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Alzolam
Alprazolam
Alzolam
Alprazolam
Indications
Vestibular neuritis
Indication detailsView
Alprazolam is indicated in-
- Anxiety disorder
- Short term relief of anxiety
- Anxiety associated with depression
- Panic disorder, with or without agoraphobia.
Therapeutic classView
Benzodiazepine sedatives
PharmacologyView
Alprazolam is a triazole analog of the 1,4-benzodiazepine class of drugs. It is an anxiolytic with hypnotic and anticonvulsive properties. Alprazolam is presumed to produce its effects via interacting with the Gamma Aminobutyric Acid (GABA)- benzodiazepine receptor complex. Like all benzodiazepines, it causes a dose-related CNS depressant activity varying from mild impairment of task performance to hypnosis.
DosageView
Treatment should be initiated with a dose of 0.25 to 0.5 mg three times daily. Depending on the response, dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg/day. The maximum dose should not exceed 4 mg/day. Occasional patients with panic disorder may need as much as 10 mg a day to achieve a successful response and in these cases periodic reassessment and consideration of dosage adjustment is required.
Dosage should be individualized for maximum beneficial effect with the lowest possible dose. If side-effects occur at starting dose, dose may be lowered. When discontinuing therapy, dosage should be reduced gradually by no more than 0.5 mg every three days.
In elderly patients or in patients with advanced liver disease, the usual starting dose is 0.25 mg, two or three times daily and may be gradually increased if needed and tolerated.
Alprazolam 1 mg should be administered once daily, preferably in the morning by patients who are on multiple dosage regimens of Alprazolam 0.25/0.5 mg. The tablets should be taken intact, they should not be chewed, crushed, or broken.
Dosage should be individualized for maximum beneficial effect with the lowest possible dose. If side-effects occur at starting dose, dose may be lowered. When discontinuing therapy, dosage should be reduced gradually by no more than 0.5 mg every three days.
In elderly patients or in patients with advanced liver disease, the usual starting dose is 0.25 mg, two or three times daily and may be gradually increased if needed and tolerated.
Alprazolam 1 mg should be administered once daily, preferably in the morning by patients who are on multiple dosage regimens of Alprazolam 0.25/0.5 mg. The tablets should be taken intact, they should not be chewed, crushed, or broken.
Side effectsView
Side effects, if occur, are generally observed at the beginning of therapy and usually disappear upon continued medication. The most frequent side effects are drowsiness and light-headedness. The other side effects, that may occur include depression, headache, confusion, dry mouth, constipation, etc.
PrecautionsView
Because Alprazolam may produce psychological and physical dependence, the increment of dose or abrupt discontinuation of Alprazolam therapy should not be done without the physician's advice. The duration of therapy must be determined by the physicians. Alprazolam should be administered with caution to patients with hepatic or renal disease, chronic pulmonary insufficiency, or sleep apnea.
InteractionsView
The CNS-depressant action of Alprazolam may be aggravated by concomitant use of other psychotropic drugs, anticonvulsants, antihistaminics, alcohol and oral ontraceptives.
Pregnancy & lactationView
Alprazolam has been categorized in pregnancy category D; that means, it should be avoided in pregnancy. Like other benzodiazepines, Alprazolam is assumed to be excreted in breast milk. Therefore, nursing should not be undertaken by mothers who must use Alprazolam.
Pediatric usageView
The safety and effectiveness of Alprazolam in individuals below 18 years of age have not been established.
Overdose effectsView
Manifestations of Alprazolam overdosage include somnolence, confusion, impaired coordination, diminished reflexes, and coma. In such cases of overdosage general supportive measures should be employed along with immediate gastric lavage.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Alzolam
Alprazolam
Alzolam
Alprazolam
Indications
Vestibular neuritis
Indication detailsView
Alprazolam is indicated in-
- Anxiety disorder
- Short term relief of anxiety
- Anxiety associated with depression
- Panic disorder, with or without agoraphobia.
Therapeutic classView
Benzodiazepine sedatives
PharmacologyView
Alprazolam is a triazole analog of the 1,4-benzodiazepine class of drugs. It is an anxiolytic with hypnotic and anticonvulsive properties. Alprazolam is presumed to produce its effects via interacting with the Gamma Aminobutyric Acid (GABA)- benzodiazepine receptor complex. Like all benzodiazepines, it causes a dose-related CNS depressant activity varying from mild impairment of task performance to hypnosis.
DosageView
Treatment should be initiated with a dose of 0.25 to 0.5 mg three times daily. Depending on the response, dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg/day. The maximum dose should not exceed 4 mg/day. Occasional patients with panic disorder may need as much as 10 mg a day to achieve a successful response and in these cases periodic reassessment and consideration of dosage adjustment is required.
Dosage should be individualized for maximum beneficial effect with the lowest possible dose. If side-effects occur at starting dose, dose may be lowered. When discontinuing therapy, dosage should be reduced gradually by no more than 0.5 mg every three days.
In elderly patients or in patients with advanced liver disease, the usual starting dose is 0.25 mg, two or three times daily and may be gradually increased if needed and tolerated.
Alprazolam 1 mg should be administered once daily, preferably in the morning by patients who are on multiple dosage regimens of Alprazolam 0.25/0.5 mg. The tablets should be taken intact, they should not be chewed, crushed, or broken.
Dosage should be individualized for maximum beneficial effect with the lowest possible dose. If side-effects occur at starting dose, dose may be lowered. When discontinuing therapy, dosage should be reduced gradually by no more than 0.5 mg every three days.
In elderly patients or in patients with advanced liver disease, the usual starting dose is 0.25 mg, two or three times daily and may be gradually increased if needed and tolerated.
Alprazolam 1 mg should be administered once daily, preferably in the morning by patients who are on multiple dosage regimens of Alprazolam 0.25/0.5 mg. The tablets should be taken intact, they should not be chewed, crushed, or broken.
Side effectsView
Side effects, if occur, are generally observed at the beginning of therapy and usually disappear upon continued medication. The most frequent side effects are drowsiness and light-headedness. The other side effects, that may occur include depression, headache, confusion, dry mouth, constipation, etc.
PrecautionsView
Because Alprazolam may produce psychological and physical dependence, the increment of dose or abrupt discontinuation of Alprazolam therapy should not be done without the physician's advice. The duration of therapy must be determined by the physicians. Alprazolam should be administered with caution to patients with hepatic or renal disease, chronic pulmonary insufficiency, or sleep apnea.
InteractionsView
The CNS-depressant action of Alprazolam may be aggravated by concomitant use of other psychotropic drugs, anticonvulsants, antihistaminics, alcohol and oral ontraceptives.
Pregnancy & lactationView
Alprazolam has been categorized in pregnancy category D; that means, it should be avoided in pregnancy. Like other benzodiazepines, Alprazolam is assumed to be excreted in breast milk. Therefore, nursing should not be undertaken by mothers who must use Alprazolam.
Pediatric usageView
The safety and effectiveness of Alprazolam in individuals below 18 years of age have not been established.
Overdose effectsView
Manifestations of Alprazolam overdosage include somnolence, confusion, impaired coordination, diminished reflexes, and coma. In such cases of overdosage general supportive measures should be employed along with immediate gastric lavage.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Alzolux DS
Albendazole
Alzolux DS
Albendazole
Indications
Worm infections
Indication detailsView
Albendazole is indicated in single and mixed infestations of-
- Hookworm (Ancylostoma, Necator)
- Roundworm (Ascaris)
- Threadworm (Enterobius)
- Whipworm (Trichuris)
- Strongyloides
- Tapeworm
- Opisthorchi
- Hydatid.
Therapeutic classView
Anthelmintic
PharmacologyView
Albendazole is a broad spectrum anthelmintic. Albendazole exhibits vermicidal, ovicidal and larvicidal activities. The drug is thought to exert its anthelmintic effect by blocking glucose uptake in the susceptible helminths, thereby depleting the energy level until it becomes inadequate for survival. Immobilization is followed by the parasite. These events may be a consequence of the binding and subsequent inhibition of parasite tubulin polymerization by Albendazole and its metabolites, although the drug also binds to human tubulin. Albendazole is extensively metabolized, probably in the liver. Albendazole is poorly absorbed from the gastrointestinal tract but rapidly undergoes extensive first-pass metabolism. The principal metabolite albendazole sulphoxide has anthelmintic activity and a plasma half-life of about 8.5 hrs. It is excreted in the urine together with other metabolites.
DosageView
Adults & children over 2 years:
Children under 1 year: Not recommended.
In Hydatid disease (Echinococcosis):
- 400 mg (1 tablet or 10 ml suspension) as a single dose in cases of Enterobius vermicularis, Trichuris trichiura, Ascaris lumbricoides, Ancylostoma duodenale and Necator americanus.
- In cases of strongyloidiasis or taeniasis, 400 mg (1 tablet or 10 ml suspension) daily should be given for 3 consecutive days. If the patient is not cured on follow-up after three weeks, a second course of treatment is indicated.
Children under 1 year: Not recommended.
In Hydatid disease (Echinococcosis):
- Albendazole is given by mouth with meals in a dose of 400 mg twice daily for 28 days for patients weighing over 60 kg.
- A dose of 15 mg/kg body weight daily in two divided doses (to a maximum total daily dose of 800 mg) is used for patients weighing less than 60 kg.
- For cystic echinococcosis, the 28 days course may be repeated after 14 days without treatment, to a total of 3 treatment cycles.
- For alveolar echinococcosis, cycles of 28 days of treatment followed by 14 days without treatment, may need to continue for months or years.
- In giardiasis, 400 mg (1 tablet or 10 ml suspension) once daily for five days is used.
Side effectsView
Gastrointestinal disturbances, headache, dizziness, changes in liver enzymes, rarely reversible alopecia; rash, fever, blood disorders including leucopenia and pancytopenia reported; allergic shock if cyst leakage; convulsion and meningism in cerebral disease.
ContraindicationsView
Neonates: Albendazole is not normally used in neonates.
Children: Reduction of the dose from 400 mg to 200 mg may be indicated in children weighing less than 10 kg but there are no grounds for a general reduction in dosage to children.
Pregnant woman: Albendazole should not be given during pregnancy or women thought to be pregnant. No information is available on placental transfer.
Concurrent disease: There is no evidence to suggest that dose should be altered in renal, hepatic or cardiac failure.
Children: Reduction of the dose from 400 mg to 200 mg may be indicated in children weighing less than 10 kg but there are no grounds for a general reduction in dosage to children.
Pregnant woman: Albendazole should not be given during pregnancy or women thought to be pregnant. No information is available on placental transfer.
Concurrent disease: There is no evidence to suggest that dose should be altered in renal, hepatic or cardiac failure.
PrecautionsView
Blood counts and liver function tests before treatment and twice during each cycle; breastfeeding; exclude pregnancy before starting treatment. Albendazole should only be used in the treatment of Echinococcosis if there is constant medical supervision with regular monitoring of serum-transaminase concentrations and of leucocyte and platelet counts
InteractionsView
No interaction involving Albendazole, either pharmacodynamic or pharmacokinetic, has been reported.
Pregnancy & lactationView
US FDA Pregnancy category of Albendazole is C. So, Albendazole should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.
AmCivit
Emblica officinalis + Piper longum
AmCivit
Emblica officinalis + Piper longum
Indications
Vitamin C deficiency
Indication detailsView
This syrup is indicated in vitamin C deficiency, scurvy, gastritis and anemia. It also acts as an antioxidant and prevents aging and premature graying of hair, supports cardiovascular health and wellness.
