycin, Phenobarbital, Phenytoin, Rifampin and Ketoconazole inhibit the metabolism of Methylprednisolone. Estrogens, including With control pills, can increase the effect of corticosteroids by 50%. Cyclosporin reduces the metabolism of Methylprednisolone. while Methylprednisolone reduces the metabolism of Cyclosporin. Methylprednisolone may increase or decrease the effect of blood thinners (e.g. Warfarin). For all these Interactions, the dose of Methylprednisolone may need to be lowered.
Pregnancy & lactationView
Pregnancy category C. Dregs should be given only if the potential benefit justifies the potential risk te the foetus. Mefhyiprednisofone has not been adequately evaluated in nursing mothers.
Overdose effectsView
Report of acute toxicity and/or death following an overdose of glucocorticoid ere rare. No specific antidote is available; treatment is supportive and symptomatic. Serum electrolytes should be monitored.
StorageView
Store in a cool and dry place, away from light. Keep out of reach of children.
Methipred
Methylprednisolone Sodium Succcinate
Methipred
Methylprednisolone Sodium Succcinate
Indications
Vestibular neuritis
Indication detailsView
Methylprednisolone Sodium Succinate IM/IV is indicated in the following conditions:
Endocrine disorder: Primary or secondary adrenocortical insufficiency, acute adrenocortical insufficiency, shock unresponsive to conventional, congenital adrenal hyperplasia, Nonsuppurative thyroiditis. Hypercalcemia associated with cancer.
Rheumatic disorder: Rheumatoid arthritis, including juvenile rheumatoid arthritis, acute and subacute bursitis, epicondylitis, acute nonspecific tenosynovitis, acute gouty arthritis, psoriatic arthritis, ankylosing spondylitis.
Collagen disease: During an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus; acute rheumatic carditis, systemic dermatomyositis (polymyositis).
Dermatological disease: Pemphigus, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, bullous dermatitis herpetiformis, severe seborrheic dermatitis, severe psoriasis, mycosis fungoides.
Allergic states: Controls bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, seasonal or perennial allergic rhinitis, drug hypersensitivity reaction, urticarial transfusion reactions, acute noninfectious laryngeal edema (epinephrine is the drug of first choice), anaphylactic reactions.
Ophthalmic disease: Severe acute and chronic allergic and inflammatory processes involving the eye, such as: herpes zoster ophthalmicus, iritis, iridocyclitis, chorioretinitis, diffuse posterior uveitis and chroiditis, optic neuritis, sympathetic ophthalmia, anterior segment inflammation, allergic conjunctivitis, allergic corneal marginal ulcers, keratitis.
Gastrointestinal disease: To tide the patient over a critical period of the disease in: ulcerative colitis (systemic therapy), regional enteritis (systemic therapy), Crohn’s disease.
Respiratory disease: Symptomatic sarcoidosis, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculosis chemotherapy, Loafer syndrome not manageable by other means, aspiration pneumonitis.
Hematologic disorder: Acquired (autoimmune) hemolytic anemia, idiopathic thrombocytopenic purpura in adults (IV only, IM administration is contraindicated), erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia, secondary thrombocytopenia in adults.
Neoplastic disease: For palliative management of: leukemias and lymphoma in adults, acute leukemia of childhood.
Edematous state: To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia of the idiopathic type or that due to lupus erythematosus.
Miscellaneous: Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculosis chemotherapy. Trichinosis with neurologic or myocardial involvement.
Endocrine disorder: Primary or secondary adrenocortical insufficiency, acute adrenocortical insufficiency, shock unresponsive to conventional, congenital adrenal hyperplasia, Nonsuppurative thyroiditis. Hypercalcemia associated with cancer.
Rheumatic disorder: Rheumatoid arthritis, including juvenile rheumatoid arthritis, acute and subacute bursitis, epicondylitis, acute nonspecific tenosynovitis, acute gouty arthritis, psoriatic arthritis, ankylosing spondylitis.
Collagen disease: During an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus; acute rheumatic carditis, systemic dermatomyositis (polymyositis).
Dermatological disease: Pemphigus, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, bullous dermatitis herpetiformis, severe seborrheic dermatitis, severe psoriasis, mycosis fungoides.
Allergic states: Controls bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, seasonal or perennial allergic rhinitis, drug hypersensitivity reaction, urticarial transfusion reactions, acute noninfectious laryngeal edema (epinephrine is the drug of first choice), anaphylactic reactions.
Ophthalmic disease: Severe acute and chronic allergic and inflammatory processes involving the eye, such as: herpes zoster ophthalmicus, iritis, iridocyclitis, chorioretinitis, diffuse posterior uveitis and chroiditis, optic neuritis, sympathetic ophthalmia, anterior segment inflammation, allergic conjunctivitis, allergic corneal marginal ulcers, keratitis.
Gastrointestinal disease: To tide the patient over a critical period of the disease in: ulcerative colitis (systemic therapy), regional enteritis (systemic therapy), Crohn’s disease.
Respiratory disease: Symptomatic sarcoidosis, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculosis chemotherapy, Loafer syndrome not manageable by other means, aspiration pneumonitis.
Hematologic disorder: Acquired (autoimmune) hemolytic anemia, idiopathic thrombocytopenic purpura in adults (IV only, IM administration is contraindicated), erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia, secondary thrombocytopenia in adults.
Neoplastic disease: For palliative management of: leukemias and lymphoma in adults, acute leukemia of childhood.
Edematous state: To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia of the idiopathic type or that due to lupus erythematosus.
Miscellaneous: Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculosis chemotherapy. Trichinosis with neurologic or myocardial involvement.
Therapeutic classView
Glucocorticoids
PharmacologyView
Methylprednisolone, a naturally occurring glucocorticoid (hydrocortisone and cortisone), which has also salt-retaining properties, is used as replacement therapy in adrenocortical deficiency states. This synthetic analog is primarily used for its potent anti-inflammatory effects in disorders of many organ systems. The intravenous injection of Methylprednisolone Sodium Succinate, demonstrable effects are evident within one hour and persist for a variable period. Excretion of the administered dose is nearly complete within 12 hours. Thus, if constantly high blood levels are required, injections should be made every 4 to 6 hours. This preparation is also rapidly absorbed when administered intramuscularly and is excreted in a pattern similar to that observed after intravenous injection. Its anti-inflammatory potency is greater than prednisolone in the ratio of 5 to 4. It has only minimal mineralocorticoid properties and has less tendency than prednisolone to induce sodium and water retention. It influences carbohydrate, protein, fat and purine metabolism, electrolyte and water balance, and the functional capacities of the cardiovascular system, the kidney, the skeletal muscle, nervous system and other organs and tissues. It exerts a suppressive effect on the immune response.
DosageView
Methylprednisolone may be administered by IM or IV or by IV infusion. To administer by IM or IV injection, prepare solution as direction for reconstitution. The desired dose may be administered intravenously over a period of several minutes. When high dose therapy is desired, the recommended dose of Methylprednisolone Sodium Succinate for Injection, USP is 30 mg/kg administered intravenously over at least 30 minutes. This dose may be repeated every 4 to 6 hours for 48 hours. In general, high-dose corticosteroid therapy should be continued only until the patient’s condition has stabilized usually not beyond 48 to 72 hours.
Although adverse effects associated with high dose short-term corticoid therapy are uncommon, peptic ulceration may occur. Prophylactic antacid therapy may be indicated.
In other indications, the initial dosage will vary from 10 to 40 mg of Methylprednisolone depending on the clinical problem being treated. The larger doses may be required for short-term management of severe, acute conditions. The initial dose usually should be given intravenously over a period of several minutes. Subsequent doses may be given intravenously or intramuscularly at intervals dictated by the patient’s response and clinical condition. Corticoid therapy is an adjunct to, and not a replacement for conventional therapy.
Dosage must be decreased or discontinued gradually when the drug has been administered for more than a few days. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued. Routine laboratory studies, such as urinalysis, two-hour postprandial blood sugar, determination of blood pressure and body weight, and a chest X-ray should be made at regular intervals during prolonged therapy. Upper GI X-rays are desirable in patients with an ulcer history or significant dyspepsia.
