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Inospiron
Spironolactone
Inospiron
Spironolactone
Indications
Severe congestive heart failure
Indication detailsView
Spironolactone is indicated in Congestive heart failure, Hepatic cirrhosis with ascites and oedema, Nephrotic syndrome, Primary hyperaldosteronism, Essential hypertension, For the treatment of patients with hypokalemia
Therapeutic classView
Potassium-sparing diuretics, Potassium-sparing diuretics & Aldosterone antagonists
PharmacologyView
Spironolactone is a specific pharmacologic antagonist of aldosterone, acting primarily through competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tubule. Spironolactone causes increased amounts of sodium and water to be excreted, while potassium is retained. Spironolactone acts both as a diuretic and as an antihypertensive drug by this mechanism. It may be given alone or with other diuretic agents which act more proximally in the renal tubule. Aldosterone interacts with a cytoplasmic mineralocorticoid receptor to enhance the expression of the Na+ K+ ATPase and the Na+ channel involved in a Na+ K+ transport in the distal tubule . Spironolactone bind to this mineralcorticoid receptor, blocking the actions of aldosterone on gene expression. Aldosterone is a hormone; its primary function is to retain sodium and excrete potassium in the kidneys.
DosageView
Edema in adults (congestive heart failure, hepatic cirrhosis, or nephrotic syndrome): An initial daily dosage of 100 mg of Spironolactone administered in either single or divided doses is recommended, but may range from 25 to 200 mg daily. Combined therapy with other diuretics is indicated when more rapid diuresis is desired.
Primary hyperaldosteronism: After the diagnosis of hyperaldosteronism has been established, Spironolactone may be administered in doses of 100 to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, Spironolactone may be employed for long-term maintenance therapy at the lowest effective dosage determined for the individual patient.
Essential hypertension: For adults, an initial daily dosage of 50 to 100 mg of Spironolactone administered in either single or divided doses is recommended.
Hypokalemia: Spironolactone in a dosage ranging from 25 mg to 100 mg daily is useful in treating a diuretic-induced hypokalemia.
Primary hyperaldosteronism: After the diagnosis of hyperaldosteronism has been established, Spironolactone may be administered in doses of 100 to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, Spironolactone may be employed for long-term maintenance therapy at the lowest effective dosage determined for the individual patient.
Essential hypertension: For adults, an initial daily dosage of 50 to 100 mg of Spironolactone administered in either single or divided doses is recommended.
Hypokalemia: Spironolactone in a dosage ranging from 25 mg to 100 mg daily is useful in treating a diuretic-induced hypokalemia.
Side effectsView
Gynaecomastia may develop in association with the use of Spironolactone. Other adverse reactions are: GI symptoms including cramping and diarrhoea, drowsiness, lethargy, headache, urticaria, mental confusion, impotence, irregular menses or amenorrhoea and post-menopausal bleeding.
ContraindicationsView
Spironolactone is contraindicated in patients with acute renal insufficiency, significant impairment of renal function, anuria, hyperkalaemia or sensitivity to Spironolactone.
PrecautionsView
All patients receiving diuretic therapy should be observed for evidence of fluid or electrolyte imbalance. Hyperkalemia may occur in patients with impaired renal function or excessive potassium intake and can cause cardiac irregularities, which may be fatal.
InteractionsView
ACE inhibitors: Concomitant administration of ACE inhibitors with potassium-sparing diuretics has been associated with severe hyperkalemia.
Alcohol, barbiturates, or narcotics: Potentiation of orthostatic hypotension may occur.
Corticosteroids, ACTH: Intensified electrolyte depletion, particularly hypokalemia, may occur.
Lithium: Lithium generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity.
Digoxin: Spironolactone has been shown to increase the half-life of digoxin.
Alcohol, barbiturates, or narcotics: Potentiation of orthostatic hypotension may occur.
Corticosteroids, ACTH: Intensified electrolyte depletion, particularly hypokalemia, may occur.
Lithium: Lithium generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity.
Digoxin: Spironolactone has been shown to increase the half-life of digoxin.
Pregnancy & lactationView
Pregnancy: Spironolactone should not be used during pregnancy
Lactation: Canrenone, an active metabolite of Spironolactone, appears in breast milk. If use of the drug is deemed essential an alternative method of infant feeding should be instituted.
Lactation: Canrenone, an active metabolite of Spironolactone, appears in breast milk. If use of the drug is deemed essential an alternative method of infant feeding should be instituted.
Overdose effectsView
Symptoms of overdosage include drowsiness, mental confusion, dizziness, diarrhea and vomiting etc. Patients should induce vomiting or evacuate the stomach by lavage during Spironolactone overdoasge.
StorageView
Store in a cool and dry place protected from light. Keep out of reach of children.
Inoten
Tenoxicam
Inoten
Tenoxicam
Indications
Pain and inflammation associated with musculoskeletal and joint disorders
Indication detailsView
Tenoxicam is indicated for the symptomatic treatment of the following painful inflammatory and degenerative disorders of the musculoskeletal system:
- Rheumatoid arthritis.
- Osteoarthritis.
- Arthrosis.
- Ankylosing spondylitis.
- Extra-articular disorders, e.g. tendinitis, bursitis, periarthritis of the shoulders (shoulder-hand syndrome) or hips, strains, and sprains.
- Acute gout.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Tenoxicam is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic properties and it also inhibits platelet aggregation. Tenoxicam inhibits prostaglandin biosynthesis. In-vitro tests of leukocyte peroxidase suggest that tenoxicam may act as a scavenger for active oxygen at the site of inflammation. Tenoxicam is a potent in-vitro inhibitor of human metalloproteinases (stromelysin and collagenase), which induce cartilage breakdown. These pharmacological effects explain, at least in part, the therapeutic benefit of Tenoxicam in the treatment of painful inflammatory and degenerative disorders of the musculoskeletal system. Tenoxicam showed no mutagenic, carcinogenic or teratogenic effects in animals. As with other prostaglandin inhibitors, renal and gastrointestinal effects, increased incidence of dystocia and delayed parturition were observed in animal safety studies.
DosageView
Standard dosage: For all indications except acute gout, a daily dosage of 20 mg should be given at the same time of day.
In acute attacks of gout: The recommended dose for acute attacks of gout is 40 mg once daily for two days followed by 20 mg once daily for a further five days.
In the treatment of chronic disorders: The therapeutic effect of tenoxicam is evident early in treatment but there is a progressive increase in response over time. In chronic disorders, daily doses higher than 20 mg should be avoided since this would increase the frequency and intensity of unwanted reactions without significantly increasing efficacy. For patients needing long-term treatment, a reduction to a daily oral dose of 10 mg may be tried for maintenance.
Special dosage instructions: In principle, the above dosage recommendations also apply to elderly patients and to patients suffering from kidney or liver disease. Because of lack of clinical experience, no dosage recommendations have so far been established for children and adolescents.
In acute attacks of gout: The recommended dose for acute attacks of gout is 40 mg once daily for two days followed by 20 mg once daily for a further five days.
In the treatment of chronic disorders: The therapeutic effect of tenoxicam is evident early in treatment but there is a progressive increase in response over time. In chronic disorders, daily doses higher than 20 mg should be avoided since this would increase the frequency and intensity of unwanted reactions without significantly increasing efficacy. For patients needing long-term treatment, a reduction to a daily oral dose of 10 mg may be tried for maintenance.
Special dosage instructions: In principle, the above dosage recommendations also apply to elderly patients and to patients suffering from kidney or liver disease. Because of lack of clinical experience, no dosage recommendations have so far been established for children and adolescents.
AdministrationView
The tablets should be taken with a glass of water. It is preferable to take this medicine during or immediately after a meal.
Side effectsView
Based on clinical trials including large numbers of patients, Tenoxicam proved to be well tolerated in the recommended dose. Usually, the undesirable effects reported were mild and transient. In a small proportion of patients, the interruption of treatment due to undesirable effects was necessary. Local tolerance of Tenoxicam given parenterally was good. The following undesirable effects have been reported:
Frequency is greater than 1%-
Frequency is greater than 1%-
- Gastrointestinal tract: gastric, epigastric and abdominal discomfort, dyspepsia, heartburn, nausea.
- Central nervous system: dizziness, headache.