Other beneficial usage: For the treatment of infection, healing of ulcers, burn and trauma, quick healing of fracture. It is especially valuable in tuberculosis of lungs, asthma and bronchitis. Vitamin C may also be useful in lowering serum uric acid levels resulting in a correspondingly lower incidence of gout.
Other beneficial usage: For the treatment of infection, healing of ulcers, burn and trauma, quick healing of fracture. It is especially valuable in tuberculosis of lungs, asthma and bronchitis. Vitamin C may also be useful in lowering serum uric acid levels resulting in a correspondingly lower incidence of gout.
Therapeutic classView
Herbal and Nutraceuticals
PharmacologyView
This is the highest quality and most potent Amla syrup, which is time-tested and proven to be clinically effective.
Emblica officinalis: Emblica officinalis is highly nutritious and is an important dietary source of vitamin C, minerals and amino acids. It contains Emblicanin A & B, Puniglucanin, Pedunculagin, 2-keto-gluconolactone (vitamin-C equivalents), ellagic acid, hexahydroxy-diphenic acid and conjugates. In addition, the fruit contains phenols including gallic acid, quercetin, kaempferol, corilagin. A tannin containing gallic acid, ellagic acid and glucose in its molecule are naturally present in the fruit, which prevent the oxidation of vitamin and renders fruit valuable in vitamin C.
The presence of flavonoids in the E. officinalis enables them to be used as an antioxidant. It counteracts the toxic effects of prolonged exposure to environmental heavy metals. It increases glutathione (GSH) levels and glutathione peroxidase (GPx) activity in macrophages and decreases free radical production.E.officinalis is also used to detoxify blood from chemicals and harmful toxic substances and this is due to presence of phenols in E. officinalis, because phenols act as a detoxifying agent. Terpenoids of E. officinalis improves lung function.
Piper longum: Piper longum is certainly one of the most widely used of all Ayurvedic herbs for enhancing digestion, assimilation and metabolism of the foods that we eat. It is also highly prized for its ability to enhance the assimilation and potency of herbs. In a study, antiulcerogenic activity of Piper longum was noted against gastric ulcer.
Emblica officinalis: Emblica officinalis is highly nutritious and is an important dietary source of vitamin C, minerals and amino acids. It contains Emblicanin A & B, Puniglucanin, Pedunculagin, 2-keto-gluconolactone (vitamin-C equivalents), ellagic acid, hexahydroxy-diphenic acid and conjugates. In addition, the fruit contains phenols including gallic acid, quercetin, kaempferol, corilagin. A tannin containing gallic acid, ellagic acid and glucose in its molecule are naturally present in the fruit, which prevent the oxidation of vitamin and renders fruit valuable in vitamin C.
The presence of flavonoids in the E. officinalis enables them to be used as an antioxidant. It counteracts the toxic effects of prolonged exposure to environmental heavy metals. It increases glutathione (GSH) levels and glutathione peroxidase (GPx) activity in macrophages and decreases free radical production.E.officinalis is also used to detoxify blood from chemicals and harmful toxic substances and this is due to presence of phenols in E. officinalis, because phenols act as a detoxifying agent. Terpenoids of E. officinalis improves lung function.
Piper longum: Piper longum is certainly one of the most widely used of all Ayurvedic herbs for enhancing digestion, assimilation and metabolism of the foods that we eat. It is also highly prized for its ability to enhance the assimilation and potency of herbs. In a study, antiulcerogenic activity of Piper longum was noted against gastric ulcer.
DosageView
Children under 12 years: 1 teaspoonful (5 ml) two times daily.
Adult: 1-2 teaspoonfuls (5-10 ml) 2-3 times daily.
Adult: 1-2 teaspoonfuls (5-10 ml) 2-3 times daily.
Side effectsView
There is no known significant side effect.
ContraindicationsView
There is no evidence available on contraindication but it may happen in patients who are hypersensitive to any of its ingredients.
PrecautionsView
Caution is advised when taking vitamin C and agents that may damage the kidneys due to an increased risk of kidney failure.
InteractionsView
There is no known interaction with other drugs.But large dose of vitamin C may interfere with the absorption and metabolism of vitamin B12.
Pregnancy & lactationView
No adverse effect of this syrup has been reported. In a study conducted in animals during the first month of pregnancy, high doses of vitamin C suppresed the production of progesterone from the corpus luteum. So caution should be taken in first month of pregnancy.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Amantril
Amantadine Hydrochloride
Amantril
Amantadine Hydrochloride
Indications
Parkinson’s disease
Indication detailsView
Amantadine Hydrochloride is indicated for-
- Treatment of parkinsonism
- Treatment of drug-induced extrapyramidal reactions
- Prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus
Therapeutic classView
Respiratory viral infections (Influenza)
PharmacologyView
The mechanism by which amantadine exerts its antiviral activity is not clearly understood. It appears to mainly prevent the release of infectious viral nucleic acid into the host cell by interfering with the function of the transmembrane domain of the viral M2 protein. In certain cases, amantadine is also known to prevent virus assembly during virus replication. It does not appear to interfere with the immunogenicity of inactivated influenza A virus vaccine.
Amantadine inhibits the replication of influenza A virus isolates from each of the subtypes, i.e., H1N1, H2N2 and H3N2. It has very little or no activity against influenza B virus isolates. A quantitative relationship between the in vitrosusceptibility of influenza A virus to amantadine and the clinical response to therapy has not been established in man. Sensitivity test results, expressed as the concentration of amantadine required to inhibit by 50% the growth of virus (ED50) in tissue culture vary greatly (from 0.1 µg/mL to 25.0 µg/mL) depending upon the assay protocol used, size of virus inoculum, isolates of influenza A virus strains tested, and the cell type used. Host cells in tissue culture readily tolerated amantadine up to a concentration of 100 µg/mL.
Amantadine inhibits the replication of influenza A virus isolates from each of the subtypes, i.e., H1N1, H2N2 and H3N2. It has very little or no activity against influenza B virus isolates. A quantitative relationship between the in vitrosusceptibility of influenza A virus to amantadine and the clinical response to therapy has not been established in man. Sensitivity test results, expressed as the concentration of amantadine required to inhibit by 50% the growth of virus (ED50) in tissue culture vary greatly (from 0.1 µg/mL to 25.0 µg/mL) depending upon the assay protocol used, size of virus inoculum, isolates of influenza A virus strains tested, and the cell type used. Host cells in tissue culture readily tolerated amantadine up to a concentration of 100 µg/mL.
DosageView
Parkinson's disease:
- Adult: Initially, 100 mg/day, increased to 100 mg bid after a wk or more. Max dose: 400 mg daily.
- Elderly: >65 yr: Lowest effective dose.
- Adult: 100 mg daily for up to 6 wk; when used with influenza vaccination: only up to 3 wk after vaccination.
- Child: 10-15 yr: 100 mg daily.
- Adult: 100 mg daily for 5 days.
- Elderly: >65 yr: Daily dose of 1 day.
- Adult: 100 mg bid for 14 days, continued for another 14 days if pain persists.
Side effectsView
The adverse effects of Amantadine are generally mild and, when they occur, may diminish or cease after a week or more on the medication. The most commonly reported side effects include nausea, dizziness/ lightheadedness, and insomnia.
Other side effects may include edema of ankles, livedo reticularis; anxiety, elevation of mood, headache, lethargy, hallucinations, ataxia, slurred speech, blurred vision, loss of concentration, nervousness, depression, myalgia, palpitations, orthostatic hypotension, dry mouth, anorexia, constipation and diaphoresis.
Other side effects may include edema of ankles, livedo reticularis; anxiety, elevation of mood, headache, lethargy, hallucinations, ataxia, slurred speech, blurred vision, loss of concentration, nervousness, depression, myalgia, palpitations, orthostatic hypotension, dry mouth, anorexia, constipation and diaphoresis.
ContraindicationsView
Amantadine is contraindicated in patients with known hypersensitivity to the active substances or to any of the excipients.
PrecautionsView
Amantadine should not be discontinued abruptly in patients with Parkinson's disease since a few patients have experienced a parkinsonian crisis, i.e., a sudden marked clinical deterioration, when this medication was suddenly stopped. The dose of anticholinergic drugs or of Amantadine Hydrochloride should be reduced if atropine-like effects appear when these drugs are used concurrently. Abrupt discontinuation may also precipitate delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression and slurred speech.
InteractionsView
Concurrent administration of Amantadine and anticholinergic agents or levodopa may increase confusion, hallucinations, nightmares, gastro-intestinal disturbances, or other atropine-like side effects. Psychotic reactions have been observed in patients receiving Amantadine and Levodopa.
Concurrent administration of Amantadine and drugs or substances (e.g. alcohol) acting on the CNS may result in additive CNS toxicity. Close observation is recommended.
Concurrent administration of Amantadine and drugs or substances (e.g. alcohol) acting on the CNS may result in additive CNS toxicity. Close observation is recommended.
Pregnancy & lactationView
Pregnancy category C. No well-controlled studies have been done in pregnant women to evaluate Amantadine's safety. Amantadine may be used during pregnancy when the potential benefits outweigh the potential but unknown risks to the fetus.
Amantadine is excreted into breast milk in low concentrations. As no information is available on the effects in infants, therefore amantadine should be used cautiously in women who are breastfeeding.
Amantadine is excreted into breast milk in low concentrations. As no information is available on the effects in infants, therefore amantadine should be used cautiously in women who are breastfeeding.
Pediatric usageView
Patients with renal impairment: The dose should be reduced. This can be achieved by either reducing the total daily dose, or by increasing the dosage interval in accordance with the creatinine clearance. For example:
- CrCl <15 ml/min: Contraindicated
- CrCl 15-35 ml/min: 100 mg every 2 to 3 days
- CrCl >35 ml/min: 100mg every day
StorageView
Store at 20-25°C in dry place. Protect from light.
Amarin
Pheniramine Maleate
Amarin
Pheniramine Maleate
Indications
Motion sickness
Indication detailsView
Pheniramine Maleate is indicated for-
- Allergic conditions including hay fever, drug rashes, angioneurotic edema, serum sickness, allergic conjunctivitis, food allergy etc.
- Conditions of the respiratory tract that are accompanied by increased secretion, including vasomotor rhinitis and acute rhinitis.
- All itching skin conditions, including neurodermatitis, eczema of any origin, lichen planus, acute and chronic urticaria, pruritis of the anus or genitals, pruritus in icterus and diabetes, radiation sickness etc.
- Prevention and treatment of motion sickness.
- Prevention and treatment of nausea, vomiting and vertigo due to Meniere’s disease and other labyrinthine disturbances.
Therapeutic classView
Sedating Anti-histamine
PharmacologyView
Pheniramine competes with histamine for the histamine H1 receptor, acting as an inverse agonist once bound. The reduction in H1 receptor activity is responsible for reduced itching as well as reduced vasodilation and capillary leakage leading to less redness and edema. This can be seen in the suppression of the histamine-induced wheal (swelling) and flare (vasodilation) response. Inverse agonism of the H1 receptor in the CNS is also responsible for the sedation produced by first-generation antihistamines like pheniramine. The binding of pheniramine to H4 receptors, and subsequent inverse agonism, may also contribute to reduced itching by antagonizing inflammation.