In pediatric patients, the initial dose of Methylprednisolone may vary depending on the specific disease being treated. The initial dose is 0.11-1.6 mg/day in three or four divided doses. Dosage may be reduced for infants and children but should be governed more by the severity of the condition and response of the patient than by age or size but it should not be less than 0.5 mg per kg every 24 hours.
In the treatment of acute exacerbations of multiple sclerosis daily doses is 160 mg daily for 3 days. Methylprednisolone powder for injection/infusion should be given as an intravenous infusion over at least 30 minutes.
Although adverse effects associated with high dose short-term corticoid therapy are uncommon, peptic ulceration may occur. Prophylactic antacid therapy may be indicated.
In other indications, the initial dosage will vary from 10 to 40 mg of Methylprednisolone depending on the clinical problem being treated. The larger doses may be required for short-term management of severe, acute conditions. The initial dose usually should be given intravenously over a period of several minutes. Subsequent doses may be given intravenously or intramuscularly at intervals dictated by the patient’s response and clinical condition. Corticoid therapy is an adjunct to, and not a replacement for conventional therapy.
Dosage must be decreased or discontinued gradually when the drug has been administered for more than a few days. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued. Routine laboratory studies, such as urinalysis, two-hour postprandial blood sugar, determination of blood pressure and body weight, and a chest X-ray should be made at regular intervals during prolonged therapy. Upper GI X-rays are desirable in patients with an ulcer history or significant dyspepsia.
In pediatric patients, the initial dose of Methylprednisolone may vary depending on the specific disease being treated. The initial dose is 0.11-1.6 mg/day in three or four divided doses. Dosage may be reduced for infants and children but should be governed more by the severity of the condition and response of the patient than by age or size but it should not be less than 0.5 mg per kg every 24 hours.
In the treatment of acute exacerbations of multiple sclerosis daily doses is 160 mg daily for 3 days. Methylprednisolone powder for injection/infusion should be given as an intravenous infusion over at least 30 minutes.
Side effectsView
Fluid and Electrolyte Disturbances: Sodium retention, fluid retention, congestive heart failure in susceptible patients, potassium loss, hypokalemic alkalosis, hypertension.
Musculoskeletal: Muscle weakness, steroid myopathy, loss of muscle mass, severe arthralgia, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones, osteoporosis.
Gastrointestinal: Peptic ulcer with possible perforation and hemorrhage, pancreatitis, abdominal distention, and ulcerative esophagitis.
Dermatologic: Impaired wound healing, thin fragile skin, petechiae and ecchymoses, facial erythema, increased sweating, may suppress reactions to skin tests.
Neurological: Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment, convulsions, vertigo, headache.
Endocrine: Development of Cushingoid state, suppression of growth in children, secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness, menstrual irregularities, decreased carbohydrate tolerance, manifestations of latent diabetes mellitus, increased requirements for insulin or oral hypoglycemic agents in diabetics.
Ophthalmic: Posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos.
Others: Negative nitrogen balance due to protein catabolism.
The following additional adverse reactions are related to parenteral corticosteroid therapy: hyperpigmentation or hypopigmentation, subcutaneous and cutaneous atrophy, sterile abscess, anaphylactic reaction with or without circulatory collapse, cardiac arrest, bronchospasm, urticaria, nausea and vomiting, cardiac arrhythmias; hypotension or hypertension.
Musculoskeletal: Muscle weakness, steroid myopathy, loss of muscle mass, severe arthralgia, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones, osteoporosis.
Gastrointestinal: Peptic ulcer with possible perforation and hemorrhage, pancreatitis, abdominal distention, and ulcerative esophagitis.
Dermatologic: Impaired wound healing, thin fragile skin, petechiae and ecchymoses, facial erythema, increased sweating, may suppress reactions to skin tests.
Neurological: Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment, convulsions, vertigo, headache.
Endocrine: Development of Cushingoid state, suppression of growth in children, secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness, menstrual irregularities, decreased carbohydrate tolerance, manifestations of latent diabetes mellitus, increased requirements for insulin or oral hypoglycemic agents in diabetics.
Ophthalmic: Posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos.
Others: Negative nitrogen balance due to protein catabolism.
The following additional adverse reactions are related to parenteral corticosteroid therapy: hyperpigmentation or hypopigmentation, subcutaneous and cutaneous atrophy, sterile abscess, anaphylactic reaction with or without circulatory collapse, cardiac arrest, bronchospasm, urticaria, nausea and vomiting, cardiac arrhythmias; hypotension or hypertension.
ContraindicationsView
Methylprednisolone Sterile Powder is contraindicated:
- In systemic fungal infections and patients with known hypersensitivity to the product and its constituents.
- For intrathecal administration. Reports of severe medical events have been associated with this route of administration.
- Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.
PrecautionsView
Methylprednisolone, like many other steroid formulations, is sensitive to heat. Therefore, it should not be autoclaved when it is desirable to sterilize the exterior of the vial. The lowest possible dose of corticosteroid should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. For chronic conditions, discontinuation of corticosteroids may result in clinical improvement.
InteractionsView
- Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression.
- Amphotericin B injection and potassium-depleting agents- When corticosteroids are administered concomitantly with potassium-depleting agents (i.e., amphotericin B, diuretics), patients should be observed closely for the development of hypokalemia.
- Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance.
- Anticholinesterases- Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.
- Anticoagulants, oral- Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports.
- Antidiabetics- Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.
- Antitubercular drugs- Serum concentrations of isoniazid may be decreased.
- Cholestyramine may increase the clearance of corticosteroids.
- Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.
- Digitalis glycosides- Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.
- Estrogens, including oral contraceptives- Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.
- Hepatic Enzyme Inhibitors- Drugs which inhibit cytochrome P450 3A4 have the potential to result in increased plasma concentrations of corticosteroids.
- Ketoconazole has been reported to significantly decrease the metabolism of certain corticosteroids by up to 60%, leading to an increased risk of corticosteroid side effects.
- Nonsteroidal anti-inflammatory agents (NSAIDs)- Concomitant use of aspirin and corticosteroids increases the risk of gastrointestinal side effects.
- Skin tests- Corticosteroids may suppress reactions to skin tests.
- Vaccines- Patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response.
Pregnancy & lactationView
Pregnancy: Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
Lactation: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to continue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Lactation: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to continue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric Use: The adverse effects of corticosteroids in pediatric patients are similar to those in adults. Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose.
Geriatric Use: Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, refecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy.
Overdose effectsView
Treatment of acute over dosage is by supportive and symptomatic therapy. For chronic over dosage in the face of severe disease requiring continuous steroid therapy, the dosage of the corticosteroid may be reduced only temporarily or alternate day treatment may be introduced.
ReconstitutionView
Directions for Reconstitution-
- Remove protective plastic flip-of seal.
- Cleanse stopper with a suitable germicide.
- Aseptically add 8 mL Water for Injection BP for the 500 mg vial or 16 ml for 1 gm vial by means of a syringe into the vial.
- Agitate to effect solution to dissolve the powder content.
- Invert vial. Insert the needle through the target area of stopper until the tip is just visible. Withdraw dose.
StorageView
Protect from light. Store at controlled room temperature 20° to 25°C. Store solution at controlled room temperature 20° to 25°C.Use solution within 48 hours after mixing.
Methipred
Methylprednisolone Sodium Succcinate
Methipred
Methylprednisolone Sodium Succcinate
Indications
Vestibular neuritis
Indication detailsView
Methylprednisolone Sodium Succinate IM/IV is indicated in the following conditions:
Endocrine disorder: Primary or secondary adrenocortical insufficiency, acute adrenocortical insufficiency, shock unresponsive to conventional, congenital adrenal hyperplasia, Nonsuppurative thyroiditis. Hypercalcemia associated with cancer.
Rheumatic disorder: Rheumatoid arthritis, including juvenile rheumatoid arthritis, acute and subacute bursitis, epicondylitis, acute nonspecific tenosynovitis, acute gouty arthritis, psoriatic arthritis, ankylosing spondylitis.