- Gastrointestinal tract: constipation, diarrhea, stomatitis, gastritis, vomiting, ulcers, Gl-bleeding including hematemesis and melena.
- Central nervous system: fatigue, sleep disturbances, appetite loss, dry mouth, vertigo.
- Skin: itching (also in the anal region after rectal administration), erythema, exanthema, rash, urticaria.
- Urinary tract and kidneys: increase in BUN or creatinine, edema.
- Liver and biliary tract: increased liver enzyme activity.
- Cardiovascular system: palpitations.
- Gastrointestinal tract: Gl-perforation.
- Central nervous system: visual disturbances.
- Skin: Stevens-Johnson and Lyell's syndrome, photosensitivity reaction, vasculitis.
- Blood: anemia, agranulocytosis, leukopenia, thrombocytopenia.
- Hypersensitivity reactions: dyspnea, asthma, anaphylaxis, angioedema.
- Cardiovascular system: elevated blood pressure, mainly in patients treated with cardiovascular drugs.
- Liver/Biliary tract: hepatitis.
ContraindicationsView
Tenoxicam must not be administered to patients:
- known to be hypersensitive to the drug;
- in whom salicylates or other non-steroidal anti-inflammatory drugs (NSAIDs) induce symptoms of asthma, rhinitis, or urticaria;
- suffering or having suffered from the disease of the upper gastrointestinal tract, such as gastritis, gastric and duodenal ulcer.
PrecautionsView
NSAIDs inhibit renal prostaglandin synthesis and consequently may have an undesirable effect on renal hemodynamics and on salt and water balance. It is necessary to adequately monitor the patient with a special emphasis on cardiac and renal function (BUN, creatinine, development of edema, weight gain, etc.) when giving Tenoxicam to patients with conditions that could increase their risk of developing renal failure, such as pre-existing renal disease, impaired renal function in diabetics, hepatic cirrhosis, congestive heart failure, volume depletion or concomitant treatment with potentially nephrotoxic drugs, diuretics and corticosteroids. Tenoxicam inhibits platelet aggregation and may affect hemostasis. Tenoxicam has no significant influence on blood coagulation factors, coagulation time, prothrombin time or activated thromboplastin time. Patients having coagulation disorders or receiving drug therapy that interferes with hemostasis should, however, be carefully observed when Tenoxicam is administered. Any patient being treated with Tenoxicam who presents with symptoms of gastrointestinal disease should be closely monitored. If peptic ulceration or gastrointestinal bleeding occurs, Tenoxicam should be immediately withdrawn. If severe skin reactions (e.g. Lyell's or Stevens-Johnson syndrome) occur, the treatment should be discontinued immediately. Adverse eye findings have been reported with Tenoxicam. Thus ophthalmic evaluation is recommended for patients who develop visual disturbances. Because of the high plasma protein binding of tenoxicam, caution is required when plasma albumin levels are markedly reduced. In common with anti-inflammatory drugs, Tenoxicam may mask the usual signs of infection. Tenoxicam Tablets should not be given to patients who either dislike or do not tolerate milk products.
InteractionsView
As in the case of other NSAIDs, salicylate displaces tenoxicam from protein-binding sites and increases clearance and volume of distribution of tenoxicam. Concurrent treatment with salicylate or other NSAIDs should be avoided because of increased risk of gastrointestinal undesirable reactions. The co-administration of some NSAIDs and methotrexate has been associated with reduced renal tubular secretion of methotrexate, higher plasma concentrations of methotrexate, and severe methotrexate toxicity. Therefore, caution should be exercised when Tenoxicam is administered concurrently with methotrexate. No clinically relevant interaction was found in the small number of patients receiving concomitant treatment with gold, penicillamine or probenecid. As Tenoxicam may decrease the renal clearance of lithium, their concomitant administration may lead to increased plasma levels and toxicity of lithium. The plasma levels of lithium should be closely monitored. As with NSAIDs in general, Tenoxicam should not be administered concurrently with K-sparing diuretics. There is a known interaction between these two classes of compounds, which may cause hyperkalemia and renal failure. No clinically significant interaction between Tenoxicam and furosemide was noted, but Tenoxicam attenuates the blood pressure-lowering effect of hydrochlorothiazide. As known from other NSAIDs, Tenoxicam might attenuate the antihypertensive effects of alpha-adrenergic blockers and ACE-inhibitors. No interactions have been reported between NSAIDs and centrally-acting alpha agonists or calcium channel blockers. There was no clinically relevant interaction when Tenoxicam was administered together with atenolol. During clinical trials no interaction was reported for patients treated concomitantly with digitalis products. Thus concurrent dosing of Tenoxicam and digoxin appears to be without major risk. No interaction has been found with concomitantly administered antacids, cimetidine, warfarin and phenprocoumon at the recommended dosages. The clinical effect of oral antidiabetic drugs (glibornuride, glibenclamide, tolbutamide) was likewise not modified by Tenoxicam. Nevertheless, careful monitoring is recommended when patients concomitantly receive anticoagulants or oral antidiabetic drugs. No clinically relevant interaction has been found between Tenoxicam and low molecular weight heparin.
Pregnancy & lactationView
NSAIDs have an inhibitory effect on prostaglandin synthesis and, when given during late pregnancy, may cause the closure of the fetal ductus arteriosus, prolong labor and delay parturition. Treatment during the third trimester of pregnancy should be avoided. Based on findings from single-dose administration, a very small amount (approximately 0.2%) of tenoxicam passes into breast milk. There is no evidence of adverse reactions in breast-fed infants of mothers taking Tenoxicam. Nevertheless, infants should be weaned or the drug discontinued.
Pediatric usageView
Use in Children & adolescent: Tenoxicam is not recommended for use in patients under 16 years of age, as the dose and indications in this population have not been established.
Effects on ability to drive and use machines: Patients experiencing adverse events that might affect driving or using machines, such as vertigo, dizziness or visual disturbances should refrain from driving a car or using machines.
Effects on ability to drive and use machines: Patients experiencing adverse events that might affect driving or using machines, such as vertigo, dizziness or visual disturbances should refrain from driving a car or using machines.
Overdose effectsView
Although there is no experience of acute overdosage with Tenoxicam, it may be expected that the signs and symptoms mentioned under Undesirable effects would be more pronounced. Overdose should be countered by conventional measures to reduce absorption (e.g. gastrolavage and charcoal) and speed up elimination (e.g. cholestyramine).
StorageView
Do not store above 30°C, protect from light & moisture. Keep out of the reach of children.
Inovit E
Vitamin E [Alpha Tocopherol Acetate]
Inovit E
Vitamin E [Alpha Tocopherol Acetate]
Indications
Vitamin E deficiency and peripheral neuropathy
Indication detailsView
As dietary supplement:
- Vitamin E deficiency resulting from impaired absorption
- Increased requirements due to diet rich in polyunsaturated fats
- For healthy hair & skin
- As an antioxidant
- Hemolytic anemia due to Vitamin E deficiency
- Cardiovascular disease
- Heavy metal poisoning
- Hepatotoxin poisoning
- Hemolytic anemia
- Oxygen therapy
- In nutritional deficiency states.
Therapeutic classView
Herbal and Nutraceuticals, Vitamin-E Preparations
PharmacologyView
Vitamin E acts as an antioxidant in the body. Vitamin E protects polyunsaturated fatty acids (which are components of cellular membrane) and other oxygen-sensitive substances such as vitamin A & vitamin C from oxidation. In premature neonates irritability, edema, thrombosis and hemolytic anemia may be caused due to vitamin E deficiency. Creatinuria, ceroid deposition, muscle weakness, decreased erythrocyte survival or increased in vitro hemolysis by oxidizing agents have been identified in adults and children with low serum tocopherol concentrations.
DosageView
Betterment of cardiovascular health: 400 IU-800 IU per day
Deficiency syndrome in adults: 200 IU-400 IU per day
Deficiency syndrome in children: 200 IU per day
Thalassemia: 800 IU per day
Sickle-cell anemia: 400 IU per day
Betterment of skin & hair: 200 IU-400 IU per day (Topical use is also established for beautification)
Chronic cold in adults: 200 IU per day
Deficiency syndrome in adults: 200 IU-400 IU per day
Deficiency syndrome in children: 200 IU per day
Thalassemia: 800 IU per day
Sickle-cell anemia: 400 IU per day
Betterment of skin & hair: 200 IU-400 IU per day (Topical use is also established for beautification)
Chronic cold in adults: 200 IU per day
Side effectsView
Overdosage (>1 gm) have been associated with minor side effects, including hypertension, fatigue, diarrhea and myopathy.