DosageView
Doses must be individually determined in all cases and should be taken with or soon after food. Treatment should be commenced at the lowest possible dose because experience has shown that antihistamines are often effective at low doses. The maximum dose of 3 mg/kg per day should not be exceeded. Elderly patients should use the adult dose with caution.
To prevent travel sickness, it is recommended that the first dose be taken at least 30 minutes before traveling. Due to the risk of drowsiness, the patient should not drive a motor vehicle or operate machinery after taking a dose.
Pheniramine Maleate tablets:
To prevent travel sickness, it is recommended that the first dose be taken at least 30 minutes before traveling. Due to the risk of drowsiness, the patient should not drive a motor vehicle or operate machinery after taking a dose.
Pheniramine Maleate tablets:
- In adults and children over 10 years of age: Treatment is commenced with half a tablet taken up to three times daily. This dose may be increased to one tablet taken up to three times daily if required.
- Children 5-10 years of age: Half a tablet up to three times daily. Pheniramine Maleate tablets are not recommended in children under 5 years of age.
Side effectsView
The most common adverse reaction is sedation, which often disappears after a few days if tolerance is acquired. Hypersensitivity reactions have been reported.
- Central Nervous System: Lassitude, dizziness, tinnitus, inability to concentrate, incoordination, irritability, insomnia and tremors. Agitation and convulsions, especially in children and restlessness, disorientation and hallucinations in adults, are common symptoms following overdose.
- Gastrointestinal: Nausea, vomiting, diarrhoea, colic, epigastric pain, anorexia, dryness of mouth and constipation.
- Genitourinary: Urinary retention.
- Cardiovascular: Palpitations, headache.
- Ocular: Blurred vision, increased intraocular pressure.
- Musculoskeletal: Muscular weakness.
- Haematological: Rare cases of blood dyscrasias including agranulocytosis and haemolytic anaemia have been reported.
ContraindicationsView
- Patients with hypersensitivity to pheniramine or any other ingredient (eg. Methyl hydroxybenzoate or propyl hydroxybenzoate in the syrup).
- Patients with symptomatic prostatic hypertrophy.
- Patients receiving MAO-inhibitor therapy.
- Newborn and premature infants.
PrecautionsView
- Pheniramine Maleate may cause drowsiness. Both the dosage and the time of administration should be carefully considered in patients whose activities (e.g. driving a car or operating machinery) demand special concentration.
- Patients should be cautioned against the simultaneous ingestion of alcohol and other central nervous system depressants. Pheniramine Maleate may possibly be hallucinogenic in toxic doses. Due to the possible CNS stimulating effects of antihistamines, pheniramine has the potential for abuse.
- Due to the anticholinergic effect of pheniramine, caution and close monitoring are required if it is used in patients with conditions such as prostatic hypertrophy, narrow angle glaucoma, asthma or severe cardiovascular disease.
- The anti-emetic effect of pheniramine may mask the signs of other conditions. Products containing pheniramine should not be taken on an empty stomach.
InteractionsView
- MAO-inhibitors may prolong and intensify the anticholinergic effect of pheniramine (see Contraindications).
- Adverse CNS effects of pheniramine may be enhanced when it is taken with alcohol or other CNS depressants (eg. hypnotics, sedatives, tranquilizers).
- Atropine and related drugs may enhance the anticholinergic activity of pheniramine.
Pregnancy & lactationView
pregnancy Category A. Use only if strictly indicated. Use only if strictly indicated.
Overdose effectsView
Symptoms: Antihistamine drugs in toxic doses produce a complex of CNS excitatory and depressant effects. Accidental ingestion in small children has resulted in convulsions and sometimes death.
Management: As there is no specific antidote, treatment should be symptomatic and supportive. Induction of vomiting should only be used immediately after ingestion as the sedative action of any absorbed antihistamine can lead to life-threatening pulmonary aspiration during emesis. Gastric lavage with a cuffed endotracheal tube in situ may be useful for some time after ingestion of antihistamines as their anticholinergic action slows down gastric emptying. Stimulants should not be used as they may precipitate convulsions. Diazepam or short-acting barbiturates may be used to control convulsions. Vasopressors may be used to treat hypotension. Mechanical support of respiration may be required if respiration is seriously depressed. Continuous ECG monitoring is recommended if cardiac toxicity develops, which can be treated with centrally-acting anticholinesterases such as physostigmine.
Management: As there is no specific antidote, treatment should be symptomatic and supportive. Induction of vomiting should only be used immediately after ingestion as the sedative action of any absorbed antihistamine can lead to life-threatening pulmonary aspiration during emesis. Gastric lavage with a cuffed endotracheal tube in situ may be useful for some time after ingestion of antihistamines as their anticholinergic action slows down gastric emptying. Stimulants should not be used as they may precipitate convulsions. Diazepam or short-acting barbiturates may be used to control convulsions. Vasopressors may be used to treat hypotension. Mechanical support of respiration may be required if respiration is seriously depressed. Continuous ECG monitoring is recommended if cardiac toxicity develops, which can be treated with centrally-acting anticholinesterases such as physostigmine.
StorageView
Store in a cool and dry place, protected from light. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.
Amarin
Pheniramine Maleate
Amarin
Pheniramine Maleate
Indications
Motion sickness
Indication detailsView
Pheniramine Maleate is indicated for-
- Allergic conditions including hay fever, drug rashes, angioneurotic edema, serum sickness, allergic conjunctivitis, food allergy etc.
- Conditions of the respiratory tract that are accompanied by increased secretion, including vasomotor rhinitis and acute rhinitis.
- All itching skin conditions, including neurodermatitis, eczema of any origin, lichen planus, acute and chronic urticaria, pruritis of the anus or genitals, pruritus in icterus and diabetes, radiation sickness etc.
- Prevention and treatment of motion sickness.
- Prevention and treatment of nausea, vomiting and vertigo due to Meniere’s disease and other labyrinthine disturbances.
Therapeutic classView
Sedating Anti-histamine
PharmacologyView
Pheniramine competes with histamine for the histamine H1 receptor, acting as an inverse agonist once bound. The reduction in H1 receptor activity is responsible for reduced itching as well as reduced vasodilation and capillary leakage leading to less redness and edema. This can be seen in the suppression of the histamine-induced wheal (swelling) and flare (vasodilation) response. Inverse agonism of the H1 receptor in the CNS is also responsible for the sedation produced by first-generation antihistamines like pheniramine. The binding of pheniramine to H4 receptors, and subsequent inverse agonism, may also contribute to reduced itching by antagonizing inflammation.
DosageView
Doses must be individually determined in all cases and should be taken with or soon after food. Treatment should be commenced at the lowest possible dose because experience has shown that antihistamines are often effective at low doses. The maximum dose of 3 mg/kg per day should not be exceeded. Elderly patients should use the adult dose with caution.
To prevent travel sickness, it is recommended that the first dose be taken at least 30 minutes before traveling. Due to the risk of drowsiness, the patient should not drive a motor vehicle or operate machinery after taking a dose.
Pheniramine Maleate tablets:
To prevent travel sickness, it is recommended that the first dose be taken at least 30 minutes before traveling. Due to the risk of drowsiness, the patient should not drive a motor vehicle or operate machinery after taking a dose.
Pheniramine Maleate tablets:
- In adults and children over 10 years of age: Treatment is commenced with half a tablet taken up to three times daily. This dose may be increased to one tablet taken up to three times daily if required.
- Children 5-10 years of age: Half a tablet up to three times daily. Pheniramine Maleate tablets are not recommended in children under 5 years of age.
Side effectsView
The most common adverse reaction is sedation, which often disappears after a few days if tolerance is acquired. Hypersensitivity reactions have been reported.
- Central Nervous System: Lassitude, dizziness, tinnitus, inability to concentrate, incoordination, irritability, insomnia and tremors. Agitation and convulsions, especially in children and restlessness, disorientation and hallucinations in adults, are common symptoms following overdose.
- Gastrointestinal: Nausea, vomiting, diarrhoea, colic, epigastric pain, anorexia, dryness of mouth and constipation.
- Genitourinary: Urinary retention.
- Cardiovascular: Palpitations, headache.
- Ocular: Blurred vision, increased intraocular pressure.
- Musculoskeletal: Muscular weakness.
- Haematological: Rare cases of blood dyscrasias including agranulocytosis and haemolytic anaemia have been reported.
ContraindicationsView
- Patients with hypersensitivity to pheniramine or any other ingredient (eg. Methyl hydroxybenzoate or propyl hydroxybenzoate in the syrup).
- Patients with symptomatic prostatic hypertrophy.
- Patients receiving MAO-inhibitor therapy.
- Newborn and premature infants.
PrecautionsView
- Pheniramine Maleate may cause drowsiness. Both the dosage and the time of administration should be carefully considered in patients whose activities (e.g. driving a car or operating machinery) demand special concentration.
- Patients should be cautioned against the simultaneous ingestion of alcohol and other central nervous system depressants. Pheniramine Maleate may possibly be hallucinogenic in toxic doses. Due to the possible CNS stimulating effects of antihistamines, pheniramine has the potential for abuse.
- Due to the anticholinergic effect of pheniramine, caution and close monitoring are required if it is used in patients with conditions such as prostatic hypertrophy, narrow angle glaucoma, asthma or severe cardiovascular disease.
- The anti-emetic effect of pheniramine may mask the signs of other conditions. Products containing pheniramine should not be taken on an empty stomach.
InteractionsView
- MAO-inhibitors may prolong and intensify the anticholinergic effect of pheniramine (see Contraindications).
- Adverse CNS effects of pheniramine may be enhanced when it is taken with alcohol or other CNS depressants (eg. hypnotics, sedatives, tranquilizers).
- Atropine and related drugs may enhance the anticholinergic activity of pheniramine.
Pregnancy & lactationView
pregnancy Category A. Use only if strictly indicated. Use only if strictly indicated.
Overdose effectsView
Symptoms: Antihistamine drugs in toxic doses produce a complex of CNS excitatory and depressant effects. Accidental ingestion in small children has resulted in convulsions and sometimes death.
Management: As there is no specific antidote, treatment should be symptomatic and supportive. Induction of vomiting should only be used immediately after ingestion as the sedative action of any absorbed antihistamine can lead to life-threatening pulmonary aspiration during emesis. Gastric lavage with a cuffed endotracheal tube in situ may be useful for some time after ingestion of antihistamines as their anticholinergic action slows down gastric emptying. Stimulants should not be used as they may precipitate convulsions. Diazepam or short-acting barbiturates may be used to control convulsions. Vasopressors may be used to treat hypotension. Mechanical support of respiration may be required if respiration is seriously depressed. Continuous ECG monitoring is recommended if cardiac toxicity develops, which can be treated with centrally-acting anticholinesterases such as physostigmine.
Management: As there is no specific antidote, treatment should be symptomatic and supportive. Induction of vomiting should only be used immediately after ingestion as the sedative action of any absorbed antihistamine can lead to life-threatening pulmonary aspiration during emesis. Gastric lavage with a cuffed endotracheal tube in situ may be useful for some time after ingestion of antihistamines as their anticholinergic action slows down gastric emptying. Stimulants should not be used as they may precipitate convulsions. Diazepam or short-acting barbiturates may be used to control convulsions. Vasopressors may be used to treat hypotension. Mechanical support of respiration may be required if respiration is seriously depressed. Continuous ECG monitoring is recommended if cardiac toxicity develops, which can be treated with centrally-acting anticholinesterases such as physostigmine.
StorageView
Store in a cool and dry place, protected from light. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.