Collagen disease: During an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus; acute rheumatic carditis, systemic dermatomyositis (polymyositis).
Dermatological disease: Pemphigus, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, bullous dermatitis herpetiformis, severe seborrheic dermatitis, severe psoriasis, mycosis fungoides.
Allergic states: Controls bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, seasonal or perennial allergic rhinitis, drug hypersensitivity reaction, urticarial transfusion reactions, acute noninfectious laryngeal edema (epinephrine is the drug of first choice), anaphylactic reactions.
Ophthalmic disease: Severe acute and chronic allergic and inflammatory processes involving the eye, such as: herpes zoster ophthalmicus, iritis, iridocyclitis, chorioretinitis, diffuse posterior uveitis and chroiditis, optic neuritis, sympathetic ophthalmia, anterior segment inflammation, allergic conjunctivitis, allergic corneal marginal ulcers, keratitis.
Gastrointestinal disease: To tide the patient over a critical period of the disease in: ulcerative colitis (systemic therapy), regional enteritis (systemic therapy), Crohn’s disease.
Respiratory disease: Symptomatic sarcoidosis, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculosis chemotherapy, Loafer syndrome not manageable by other means, aspiration pneumonitis.
Hematologic disorder: Acquired (autoimmune) hemolytic anemia, idiopathic thrombocytopenic purpura in adults (IV only, IM administration is contraindicated), erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia, secondary thrombocytopenia in adults.
Neoplastic disease: For palliative management of: leukemias and lymphoma in adults, acute leukemia of childhood.
Edematous state: To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia of the idiopathic type or that due to lupus erythematosus.
Miscellaneous: Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculosis chemotherapy. Trichinosis with neurologic or myocardial involvement.
Endocrine disorder: Primary or secondary adrenocortical insufficiency, acute adrenocortical insufficiency, shock unresponsive to conventional, congenital adrenal hyperplasia, Nonsuppurative thyroiditis. Hypercalcemia associated with cancer.
Rheumatic disorder: Rheumatoid arthritis, including juvenile rheumatoid arthritis, acute and subacute bursitis, epicondylitis, acute nonspecific tenosynovitis, acute gouty arthritis, psoriatic arthritis, ankylosing spondylitis.
Collagen disease: During an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus; acute rheumatic carditis, systemic dermatomyositis (polymyositis).
Dermatological disease: Pemphigus, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, bullous dermatitis herpetiformis, severe seborrheic dermatitis, severe psoriasis, mycosis fungoides.
Allergic states: Controls bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, seasonal or perennial allergic rhinitis, drug hypersensitivity reaction, urticarial transfusion reactions, acute noninfectious laryngeal edema (epinephrine is the drug of first choice), anaphylactic reactions.
Ophthalmic disease: Severe acute and chronic allergic and inflammatory processes involving the eye, such as: herpes zoster ophthalmicus, iritis, iridocyclitis, chorioretinitis, diffuse posterior uveitis and chroiditis, optic neuritis, sympathetic ophthalmia, anterior segment inflammation, allergic conjunctivitis, allergic corneal marginal ulcers, keratitis.
Gastrointestinal disease: To tide the patient over a critical period of the disease in: ulcerative colitis (systemic therapy), regional enteritis (systemic therapy), Crohn’s disease.
Respiratory disease: Symptomatic sarcoidosis, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculosis chemotherapy, Loafer syndrome not manageable by other means, aspiration pneumonitis.
Hematologic disorder: Acquired (autoimmune) hemolytic anemia, idiopathic thrombocytopenic purpura in adults (IV only, IM administration is contraindicated), erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia, secondary thrombocytopenia in adults.
Neoplastic disease: For palliative management of: leukemias and lymphoma in adults, acute leukemia of childhood.
Edematous state: To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia of the idiopathic type or that due to lupus erythematosus.
Miscellaneous: Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculosis chemotherapy. Trichinosis with neurologic or myocardial involvement.
Therapeutic classView
Glucocorticoids
PharmacologyView
Methylprednisolone, a naturally occurring glucocorticoid (hydrocortisone and cortisone), which has also salt-retaining properties, is used as replacement therapy in adrenocortical deficiency states. This synthetic analog is primarily used for its potent anti-inflammatory effects in disorders of many organ systems. The intravenous injection of Methylprednisolone Sodium Succinate, demonstrable effects are evident within one hour and persist for a variable period. Excretion of the administered dose is nearly complete within 12 hours. Thus, if constantly high blood levels are required, injections should be made every 4 to 6 hours. This preparation is also rapidly absorbed when administered intramuscularly and is excreted in a pattern similar to that observed after intravenous injection. Its anti-inflammatory potency is greater than prednisolone in the ratio of 5 to 4. It has only minimal mineralocorticoid properties and has less tendency than prednisolone to induce sodium and water retention. It influences carbohydrate, protein, fat and purine metabolism, electrolyte and water balance, and the functional capacities of the cardiovascular system, the kidney, the skeletal muscle, nervous system and other organs and tissues. It exerts a suppressive effect on the immune response.
DosageView
Methylprednisolone may be administered by IM or IV or by IV infusion. To administer by IM or IV injection, prepare solution as direction for reconstitution. The desired dose may be administered intravenously over a period of several minutes. When high dose therapy is desired, the recommended dose of Methylprednisolone Sodium Succinate for Injection, USP is 30 mg/kg administered intravenously over at least 30 minutes. This dose may be repeated every 4 to 6 hours for 48 hours. In general, high-dose corticosteroid therapy should be continued only until the patient’s condition has stabilized usually not beyond 48 to 72 hours.
Although adverse effects associated with high dose short-term corticoid therapy are uncommon, peptic ulceration may occur. Prophylactic antacid therapy may be indicated.
In other indications, the initial dosage will vary from 10 to 40 mg of Methylprednisolone depending on the clinical problem being treated. The larger doses may be required for short-term management of severe, acute conditions. The initial dose usually should be given intravenously over a period of several minutes. Subsequent doses may be given intravenously or intramuscularly at intervals dictated by the patient’s response and clinical condition. Corticoid therapy is an adjunct to, and not a replacement for conventional therapy.
Dosage must be decreased or discontinued gradually when the drug has been administered for more than a few days. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued. Routine laboratory studies, such as urinalysis, two-hour postprandial blood sugar, determination of blood pressure and body weight, and a chest X-ray should be made at regular intervals during prolonged therapy. Upper GI X-rays are desirable in patients with an ulcer history or significant dyspepsia.
In pediatric patients, the initial dose of Methylprednisolone may vary depending on the specific disease being treated. The initial dose is 0.11-1.6 mg/day in three or four divided doses. Dosage may be reduced for infants and children but should be governed more by the severity of the condition and response of the patient than by age or size but it should not be less than 0.5 mg per kg every 24 hours.
In the treatment of acute exacerbations of multiple sclerosis daily doses is 160 mg daily for 3 days. Methylprednisolone powder for injection/infusion should be given as an intravenous infusion over at least 30 minutes.
Although adverse effects associated with high dose short-term corticoid therapy are uncommon, peptic ulceration may occur. Prophylactic antacid therapy may be indicated.
In other indications, the initial dosage will vary from 10 to 40 mg of Methylprednisolone depending on the clinical problem being treated. The larger doses may be required for short-term management of severe, acute conditions. The initial dose usually should be given intravenously over a period of several minutes. Subsequent doses may be given intravenously or intramuscularly at intervals dictated by the patient’s response and clinical condition. Corticoid therapy is an adjunct to, and not a replacement for conventional therapy.
Dosage must be decreased or discontinued gradually when the drug has been administered for more than a few days. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued. Routine laboratory studies, such as urinalysis, two-hour postprandial blood sugar, determination of blood pressure and body weight, and a chest X-ray should be made at regular intervals during prolonged therapy. Upper GI X-rays are desirable in patients with an ulcer history or significant dyspepsia.
In pediatric patients, the initial dose of Methylprednisolone may vary depending on the specific disease being treated. The initial dose is 0.11-1.6 mg/day in three or four divided doses. Dosage may be reduced for infants and children but should be governed more by the severity of the condition and response of the patient than by age or size but it should not be less than 0.5 mg per kg every 24 hours.