ContraindicationsView
No known contraindications found.
PrecautionsView
It may increase the risk of thrombosis in some patients, such as those taking estrogens.
InteractionsView
Vitamin E may impair the absorption of Vitamin A & function of Vitamin K and potentiates the effect of Warfarin.
Pregnancy & lactationView
Vitamin E is safe in pregnancy and lactation, when used as recommended doses. Higher doses are not established.
Pediatric usageView
Vitamin E is safe for children.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Inovit E
Vitamin E [Alpha Tocopherol Acetate]
Inovit E
Vitamin E [Alpha Tocopherol Acetate]
Indications
Vitamin E deficiency and peripheral neuropathy
Indication detailsView
As dietary supplement:
- Vitamin E deficiency resulting from impaired absorption
- Increased requirements due to diet rich in polyunsaturated fats
- For healthy hair & skin
- As an antioxidant
- Hemolytic anemia due to Vitamin E deficiency
- Cardiovascular disease
- Heavy metal poisoning
- Hepatotoxin poisoning
- Hemolytic anemia
- Oxygen therapy
- In nutritional deficiency states.
Therapeutic classView
Herbal and Nutraceuticals, Vitamin-E Preparations
PharmacologyView
Vitamin E acts as an antioxidant in the body. Vitamin E protects polyunsaturated fatty acids (which are components of cellular membrane) and other oxygen-sensitive substances such as vitamin A & vitamin C from oxidation. In premature neonates irritability, edema, thrombosis and hemolytic anemia may be caused due to vitamin E deficiency. Creatinuria, ceroid deposition, muscle weakness, decreased erythrocyte survival or increased in vitro hemolysis by oxidizing agents have been identified in adults and children with low serum tocopherol concentrations.
DosageView
Betterment of cardiovascular health: 400 IU-800 IU per day
Deficiency syndrome in adults: 200 IU-400 IU per day
Deficiency syndrome in children: 200 IU per day
Thalassemia: 800 IU per day
Sickle-cell anemia: 400 IU per day
Betterment of skin & hair: 200 IU-400 IU per day (Topical use is also established for beautification)
Chronic cold in adults: 200 IU per day
Deficiency syndrome in adults: 200 IU-400 IU per day
Deficiency syndrome in children: 200 IU per day
Thalassemia: 800 IU per day
Sickle-cell anemia: 400 IU per day
Betterment of skin & hair: 200 IU-400 IU per day (Topical use is also established for beautification)
Chronic cold in adults: 200 IU per day
Side effectsView
Overdosage (>1 gm) have been associated with minor side effects, including hypertension, fatigue, diarrhea and myopathy.
ContraindicationsView
No known contraindications found.
PrecautionsView
It may increase the risk of thrombosis in some patients, such as those taking estrogens.
InteractionsView
Vitamin E may impair the absorption of Vitamin A & function of Vitamin K and potentiates the effect of Warfarin.
Pregnancy & lactationView
Vitamin E is safe in pregnancy and lactation, when used as recommended doses. Higher doses are not established.
Pediatric usageView
Vitamin E is safe for children.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Inoxon
Ceftriaxone Sodium
Inoxon
Ceftriaxone Sodium
Indications
Urinary tract infection
Indication detailsView
Ceftriaxone is indicated for the treatment of the following major infections:
- Lower respiratory tract infections
- Acute Bacterial Otitis Media
- Skin and skin structure infections
- Urinary tract infections
- Gonorrhea
- Bacterial Septicemia
- Bone and joint infections
- Meningitis
- Prevention of postoperative infections
- Perioperative prophylaxis of infections associated with surgery
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).
DosageView
Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
- Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
- Uncomplicated gonococcal infections: 250 mg IM as a single dose
- Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery
- Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
- Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
- Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day
AdministrationView
Preparation of Solutions for Intramuscular / Intravenous Injections:
- For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
- For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.
Side effectsView
Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.
ContraindicationsView
Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.
PrecautionsView
As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.
InteractionsView
No drug interactions have been reported.
Pregnancy & lactationView
Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.
Pediatric usageView
Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).
Overdose effectsView
There is no specific antidote. Treatment of overdosage should be symptomatic.
StorageView
Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.
Inoxon
Ceftriaxone Sodium
Inoxon
Ceftriaxone Sodium
Indications
Urinary tract infection
Indication detailsView
Ceftriaxone is indicated for the treatment of the following major infections:
- Lower respiratory tract infections
- Acute Bacterial Otitis Media
- Skin and skin structure infections
- Urinary tract infections
- Gonorrhea
- Bacterial Septicemia
- Bone and joint infections
- Meningitis
- Prevention of postoperative infections
- Perioperative prophylaxis of infections associated with surgery
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).
DosageView
Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
- Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
- Uncomplicated gonococcal infections: 250 mg IM as a single dose
- Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery
- Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
- Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
- Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day
AdministrationView
Preparation of Solutions for Intramuscular / Intravenous Injections:
- For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
- For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.
Side effectsView
Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.
ContraindicationsView
Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.
PrecautionsView
As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.
InteractionsView
No drug interactions have been reported.
Pregnancy & lactationView
Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.
Pediatric usageView
Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).
Overdose effectsView
There is no specific antidote. Treatment of overdosage should be symptomatic.
StorageView
Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.
Inoxon
Ceftriaxone Sodium
Inoxon
Ceftriaxone Sodium
Indications
Urinary tract infection
Indication detailsView
Ceftriaxone is indicated for the treatment of the following major infections:
- Lower respiratory tract infections
- Acute Bacterial Otitis Media
- Skin and skin structure infections
- Urinary tract infections
- Gonorrhea
- Bacterial Septicemia
- Bone and joint infections
- Meningitis
- Prevention of postoperative infections
- Perioperative prophylaxis of infections associated with surgery
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).
DosageView
Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
- Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
- Uncomplicated gonococcal infections: 250 mg IM as a single dose
- Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery
- Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
- Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
- Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day
AdministrationView
Preparation of Solutions for Intramuscular / Intravenous Injections:
- For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
- For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.
Side effectsView
Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.
ContraindicationsView
Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.
PrecautionsView
As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.
InteractionsView
No drug interactions have been reported.
Pregnancy & lactationView
Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.
Pediatric usageView
Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).
Overdose effectsView
There is no specific antidote. Treatment of overdosage should be symptomatic.
StorageView
Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.
Inoxon
Ceftriaxone Sodium
Inoxon
Ceftriaxone Sodium
Indications
Urinary tract infection
Indication detailsView
Ceftriaxone is indicated for the treatment of the following major infections:
- Lower respiratory tract infections
- Acute Bacterial Otitis Media
- Skin and skin structure infections
- Urinary tract infections
- Gonorrhea
- Bacterial Septicemia
- Bone and joint infections
- Meningitis
- Prevention of postoperative infections
- Perioperative prophylaxis of infections associated with surgery
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).
DosageView
Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
- Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
- Uncomplicated gonococcal infections: 250 mg IM as a single dose
- Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery
- Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
- Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
- Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day
AdministrationView
Preparation of Solutions for Intramuscular / Intravenous Injections:
- For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
- For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.
Side effectsView
Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.
ContraindicationsView
Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.
PrecautionsView
As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.
InteractionsView
No drug interactions have been reported.
Pregnancy & lactationView
Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.
Pediatric usageView
Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).
Overdose effectsView
There is no specific antidote. Treatment of overdosage should be symptomatic.
StorageView
Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.
Inoxon
Ceftriaxone Sodium
Inoxon
Ceftriaxone Sodium
Indications
Urinary tract infection
Indication detailsView
Ceftriaxone is indicated for the treatment of the following major infections:
- Lower respiratory tract infections
- Acute Bacterial Otitis Media
- Skin and skin structure infections
- Urinary tract infections
- Gonorrhea
- Bacterial Septicemia
- Bone and joint infections
- Meningitis
- Prevention of postoperative infections
- Perioperative prophylaxis of infections associated with surgery
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).