Amarin
Pheniramine Maleate
Amarin
Pheniramine Maleate
Indications
Motion sickness
Indication detailsView
Pheniramine Maleate is indicated for-
- Allergic conditions including hay fever, drug rashes, angioneurotic edema, serum sickness, allergic conjunctivitis, food allergy etc.
- Conditions of the respiratory tract that are accompanied by increased secretion, including vasomotor rhinitis and acute rhinitis.
- All itching skin conditions, including neurodermatitis, eczema of any origin, lichen planus, acute and chronic urticaria, pruritis of the anus or genitals, pruritus in icterus and diabetes, radiation sickness etc.
- Prevention and treatment of motion sickness.
- Prevention and treatment of nausea, vomiting and vertigo due to Meniere’s disease and other labyrinthine disturbances.
Therapeutic classView
Sedating Anti-histamine
PharmacologyView
Pheniramine competes with histamine for the histamine H1 receptor, acting as an inverse agonist once bound. The reduction in H1 receptor activity is responsible for reduced itching as well as reduced vasodilation and capillary leakage leading to less redness and edema. This can be seen in the suppression of the histamine-induced wheal (swelling) and flare (vasodilation) response. Inverse agonism of the H1 receptor in the CNS is also responsible for the sedation produced by first-generation antihistamines like pheniramine. The binding of pheniramine to H4 receptors, and subsequent inverse agonism, may also contribute to reduced itching by antagonizing inflammation.
DosageView
Doses must be individually determined in all cases and should be taken with or soon after food. Treatment should be commenced at the lowest possible dose because experience has shown that antihistamines are often effective at low doses. The maximum dose of 3 mg/kg per day should not be exceeded. Elderly patients should use the adult dose with caution.
To prevent travel sickness, it is recommended that the first dose be taken at least 30 minutes before traveling. Due to the risk of drowsiness, the patient should not drive a motor vehicle or operate machinery after taking a dose.
Pheniramine Maleate tablets:
To prevent travel sickness, it is recommended that the first dose be taken at least 30 minutes before traveling. Due to the risk of drowsiness, the patient should not drive a motor vehicle or operate machinery after taking a dose.
Pheniramine Maleate tablets:
- In adults and children over 10 years of age: Treatment is commenced with half a tablet taken up to three times daily. This dose may be increased to one tablet taken up to three times daily if required.
- Children 5-10 years of age: Half a tablet up to three times daily. Pheniramine Maleate tablets are not recommended in children under 5 years of age.
Side effectsView
The most common adverse reaction is sedation, which often disappears after a few days if tolerance is acquired. Hypersensitivity reactions have been reported.
- Central Nervous System: Lassitude, dizziness, tinnitus, inability to concentrate, incoordination, irritability, insomnia and tremors. Agitation and convulsions, especially in children and restlessness, disorientation and hallucinations in adults, are common symptoms following overdose.
- Gastrointestinal: Nausea, vomiting, diarrhoea, colic, epigastric pain, anorexia, dryness of mouth and constipation.
- Genitourinary: Urinary retention.
- Cardiovascular: Palpitations, headache.
- Ocular: Blurred vision, increased intraocular pressure.
- Musculoskeletal: Muscular weakness.
- Haematological: Rare cases of blood dyscrasias including agranulocytosis and haemolytic anaemia have been reported.
ContraindicationsView
- Patients with hypersensitivity to pheniramine or any other ingredient (eg. Methyl hydroxybenzoate or propyl hydroxybenzoate in the syrup).
- Patients with symptomatic prostatic hypertrophy.
- Patients receiving MAO-inhibitor therapy.
- Newborn and premature infants.
PrecautionsView
- Pheniramine Maleate may cause drowsiness. Both the dosage and the time of administration should be carefully considered in patients whose activities (e.g. driving a car or operating machinery) demand special concentration.
- Patients should be cautioned against the simultaneous ingestion of alcohol and other central nervous system depressants. Pheniramine Maleate may possibly be hallucinogenic in toxic doses. Due to the possible CNS stimulating effects of antihistamines, pheniramine has the potential for abuse.
- Due to the anticholinergic effect of pheniramine, caution and close monitoring are required if it is used in patients with conditions such as prostatic hypertrophy, narrow angle glaucoma, asthma or severe cardiovascular disease.
- The anti-emetic effect of pheniramine may mask the signs of other conditions. Products containing pheniramine should not be taken on an empty stomach.
InteractionsView
- MAO-inhibitors may prolong and intensify the anticholinergic effect of pheniramine (see Contraindications).
- Adverse CNS effects of pheniramine may be enhanced when it is taken with alcohol or other CNS depressants (eg. hypnotics, sedatives, tranquilizers).
- Atropine and related drugs may enhance the anticholinergic activity of pheniramine.
Pregnancy & lactationView
pregnancy Category A. Use only if strictly indicated. Use only if strictly indicated.
Overdose effectsView
Symptoms: Antihistamine drugs in toxic doses produce a complex of CNS excitatory and depressant effects. Accidental ingestion in small children has resulted in convulsions and sometimes death.
Management: As there is no specific antidote, treatment should be symptomatic and supportive. Induction of vomiting should only be used immediately after ingestion as the sedative action of any absorbed antihistamine can lead to life-threatening pulmonary aspiration during emesis. Gastric lavage with a cuffed endotracheal tube in situ may be useful for some time after ingestion of antihistamines as their anticholinergic action slows down gastric emptying. Stimulants should not be used as they may precipitate convulsions. Diazepam or short-acting barbiturates may be used to control convulsions. Vasopressors may be used to treat hypotension. Mechanical support of respiration may be required if respiration is seriously depressed. Continuous ECG monitoring is recommended if cardiac toxicity develops, which can be treated with centrally-acting anticholinesterases such as physostigmine.
Management: As there is no specific antidote, treatment should be symptomatic and supportive. Induction of vomiting should only be used immediately after ingestion as the sedative action of any absorbed antihistamine can lead to life-threatening pulmonary aspiration during emesis. Gastric lavage with a cuffed endotracheal tube in situ may be useful for some time after ingestion of antihistamines as their anticholinergic action slows down gastric emptying. Stimulants should not be used as they may precipitate convulsions. Diazepam or short-acting barbiturates may be used to control convulsions. Vasopressors may be used to treat hypotension. Mechanical support of respiration may be required if respiration is seriously depressed. Continuous ECG monitoring is recommended if cardiac toxicity develops, which can be treated with centrally-acting anticholinesterases such as physostigmine.
StorageView
Store in a cool and dry place, protected from light. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.
Amaryl
Glimepiride
Amaryl
Glimepiride
Indications
Type 2 DM
Indication detailsView
Glimepiride is indicated in following conditions-
- Glimepiride is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin dependent (Type II) diabetes mellitus (NIDDM) whose hyperglycaemia cannot be controlled by diet and exercise alone.
- Glimepiride may be used concomitantly with metformin when diet, exercise, and Glimepiride or metformin alone does not result in adequate glycaemic control.
- Glimepiride is also indicated for use in combination with insulin to lower blood glucose in patients whose hyperglycaemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycaemic agent.
- Combined use of Glimepiride and insulin may increase the potential for hypoglycaemia.
Therapeutic classView
Sulfonylureas
PharmacologyView
Glimepiride is a sulfonylurea antidiabetic agent which decreases blood glucose concentration. The primary mechanism of action of Glimepiride appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. Glimepiride acts in concert with glucose by improving the sensitivity of beta cells to physiological glucose stimulus, resulting in insulin secretion. In addition, extrapancreatic effects like reduction of basal hepatic glucose production, increased peripheral tissue sensitivity to insulin and glucose uptake may also play role in the activity of Glimepiride. In non-fasting diabetic patients, the hypoglycaemic action of a single dose of Glimepiride persists for 24 hours.
DosageView
In principle, the dosage of Glimepiride is governed by the desired blood sugar level. The dosage of Glimepiride must be the lowest which is sufficient to achieve the desired metabolic control. The initial and the maintenance doses are set based on the results of regular check of glucose in blood and urine. Monitoring of glucose levels in blood and urine also serves to detect either primary or secondary failure of therapy.
Initial dose and dose titration: the usual initial dose is 1 mg once daily, if necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of 1 to 2 weeks, and carried out stepwise, as follows: 1 mg -> 2 mg -> 3 mg -> 4 mg -> 6 mg.
Dose in patients with well controlled diabetes: the usual dose range in patients with well controlled diabetes is 1 to 4 mg daily.
Distribution of doses: Timing and distribution of doses are decided by the physician, in consideration of the patient's current life-style. Normally, a single daily dose is sufficient. This should be taken immediately before a substantial breakfast or if none is taken immediately before the first main meal. It is very important not to skip meals after taking the drug.
Secondary dosage adjustment: As control of diabetes improves, sensitivity to insuiin increases; therefore, Glimepiride requirement may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Glimepiride therapy must be considered. A dose adjustment must also be considered whenever the patient's weight or life-styie changes, or other factors arise which cause an increased susceptibility to hypo or hyperglycaemia.
Changeover from other oral antidiabetics to Glimepiride: There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When substituting Glimepiride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from maximum dose of other oral blood sugar lowering agents. Any dose increase should be in accordance with guideline given above in 'initial dose and dose titration'. Consideration must be given to the potency and duration of action of the previous blood sugar lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia.
Initial dose and dose titration: the usual initial dose is 1 mg once daily, if necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of 1 to 2 weeks, and carried out stepwise, as follows: 1 mg -> 2 mg -> 3 mg -> 4 mg -> 6 mg.
Dose in patients with well controlled diabetes: the usual dose range in patients with well controlled diabetes is 1 to 4 mg daily.
Distribution of doses: Timing and distribution of doses are decided by the physician, in consideration of the patient's current life-style. Normally, a single daily dose is sufficient. This should be taken immediately before a substantial breakfast or if none is taken immediately before the first main meal. It is very important not to skip meals after taking the drug.
Secondary dosage adjustment: As control of diabetes improves, sensitivity to insuiin increases; therefore, Glimepiride requirement may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Glimepiride therapy must be considered. A dose adjustment must also be considered whenever the patient's weight or life-styie changes, or other factors arise which cause an increased susceptibility to hypo or hyperglycaemia.
Changeover from other oral antidiabetics to Glimepiride: There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When substituting Glimepiride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from maximum dose of other oral blood sugar lowering agents. Any dose increase should be in accordance with guideline given above in 'initial dose and dose titration'. Consideration must be given to the potency and duration of action of the previous blood sugar lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia.
AdministrationView
Glimepiride tablet must be swallowed with sufficient amount of liquid.
Side effectsView
Hypoglycaemia, temporary visual impairment, nausea, vomiting, diarrhoea, abdominal pain, urticaria, fall in blood pressure.
ContraindicationsView
Glimepiride is not suitable for the treatment of insulin dependent (type I) diabetes mellitus, or for the treatment of diabetic ketoacidosis, nor for the treatment of diabetic coma. Glimepiride must not be used in patients hypersensitive to Glimepiride, other sulfonylureas, other sulfonamides, severe hepatic dysfunction, severe impairment of renal function and dialysis patients.
PrecautionsView
in the initial weeks of treatment, the risk of hypoglycaemia may be increased and necessitates careful monitoring. If such risk present it may be necessary to adjust the dosage of Glimepiride, Hypoglycaemia can almost be promptly controlled by immediate intake of carbohydrates (glucose or sugar).
InteractionsView
Based on experience with Glimepiride and known interactions for other sulfonylureas, the following interactions must be considered.