In the treatment of acute exacerbations of multiple sclerosis daily doses is 160 mg daily for 3 days. Methylprednisolone powder for injection/infusion should be given as an intravenous infusion over at least 30 minutes.
Side effectsView
Fluid and Electrolyte Disturbances: Sodium retention, fluid retention, congestive heart failure in susceptible patients, potassium loss, hypokalemic alkalosis, hypertension.
Musculoskeletal: Muscle weakness, steroid myopathy, loss of muscle mass, severe arthralgia, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones, osteoporosis.
Gastrointestinal: Peptic ulcer with possible perforation and hemorrhage, pancreatitis, abdominal distention, and ulcerative esophagitis.
Dermatologic: Impaired wound healing, thin fragile skin, petechiae and ecchymoses, facial erythema, increased sweating, may suppress reactions to skin tests.
Neurological: Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment, convulsions, vertigo, headache.
Endocrine: Development of Cushingoid state, suppression of growth in children, secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness, menstrual irregularities, decreased carbohydrate tolerance, manifestations of latent diabetes mellitus, increased requirements for insulin or oral hypoglycemic agents in diabetics.
Ophthalmic: Posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos.
Others: Negative nitrogen balance due to protein catabolism.
The following additional adverse reactions are related to parenteral corticosteroid therapy: hyperpigmentation or hypopigmentation, subcutaneous and cutaneous atrophy, sterile abscess, anaphylactic reaction with or without circulatory collapse, cardiac arrest, bronchospasm, urticaria, nausea and vomiting, cardiac arrhythmias; hypotension or hypertension.
Musculoskeletal: Muscle weakness, steroid myopathy, loss of muscle mass, severe arthralgia, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones, osteoporosis.
Gastrointestinal: Peptic ulcer with possible perforation and hemorrhage, pancreatitis, abdominal distention, and ulcerative esophagitis.
Dermatologic: Impaired wound healing, thin fragile skin, petechiae and ecchymoses, facial erythema, increased sweating, may suppress reactions to skin tests.
Neurological: Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment, convulsions, vertigo, headache.
Endocrine: Development of Cushingoid state, suppression of growth in children, secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness, menstrual irregularities, decreased carbohydrate tolerance, manifestations of latent diabetes mellitus, increased requirements for insulin or oral hypoglycemic agents in diabetics.
Ophthalmic: Posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos.
Others: Negative nitrogen balance due to protein catabolism.
The following additional adverse reactions are related to parenteral corticosteroid therapy: hyperpigmentation or hypopigmentation, subcutaneous and cutaneous atrophy, sterile abscess, anaphylactic reaction with or without circulatory collapse, cardiac arrest, bronchospasm, urticaria, nausea and vomiting, cardiac arrhythmias; hypotension or hypertension.
ContraindicationsView
Methylprednisolone Sterile Powder is contraindicated:
- In systemic fungal infections and patients with known hypersensitivity to the product and its constituents.
- For intrathecal administration. Reports of severe medical events have been associated with this route of administration.
- Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.
PrecautionsView
Methylprednisolone, like many other steroid formulations, is sensitive to heat. Therefore, it should not be autoclaved when it is desirable to sterilize the exterior of the vial. The lowest possible dose of corticosteroid should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. For chronic conditions, discontinuation of corticosteroids may result in clinical improvement.
InteractionsView
- Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression.
- Amphotericin B injection and potassium-depleting agents- When corticosteroids are administered concomitantly with potassium-depleting agents (i.e., amphotericin B, diuretics), patients should be observed closely for the development of hypokalemia.
- Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance.
- Anticholinesterases- Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.
- Anticoagulants, oral- Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports.
- Antidiabetics- Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.
- Antitubercular drugs- Serum concentrations of isoniazid may be decreased.
- Cholestyramine may increase the clearance of corticosteroids.
- Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.
- Digitalis glycosides- Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.
- Estrogens, including oral contraceptives- Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.
- Hepatic Enzyme Inhibitors- Drugs which inhibit cytochrome P450 3A4 have the potential to result in increased plasma concentrations of corticosteroids.
- Ketoconazole has been reported to significantly decrease the metabolism of certain corticosteroids by up to 60%, leading to an increased risk of corticosteroid side effects.
- Nonsteroidal anti-inflammatory agents (NSAIDs)- Concomitant use of aspirin and corticosteroids increases the risk of gastrointestinal side effects.
- Skin tests- Corticosteroids may suppress reactions to skin tests.
- Vaccines- Patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response.
Pregnancy & lactationView
Pregnancy: Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
Lactation: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to continue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Lactation: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to continue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric Use: The adverse effects of corticosteroids in pediatric patients are similar to those in adults. Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose.
Geriatric Use: Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, refecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy.
Overdose effectsView
Treatment of acute over dosage is by supportive and symptomatic therapy. For chronic over dosage in the face of severe disease requiring continuous steroid therapy, the dosage of the corticosteroid may be reduced only temporarily or alternate day treatment may be introduced.
ReconstitutionView
Directions for Reconstitution-
- Remove protective plastic flip-of seal.
- Cleanse stopper with a suitable germicide.
- Aseptically add 8 mL Water for Injection BP for the 500 mg vial or 16 ml for 1 gm vial by means of a syringe into the vial.
- Agitate to effect solution to dissolve the powder content.
- Invert vial. Insert the needle through the target area of stopper until the tip is just visible. Withdraw dose.
StorageView
Protect from light. Store at controlled room temperature 20° to 25°C. Store solution at controlled room temperature 20° to 25°C.Use solution within 48 hours after mixing.
Methipred
Methylprednisolone
Methipred
Methylprednisolone
Indications
Rheumatic disorders
Indication detailsView
Endocrine Disorders: Primary or Secondary Adrenocortical Insufficiency, Congenital Adrenal Hyperplasia, Nonsuppurative Thyroiditis, Hypercalcemia associated with Cancer.
Rheumatic Disorders: Rheumatoid Arthritis. Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis, Acute and Subacute Bursitis, Synovitis of Osteoarthritis, Acute nonspecific Tenosynovitis, Post-traumatic Osteoarthritis, Psoriatic Arthritis, Epicondylitis, Acute Gouty Arthritis.
Collagen Diseases: Systemic lupus Erythematosus, Systemic Dermatomyositis and Acute Rheumatic Carditis.
Dermatologic Diseases: Bullous Dermatitis Herpetiformis, Severe Erythema Multiforme (Stevens-Johnson syndrome), Severe Seborrheic Dermatitis, Exfoliative Dermatitis, Mycosis Fungoides, Pemphigus, Severe Psoriasis.
Allergy: Seasonal or Perennial Allergic Rhinitis, Drug hypersensitivity reactions, Serum Sickness, Contact Dermatitis, Bronchial Asthma and Atopic Dermatitis;
Ophthalmic Diseases: Allergic Corneal Ulcers, Herpes Zoster Ophthalmicus, Anterior segment inflammation, Sympathetic Ophthalmia, Keratitis, Optic Neuritis, Allergic Conjunctivitis, Chorioretinitis, iritis end iridocyclitis.
Respiratory Diseases: Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, Aspiration Pneumonitis.
Hematological Disorders: Idiopathic Thrombocytopenic Purpura in adults, Secondary Thrombocytopenia in adults, Acquired (Autoimmune) Hemolytic Anemia, Erythroblastopenia, Congenital (Erythroid) Hypoplastic Anemia.
Neoplastic Diseases: For palliative management of Leukemias and Lymphomas in adults, Acute leukemia of childhood.
Edematous States: To induce a diuresis or remission of Proteinuria in the Nephrotic Syndrome, without Uremia, of the idiopathic type or that due to Lupus Erythematosus.
Gastrointestinal Disease: To tide the patient over a critical period of the disease in Ulcerative Colitis & Regional Enteritis.
CNS Disease: Acute Exacerbations of Multiple Sclerosis.