DosageView
Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
- Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
- Uncomplicated gonococcal infections: 250 mg IM as a single dose
- Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery
- Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
- Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
- Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day
AdministrationView
Preparation of Solutions for Intramuscular / Intravenous Injections:
- For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
- For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.
Side effectsView
Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.
ContraindicationsView
Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.
PrecautionsView
As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.
InteractionsView
No drug interactions have been reported.
Pregnancy & lactationView
Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.
Pediatric usageView
Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).
Overdose effectsView
There is no specific antidote. Treatment of overdosage should be symptomatic.
StorageView
Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.
Inpen
Meropenem Trihydrate
Inpen
Meropenem Trihydrate
Indications
Uncomplicated pneumococcal pneumonia
Indication detailsView
Meropenem is indicated for treatment in adults and children for the following infections caused by single or multiple bacteria sensitive to Meropenem.
- Pneumonia and Nosocomial Pneumonia
- Urinary Tract Infections
- Intra-abdominal Infections
- Gynaecological Infections, such as endometritis and pelvic inflammatory disease
- Skin and Skin Structure Infections
- Meningitis
- Septicaemia
- Pulmonary infections in cystic fibrosis
- Empiric treatment for presumed infections in patients with febrile neutropenia.
Therapeutic classView
Other beta-lactam Antibiotics
PharmacologyView
Meropenem is a carbapenem antibiotic for parenteral use . It exerts its bactericidal action by interfering with bacterial cell wall synthesis. It penetrates bacterial cell walls, its high level of stability to all serine beta-lactamases and its marked affinity for the Penicillin Binding Proteins (PBPs.). It shows potent bactericidal activity against a broad spectrum of Gram-positive and Gram-negative, aerobic and anaerobic bacteria.
DosageView
The dosage and duration of therapy shall be established depending on type, severity of infection and the condition of the patient. The recommended daily dosage is as follows-
Adults:
Adults:
- The usual dose is 500 mg to 1 gm by intravenous administration every 8 hours.
- Pneumonia, urinary tract infections, gynaecological infections such as endometritis, pelvic inflammatory disease, skin and skin structure infections: 500 mg IV every 8 hours.
- Nosocomial pneumonias, peritonitis, presumed infections in neutropenic patients and septicaemia: 1 g IV every 8 hours.
- Intra-abdominal infections: 500 mg to 1 gm every 8 hours.
- Cystic fibrosis: Upto 2 gm every 8 hours.
- Meningitis: 2 gm IV every 8 hours.
- 3 months to 12 years: 10 to 40 mg/kg intravenously every 8 hours depending on type and severity of infection, susceptibility of the pathogens and the condition of the patient.
- Intra-abdominal infections: 20 mg/kg every 8 hours.
- Cystic fibrosis (4-18 years): 25-40 mg/kg every 8 hours.
- Meningitis: 40 mg/kg IV every 8 hours.
- Febrile neutropenia: 20 mg/kg every 8 hours.
- Children over 50 kg weight: use adult dosage.
- There is no experience in children with hepatic or renal impairment.
AdministrationView
Meropenem should be administered by intravenous Infusion over approximately 15-30 minutes or as intravenous bolus (5 to 20 ml) over approximately 3-5 minutes
Side effectsView
Meropenem is generally well tolerated. Side effects like inflammation, thrombophlebitis, pain at the site of injection, skin reactions like rash, pruritus, urticaria, abdominal pain, nausea, vomiting, diarrhea, headache may occur.
ContraindicationsView
Meropenem is contraindicated in patients who have demonstrated hypersensitivity to this product.
PrecautionsView
If an allergic reaction to Meropenem occurs, the drug should be discontinued and appropriate measures taken. Use of Meropenem in patients with hepatic disease should be made with careful monitoring of transaminase and bilirubin levels.
InteractionsView
Probenecid competes with Meropenem for active tubular secretion and thus inhibits the renal excretion, with the effect of increasing the elimination half-life and plasma concentration of meropenem. Meropenem may reduce serum valproic acid levels. Sub therapeutic levels may be reached in some patients.
Pregnancy & lactationView
Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. So this drug should be used during pregnancy only if clearly needed. Because many drugs are excreted in human milk, caution should be exercised when Meropenem is administered to a nursing woman.
Pediatric usageView
Renal impairment: Dosage should be reduced in patients with creatinine clearance less than 51 ml/min.
Hepatic impairment: No dosage adjustments are necessary with impairment of liver function. Hemodialysis patients should receive Meropenem after dialysis has been completed.
Elderly: No dosage adjustments are necessary in elderly patients unless creatinine clearance is <51 ml/min.
Use in Children: Efficacy and tolerability in infants under 3 months have not been established.
Hepatic impairment: No dosage adjustments are necessary with impairment of liver function. Hemodialysis patients should receive Meropenem after dialysis has been completed.
Elderly: No dosage adjustments are necessary in elderly patients unless creatinine clearance is <51 ml/min.
Use in Children: Efficacy and tolerability in infants under 3 months have not been established.
Overdose effectsView
Accidental overdose could occur during therapy, particularly in patients with renal impairment. Treatment of overdose should be symptomatic. In normal individuals, rapid renal elimination will occur; in subjects with renal impairment, haemodialysis will remove Meropenem and its metabolite.
ReconstitutionView
Preparation of solution:
Intravenous bolus Administration: Reconstitute Meropenem (500 mg or 1 g) with sterile water for injection. Shake to dissolve and to obtain solution which is clear and colorless or pale yellow.
Intravenous infusion administration: Meropenem for intravenous infusion may be directly constituted with a compatible infusion fluid and then further diluted (50 to 200 ml) with the compatible infusion fluid, as needed.
Meropenem is compatible with the following infusion fluids: 0.9% sodium chloride intravenous infusion, 5% or 10% glucose intravenous infusion, 5% glucose intravenous infusion with 0.02% sodium bicarbonate, 5% glucose and 0.9% sodium chloride intravenous infusion, 5% glucose with 0.225% sodium chloride intravenous infusion, 5% glucose with 0.15% potassium chloride intravenous infusion, 2.5% and 10% mannitol intravenous infusion, normosol-M in 5% glucose intravenous infusion.
The use of freshly reconstituted solution is recommended. However, it maintains potency for up to 3 hours at up to 25oC or 13 hours at up to 5oC
Intravenous bolus Administration: Reconstitute Meropenem (500 mg or 1 g) with sterile water for injection. Shake to dissolve and to obtain solution which is clear and colorless or pale yellow.
Intravenous infusion administration: Meropenem for intravenous infusion may be directly constituted with a compatible infusion fluid and then further diluted (50 to 200 ml) with the compatible infusion fluid, as needed.
Meropenem is compatible with the following infusion fluids: 0.9% sodium chloride intravenous infusion, 5% or 10% glucose intravenous infusion, 5% glucose intravenous infusion with 0.02% sodium bicarbonate, 5% glucose and 0.9% sodium chloride intravenous infusion, 5% glucose with 0.225% sodium chloride intravenous infusion, 5% glucose with 0.15% potassium chloride intravenous infusion, 2.5% and 10% mannitol intravenous infusion, normosol-M in 5% glucose intravenous infusion.
The use of freshly reconstituted solution is recommended. However, it maintains potency for up to 3 hours at up to 25oC or 13 hours at up to 5oC
StorageView
Vial store in a cool, dry place (below 30oC), away from light & moisture. Keep out of the reach of children.
Inpen
Meropenem Trihydrate
Inpen
Meropenem Trihydrate
Indications
Uncomplicated pneumococcal pneumonia
Indication detailsView
Meropenem is indicated for treatment in adults and children for the following infections caused by single or multiple bacteria sensitive to Meropenem.
- Pneumonia and Nosocomial Pneumonia
- Urinary Tract Infections
- Intra-abdominal Infections
- Gynaecological Infections, such as endometritis and pelvic inflammatory disease
- Skin and Skin Structure Infections
- Meningitis
- Septicaemia
- Pulmonary infections in cystic fibrosis
- Empiric treatment for presumed infections in patients with febrile neutropenia.