In addition to insulin and other oral antidiabetic agents, drugs which may potentiate the hypoglycaemic action of Glimepiride include: ACE inhibitors, aminosalicylic acid, anabolic steroids and male sex hormones, azapropazone, chloramphenicol, ciofibrate, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluconazole, fluoxetine, guanethidine, ifosfamide, MAO-inhibitors, miconazole, oxpentifylline (high dose parenteral), oxyphenbutazone, para-aminosalicylic acid, phenylbutazone, probenecid, quinolones, salicylates, sulphinpyrazone, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide.
Drugs which may attenuate the hypoglycaemic action of Glimepiride include:
In addition to insulin and other oral antidiabetic agents, drugs which may potentiate the hypoglycaemic action of Glimepiride include: ACE inhibitors, aminosalicylic acid, anabolic steroids and male sex hormones, azapropazone, chloramphenicol, ciofibrate, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluconazole, fluoxetine, guanethidine, ifosfamide, MAO-inhibitors, miconazole, oxpentifylline (high dose parenteral), oxyphenbutazone, para-aminosalicylic acid, phenylbutazone, probenecid, quinolones, salicylates, sulphinpyrazone, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide.
Drugs which may attenuate the hypoglycaemic action of Glimepiride include:
- Acetazoiamide, barbiturates, calcium channel blockers, corticosteroids, diazoxide, diuretics, glucagon, isoniazid, laxatives, nicotinic acid (high doses), oestrogens, phenothiazines, phenytoin, progestagens, rifampicin, sympathomimetic agents, thyroid hormones.
- H2 receptor antagonists, beta-blockers, clonidine and reserpine may lead to either potentiation or weakening of the blood-glucose-lowering effect.
- Concomitant treatment with a beta-receptor blocker, clonidine, guanethidine or reserpine may mask the warning symptoms of a hypoglycaemic attack.
- Acute and chronic aicohol intake may either potentiate or attenuate the activity of Glimepiride in an unpredictable fashion.
Pregnancy & lactationView
Glimepiride must not be taken during pregnancy; a changeover to insulin is necessary. Patients planning a pregnancy must inform their physician, and should change over to insulin. Ingestion of Glimepiride with breast milk feeding may harm the child. Therefore, Glimepiride must not be taken by breastfeeding women. Either a changeover or complete discontinuation of breastfeeding is necessary.
Overdose effectsView
Overdosage of sulfonylureas, including Glimepiride, can produce hypoglycaemia. Mild hypoglycaemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycaemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medicai emergencies requiring immediate hospitalization. If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dl. Patients should be closely monitored for a minimum of 24 to 48 hours, because hypoglycaemia may recur after apparent clinical recovery.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Amaryl
Glimepiride
Amaryl
Glimepiride
Indications
Type 2 DM
Indication detailsView
Glimepiride is indicated in following conditions-
- Glimepiride is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin dependent (Type II) diabetes mellitus (NIDDM) whose hyperglycaemia cannot be controlled by diet and exercise alone.
- Glimepiride may be used concomitantly with metformin when diet, exercise, and Glimepiride or metformin alone does not result in adequate glycaemic control.
- Glimepiride is also indicated for use in combination with insulin to lower blood glucose in patients whose hyperglycaemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycaemic agent.
- Combined use of Glimepiride and insulin may increase the potential for hypoglycaemia.
Therapeutic classView
Sulfonylureas
PharmacologyView
Glimepiride is a sulfonylurea antidiabetic agent which decreases blood glucose concentration. The primary mechanism of action of Glimepiride appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. Glimepiride acts in concert with glucose by improving the sensitivity of beta cells to physiological glucose stimulus, resulting in insulin secretion. In addition, extrapancreatic effects like reduction of basal hepatic glucose production, increased peripheral tissue sensitivity to insulin and glucose uptake may also play role in the activity of Glimepiride. In non-fasting diabetic patients, the hypoglycaemic action of a single dose of Glimepiride persists for 24 hours.
DosageView
In principle, the dosage of Glimepiride is governed by the desired blood sugar level. The dosage of Glimepiride must be the lowest which is sufficient to achieve the desired metabolic control. The initial and the maintenance doses are set based on the results of regular check of glucose in blood and urine. Monitoring of glucose levels in blood and urine also serves to detect either primary or secondary failure of therapy.
Initial dose and dose titration: the usual initial dose is 1 mg once daily, if necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of 1 to 2 weeks, and carried out stepwise, as follows: 1 mg -> 2 mg -> 3 mg -> 4 mg -> 6 mg.
Dose in patients with well controlled diabetes: the usual dose range in patients with well controlled diabetes is 1 to 4 mg daily.
Distribution of doses: Timing and distribution of doses are decided by the physician, in consideration of the patient's current life-style. Normally, a single daily dose is sufficient. This should be taken immediately before a substantial breakfast or if none is taken immediately before the first main meal. It is very important not to skip meals after taking the drug.
Secondary dosage adjustment: As control of diabetes improves, sensitivity to insuiin increases; therefore, Glimepiride requirement may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Glimepiride therapy must be considered. A dose adjustment must also be considered whenever the patient's weight or life-styie changes, or other factors arise which cause an increased susceptibility to hypo or hyperglycaemia.
Changeover from other oral antidiabetics to Glimepiride: There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When substituting Glimepiride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from maximum dose of other oral blood sugar lowering agents. Any dose increase should be in accordance with guideline given above in 'initial dose and dose titration'. Consideration must be given to the potency and duration of action of the previous blood sugar lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia.
Initial dose and dose titration: the usual initial dose is 1 mg once daily, if necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of 1 to 2 weeks, and carried out stepwise, as follows: 1 mg -> 2 mg -> 3 mg -> 4 mg -> 6 mg.
Dose in patients with well controlled diabetes: the usual dose range in patients with well controlled diabetes is 1 to 4 mg daily.
Distribution of doses: Timing and distribution of doses are decided by the physician, in consideration of the patient's current life-style. Normally, a single daily dose is sufficient. This should be taken immediately before a substantial breakfast or if none is taken immediately before the first main meal. It is very important not to skip meals after taking the drug.
Secondary dosage adjustment: As control of diabetes improves, sensitivity to insuiin increases; therefore, Glimepiride requirement may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Glimepiride therapy must be considered. A dose adjustment must also be considered whenever the patient's weight or life-styie changes, or other factors arise which cause an increased susceptibility to hypo or hyperglycaemia.
Changeover from other oral antidiabetics to Glimepiride: There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When substituting Glimepiride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from maximum dose of other oral blood sugar lowering agents. Any dose increase should be in accordance with guideline given above in 'initial dose and dose titration'. Consideration must be given to the potency and duration of action of the previous blood sugar lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia.
AdministrationView
Glimepiride tablet must be swallowed with sufficient amount of liquid.
Side effectsView
Hypoglycaemia, temporary visual impairment, nausea, vomiting, diarrhoea, abdominal pain, urticaria, fall in blood pressure.
ContraindicationsView
Glimepiride is not suitable for the treatment of insulin dependent (type I) diabetes mellitus, or for the treatment of diabetic ketoacidosis, nor for the treatment of diabetic coma. Glimepiride must not be used in patients hypersensitive to Glimepiride, other sulfonylureas, other sulfonamides, severe hepatic dysfunction, severe impairment of renal function and dialysis patients.
PrecautionsView
in the initial weeks of treatment, the risk of hypoglycaemia may be increased and necessitates careful monitoring. If such risk present it may be necessary to adjust the dosage of Glimepiride, Hypoglycaemia can almost be promptly controlled by immediate intake of carbohydrates (glucose or sugar).
InteractionsView
Based on experience with Glimepiride and known interactions for other sulfonylureas, the following interactions must be considered.
In addition to insulin and other oral antidiabetic agents, drugs which may potentiate the hypoglycaemic action of Glimepiride include: ACE inhibitors, aminosalicylic acid, anabolic steroids and male sex hormones, azapropazone, chloramphenicol, ciofibrate, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluconazole, fluoxetine, guanethidine, ifosfamide, MAO-inhibitors, miconazole, oxpentifylline (high dose parenteral), oxyphenbutazone, para-aminosalicylic acid, phenylbutazone, probenecid, quinolones, salicylates, sulphinpyrazone, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide.
Drugs which may attenuate the hypoglycaemic action of Glimepiride include:
In addition to insulin and other oral antidiabetic agents, drugs which may potentiate the hypoglycaemic action of Glimepiride include: ACE inhibitors, aminosalicylic acid, anabolic steroids and male sex hormones, azapropazone, chloramphenicol, ciofibrate, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluconazole, fluoxetine, guanethidine, ifosfamide, MAO-inhibitors, miconazole, oxpentifylline (high dose parenteral), oxyphenbutazone, para-aminosalicylic acid, phenylbutazone, probenecid, quinolones, salicylates, sulphinpyrazone, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide.
Drugs which may attenuate the hypoglycaemic action of Glimepiride include:
- Acetazoiamide, barbiturates, calcium channel blockers, corticosteroids, diazoxide, diuretics, glucagon, isoniazid, laxatives, nicotinic acid (high doses), oestrogens, phenothiazines, phenytoin, progestagens, rifampicin, sympathomimetic agents, thyroid hormones.
- H2 receptor antagonists, beta-blockers, clonidine and reserpine may lead to either potentiation or weakening of the blood-glucose-lowering effect.
- Concomitant treatment with a beta-receptor blocker, clonidine, guanethidine or reserpine may mask the warning symptoms of a hypoglycaemic attack.
- Acute and chronic aicohol intake may either potentiate or attenuate the activity of Glimepiride in an unpredictable fashion.
Pregnancy & lactationView
Glimepiride must not be taken during pregnancy; a changeover to insulin is necessary. Patients planning a pregnancy must inform their physician, and should change over to insulin. Ingestion of Glimepiride with breast milk feeding may harm the child. Therefore, Glimepiride must not be taken by breastfeeding women. Either a changeover or complete discontinuation of breastfeeding is necessary.
Overdose effectsView
Overdosage of sulfonylureas, including Glimepiride, can produce hypoglycaemia. Mild hypoglycaemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycaemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medicai emergencies requiring immediate hospitalization. If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dl. Patients should be closely monitored for a minimum of 24 to 48 hours, because hypoglycaemia may recur after apparent clinical recovery.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Amaryl
Glimepiride
Amaryl
Glimepiride
Indications
Type 2 DM
Indication detailsView
Glimepiride is indicated in following conditions-
- Glimepiride is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin dependent (Type II) diabetes mellitus (NIDDM) whose hyperglycaemia cannot be controlled by diet and exercise alone.
- Glimepiride may be used concomitantly with metformin when diet, exercise, and Glimepiride or metformin alone does not result in adequate glycaemic control.
- Glimepiride is also indicated for use in combination with insulin to lower blood glucose in patients whose hyperglycaemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycaemic agent.
- Combined use of Glimepiride and insulin may increase the potential for hypoglycaemia.
Therapeutic classView
Sulfonylureas
PharmacologyView
Glimepiride is a sulfonylurea antidiabetic agent which decreases blood glucose concentration. The primary mechanism of action of Glimepiride appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. Glimepiride acts in concert with glucose by improving the sensitivity of beta cells to physiological glucose stimulus, resulting in insulin secretion. In addition, extrapancreatic effects like reduction of basal hepatic glucose production, increased peripheral tissue sensitivity to insulin and glucose uptake may also play role in the activity of Glimepiride. In non-fasting diabetic patients, the hypoglycaemic action of a single dose of Glimepiride persists for 24 hours.