Rheumatic Disorders: Rheumatoid Arthritis. Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis, Acute and Subacute Bursitis, Synovitis of Osteoarthritis, Acute nonspecific Tenosynovitis, Post-traumatic Osteoarthritis, Psoriatic Arthritis, Epicondylitis, Acute Gouty Arthritis.
Collagen Diseases: Systemic lupus Erythematosus, Systemic Dermatomyositis and Acute Rheumatic Carditis.
Dermatologic Diseases: Bullous Dermatitis Herpetiformis, Severe Erythema Multiforme (Stevens-Johnson syndrome), Severe Seborrheic Dermatitis, Exfoliative Dermatitis, Mycosis Fungoides, Pemphigus, Severe Psoriasis.
Allergy: Seasonal or Perennial Allergic Rhinitis, Drug hypersensitivity reactions, Serum Sickness, Contact Dermatitis, Bronchial Asthma and Atopic Dermatitis;
Ophthalmic Diseases: Allergic Corneal Ulcers, Herpes Zoster Ophthalmicus, Anterior segment inflammation, Sympathetic Ophthalmia, Keratitis, Optic Neuritis, Allergic Conjunctivitis, Chorioretinitis, iritis end iridocyclitis.
Respiratory Diseases: Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, Aspiration Pneumonitis.
Hematological Disorders: Idiopathic Thrombocytopenic Purpura in adults, Secondary Thrombocytopenia in adults, Acquired (Autoimmune) Hemolytic Anemia, Erythroblastopenia, Congenital (Erythroid) Hypoplastic Anemia.
Neoplastic Diseases: For palliative management of Leukemias and Lymphomas in adults, Acute leukemia of childhood.
Edematous States: To induce a diuresis or remission of Proteinuria in the Nephrotic Syndrome, without Uremia, of the idiopathic type or that due to Lupus Erythematosus.
Gastrointestinal Disease: To tide the patient over a critical period of the disease in Ulcerative Colitis & Regional Enteritis.
CNS Disease: Acute Exacerbations of Multiple Sclerosis.
Therapeutic classView
Glucocorticoids
PharmacologyView
Pharmacodynamic properties: Methylprednisolone Is a potent anti-inflammatory agent with the capacity to profoundly inhibit the immune system. Glucocorticoids primarily bind to and activate intracellular glucocorticoid receptors that being activated bind to promoter regions of DMA (which may activate or suppress transcription) and activate transcription factors that result in inactivation of genes through deacetylation of histones. Methylprednisolone influences the kidney and fluid & electrolyte balance, lipid,
protein, and carbohydrate metabolism, skeletal muscle, the cardiovascular system, the immune system, the nervous system, and the endocrine system.
Pharmacokinetic properties: The absolute bioavailability of Methylprednisclone is generally high (82% to 89%) following oral administration and rapidly absorbed and the maximum plasma concentration is achieved around 1.5 to 2.3 hours across doses following oral administration in normal healthy adults. Methylprednisolone is widely distributed into the tissues and its volume of distribution is 41-61.5 liter. It crosses the Wood-brain barrier and the placental barrier and is secreted in breast milk. The plasma protein binding of Methylprednisolone in humans is approximately 77%. Methylprednisolone is metabolized in the liver to inactive metabolites. No dosing adjustments are necessary for renal failure. Methylprednisolone is haemodializable.
protein, and carbohydrate metabolism, skeletal muscle, the cardiovascular system, the immune system, the nervous system, and the endocrine system.
Pharmacokinetic properties: The absolute bioavailability of Methylprednisclone is generally high (82% to 89%) following oral administration and rapidly absorbed and the maximum plasma concentration is achieved around 1.5 to 2.3 hours across doses following oral administration in normal healthy adults. Methylprednisolone is widely distributed into the tissues and its volume of distribution is 41-61.5 liter. It crosses the Wood-brain barrier and the placental barrier and is secreted in breast milk. The plasma protein binding of Methylprednisolone in humans is approximately 77%. Methylprednisolone is metabolized in the liver to inactive metabolites. No dosing adjustments are necessary for renal failure. Methylprednisolone is haemodializable.
DosageView
The usual range is 2-48 mg daily in divided doses, depending on the specific disease being treated.
As anti-inflammatory or immunosuppressive initial dosage: As anti-inflammatory or immunosuppressive, the initial dosage of Methylprednisolone tablets may vary from 4-48 mg per day depending on the specific disease entity being treated, in situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory dirtied response, Methylprednisolone should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be Individualized on the basis of the disease under treatment and the response of the patient.
As anti-inflammatory or immunosuppressive maintenance dosage: After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis: In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of Methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.
Methylprednisolone 4 mg tablet can be used to treat and to control severe allergy end dermatitis following the guideline listed below to minimize the steroid withdrawal syndromes:
The following should be kept in mind when considering alternate-day therapy:
As anti-inflammatory or immunosuppressive initial dosage: As anti-inflammatory or immunosuppressive, the initial dosage of Methylprednisolone tablets may vary from 4-48 mg per day depending on the specific disease entity being treated, in situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory dirtied response, Methylprednisolone should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be Individualized on the basis of the disease under treatment and the response of the patient.
As anti-inflammatory or immunosuppressive maintenance dosage: After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis: In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of Methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.
Methylprednisolone 4 mg tablet can be used to treat and to control severe allergy end dermatitis following the guideline listed below to minimize the steroid withdrawal syndromes:
- Day 1: 2 tablets before breakfast + 1 tablet after lunch + 1 tablet after dinner + 2 tablets at bedtime
- Day 2: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet after dinner + 2 tablets at bedtime
- Day 3: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet after dinner + 1 tablet at bedtime
- Day 4: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet at bedtime
- Day 5: 1 tablet before breakfast + 1 tablet at bedtime
- Day 6: 1 tablet before breakfast
The following should be kept in mind when considering alternate-day therapy:
- Basic principles and indications for corticosteroid therapy should be applied.
- Alternate-day therapy is a therapeutic technique primarily designed for pefienis in whom long-term pharmacologic corticoid therapy is anticipated.
- In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate-day therapy. More severe disease state usually will require daily divided high dose therapy for initiai control of the disease process. The initial suppressive dose level should be continued until a satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases.
Side effectsView
Short courses of Methylprednisolone are usually well-tolerated with few, mild side effects. Long term, high doses of Methyiprednisoione may produce predictable and potentially serious side effects. Whenever possible, the lowest effective doses of Methylprednisolone should be used for the shortest length of time to minimize side effects. Alternate day dosing also can help reduce side effects. Side effects of Methylprednisolone and other corticosteroids range from mild annoyances to serious irreversible bodily damage. Side effects include fluid retention, weight gain, high blood pressure, potassium loss, headache, muscle weakness, hair growth on the face, glaucoma, cataracts, peptic ulceration, growth retardation in children, convulsions, and psychic disturbances including depression, euphoria, insomnia etc. Prolonged use of Methylprednisolone can depress the ability of the body's adrenal glands to produce corticosteroids. Abruptly stopping Methylprednisolone in these individuals can cause symptoms of corticosteroid insufficiency, with accompanying nausea, vomiting, and even shock. Therefore, withdrawal of Methylprednisolone usually is accomplished by gradually lowering the dose. Gradually tapering Methylprednisolone not only minimizes the symptoms of corticosteroid insufficiency, it also reduces the risk of an abrupt flare of the disease being treated.
ContraindicationsView
Systemic fungal infections arid known hypersensitivity to components.
PrecautionsView
Adrenocortical insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
InteractionsView
Erythromycin, Clarithromycin, Phenobarbital, Phenytoin, Rifampin and Ketoconazole inhibit the metabolism of Methylprednisolone. Estrogens, including With control pills, can increase the effect of corticosteroids by 50%. Cyclosporin reduces the metabolism of Methylprednisolone. while Methylprednisolone reduces the metabolism of Cyclosporin. Methylprednisolone may increase or decrease the effect of blood thinners (e.g. Warfarin). For all these Interactions, the dose of Methylprednisolone may need to be lowered.
Pregnancy & lactationView
Pregnancy category C. Dregs should be given only if the potential benefit justifies the potential risk te the foetus. Mefhyiprednisofone has not been adequately evaluated in nursing mothers.