Therapeutic classView
Other beta-lactam Antibiotics
PharmacologyView
Meropenem is a carbapenem antibiotic for parenteral use . It exerts its bactericidal action by interfering with bacterial cell wall synthesis. It penetrates bacterial cell walls, its high level of stability to all serine beta-lactamases and its marked affinity for the Penicillin Binding Proteins (PBPs.). It shows potent bactericidal activity against a broad spectrum of Gram-positive and Gram-negative, aerobic and anaerobic bacteria.
DosageView
The dosage and duration of therapy shall be established depending on type, severity of infection and the condition of the patient. The recommended daily dosage is as follows-
Adults:
Adults:
- The usual dose is 500 mg to 1 gm by intravenous administration every 8 hours.
- Pneumonia, urinary tract infections, gynaecological infections such as endometritis, pelvic inflammatory disease, skin and skin structure infections: 500 mg IV every 8 hours.
- Nosocomial pneumonias, peritonitis, presumed infections in neutropenic patients and septicaemia: 1 g IV every 8 hours.
- Intra-abdominal infections: 500 mg to 1 gm every 8 hours.
- Cystic fibrosis: Upto 2 gm every 8 hours.
- Meningitis: 2 gm IV every 8 hours.
- 3 months to 12 years: 10 to 40 mg/kg intravenously every 8 hours depending on type and severity of infection, susceptibility of the pathogens and the condition of the patient.
- Intra-abdominal infections: 20 mg/kg every 8 hours.
- Cystic fibrosis (4-18 years): 25-40 mg/kg every 8 hours.
- Meningitis: 40 mg/kg IV every 8 hours.
- Febrile neutropenia: 20 mg/kg every 8 hours.
- Children over 50 kg weight: use adult dosage.
- There is no experience in children with hepatic or renal impairment.
AdministrationView
Meropenem should be administered by intravenous Infusion over approximately 15-30 minutes or as intravenous bolus (5 to 20 ml) over approximately 3-5 minutes
Side effectsView
Meropenem is generally well tolerated. Side effects like inflammation, thrombophlebitis, pain at the site of injection, skin reactions like rash, pruritus, urticaria, abdominal pain, nausea, vomiting, diarrhea, headache may occur.
ContraindicationsView
Meropenem is contraindicated in patients who have demonstrated hypersensitivity to this product.
PrecautionsView
If an allergic reaction to Meropenem occurs, the drug should be discontinued and appropriate measures taken. Use of Meropenem in patients with hepatic disease should be made with careful monitoring of transaminase and bilirubin levels.
InteractionsView
Probenecid competes with Meropenem for active tubular secretion and thus inhibits the renal excretion, with the effect of increasing the elimination half-life and plasma concentration of meropenem. Meropenem may reduce serum valproic acid levels. Sub therapeutic levels may be reached in some patients.
Pregnancy & lactationView
Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. So this drug should be used during pregnancy only if clearly needed. Because many drugs are excreted in human milk, caution should be exercised when Meropenem is administered to a nursing woman.
Pediatric usageView
Renal impairment: Dosage should be reduced in patients with creatinine clearance less than 51 ml/min.
Hepatic impairment: No dosage adjustments are necessary with impairment of liver function. Hemodialysis patients should receive Meropenem after dialysis has been completed.
Elderly: No dosage adjustments are necessary in elderly patients unless creatinine clearance is <51 ml/min.
Use in Children: Efficacy and tolerability in infants under 3 months have not been established.
Hepatic impairment: No dosage adjustments are necessary with impairment of liver function. Hemodialysis patients should receive Meropenem after dialysis has been completed.
Elderly: No dosage adjustments are necessary in elderly patients unless creatinine clearance is <51 ml/min.
Use in Children: Efficacy and tolerability in infants under 3 months have not been established.
Overdose effectsView
Accidental overdose could occur during therapy, particularly in patients with renal impairment. Treatment of overdose should be symptomatic. In normal individuals, rapid renal elimination will occur; in subjects with renal impairment, haemodialysis will remove Meropenem and its metabolite.
ReconstitutionView
Preparation of solution:
Intravenous bolus Administration: Reconstitute Meropenem (500 mg or 1 g) with sterile water for injection. Shake to dissolve and to obtain solution which is clear and colorless or pale yellow.
Intravenous infusion administration: Meropenem for intravenous infusion may be directly constituted with a compatible infusion fluid and then further diluted (50 to 200 ml) with the compatible infusion fluid, as needed.
Meropenem is compatible with the following infusion fluids: 0.9% sodium chloride intravenous infusion, 5% or 10% glucose intravenous infusion, 5% glucose intravenous infusion with 0.02% sodium bicarbonate, 5% glucose and 0.9% sodium chloride intravenous infusion, 5% glucose with 0.225% sodium chloride intravenous infusion, 5% glucose with 0.15% potassium chloride intravenous infusion, 2.5% and 10% mannitol intravenous infusion, normosol-M in 5% glucose intravenous infusion.
The use of freshly reconstituted solution is recommended. However, it maintains potency for up to 3 hours at up to 25oC or 13 hours at up to 5oC
Intravenous bolus Administration: Reconstitute Meropenem (500 mg or 1 g) with sterile water for injection. Shake to dissolve and to obtain solution which is clear and colorless or pale yellow.
Intravenous infusion administration: Meropenem for intravenous infusion may be directly constituted with a compatible infusion fluid and then further diluted (50 to 200 ml) with the compatible infusion fluid, as needed.
Meropenem is compatible with the following infusion fluids: 0.9% sodium chloride intravenous infusion, 5% or 10% glucose intravenous infusion, 5% glucose intravenous infusion with 0.02% sodium bicarbonate, 5% glucose and 0.9% sodium chloride intravenous infusion, 5% glucose with 0.225% sodium chloride intravenous infusion, 5% glucose with 0.15% potassium chloride intravenous infusion, 2.5% and 10% mannitol intravenous infusion, normosol-M in 5% glucose intravenous infusion.
The use of freshly reconstituted solution is recommended. However, it maintains potency for up to 3 hours at up to 25oC or 13 hours at up to 5oC
StorageView
Vial store in a cool, dry place (below 30oC), away from light & moisture. Keep out of the reach of children.
Inpoza
Olaparib
Inpoza
Olaparib
Indications
Ovarian cancer
Indication detailsView
Breast Cancer: Olaparib is indicated as monotherapy for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have progressed on or be considered inappropriate for endocrine therapy. Germline BRCA mutation must be confirmed before Olaparib treatment is initiated.
Ovarian Cancer: Olaparib is indicated as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed (PSR) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to platinumbased chemotherapy.
Ovarian Cancer: Olaparib is indicated as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed (PSR) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to platinumbased chemotherapy.
Therapeutic classView
Targeted Cancer Therapy
PharmacologyView
Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3. PARP enzymes are involved in normal cellular homeostasis, such as DNA transcription, cell cycle regulation, and DNA repair. Olaparib has been shown to inhibit growth of select tumor cell lines in vitro and decrease tumor growth in mouse xenograft models of human cancer both as monotherapy or following platinum-based chemotherapy. Increased cytotoxicity and anti-tumor activity following treatment with olaparib were noted in cell lines and mouse tumor models with deficiencies in BRCA. In vitro studies have shown that olaparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complex, resulting in disruption of cellular homeostasis and cell death.
DosageView
There is a risk of medication errors between Olaparib tablets and Olaparib capsules. In order to minimize this risk, check the bottle labels to ensure that the drug being prepared and dispensed is Olaparib tablets and not Olaparib capsules. Prescribers should specify the formulation and dosage of Olaparib on each prescription.
The recommended total daily dose of Olaparib tablets is 600 mg, taken as two 150 mg tablets twice daily. The 100 mg tablet is available for dose reduction.
For treatment of ovarian cancer: Patients should start treatment with Olaparib no later than 8 weeks after completion of their final dose of the platinum-containing regimen. Patients should have recovered from prior hematologic toxicities prior to starting Olaparib therapy (hemoglobin, platelet, and neutrophil levels should be ≤ CTCAE grade 1).
It is recommended that Olaparib treatment be continued until progression of the underlying disease or unacceptable toxicity. Olaparib should not be given in combination with other anti cancer therapy. Grapefruit or other similar fruit juices that are known to inhibit CYP3A should not be consumed while taking Olaparib.
The recommended total daily dose of Olaparib tablets is 600 mg, taken as two 150 mg tablets twice daily. The 100 mg tablet is available for dose reduction.