DosageView
In principle, the dosage of Glimepiride is governed by the desired blood sugar level. The dosage of Glimepiride must be the lowest which is sufficient to achieve the desired metabolic control. The initial and the maintenance doses are set based on the results of regular check of glucose in blood and urine. Monitoring of glucose levels in blood and urine also serves to detect either primary or secondary failure of therapy.
Initial dose and dose titration: the usual initial dose is 1 mg once daily, if necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of 1 to 2 weeks, and carried out stepwise, as follows: 1 mg -> 2 mg -> 3 mg -> 4 mg -> 6 mg.
Dose in patients with well controlled diabetes: the usual dose range in patients with well controlled diabetes is 1 to 4 mg daily.
Distribution of doses: Timing and distribution of doses are decided by the physician, in consideration of the patient's current life-style. Normally, a single daily dose is sufficient. This should be taken immediately before a substantial breakfast or if none is taken immediately before the first main meal. It is very important not to skip meals after taking the drug.
Secondary dosage adjustment: As control of diabetes improves, sensitivity to insuiin increases; therefore, Glimepiride requirement may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Glimepiride therapy must be considered. A dose adjustment must also be considered whenever the patient's weight or life-styie changes, or other factors arise which cause an increased susceptibility to hypo or hyperglycaemia.
Changeover from other oral antidiabetics to Glimepiride: There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When substituting Glimepiride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from maximum dose of other oral blood sugar lowering agents. Any dose increase should be in accordance with guideline given above in 'initial dose and dose titration'. Consideration must be given to the potency and duration of action of the previous blood sugar lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia.
Initial dose and dose titration: the usual initial dose is 1 mg once daily, if necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of 1 to 2 weeks, and carried out stepwise, as follows: 1 mg -> 2 mg -> 3 mg -> 4 mg -> 6 mg.
Dose in patients with well controlled diabetes: the usual dose range in patients with well controlled diabetes is 1 to 4 mg daily.
Distribution of doses: Timing and distribution of doses are decided by the physician, in consideration of the patient's current life-style. Normally, a single daily dose is sufficient. This should be taken immediately before a substantial breakfast or if none is taken immediately before the first main meal. It is very important not to skip meals after taking the drug.
Secondary dosage adjustment: As control of diabetes improves, sensitivity to insuiin increases; therefore, Glimepiride requirement may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Glimepiride therapy must be considered. A dose adjustment must also be considered whenever the patient's weight or life-styie changes, or other factors arise which cause an increased susceptibility to hypo or hyperglycaemia.
Changeover from other oral antidiabetics to Glimepiride: There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When substituting Glimepiride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from maximum dose of other oral blood sugar lowering agents. Any dose increase should be in accordance with guideline given above in 'initial dose and dose titration'. Consideration must be given to the potency and duration of action of the previous blood sugar lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia.
AdministrationView
Glimepiride tablet must be swallowed with sufficient amount of liquid.
Side effectsView
Hypoglycaemia, temporary visual impairment, nausea, vomiting, diarrhoea, abdominal pain, urticaria, fall in blood pressure.
ContraindicationsView
Glimepiride is not suitable for the treatment of insulin dependent (type I) diabetes mellitus, or for the treatment of diabetic ketoacidosis, nor for the treatment of diabetic coma. Glimepiride must not be used in patients hypersensitive to Glimepiride, other sulfonylureas, other sulfonamides, severe hepatic dysfunction, severe impairment of renal function and dialysis patients.
PrecautionsView
in the initial weeks of treatment, the risk of hypoglycaemia may be increased and necessitates careful monitoring. If such risk present it may be necessary to adjust the dosage of Glimepiride, Hypoglycaemia can almost be promptly controlled by immediate intake of carbohydrates (glucose or sugar).
InteractionsView
Based on experience with Glimepiride and known interactions for other sulfonylureas, the following interactions must be considered.
In addition to insulin and other oral antidiabetic agents, drugs which may potentiate the hypoglycaemic action of Glimepiride include: ACE inhibitors, aminosalicylic acid, anabolic steroids and male sex hormones, azapropazone, chloramphenicol, ciofibrate, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluconazole, fluoxetine, guanethidine, ifosfamide, MAO-inhibitors, miconazole, oxpentifylline (high dose parenteral), oxyphenbutazone, para-aminosalicylic acid, phenylbutazone, probenecid, quinolones, salicylates, sulphinpyrazone, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide.
Drugs which may attenuate the hypoglycaemic action of Glimepiride include:
In addition to insulin and other oral antidiabetic agents, drugs which may potentiate the hypoglycaemic action of Glimepiride include: ACE inhibitors, aminosalicylic acid, anabolic steroids and male sex hormones, azapropazone, chloramphenicol, ciofibrate, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluconazole, fluoxetine, guanethidine, ifosfamide, MAO-inhibitors, miconazole, oxpentifylline (high dose parenteral), oxyphenbutazone, para-aminosalicylic acid, phenylbutazone, probenecid, quinolones, salicylates, sulphinpyrazone, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide.
Drugs which may attenuate the hypoglycaemic action of Glimepiride include:
- Acetazoiamide, barbiturates, calcium channel blockers, corticosteroids, diazoxide, diuretics, glucagon, isoniazid, laxatives, nicotinic acid (high doses), oestrogens, phenothiazines, phenytoin, progestagens, rifampicin, sympathomimetic agents, thyroid hormones.
- H2 receptor antagonists, beta-blockers, clonidine and reserpine may lead to either potentiation or weakening of the blood-glucose-lowering effect.
- Concomitant treatment with a beta-receptor blocker, clonidine, guanethidine or reserpine may mask the warning symptoms of a hypoglycaemic attack.
- Acute and chronic aicohol intake may either potentiate or attenuate the activity of Glimepiride in an unpredictable fashion.
Pregnancy & lactationView
Glimepiride must not be taken during pregnancy; a changeover to insulin is necessary. Patients planning a pregnancy must inform their physician, and should change over to insulin. Ingestion of Glimepiride with breast milk feeding may harm the child. Therefore, Glimepiride must not be taken by breastfeeding women. Either a changeover or complete discontinuation of breastfeeding is necessary.
Overdose effectsView
Overdosage of sulfonylureas, including Glimepiride, can produce hypoglycaemia. Mild hypoglycaemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycaemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medicai emergencies requiring immediate hospitalization. If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dl. Patients should be closely monitored for a minimum of 24 to 48 hours, because hypoglycaemia may recur after apparent clinical recovery.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Amaryl
Glimepiride
Amaryl
Glimepiride
Indications
Type 2 DM
Indication detailsView
Glimepiride is indicated in following conditions-
- Glimepiride is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin dependent (Type II) diabetes mellitus (NIDDM) whose hyperglycaemia cannot be controlled by diet and exercise alone.
- Glimepiride may be used concomitantly with metformin when diet, exercise, and Glimepiride or metformin alone does not result in adequate glycaemic control.
- Glimepiride is also indicated for use in combination with insulin to lower blood glucose in patients whose hyperglycaemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycaemic agent.
- Combined use of Glimepiride and insulin may increase the potential for hypoglycaemia.
Therapeutic classView
Sulfonylureas
PharmacologyView
Glimepiride is a sulfonylurea antidiabetic agent which decreases blood glucose concentration. The primary mechanism of action of Glimepiride appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. Glimepiride acts in concert with glucose by improving the sensitivity of beta cells to physiological glucose stimulus, resulting in insulin secretion. In addition, extrapancreatic effects like reduction of basal hepatic glucose production, increased peripheral tissue sensitivity to insulin and glucose uptake may also play role in the activity of Glimepiride. In non-fasting diabetic patients, the hypoglycaemic action of a single dose of Glimepiride persists for 24 hours.
DosageView
In principle, the dosage of Glimepiride is governed by the desired blood sugar level. The dosage of Glimepiride must be the lowest which is sufficient to achieve the desired metabolic control. The initial and the maintenance doses are set based on the results of regular check of glucose in blood and urine. Monitoring of glucose levels in blood and urine also serves to detect either primary or secondary failure of therapy.
Initial dose and dose titration: the usual initial dose is 1 mg once daily, if necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of 1 to 2 weeks, and carried out stepwise, as follows: 1 mg -> 2 mg -> 3 mg -> 4 mg -> 6 mg.
Dose in patients with well controlled diabetes: the usual dose range in patients with well controlled diabetes is 1 to 4 mg daily.
Distribution of doses: Timing and distribution of doses are decided by the physician, in consideration of the patient's current life-style. Normally, a single daily dose is sufficient. This should be taken immediately before a substantial breakfast or if none is taken immediately before the first main meal. It is very important not to skip meals after taking the drug.
Secondary dosage adjustment: As control of diabetes improves, sensitivity to insuiin increases; therefore, Glimepiride requirement may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Glimepiride therapy must be considered. A dose adjustment must also be considered whenever the patient's weight or life-styie changes, or other factors arise which cause an increased susceptibility to hypo or hyperglycaemia.
Changeover from other oral antidiabetics to Glimepiride: There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When substituting Glimepiride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from maximum dose of other oral blood sugar lowering agents. Any dose increase should be in accordance with guideline given above in 'initial dose and dose titration'. Consideration must be given to the potency and duration of action of the previous blood sugar lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia.
Initial dose and dose titration: the usual initial dose is 1 mg once daily, if necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of 1 to 2 weeks, and carried out stepwise, as follows: 1 mg -> 2 mg -> 3 mg -> 4 mg -> 6 mg.
Dose in patients with well controlled diabetes: the usual dose range in patients with well controlled diabetes is 1 to 4 mg daily.
Distribution of doses: Timing and distribution of doses are decided by the physician, in consideration of the patient's current life-style. Normally, a single daily dose is sufficient. This should be taken immediately before a substantial breakfast or if none is taken immediately before the first main meal. It is very important not to skip meals after taking the drug.
Secondary dosage adjustment: As control of diabetes improves, sensitivity to insuiin increases; therefore, Glimepiride requirement may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Glimepiride therapy must be considered. A dose adjustment must also be considered whenever the patient's weight or life-styie changes, or other factors arise which cause an increased susceptibility to hypo or hyperglycaemia.
Changeover from other oral antidiabetics to Glimepiride: There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When substituting Glimepiride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from maximum dose of other oral blood sugar lowering agents. Any dose increase should be in accordance with guideline given above in 'initial dose and dose titration'. Consideration must be given to the potency and duration of action of the previous blood sugar lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia.
AdministrationView
Glimepiride tablet must be swallowed with sufficient amount of liquid.
Side effectsView
Hypoglycaemia, temporary visual impairment, nausea, vomiting, diarrhoea, abdominal pain, urticaria, fall in blood pressure.
ContraindicationsView
Glimepiride is not suitable for the treatment of insulin dependent (type I) diabetes mellitus, or for the treatment of diabetic ketoacidosis, nor for the treatment of diabetic coma. Glimepiride must not be used in patients hypersensitive to Glimepiride, other sulfonylureas, other sulfonamides, severe hepatic dysfunction, severe impairment of renal function and dialysis patients.
PrecautionsView
in the initial weeks of treatment, the risk of hypoglycaemia may be increased and necessitates careful monitoring. If such risk present it may be necessary to adjust the dosage of Glimepiride, Hypoglycaemia can almost be promptly controlled by immediate intake of carbohydrates (glucose or sugar).