Overdose effectsView
Report of acute toxicity and/or death following an overdose of glucocorticoid ere rare. No specific antidote is available; treatment is supportive and symptomatic. Serum electrolytes should be monitored.
StorageView
Store in a cool and dry place, away from light. Keep out of reach of children.
Methipred
Methylprednisolone
Methipred
Methylprednisolone
Indications
Rheumatic disorders
Indication detailsView
Endocrine Disorders: Primary or Secondary Adrenocortical Insufficiency, Congenital Adrenal Hyperplasia, Nonsuppurative Thyroiditis, Hypercalcemia associated with Cancer.
Rheumatic Disorders: Rheumatoid Arthritis. Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis, Acute and Subacute Bursitis, Synovitis of Osteoarthritis, Acute nonspecific Tenosynovitis, Post-traumatic Osteoarthritis, Psoriatic Arthritis, Epicondylitis, Acute Gouty Arthritis.
Collagen Diseases: Systemic lupus Erythematosus, Systemic Dermatomyositis and Acute Rheumatic Carditis.
Dermatologic Diseases: Bullous Dermatitis Herpetiformis, Severe Erythema Multiforme (Stevens-Johnson syndrome), Severe Seborrheic Dermatitis, Exfoliative Dermatitis, Mycosis Fungoides, Pemphigus, Severe Psoriasis.
Allergy: Seasonal or Perennial Allergic Rhinitis, Drug hypersensitivity reactions, Serum Sickness, Contact Dermatitis, Bronchial Asthma and Atopic Dermatitis;
Ophthalmic Diseases: Allergic Corneal Ulcers, Herpes Zoster Ophthalmicus, Anterior segment inflammation, Sympathetic Ophthalmia, Keratitis, Optic Neuritis, Allergic Conjunctivitis, Chorioretinitis, iritis end iridocyclitis.
Respiratory Diseases: Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, Aspiration Pneumonitis.
Hematological Disorders: Idiopathic Thrombocytopenic Purpura in adults, Secondary Thrombocytopenia in adults, Acquired (Autoimmune) Hemolytic Anemia, Erythroblastopenia, Congenital (Erythroid) Hypoplastic Anemia.
Neoplastic Diseases: For palliative management of Leukemias and Lymphomas in adults, Acute leukemia of childhood.
Edematous States: To induce a diuresis or remission of Proteinuria in the Nephrotic Syndrome, without Uremia, of the idiopathic type or that due to Lupus Erythematosus.
Gastrointestinal Disease: To tide the patient over a critical period of the disease in Ulcerative Colitis & Regional Enteritis.
CNS Disease: Acute Exacerbations of Multiple Sclerosis.
Rheumatic Disorders: Rheumatoid Arthritis. Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis, Acute and Subacute Bursitis, Synovitis of Osteoarthritis, Acute nonspecific Tenosynovitis, Post-traumatic Osteoarthritis, Psoriatic Arthritis, Epicondylitis, Acute Gouty Arthritis.
Collagen Diseases: Systemic lupus Erythematosus, Systemic Dermatomyositis and Acute Rheumatic Carditis.
Dermatologic Diseases: Bullous Dermatitis Herpetiformis, Severe Erythema Multiforme (Stevens-Johnson syndrome), Severe Seborrheic Dermatitis, Exfoliative Dermatitis, Mycosis Fungoides, Pemphigus, Severe Psoriasis.
Allergy: Seasonal or Perennial Allergic Rhinitis, Drug hypersensitivity reactions, Serum Sickness, Contact Dermatitis, Bronchial Asthma and Atopic Dermatitis;
Ophthalmic Diseases: Allergic Corneal Ulcers, Herpes Zoster Ophthalmicus, Anterior segment inflammation, Sympathetic Ophthalmia, Keratitis, Optic Neuritis, Allergic Conjunctivitis, Chorioretinitis, iritis end iridocyclitis.
Respiratory Diseases: Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, Aspiration Pneumonitis.
Hematological Disorders: Idiopathic Thrombocytopenic Purpura in adults, Secondary Thrombocytopenia in adults, Acquired (Autoimmune) Hemolytic Anemia, Erythroblastopenia, Congenital (Erythroid) Hypoplastic Anemia.
Neoplastic Diseases: For palliative management of Leukemias and Lymphomas in adults, Acute leukemia of childhood.
Edematous States: To induce a diuresis or remission of Proteinuria in the Nephrotic Syndrome, without Uremia, of the idiopathic type or that due to Lupus Erythematosus.
Gastrointestinal Disease: To tide the patient over a critical period of the disease in Ulcerative Colitis & Regional Enteritis.
CNS Disease: Acute Exacerbations of Multiple Sclerosis.
Therapeutic classView
Glucocorticoids
PharmacologyView
Pharmacodynamic properties: Methylprednisolone Is a potent anti-inflammatory agent with the capacity to profoundly inhibit the immune system. Glucocorticoids primarily bind to and activate intracellular glucocorticoid receptors that being activated bind to promoter regions of DMA (which may activate or suppress transcription) and activate transcription factors that result in inactivation of genes through deacetylation of histones. Methylprednisolone influences the kidney and fluid & electrolyte balance, lipid,
protein, and carbohydrate metabolism, skeletal muscle, the cardiovascular system, the immune system, the nervous system, and the endocrine system.
Pharmacokinetic properties: The absolute bioavailability of Methylprednisclone is generally high (82% to 89%) following oral administration and rapidly absorbed and the maximum plasma concentration is achieved around 1.5 to 2.3 hours across doses following oral administration in normal healthy adults. Methylprednisolone is widely distributed into the tissues and its volume of distribution is 41-61.5 liter. It crosses the Wood-brain barrier and the placental barrier and is secreted in breast milk. The plasma protein binding of Methylprednisolone in humans is approximately 77%. Methylprednisolone is metabolized in the liver to inactive metabolites. No dosing adjustments are necessary for renal failure. Methylprednisolone is haemodializable.
protein, and carbohydrate metabolism, skeletal muscle, the cardiovascular system, the immune system, the nervous system, and the endocrine system.
Pharmacokinetic properties: The absolute bioavailability of Methylprednisclone is generally high (82% to 89%) following oral administration and rapidly absorbed and the maximum plasma concentration is achieved around 1.5 to 2.3 hours across doses following oral administration in normal healthy adults. Methylprednisolone is widely distributed into the tissues and its volume of distribution is 41-61.5 liter. It crosses the Wood-brain barrier and the placental barrier and is secreted in breast milk. The plasma protein binding of Methylprednisolone in humans is approximately 77%. Methylprednisolone is metabolized in the liver to inactive metabolites. No dosing adjustments are necessary for renal failure. Methylprednisolone is haemodializable.
DosageView
The usual range is 2-48 mg daily in divided doses, depending on the specific disease being treated.
As anti-inflammatory or immunosuppressive initial dosage: As anti-inflammatory or immunosuppressive, the initial dosage of Methylprednisolone tablets may vary from 4-48 mg per day depending on the specific disease entity being treated, in situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory dirtied response, Methylprednisolone should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be Individualized on the basis of the disease under treatment and the response of the patient.
As anti-inflammatory or immunosuppressive maintenance dosage: After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis: In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of Methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.
Methylprednisolone 4 mg tablet can be used to treat and to control severe allergy end dermatitis following the guideline listed below to minimize the steroid withdrawal syndromes:
The following should be kept in mind when considering alternate-day therapy:
As anti-inflammatory or immunosuppressive initial dosage: As anti-inflammatory or immunosuppressive, the initial dosage of Methylprednisolone tablets may vary from 4-48 mg per day depending on the specific disease entity being treated, in situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory dirtied response, Methylprednisolone should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be Individualized on the basis of the disease under treatment and the response of the patient.
As anti-inflammatory or immunosuppressive maintenance dosage: After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis: In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of Methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.