For treatment of ovarian cancer: Patients should start treatment with Olaparib no later than 8 weeks after completion of their final dose of the platinum-containing regimen. Patients should have recovered from prior hematologic toxicities prior to starting Olaparib therapy (hemoglobin, platelet, and neutrophil levels should be ≤ CTCAE grade 1).
It is recommended that Olaparib treatment be continued until progression of the underlying disease or unacceptable toxicity. Olaparib should not be given in combination with other anti cancer therapy. Grapefruit or other similar fruit juices that are known to inhibit CYP3A should not be consumed while taking Olaparib.
Side effectsView
The most common serious adverse reaction reported was anemia (2.4% olaparib vs 2.2% chemotherapy). The following serious ADRs were reported in one patient each: dermatitis allergic, neutrophil count decreased and platelet count decreased. The proportion of patients who permanently discontinued Olaparib due to adverse events was 4.9% in the Olaparib arm compared with 7.7% in the chemotherapy arm. Anemia and platelet count decrease were the only adverse reactions leading to discontinuation of Olaparib in more than one patient.
ContraindicationsView
Olaparib is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation.
PrecautionsView
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): occurred in patients exposed to Olaparib, and the majority of reports were fatal. Monitor patients for hematological toxicity at baseline and monthly thereafter. Discontinue if MDS/AML is confirmed.
Pneumonitis: occurred in patients exposed to Olaparib, and some cases were fatal. Interrupt treatment if pneumonitis is suspected. Discontinue if pneumonitis is confirmed.
Embryo-Fetal Toxicity: Olaparib can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception
Pneumonitis: occurred in patients exposed to Olaparib, and some cases were fatal. Interrupt treatment if pneumonitis is suspected. Discontinue if pneumonitis is confirmed.
Embryo-Fetal Toxicity: Olaparib can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception
InteractionsView
Clinical studies of olaparib in combination with other anti-cancer agents, including DNA damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity. The recommended Olaparib monotherapy dose is not suitable for combination with myelosuppressive anti-cancer agents. Olaparib is predominantly metabolised by CYP3A. Co-administered CYP3A inhibitors or inducers may respectively increase or decrease olaparib plasma concentration.
Pregnancy & lactationView
Pregnancy: Olaparib can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. Olaparib wasteratogenic and caused embryo-fetal toxicity in rats at exposures below those in patients receiving the recommended human dose of 400 mg twice daily. If this drug is used during pregnancy, or if a patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for loss of the pregnancy.
Nursing Mothers: It is not known whether olaparib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from olaparib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Nursing Mothers: It is not known whether olaparib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from olaparib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric Use: The safety and efficacy of Olaparib has not been established in pediatric patients.
Overdose effectsView
There is no specific treatment in the event of Olaparib overdose, and symptoms of overdose are not established. In the event of an overdose, physicians should follow general supportive measures and should treat symptomatically.
StorageView
Store in a dry place below 30°C, protect from light. Keep out of the reach of children.
Inpoza
Olaparib
Inpoza
Olaparib
Indications
Ovarian cancer
Indication detailsView
Breast Cancer: Olaparib is indicated as monotherapy for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have progressed on or be considered inappropriate for endocrine therapy. Germline BRCA mutation must be confirmed before Olaparib treatment is initiated.
Ovarian Cancer: Olaparib is indicated as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed (PSR) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to platinumbased chemotherapy.
Ovarian Cancer: Olaparib is indicated as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed (PSR) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to platinumbased chemotherapy.
Therapeutic classView
Targeted Cancer Therapy
PharmacologyView
Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3. PARP enzymes are involved in normal cellular homeostasis, such as DNA transcription, cell cycle regulation, and DNA repair. Olaparib has been shown to inhibit growth of select tumor cell lines in vitro and decrease tumor growth in mouse xenograft models of human cancer both as monotherapy or following platinum-based chemotherapy. Increased cytotoxicity and anti-tumor activity following treatment with olaparib were noted in cell lines and mouse tumor models with deficiencies in BRCA. In vitro studies have shown that olaparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complex, resulting in disruption of cellular homeostasis and cell death.
DosageView
There is a risk of medication errors between Olaparib tablets and Olaparib capsules. In order to minimize this risk, check the bottle labels to ensure that the drug being prepared and dispensed is Olaparib tablets and not Olaparib capsules. Prescribers should specify the formulation and dosage of Olaparib on each prescription.
The recommended total daily dose of Olaparib tablets is 600 mg, taken as two 150 mg tablets twice daily. The 100 mg tablet is available for dose reduction.
For treatment of ovarian cancer: Patients should start treatment with Olaparib no later than 8 weeks after completion of their final dose of the platinum-containing regimen. Patients should have recovered from prior hematologic toxicities prior to starting Olaparib therapy (hemoglobin, platelet, and neutrophil levels should be ≤ CTCAE grade 1).
It is recommended that Olaparib treatment be continued until progression of the underlying disease or unacceptable toxicity. Olaparib should not be given in combination with other anti cancer therapy. Grapefruit or other similar fruit juices that are known to inhibit CYP3A should not be consumed while taking Olaparib.
The recommended total daily dose of Olaparib tablets is 600 mg, taken as two 150 mg tablets twice daily. The 100 mg tablet is available for dose reduction.
For treatment of ovarian cancer: Patients should start treatment with Olaparib no later than 8 weeks after completion of their final dose of the platinum-containing regimen. Patients should have recovered from prior hematologic toxicities prior to starting Olaparib therapy (hemoglobin, platelet, and neutrophil levels should be ≤ CTCAE grade 1).
It is recommended that Olaparib treatment be continued until progression of the underlying disease or unacceptable toxicity. Olaparib should not be given in combination with other anti cancer therapy. Grapefruit or other similar fruit juices that are known to inhibit CYP3A should not be consumed while taking Olaparib.
Side effectsView
The most common serious adverse reaction reported was anemia (2.4% olaparib vs 2.2% chemotherapy). The following serious ADRs were reported in one patient each: dermatitis allergic, neutrophil count decreased and platelet count decreased. The proportion of patients who permanently discontinued Olaparib due to adverse events was 4.9% in the Olaparib arm compared with 7.7% in the chemotherapy arm. Anemia and platelet count decrease were the only adverse reactions leading to discontinuation of Olaparib in more than one patient.
ContraindicationsView
Olaparib is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation.
PrecautionsView
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): occurred in patients exposed to Olaparib, and the majority of reports were fatal. Monitor patients for hematological toxicity at baseline and monthly thereafter. Discontinue if MDS/AML is confirmed.
Pneumonitis: occurred in patients exposed to Olaparib, and some cases were fatal. Interrupt treatment if pneumonitis is suspected. Discontinue if pneumonitis is confirmed.
Embryo-Fetal Toxicity: Olaparib can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception
Pneumonitis: occurred in patients exposed to Olaparib, and some cases were fatal. Interrupt treatment if pneumonitis is suspected. Discontinue if pneumonitis is confirmed.
Embryo-Fetal Toxicity: Olaparib can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception
InteractionsView
Clinical studies of olaparib in combination with other anti-cancer agents, including DNA damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity. The recommended Olaparib monotherapy dose is not suitable for combination with myelosuppressive anti-cancer agents. Olaparib is predominantly metabolised by CYP3A. Co-administered CYP3A inhibitors or inducers may respectively increase or decrease olaparib plasma concentration.
Pregnancy & lactationView
Pregnancy: Olaparib can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. Olaparib wasteratogenic and caused embryo-fetal toxicity in rats at exposures below those in patients receiving the recommended human dose of 400 mg twice daily. If this drug is used during pregnancy, or if a patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for loss of the pregnancy.
Nursing Mothers: It is not known whether olaparib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from olaparib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Nursing Mothers: It is not known whether olaparib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from olaparib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric Use: The safety and efficacy of Olaparib has not been established in pediatric patients.
Overdose effectsView
There is no specific treatment in the event of Olaparib overdose, and symptoms of overdose are not established. In the event of an overdose, physicians should follow general supportive measures and should treat symptomatically.
StorageView
Store in a dry place below 30°C, protect from light. Keep out of the reach of children.