InteractionsView
Based on experience with Glimepiride and known interactions for other sulfonylureas, the following interactions must be considered.
In addition to insulin and other oral antidiabetic agents, drugs which may potentiate the hypoglycaemic action of Glimepiride include: ACE inhibitors, aminosalicylic acid, anabolic steroids and male sex hormones, azapropazone, chloramphenicol, ciofibrate, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluconazole, fluoxetine, guanethidine, ifosfamide, MAO-inhibitors, miconazole, oxpentifylline (high dose parenteral), oxyphenbutazone, para-aminosalicylic acid, phenylbutazone, probenecid, quinolones, salicylates, sulphinpyrazone, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide.
Drugs which may attenuate the hypoglycaemic action of Glimepiride include:
In addition to insulin and other oral antidiabetic agents, drugs which may potentiate the hypoglycaemic action of Glimepiride include: ACE inhibitors, aminosalicylic acid, anabolic steroids and male sex hormones, azapropazone, chloramphenicol, ciofibrate, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluconazole, fluoxetine, guanethidine, ifosfamide, MAO-inhibitors, miconazole, oxpentifylline (high dose parenteral), oxyphenbutazone, para-aminosalicylic acid, phenylbutazone, probenecid, quinolones, salicylates, sulphinpyrazone, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide.
Drugs which may attenuate the hypoglycaemic action of Glimepiride include:
- Acetazoiamide, barbiturates, calcium channel blockers, corticosteroids, diazoxide, diuretics, glucagon, isoniazid, laxatives, nicotinic acid (high doses), oestrogens, phenothiazines, phenytoin, progestagens, rifampicin, sympathomimetic agents, thyroid hormones.
- H2 receptor antagonists, beta-blockers, clonidine and reserpine may lead to either potentiation or weakening of the blood-glucose-lowering effect.
- Concomitant treatment with a beta-receptor blocker, clonidine, guanethidine or reserpine may mask the warning symptoms of a hypoglycaemic attack.
- Acute and chronic aicohol intake may either potentiate or attenuate the activity of Glimepiride in an unpredictable fashion.
Pregnancy & lactationView
Glimepiride must not be taken during pregnancy; a changeover to insulin is necessary. Patients planning a pregnancy must inform their physician, and should change over to insulin. Ingestion of Glimepiride with breast milk feeding may harm the child. Therefore, Glimepiride must not be taken by breastfeeding women. Either a changeover or complete discontinuation of breastfeeding is necessary.
Overdose effectsView
Overdosage of sulfonylureas, including Glimepiride, can produce hypoglycaemia. Mild hypoglycaemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycaemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medicai emergencies requiring immediate hospitalization. If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dl. Patients should be closely monitored for a minimum of 24 to 48 hours, because hypoglycaemia may recur after apparent clinical recovery.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Amaryl M
Glimepiride + Metformin
Amaryl M
Glimepiride + Metformin
Indications
Type 2 DM
Indication detailsView
This tablet is indicated as an adjunct to diet and exercise in type 2 diabetes mellitus patients-
- In case that the monotherapy with glimepiride or metformin does not result in adequate glycemic control.
- Replacement of combination therapy of glimepiride and metformin.
Therapeutic classView
Combination Oral hypoglycemic preparations
PharmacologyView
Glimepiride is a sulfonylurea antidiabetic agent which decreases blood glucose concentration. The primary mechanism of action of Glimepiride appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. Glimepiride acts in concert with glucose by improving the sensitivity of beta cells to physiological glucose stimulus, resulting in insulin secretion. In addition, extrapancreatic effects like reduction of basal hepatic glucose production, increased peripheral tissue sensitivity to insulin and glucose uptake may also play role in the activity of Glimepiride. In non-fasting diabetic patients, the hypoglycaemic action of a single dose of Glimepiride persists for 24 hours.
Metformin Hydrochloride 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 Hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
Metformin Hydrochloride 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 Hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
DosageView
- The dosage of this tablet is governed by the desired blood glucose level. The dosage of this tablet must be the lowest which is sufficient to achieve the desired metabolic control. During treatment with this tablet glucose levels in blood and urine must be measured regularly.
- Mistakes, e.g. forgetting to take a dose, must never be corrected by subsequently taking a larger dose.
- As an improvement in control of diabetes is, in itself, associated with higher insulin sensitivity, glimepiride requirements may fall as treatment proceeds. To avoid hypoglycaemia timely dose reduction or cessation of this tablet therapy must therefore be considered.
- The highest recommended dose per day should be 8 mg of glimepiride and 2000 mg of metformin.
- In order to avoid hypoglycaemia the starting dose of this tablet should not exceed the daily doses of glimepiride or metformin already being taken.
- When switching from combination therapy of glimepiride plus metformin as separate tablets, this combination should be administered on the basis of dosage currently being taken.
AdministrationView
This tablet must be swallowed whole and not crushed or chewed.
Side effectsView
For Glimepiride:
Metabolism and nutrition disorders-
Gastrointestinal disorders-
General disorders-
For Metformin:
Metabolism and nutrition disorders-
- As a result of the blood-glucose-lowering action of glimepiride, Hypoglycaemia which may also be prolonged.
- The clinical picture of a severe hypoglycaemic attack may resemble that of a stroke.
Gastrointestinal disorders-
- Occasionally, Gastrointestinal symptoms such as nausea, vomiting, sensations of pressure or fulness in the epigastrium, abdominal pain and diarrhea may occur.
- In isolated cases, there may be hepatitis, elevation of liver enzyme levels and/or cholestasis and jaundice, which may progress to life-threatening liver failure.
- Dysgeusia (frequency not known)
- Changes in the blood picture may occur: Rarely, thrombocytopenia and, in isolated cases, leucopenia, hemolytic anemia, erythrocytopenia, granulocytopenia, agranulocytosis or pancytopenia may develop. Cases of severe thrombocytopenia with platelet count less than 10,000/μl and thrombocytopenic purpura have been reported in post-marketing experience (frequency not known).
General disorders-
- Occasionally, Allergic or pseudo allergic reactions may occur, e.g. in the form of itching, urticaria or rashes. Such mild reactions may develop into serious reactions with dyspnoea and a fall in blood pressure, sometimes progressing to shock.
- In isolated cases, a decrease in serum sodium concentration and allergic vasculitis or hypersensitivity of the skin to light may occur.
For Metformin:
- Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite (>10%) are very common. These occur most frequently during initiation of therapy and resolve spontaneously in most cases.
- Metallic taste (3%) is common
- Decrease of vitamin B12 absorption with decrease of serum levels has been observed in patients treated long-term with metformin and appears generally to be without clinical signifcance (<0.01%). However, Cases of peripheral neuropathy in patients with vitamin B12 defciency have been reported in post-marketing experience (frequency not known). (frequency unknown)
- Lactic acidosis (0.03 cases/1000 patient-years) is very rare
- Hemolytic anemia (frequency unknown)
- Reduction of thyrotropin level in patients with hypothyroidism (frequency unknown)
- Hypomagnesemia in the context of diarrhea (frequency unknown)
- Encephalopathy (frequency unknown)
- Photosensitivity (frequency unknown)
- Hepatobiliary disorders: Reports of liver function tests abnormalities and hepatitis resolving upon metformin discontinuation
ContraindicationsView
For Glimepiride-
For Metformin-
- In patients hypersensitive to glimepiride, metformin, other sulfonylureas, other sulfonamides, or any of the excipients of Amaryl M.
- In pregnant women.
- In breastfeeding women.
For Metformin-
- Hypersensitivity to metformin or any of the excipients.
- Any type of acute metabolic acidosis such as lactic acidosis Diabetic ketoacidosis, diabetic pre-coma.
- Severe Renal failure or renal disfunction (e.g., serum creatine levels >135 μmol/L in males and >110 μmol/L in females), GFR < 30 mL/min.
- Acute conditions with the potential to alter renal function such as Dehydration, severe infection, intravascular administration of iodinated contrast agents etc.
- 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.
- Lactation.
PrecautionsView
For Glimepiride: In the initial weeks of treatment, the risk of hypoglycemia may be increased and necessitates especially careful monitoring. If risk factors for hypoglycemia are present, it may be necessary to adjust the dosage of glimepiride or the entire therapy. This also applies whenever illness occurs during therapy or the patient's life-style changes. It is known from other sulfonylureas that, despite initially successful countermeasures, hypoglycaemia may recur. Patients must, therefore, remain under close observation. Severe hypoglycaemia further requires immediate treatment and follow-up by a physician and, in some circumstances, in-patient hospital care. Treatment of patients with G6PD-defciency with sulfonylurea agents can lead to hemolytic anaemia. Since glimepiride belongs to the class of sulfonylurea agents, caution should be used in patients with G6PD-defciency and a non-sulfonylurea alternative should be considered.
For Metformin: Regular monitoring of thyroid-stimulating hormone (TSH) levels is recommended in patients withhypothyroidism. Long-term treatment with metformin has been associated with a decrease in vitamin B12 serumlevels which may cause peripheral neuropathy. Monitoring of the vitamin B12 level is recommended.
For Metformin: Regular monitoring of thyroid-stimulating hormone (TSH) levels is recommended in patients withhypothyroidism. Long-term treatment with metformin has been associated with a decrease in vitamin B12 serumlevels which may cause peripheral neuropathy. Monitoring of the vitamin B12 level is recommended.
InteractionsView
For Glimepiride:
- Glimepiride is metabolized by cytochrome P450 2C9 (CYP2C9). This should be taken into account when glimepiride is coadministered with inducers (e.g. rifampicin) or inhibitors (e.g. fuconazole) of CYP 2C9.
- Potentiation of the blood-glucose-lowering efect and, thus, in some instances hypoglycaemia may occur when one of the following drugs is taken, for example: insulin and other, oral antidiabetics; ACE inhibitors; anabolic steroids and male sex hormones; chloramphenicol; coumarin derivatives; cyclophosphamide; disopyramide; fenfuramine; fenyramidol; fbrates; fuoxetine; guanethidine; ifosfamide; MAO inhibitors; miconazole; fuconazole; para-aminosalicylic acid; pentoxifylline (high dose parenteral); phenylbutazone; azapropazone; oxyphenbutazone; probenecid; quinolones; salicylates; sulfnpyrazone; clarithromycin; sulfonamide antibiotics; tetracyclines; tritoqualine; trofosfamide.
- Weakening of the blood-glucose-lowering efect and, thus raised blood glucose levels may occur when one of the following drugs is taken, for example: acetazolamide; barbiturates; corticosteroids; diazoxide; diuretics; epinephrine (adrenaline) and other sympathomimetic agents; glucagon; laxatives (after protracted use); nicotinic acid (in high doses); oestrogens and progestogens; phenothiazines; phenytoin; rifampicin; thyroid hormones.
- H2 receptor antagonists, beta-blockers, clonidine and reserpine may lead to either potentiation or weakening of the blood-glucose-lowering efect. Under the infuence of sympatholytic drugs such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation to hypoglycaemia may be reduced or absent.
- Both acute and chronic alcohol intake may potentiate or weaken the blood-glucose-lowering action of glimepiride in an unpredictable fashion.
- The efect of coumarin derivatives may be potentiated or weakened.
- Bile acid sequestrant: Colesevelam binds to glimepiride and reduces glimepiride absorption from the gastrointestinal tract. Glimepiride should be administered at least 4 hours prior to colesevelam.