Methylprednisolone 4 mg tablet can be used to treat and to control severe allergy end dermatitis following the guideline listed below to minimize the steroid withdrawal syndromes:
- Day 1: 2 tablets before breakfast + 1 tablet after lunch + 1 tablet after dinner + 2 tablets at bedtime
- Day 2: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet after dinner + 2 tablets at bedtime
- Day 3: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet after dinner + 1 tablet at bedtime
- Day 4: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet at bedtime
- Day 5: 1 tablet before breakfast + 1 tablet at bedtime
- Day 6: 1 tablet before breakfast
The following should be kept in mind when considering alternate-day therapy:
- Basic principles and indications for corticosteroid therapy should be applied.
- Alternate-day therapy is a therapeutic technique primarily designed for pefienis in whom long-term pharmacologic corticoid therapy is anticipated.
- In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate-day therapy. More severe disease state usually will require daily divided high dose therapy for initiai control of the disease process. The initial suppressive dose level should be continued until a satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases.
Side effectsView
Short courses of Methylprednisolone are usually well-tolerated with few, mild side effects. Long term, high doses of Methyiprednisoione may produce predictable and potentially serious side effects. Whenever possible, the lowest effective doses of Methylprednisolone should be used for the shortest length of time to minimize side effects. Alternate day dosing also can help reduce side effects. Side effects of Methylprednisolone and other corticosteroids range from mild annoyances to serious irreversible bodily damage. Side effects include fluid retention, weight gain, high blood pressure, potassium loss, headache, muscle weakness, hair growth on the face, glaucoma, cataracts, peptic ulceration, growth retardation in children, convulsions, and psychic disturbances including depression, euphoria, insomnia etc. Prolonged use of Methylprednisolone can depress the ability of the body's adrenal glands to produce corticosteroids. Abruptly stopping Methylprednisolone in these individuals can cause symptoms of corticosteroid insufficiency, with accompanying nausea, vomiting, and even shock. Therefore, withdrawal of Methylprednisolone usually is accomplished by gradually lowering the dose. Gradually tapering Methylprednisolone not only minimizes the symptoms of corticosteroid insufficiency, it also reduces the risk of an abrupt flare of the disease being treated.
ContraindicationsView
Systemic fungal infections arid known hypersensitivity to components.
PrecautionsView
Adrenocortical insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
InteractionsView
Erythromycin, Clarithromycin, Phenobarbital, Phenytoin, Rifampin and Ketoconazole inhibit the metabolism of Methylprednisolone. Estrogens, including With control pills, can increase the effect of corticosteroids by 50%. Cyclosporin reduces the metabolism of Methylprednisolone. while Methylprednisolone reduces the metabolism of Cyclosporin. Methylprednisolone may increase or decrease the effect of blood thinners (e.g. Warfarin). For all these Interactions, the dose of Methylprednisolone may need to be lowered.
Pregnancy & lactationView
Pregnancy category C. Dregs should be given only if the potential benefit justifies the potential risk te the foetus. Mefhyiprednisofone has not been adequately evaluated in nursing mothers.
Overdose effectsView
Report of acute toxicity and/or death following an overdose of glucocorticoid ere rare. No specific antidote is available; treatment is supportive and symptomatic. Serum electrolytes should be monitored.
StorageView
Store in a cool and dry place, away from light. Keep out of reach of children.
Methocid
Indomethacin (Oral)
Methocid
Indomethacin (Oral)
Indications
Rheumatoid arthritis
Indication detailsView
Indomethacin is indicated in-
- Rheumatoid arthritis
- Ankylosing spondylitis
- Osteoarthritis (degenerative joint disease)
- Gout
- Acute non-articular rheumatism (bursitis, synovitis, tendinitis).
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Indomethacin is NSAID having property of antipyretic and analgesic effect. A great number of pharmacological studies have proved that Indomethacin has strong anti-inflammatory, analgesic, and antipyretic properties. Unlike the corticosteriods, the effect of Indomethacin is not related to the pituitary gland or the adrenals. Indomethacin is absorbed promptly following oral administration and peak plasma levels occur within 2 hours. Approximately two thirds of this amount is excreted in the urine and the remainder is excreted in the feces. About 90% of a single dose is excreted in 24-48 hours. In a number of controlled clinical trials, Indomethacin has proved to be of great value in the treatment of rheumatic diseases, It relieves pain, reduces joints swelling edema and improves joint mobility.
DosageView
75 mg sustained-release capsule:
- Rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis (degenerative joint disease): The initial dose is 75 mg sustained-release capsule once daily. If severe then twice daily is required.
- Acute attacks of gout: May control with a dose of 75 mg sustained-release capsule twice daily.
- Acute non-articular rheumatism (bursitis, synovitis, tendinitis): 1-2 sustained-release capsule daily according to the severity of this case.
- Rheumatic diseases: 50-200 mg daily in divided doses
- Acute gout: 150-200 mg daily in divided doses
- Dysmenorrhea: up to 75 mg daily
Side effectsView
Headaches, usually in the morning and kild vertigo may occur during the early weeks of therapy. These symptoms are transient and usually disappear with continued use or by reduction of the dose. Rare case of mild psychic disturbances was also reported which subsided after few days of treatment, Gastrointestinal reactions such as nausea, vomiting, diarrhoea, epigastric and abdominal pain are often due to large doses of the drug and disappear when the dose is reduced. Administration of the capsule immediately after meals with an antacid it necessary, minimize the frequency and the severity of these untoward effects.
ContraindicationsView
Indomethacin is contraindicated in patients with ulcer, gastritis, active ulcerative colitis, and it should be used with caution in patients with a history of these disorders. In these cases, administration of Indomethacin suppositories should be preferred. It is also contraindicated in the previously hypersensitive patients.
PrecautionsView
Indomethacin capsule should be used with caution with psychiatric problems, epilepsy or parkinsonism since the drug may aggravate these conditions. It is not recommended for pregnant women, because at the present time clinical studies are insufficient. Indomethacin is not given nomally in neonates except when used to assist closure of a patent ductus arteriosus.
InteractionsView
It may interact with anticoagulants, Lithium, diuretics, antihypertensive drugs, diflunisal and sulfonylureas.
StorageView
Store in a cool and dry place protected from light. Keep out of the reach of children.
Metholone
Fluorometholone Acetate
Metholone
Fluorometholone Acetate
Indications
Ocular inflammation
Indication detailsView
Fluorometholone Acetate ophthalmic suspension is indicated for the treatment of-
- Acute and chronic non-infectious conjunctivitis and keratitis of allergic origin.
- Non-infectious inflammation of the anterior chamber of the eye (including anterior uveitis, episcleritis and scleritis).
- Post-operative irritative conditions after strabismus, cataract and glaucoma surgery.
Therapeutic classView
Ophthalmic Steroid preparations
PharmacologyView
Fluorometholone is a corticosteroid with an excellent anti-inflammatory action with no significant influence on the intraocular pressure. The anti-inflammatory activity of Fluorometholone is at least 40 times stronger than that of Hydrocortisone. Corticosteroids are thought to act by the introduction of phospholipase A2 inhibitory proteins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandin and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. In comparison with other corticosteroids Fluorometholone is more rapidly degraded in tissue and therefore has less effect on the intraocular pressure. The immunosuppressive action of Fluorometholone is less pronounced than that of Dexamethasone.
DosageView
1 drop instilled into the conjunctival sac 2-4 times daily. During the initial 24 to 48 hours the dosage may be safely increased to 1 drop every hour. Care should be taken not to discontinue therapy prematurely. Shake well before use.
Side effectsView
Glaucoma with optic nerve damage, visual acuity or field defects, cataract formation, secondary ocular infection following suppression of host immunity, perforation of the globe.
ContraindicationsView
- Hypersensitivity to any ingredient of the formulation.
- Infectious conjunctivitis or keratitis.
- Injuries and ulcerous processes of cornea, especially infections caused by virus, bacteria and fungi.
- Dry eyes, especially keratoconjunctivitis sicca.
- Glaucoma.
PrecautionsView
Shake well before using. If this product is used for 10 days or longer, intraocular pressure should be monitored.
InteractionsView
Specific drug interaction studies have not been conducted with Fluorometholone ophthalmic suspension.