Inpro
Omeprazole
Inpro
Omeprazole
Indications
Zollinger-Ellison syndrome
Indication detailsView
Omeprazole is indicated for the treatment of-
- Gastric and duodenal ulcer
- NSAID-associated duodenal and gastric ulcer
- As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
- Gastro-esophageal reflux disease
- Long-term management of acid reflux disease
- Acid-related dyspepsia
- Severe ulcerating reflux esophagitis
- Prophylaxis of acid aspiration during general anesthesia
- Zollinger-Ellison syndrome
- Helicobacter pylori-induced peptic ulcer.
Therapeutic classView
Proton Pump Inhibitor
PharmacologyView
Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.
DosageView
Oral-
IV Injection-
- Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
- NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
- Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily.
- Long-term management of acid reflux disease: 10-20 mg daily.
- Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
- Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
- Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
- Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
- Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.
IV Injection-
- Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
- Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
- Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.
AdministrationView
Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Side effectsView
Omeprazole is generally well tolerated. Nausea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.
ContraindicationsView
Omeprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.
PrecautionsView
When gastric ulcer is suspected, the possibility of gastric malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate the symptoms and delay diagnosis.
InteractionsView
Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin. So, reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to the treatment. There is no evidence of an interaction of Omeprazole with theophylline, propranolol or antacids.
Pregnancy & lactationView
US FDA pregnancy category of Omeprazole is C. However, results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. There is no information available on the passage of Omeprazole into breast milk or its effects on the neonate. Breast-feeding should, therefore, be discontinued, if the use of Omeprazole is considered essential.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Inpro
Omeprazole
Inpro
Omeprazole
Indications
Zollinger-Ellison syndrome
Indication detailsView
Omeprazole is indicated for the treatment of-
- Gastric and duodenal ulcer
- NSAID-associated duodenal and gastric ulcer
- As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
- Gastro-esophageal reflux disease
- Long-term management of acid reflux disease
- Acid-related dyspepsia
- Severe ulcerating reflux esophagitis
- Prophylaxis of acid aspiration during general anesthesia
- Zollinger-Ellison syndrome
- Helicobacter pylori-induced peptic ulcer.
Therapeutic classView
Proton Pump Inhibitor
PharmacologyView
Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.
DosageView
Oral-
IV Injection-
- Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
- NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
- Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily.
- Long-term management of acid reflux disease: 10-20 mg daily.
- Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
- Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
- Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
- Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
- Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.
IV Injection-
- Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
- Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
- Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.
AdministrationView
Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Side effectsView
Omeprazole is generally well tolerated. Nausea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.
ContraindicationsView
Omeprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.
PrecautionsView
When gastric ulcer is suspected, the possibility of gastric malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate the symptoms and delay diagnosis.
InteractionsView
Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin. So, reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to the treatment. There is no evidence of an interaction of Omeprazole with theophylline, propranolol or antacids.
Pregnancy & lactationView
US FDA pregnancy category of Omeprazole is C. However, results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. There is no information available on the passage of Omeprazole into breast milk or its effects on the neonate. Breast-feeding should, therefore, be discontinued, if the use of Omeprazole is considered essential.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Inpro
Omeprazole
Inpro
Omeprazole
Indications
Zollinger-Ellison syndrome
Indication detailsView
Omeprazole is indicated for the treatment of-
- Gastric and duodenal ulcer
- NSAID-associated duodenal and gastric ulcer
- As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
- Gastro-esophageal reflux disease
- Long-term management of acid reflux disease
- Acid-related dyspepsia
- Severe ulcerating reflux esophagitis
- Prophylaxis of acid aspiration during general anesthesia
- Zollinger-Ellison syndrome
- Helicobacter pylori-induced peptic ulcer.
Therapeutic classView
Proton Pump Inhibitor
PharmacologyView
Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.
DosageView
Oral-
IV Injection-
- Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
- NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
- Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily.
- Long-term management of acid reflux disease: 10-20 mg daily.
- Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
- Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
- Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
- Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
- Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.
IV Injection-
- Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
- Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
- Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.
AdministrationView
Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Side effectsView
Omeprazole is generally well tolerated. Nausea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.
ContraindicationsView
Omeprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.
PrecautionsView
When gastric ulcer is suspected, the possibility of gastric malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate the symptoms and delay diagnosis.
InteractionsView
Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin. So, reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to the treatment. There is no evidence of an interaction of Omeprazole with theophylline, propranolol or antacids.
Pregnancy & lactationView
US FDA pregnancy category of Omeprazole is C. However, results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. There is no information available on the passage of Omeprazole into breast milk or its effects on the neonate. Breast-feeding should, therefore, be discontinued, if the use of Omeprazole is considered essential.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Inran
Ranitidine Hydrochloride
Inran
Ranitidine Hydrochloride
Indications
Zollinger-Ellison syndrome
Indication detailsView
Ranitidine is indicated in:
- Treatment of active duodenal ulcer
- Benign gastric ulcer
- Treatment & prevention of ulcer associated with non-steroidal anti-inflammatory agent
- Post operative stress ulcer.
- Zollinger-Ellison Syndrome.
- Gastroesophageal reflux disease (GERD).
- Gastro-intestinal haemorrhage from stress ulcer in seriously ill patient.
- Recurrent haemorrhage in patients with bleeding peptic ulcer.
- Before general anesthesia in patient considered to be at risk of acid aspiration particulary obstetric patients.
Therapeutic classView
H2 receptor antagonist
PharmacologyView
Ranitidine competitively blocks histamine at H2-receptors of the gastric parietal cells which inhibits gastric acid secretion. It does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion or serum gastrin.
DosageView
Ranitidine Tablet & Syrup:
Duodenal and gastric ulcer: The usual dosage is 150 mg twice daily taken in the morning and evening or 300 mg as a single daily dose at night for 4 to 8 weeks.Reflux oesophagitis: 150 mg twice daily or 300 mg at bed time for up to 8 weeks.
Zollinger Ellison syndrome: 150 mg 3 times daily and increased if necessary up to 6 g daily in divided doses. Dosage should be continued as long as clinically indicated.
Episodic dyspepsia: 150 mg twice daily or 300 mg at bed time for up to 6 weeks.
Maintenance: 150 mg at night for preventing recurrences.
Child (peptic ulcer): 2-4 mg/kg twice daily, maximum 300 mg daily.
Ranitidine IV injection & IV Infusion:
Ranitidine injection may be given either as a slow (over a period of at least two minutes) intravenous injection of 50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may be repeated every six to eight hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals; or as an intramuscular injection of 50 mg (2 ml) every six to eight hours. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences.In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patient sapriming dose of 50 mg as low as intravenous injection followed by a continuous intravenous infusion of 0.125-0.250 mg/kg/hour may be preferred. In patients considered to be at risk of developing aspiration syndrome Ranitidine injection 50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.
Children: The recommended oral dose for the treatment of peptic ulcer in children is 2 mg/kg to 4 mg/kg twice daily to a maximum of 300 mg ranitidine per day. Safety and effectiveness of Ranitidine injection have not been established in case of children.
Side effectsView
Ranitidine is well tolerated and side effects are usually uncommon. Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or joint pain have rarely been reported.
ContraindicationsView
Patients hypersensitive to Ranitidine
PrecautionsView
Ranitidine should be given in reduced dosage to patients with impaired renal and hepatic function.
InteractionsView
Delayed absorption and increased peak serum concentration with propantheline bromide. Ranitidine minimally inhibits hepatic metabolism of coumarin anticoagulants, theophylline, diazepam and propanolol. May alter absorption of pH-dependent drugs (e.g. ketoconazole, midazolam, glipizide). May reduce bioavailability with antacids.
Pregnancy & lactationView
Pregnancy: Ranitidine crosses the placenta. But there is no evidence of impaired fertility or harm to the foetus due to Ranitidine. Like other drugs, Ranitidine should only be used during pregnancy if considered essential.
Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
Pediatric usageView
Use in elderly patients: In clinical trial the ulcer healing rates have been found similar in patients age 65 and over with those in younger patients. Additionally, there was no difference in the incidence of adverse effects.
Overdose effectsView
Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If required, the drug may be removed from the plasma by haemodiaiysis.
ReconstitutionView
Slow IV inj: Ranitidine 50 mg diluted to a concentration ≤2.5 mg/mL (e.g. total of 20 mL) with NaCl 0.9% inj or dextrose 5% or 10%, lactated Ringer's, Na bicarbonate 5% soln.
Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
StorageView
Store in a cool and dry place. protect from light.
Insaid
Indomethacin (Oral)
Insaid
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.
Inseac
Ranitidine Hydrochloride
Inseac
Ranitidine Hydrochloride
Indications
Zollinger-Ellison syndrome
Indication detailsView
Ranitidine is indicated in:
- Treatment of active duodenal ulcer
- Benign gastric ulcer
- Treatment & prevention of ulcer associated with non-steroidal anti-inflammatory agent
- Post operative stress ulcer.
- Zollinger-Ellison Syndrome.
- Gastroesophageal reflux disease (GERD).
- Gastro-intestinal haemorrhage from stress ulcer in seriously ill patient.
- Recurrent haemorrhage in patients with bleeding peptic ulcer.
- Before general anesthesia in patient considered to be at risk of acid aspiration particulary obstetric patients.
Therapeutic classView
H2 receptor antagonist
PharmacologyView
Ranitidine competitively blocks histamine at H2-receptors of the gastric parietal cells which inhibits gastric acid secretion. It does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion or serum gastrin.
DosageView
Ranitidine Tablet & Syrup:
Duodenal and gastric ulcer: The usual dosage is 150 mg twice daily taken in the morning and evening or 300 mg as a single daily dose at night for 4 to 8 weeks.Reflux oesophagitis: 150 mg twice daily or 300 mg at bed time for up to 8 weeks.
Zollinger Ellison syndrome: 150 mg 3 times daily and increased if necessary up to 6 g daily in divided doses. Dosage should be continued as long as clinically indicated.
Episodic dyspepsia: 150 mg twice daily or 300 mg at bed time for up to 6 weeks.
Maintenance: 150 mg at night for preventing recurrences.
Child (peptic ulcer): 2-4 mg/kg twice daily, maximum 300 mg daily.
Ranitidine IV injection & IV Infusion:
Ranitidine injection may be given either as a slow (over a period of at least two minutes) intravenous injection of 50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may be repeated every six to eight hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals; or as an intramuscular injection of 50 mg (2 ml) every six to eight hours. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences.In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patient sapriming dose of 50 mg as low as intravenous injection followed by a continuous intravenous infusion of 0.125-0.250 mg/kg/hour may be preferred. In patients considered to be at risk of developing aspiration syndrome Ranitidine injection 50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.
Children: The recommended oral dose for the treatment of peptic ulcer in children is 2 mg/kg to 4 mg/kg twice daily to a maximum of 300 mg ranitidine per day. Safety and effectiveness of Ranitidine injection have not been established in case of children.
Side effectsView
Ranitidine is well tolerated and side effects are usually uncommon. Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or joint pain have rarely been reported.
ContraindicationsView
Patients hypersensitive to Ranitidine
PrecautionsView
Ranitidine should be given in reduced dosage to patients with impaired renal and hepatic function.
InteractionsView
Delayed absorption and increased peak serum concentration with propantheline bromide. Ranitidine minimally inhibits hepatic metabolism of coumarin anticoagulants, theophylline, diazepam and propanolol. May alter absorption of pH-dependent drugs (e.g. ketoconazole, midazolam, glipizide). May reduce bioavailability with antacids.
Pregnancy & lactationView
Pregnancy: Ranitidine crosses the placenta. But there is no evidence of impaired fertility or harm to the foetus due to Ranitidine. Like other drugs, Ranitidine should only be used during pregnancy if considered essential.
Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
Pediatric usageView
Use in elderly patients: In clinical trial the ulcer healing rates have been found similar in patients age 65 and over with those in younger patients. Additionally, there was no difference in the incidence of adverse effects.
Overdose effectsView
Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If required, the drug may be removed from the plasma by haemodiaiysis.
ReconstitutionView
Slow IV inj: Ranitidine 50 mg diluted to a concentration ≤2.5 mg/mL (e.g. total of 20 mL) with NaCl 0.9% inj or dextrose 5% or 10%, lactated Ringer's, Na bicarbonate 5% soln.
Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
StorageView
Store in a cool and dry place. protect from light.
Insimet
Metformin Hydrochloride
Insimet
Metformin Hydrochloride
Indications
Type 2 DM
Indication detailsView
Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary management and exercise alone does not result in adequate glycaemic control.
- In adults: Metformin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
- In children from 10 years of age and adolescents: Metformin may be used as monotherapy or in combination with insulin.
Therapeutic classView
Biguanides
PharmacologyView
Metformin is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
DosageView
Metformin immediate release tablet: Dosage of Metformin Hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses.
- Adult: The usual starting dose of Metformin is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. For those patients requiring additional glycemic control, Glucomin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
- Children: The usual starting dose of Metformin is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.
- Adult: The usual starting dose of Metformin XR is 500 mg once daily with the evening meal. Dose should be increased in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal, alternatively increased to 1000 mg twice daily taken with meal. Patient receiving Metformin immediate release tablet may be switched to Metformin extended release tablet up to a maximum recommended daily dose.
- Children: Metformin extended release tablet has not been studied in children.
- Renal impaired patient: Do not use Metformin in patients with eGFR below 30 mL/min/1.73 m2. Asses risk/benefit of counting if eGFR falls below 45 mL/min/1.73 m2.
Side effectsView
Blood and lymphatic system disorders: Not known: Hemolytic anemia
Metabolism and nutrition disorders: Very rare: Lactic acidosis. Decrease of vitamin B12 absorption with a decrease of serum levels during long-term use of metformin. Consideration of such etiology is recommended if a patient presents with megaloblastic anemia. Cases of peripheral neuropathy in patients with vitamin B12 deficiency have been reported in post-marketing experience (frequency not known)
Nervous system disorders: Common: Taste disturbance. Not known: Encephalopathy
Gastrointestinal disorders: Very common: Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These undesirable effects occur most frequently during the initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.
Hepatobiliary disorders: Very rare: Isolated reports of liver function test abnormalities or hepatitis resolving upon metformin discontinuation.
Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.
Metabolism and nutrition disorders: Very rare: Lactic acidosis. Decrease of vitamin B12 absorption with a decrease of serum levels during long-term use of metformin. Consideration of such etiology is recommended if a patient presents with megaloblastic anemia. Cases of peripheral neuropathy in patients with vitamin B12 deficiency have been reported in post-marketing experience (frequency not known)
Nervous system disorders: Common: Taste disturbance. Not known: Encephalopathy
Gastrointestinal disorders: Very common: Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These undesirable effects occur most frequently during the initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.
Hepatobiliary disorders: Very rare: Isolated reports of liver function test abnormalities or hepatitis resolving upon metformin discontinuation.
Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.
ContraindicationsView
- Hypersensitivity to the active substance or to any of the excipients.
- Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
- Severe renal failure (GFR <30 mL/min).
- Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
- Acute or chronic disease, which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock, Hepatic insufciency, acute alcohol intoxication, alcoholism.
PrecautionsView
Metformin Hydrochloride is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Metformin may lower vitamin B12 level. It also increases risk of hypoglycemia when use in combination with insulin or insulin secretagogue.
InteractionsView
Co-administration with Carbonic anhydrase (Topiramate, Zonisamide) may increase risk of lactic acidosis. Drugs (Ranolazine, Dolutegravir, Cimetidine) that reduce Metformin clearance may increase the accumulation of Metformin. Alcohol can potentiate the effect of Metformin on lactate metabolism.
Pregnancy & lactationView
Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with an increased risk of congenital abnormalities and perinatal mortality. When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus.
Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.
Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.
Pediatric usageView
Elderly: Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.
Pediatric population: The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated. No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially prepubescent children, is recommended.
Children aged between 10 and 12 years: Particular caution is recommended when prescribing to children aged between 10 and 12 years.
Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:
Pediatric population: The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated. No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially prepubescent children, is recommended.
Children aged between 10 and 12 years: Particular caution is recommended when prescribing to children aged between 10 and 12 years.
Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:
- At least annually in patients with normal renal function,
- At least two to four times a year in patients with creatinine clearance at the lower limit of normal and in elderly subjects.
Overdose effectsView
Hypoglycemia has not been seen with Metformin doses up to 85 gm, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and Metformin is hemodialysis.
StorageView
Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.