Pregnancy & lactationView
Safety of the use of topical steroids during pregnancy and lactation has not been established. Fluorometholone ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
StorageView
Store in a cool, dry place and protected from light. Keep out of the reach of children. Discard the container 4 weeks after opening.
Methotrax
Methotrexate
Methotrax
Methotrexate
Indications
Vasculitis
Indication detailsView
Neoplastic Diseases: Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. Methotrexate is used in maintenance therapy in combination with other chemotherapeutic agents. Methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous T cell lymphoma), and lung cancer, particularly squamous cell and small cell types. Methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-Hodgkin's lymphomas.
Psoriasis: Methotrexate is indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation. It is important to ensure that a psoriasis “flare” is not due to an undiagnosed concomitant disease affecting immune responses.
Rheumatoid Arthritis Including Polyarticular-Course Juvenile Rheumatoid Arthritis: Methotrexate is indicated in the management of selected adults with severe, active, rheumatoid arthritis (ACR criteria), or children with active polyarticular course juvenile rheumatoid arthritis, who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).
Aspirin, NSAIDs, and/or low dose steroids may be continued, although the possibility of increased toxicity with concomitant use of NSAIDs including salicylates has not been fully explored. Steroids may be reduced gradually in patients who respond to methotrexate. Combined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine, or cytotoxic agents, has not been studied and may increase the incidence of adverse effects. Rest and physiotherapy as indicated should be continued.
Psoriasis: Methotrexate is indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation. It is important to ensure that a psoriasis “flare” is not due to an undiagnosed concomitant disease affecting immune responses.
Rheumatoid Arthritis Including Polyarticular-Course Juvenile Rheumatoid Arthritis: Methotrexate is indicated in the management of selected adults with severe, active, rheumatoid arthritis (ACR criteria), or children with active polyarticular course juvenile rheumatoid arthritis, who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).
Aspirin, NSAIDs, and/or low dose steroids may be continued, although the possibility of increased toxicity with concomitant use of NSAIDs including salicylates has not been fully explored. Steroids may be reduced gradually in patients who respond to methotrexate. Combined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine, or cytotoxic agents, has not been studied and may increase the incidence of adverse effects. Rest and physiotherapy as indicated should be continued.
Therapeutic classView
Antidote preparations, Immunosuppressant
PharmacologyView
Methotrexate inhibits dihydrofolic acid reductase. Dihydrofolates must be reduced to tetrahydrofolates by this enzyme before they can be utilized as carriers of one-carbon groups in the synthesis of p.r.n. nucleotides and thymidylate. Therefore, methotrexate interferes with DNA synthesis, repair, and cellular replication. Actively proliferating tissues such as malignant cells, bone marrow, fetal cells, buccal and intestinal mucosa, and cells of the urinary bladder are in general more sensitive to this effect of methotrexate. When cellular proliferation in malignant tissues is greater than in most normal tissues, methotrexate may impair malignant growth without irreversible damage to normal tissues
DosageView
Oral-
- Choriocarcinoma: 15-30 mg daily for 5 days, repeat after an interval of ≥1 wk for 3-5 courses.
- Acute lymphoblastic leukaemia: Maintenance: 15 mg/m2 once or twice wkly, with other agents.
- Burkitt's lymphoma: 10-25 mg daily for 4-8 days, repeated after 7-10 days.
- Psoriasis: 10-25 mg wkly as a single dose, adjust subsequent doses based on response.
- Rheumatoid arthritis: 7.5 mg once wkly, adjust by response. Not more than 20 mg/wk.
- Mycosis fungoides: 2.5-10 mg daily to induce remission.
- Crohn's disease: 12.5-22.5 mg once wkly for up to 1 yr.
- Psoriasis: 10-25 mg wkly as a single dose. Adjust subsequent doses based on response. May be given via IV/IM admin.
- Choriocarcinoma: 15-30 mg daily for 5 days. Repeat after at least 1 wk for 3-5 courses. Alternatively, 0.25-1 mg/kg (max: 60 mg) every 48 hr for 4 doses followed by folinic acid rescue, repeat at intervals of 7 days for 4 or more courses.
- Mycosis fungoides: 50 mg wkly as a single dose or 2 divided doses.
- Acute lymphoblastic leukaemia: Maintenance: 15 mg/m2 once or twice wkly, with other agents.
- Crohn's disease: 25 mg once wkly for 16 wk. Maintenance: 15 mg wkly.
- Meningeal leukaemia: 12 mg/m2 (max 15 mg) once wkly for 2-3 wk, then once mthly. Alternatively, 200-500 mcg/kg every 2-5 day until CSF cell count is normalised.
- Osteosarcoma: Initial recommended dose: 12 g/m2 as a 4-hr infusion, followed by folinic acid, as part of combined therapy. May increase dose to 15 g/m2 in subsequent treatments if initial dosage is insufficient to achieve peak serum methotrexate levels of 454 mcg/mL at the end of the infusion. Methotrexate infusion is administered on postoperative wk 4, 5, 6, 7, 11, 12, 15, 16, 29, 30, 44 and 45; in combination with other chemotherapy agents. Folinic acid can be given orally, IM or IV inj starting 24 hr after the beginning of the methotrexate infusion. Give via parenteral routes If patient experiences GI toxicity (e.g., nausea, vomiting). Usual dosage of folinic acid: 15 mg every 6 hr for a total of 60 hr or a total of 10 doses.
- Breast cancer: 10-60 mg/m2 often with cyclophosphamide and fluorouracil.
- Advanced lymphosarcoma: Up to 30 mg/kg, followed by folinic acid rescue.
- Acute lymphoblastic leukaemia: Maintenance: 2.5 mg/kg every 14 days.
AdministrationView
Should be taken on an empty stomach. Best taken on an empty stomach. May be taken with meals to reduce GI discomfort. Avoid taking with milk-rich products.
Side effectsView
Ulceration of the mouth and GI disturbances (e.g. stomatitis and diarrhoea), bone marrow depression, hepatotoxicity, renal failure, skin reactions, alopecia, ocular irritation, arachnoiditis in intrathecal use, megaloblastic anaemia, osteoporosis, precipitation of diabetes, arthralgias, necrosis of soft tissue and bone, anaphylaxis, impaired fertility.
ContraindicationsView
Severe renal or hepatic impairment, pre-existing profound bone marrow suppression in patients with psoriasis or rheumatoid arthritis, alcoholic liver disease, AIDS, pre-existing blood dyscrasias, pregnancy (in patients with psoriasis or rheumatoid arthritis), breast-feeding.
PrecautionsView
Hepatic or renal impairment, bone marrow depression, elderly, neonates. Ulcerative disorders of the GI tract. Monitor haematological, renal and hepatic function, and GI toxicity regularly.
InteractionsView
Decreased effectiveness with folic acid and its derivatives.
Pregnancy & lactationView
Pregnancy category X. Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
Overdose effectsView
Nausea, vomiting, alopecia, melena, and renal failure.
ReconstitutionView
Intramuscular: Dilute powder with D5W or normal saline to a concentration ≤25 mg/ml (20 mg and 50 mg vials) and 50 mg/ml (1 g vial).
Intrathecal: Reconstitute to 2.5-5 mg/ml with normal saline, D5W, lactated Ringer's, or Elliott's B solution. Use preservative-free preparations.
Intravenous: Dilute powder with D5W or normal saline to a concentration ≤25 mg/ml (20 mg and 50 mg vials) and 50 mg/ml (1 g vial).
Parenteral: Dilute powder with D5W or normal saline to a concentration ≤25 mg/ml (20 mg and 50 mg vials) and 50 mg/ml (1 g vial).
Intrathecal: Reconstitute to 2.5-5 mg/ml with normal saline, D5W, lactated Ringer's, or Elliott's B solution. Use preservative-free preparations.
Intravenous: Dilute powder with D5W or normal saline to a concentration ≤25 mg/ml (20 mg and 50 mg vials) and 50 mg/ml (1 g vial).
Parenteral: Dilute powder with D5W or normal saline to a concentration ≤25 mg/ml (20 mg and 50 mg vials) and 50 mg/ml (1 g vial).
StorageView
Store at room temperature (15-25°C).