- Alcohol: Alcohol intoxication is associated with an increased risk of lactic acidosis, particularly in case of fasting, malnutrition or hepatic insufciency. Avoid consumption of alcohol and alcohol-containing medications
- Iodinated contrast agents: Metformin must be discontinued prior to, or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable.
- Combinations requiring precautions for use: Some medicinal products can adversely afect renal function which may increase the risk of lactic Acidosis. When starting or using such products in combination with metformin, close monitoring of renal function is necessary. Glucocorticoids, beta-2-agonists, and diuretics have intrinsic hyperglycemic activity. Inform the patient and perform more frequent blood glucose monitoring. ACE-inhibitors may decrease the blood glucose levels. Metformin may decrease the anticoagulant efect of phenprocoumon. Therefore, a close monitoring of the INR is recommended. Levothyroxine can reduce the hypoglycemic efect of metformin. Monitoring of blood glucose levels is recommended, especially when thyroid hormone therapy is initiated or stopped, and the dosage of metformin must be adjusted if necessary.
- Inhibitors of OCT1 (such as verapamil) may reduce efcacy of metformin.
- Inducers of OCT1 (such as rifampicin) may increase gastrointestinal absorption and efcacy of metformin.
- Inhibitors of OCT2 (such as cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole) may decrease the renal elimination of metformin and thus lead to an increase in metformin plasma concentration.
- Inhibitors of both OCT1 and OCT2 (such as crizotinib, olaparib) may alter efcacy and renal elimination of metformin.
Pregnancy & lactationView
Pregnancy-
- For Glimepiride: Glimepiride must not be taken during pregnancy. Otherwise, there is risk of harm to the child. The patient must change over to insulin during pregnancy. Patients planning a pregnancy must inform their physician. It is recommended that such patients change over to insulin.
- For Metformin: When the patient plans to become pregnant and during pregnancy, diabetes should not be treated with metformin but insulin should be used to maintain blood glucose levels as close to normal as possible in order to lower the risk of fetal malformations associated with abnormal blood glucose levels.
- For Glimepiride: To prevent possible ingestion with the breast milk and possible harm to the child, glimepiride must not be taken by breast-feeding women. If necessary the patient must change over to insulin, or must stop breastfeeding.
- For Metformin: Metformin is excreted into milk in lactating rats. Similar data is not available in humans and a decision should be made whether to discontinue nursing or to discontinue metformin, taking into account the importance of the compound to the mother.
Pediatric usageView
Children: Data is insufficient to recommend pediatric use of this tablet.
Renal impairment: A GFR should be assessed before initiation of treatment with metformin-containing products and at least annually thereafter. In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months. The maximum daily dose of metformin should preferably be divided into 2-3 daily doses. Factors that may increase the risk of lactic acidosis should be reviewed before considering the initiation of metformin in patients with GFR<60 mL/min. If no adequate strength of this tablet is available, individual monocomponents should be used instead of the fixed dose combination.
GFR 60-89 ml/min:
Renal impairment: A GFR should be assessed before initiation of treatment with metformin-containing products and at least annually thereafter. In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months. The maximum daily dose of metformin should preferably be divided into 2-3 daily doses. Factors that may increase the risk of lactic acidosis should be reviewed before considering the initiation of metformin in patients with GFR<60 mL/min. If no adequate strength of this tablet is available, individual monocomponents should be used instead of the fixed dose combination.
GFR 60-89 ml/min:
- Metformin: Maximum daily dose is 3000 mg. Dose reduction may be considered in relation to declining renal function.
- Glimepiride: The highest recommended dose per day should be 8 mg of glimepiride.
- Metformin: Maximum daily dose is 2000 mg. The starting dose is at most half of the maximum dose.
- Metformin: Maximum daily dose is 1000 mg. The starting dose is at most half of the maximum dose.
- Metformin: Metformin is contraindicated
- Glimepiride: Change-over to insulin is indicated, not least to achieve optimal metabolic control.
Overdose effectsView
For Glimepiride: Acute overdosage, as well as long-term treatment with too high a dose of glimepiride, may lead to severe life-threatening hypoglycaemia. As soon as an overdose of glimepiride has been discovered, a physician must be notifed without delay. The patient must immediately take sugar, if possible in the form of glucose unless a physician has already undertaken responsibility for treating the overdose. Careful monitoring is essential until the physician is confdent that the patient is out of danger. It must be remembered that hypoglycaemia may recur after initial recovery. Admission to hospital may sometimes be necessary even as a precautionary measure. In particular, signifcant overdoses and severe reactions with signs such as loss of consciousness or other serious neurological disorders are medical emergencies and require immediate treatment and admission to hospital. If, for example, the patient is unconscious, an intravenous injection of concentrated glucose solution is indicated (for adults starting with 40 ml of 20% solution, for example). Alternatively in adults, administration of glucagon, e.g. in doses of 0.5 to 1 mg i.v., s.c. or i.m., may be considered. In particular when treating hypoglycaemia due to accidental intake of glimepiride in infants and young children, the dose of glucose given must be very carefully adjusted in view of the possibility of producing dangerous hyperglycaemia, and must be controlled by close monitoring of blood glucose. Patients who have ingested life-threatening amounts of glimepiride require detoxifcation (e.g. by gastric lavage and medicinal charcoal). After acute glucose replacement has been completed it is usually necessary to give an intravenous glucose infusion in lower concentration so as to ensure that the hypoglycaemia does not recur. The patient's blood glucose level should be carefully monitored for at least 24 hours. In severe cases with a protracted course, hypoglycaemia, or the danger of slipping back into hypoglycaemia, may persist for several days.
For Metformin: Hypoglycaemia has not been seen with metformin doses of up to 85 g, although Lactic acidosis has occurred in such circumstances. High overdose or concomitant risks of metformin may lead to lactic acidosis Lactic acidosis is a medical emergency and must be treated in hospital. The most efective method to remove lactate and metformin is haemodialysis. Pancreatitis may occur in the context of a metformin overdose.
For Metformin: Hypoglycaemia has not been seen with metformin doses of up to 85 g, although Lactic acidosis has occurred in such circumstances. High overdose or concomitant risks of metformin may lead to lactic acidosis Lactic acidosis is a medical emergency and must be treated in hospital. The most efective method to remove lactate and metformin is haemodialysis. Pancreatitis may occur in the context of a metformin overdose.
StorageView
Store in a cool (not exceeding 25°C) and dry place, protected from light.
Amaryl M
Glimepiride + Metformin
Amaryl M
Glimepiride + Metformin
Indications
Type 2 DM
Indication detailsView
This tablet is indicated as an adjunct to diet and exercise in type 2 diabetes mellitus patients-
- In case that the monotherapy with glimepiride or metformin does not result in adequate glycemic control.
- Replacement of combination therapy of glimepiride and metformin.
Therapeutic classView
Combination Oral hypoglycemic preparations
PharmacologyView
Glimepiride is a sulfonylurea antidiabetic agent which decreases blood glucose concentration. The primary mechanism of action of Glimepiride appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. Glimepiride acts in concert with glucose by improving the sensitivity of beta cells to physiological glucose stimulus, resulting in insulin secretion. In addition, extrapancreatic effects like reduction of basal hepatic glucose production, increased peripheral tissue sensitivity to insulin and glucose uptake may also play role in the activity of Glimepiride. In non-fasting diabetic patients, the hypoglycaemic action of a single dose of Glimepiride persists for 24 hours.
Metformin Hydrochloride 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 Hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
Metformin Hydrochloride 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 Hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
DosageView
- The dosage of this tablet is governed by the desired blood glucose level. The dosage of this tablet must be the lowest which is sufficient to achieve the desired metabolic control. During treatment with this tablet glucose levels in blood and urine must be measured regularly.
- Mistakes, e.g. forgetting to take a dose, must never be corrected by subsequently taking a larger dose.
- As an improvement in control of diabetes is, in itself, associated with higher insulin sensitivity, glimepiride requirements may fall as treatment proceeds. To avoid hypoglycaemia timely dose reduction or cessation of this tablet therapy must therefore be considered.
- The highest recommended dose per day should be 8 mg of glimepiride and 2000 mg of metformin.
- In order to avoid hypoglycaemia the starting dose of this tablet should not exceed the daily doses of glimepiride or metformin already being taken.
- When switching from combination therapy of glimepiride plus metformin as separate tablets, this combination should be administered on the basis of dosage currently being taken.
AdministrationView
This tablet must be swallowed whole and not crushed or chewed.
Side effectsView
For Glimepiride:
Metabolism and nutrition disorders-
Gastrointestinal disorders-
General disorders-
For Metformin:
Metabolism and nutrition disorders-
- As a result of the blood-glucose-lowering action of glimepiride, Hypoglycaemia which may also be prolonged.
- The clinical picture of a severe hypoglycaemic attack may resemble that of a stroke.
Gastrointestinal disorders-
- Occasionally, Gastrointestinal symptoms such as nausea, vomiting, sensations of pressure or fulness in the epigastrium, abdominal pain and diarrhea may occur.
- In isolated cases, there may be hepatitis, elevation of liver enzyme levels and/or cholestasis and jaundice, which may progress to life-threatening liver failure.
- Dysgeusia (frequency not known)
- Changes in the blood picture may occur: Rarely, thrombocytopenia and, in isolated cases, leucopenia, hemolytic anemia, erythrocytopenia, granulocytopenia, agranulocytosis or pancytopenia may develop. Cases of severe thrombocytopenia with platelet count less than 10,000/μl and thrombocytopenic purpura have been reported in post-marketing experience (frequency not known).
General disorders-
- Occasionally, Allergic or pseudo allergic reactions may occur, e.g. in the form of itching, urticaria or rashes. Such mild reactions may develop into serious reactions with dyspnoea and a fall in blood pressure, sometimes progressing to shock.
- In isolated cases, a decrease in serum sodium concentration and allergic vasculitis or hypersensitivity of the skin to light may occur.
For Metformin:
- Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite (>10%) are very common. These occur most frequently during initiation of therapy and resolve spontaneously in most cases.
- Metallic taste (3%) is common
- Decrease of vitamin B12 absorption with decrease of serum levels has been observed in patients treated long-term with metformin and appears generally to be without clinical signifcance (<0.01%). However, Cases of peripheral neuropathy in patients with vitamin B12 defciency have been reported in post-marketing experience (frequency not known). (frequency unknown)
- Lactic acidosis (0.03 cases/1000 patient-years) is very rare
- Hemolytic anemia (frequency unknown)
- Reduction of thyrotropin level in patients with hypothyroidism (frequency unknown)
- Hypomagnesemia in the context of diarrhea (frequency unknown)
- Encephalopathy (frequency unknown)
- Photosensitivity (frequency unknown)
- Hepatobiliary disorders: Reports of liver function tests abnormalities and hepatitis resolving upon metformin discontinuation
ContraindicationsView
For Glimepiride-
For Metformin-
- In patients hypersensitive to glimepiride, metformin, other sulfonylureas, other sulfonamides, or any of the excipients of Amaryl M.
- In pregnant women.
- In breastfeeding women.
For Metformin-
- Hypersensitivity to metformin or any of the excipients.
- Any type of acute metabolic acidosis such as lactic acidosis Diabetic ketoacidosis, diabetic pre-coma.
- Severe Renal failure or renal disfunction (e.g., serum creatine levels >135 μmol/L in males and >110 μmol/L in females), GFR < 30 mL/min.
- Acute conditions with the potential to alter renal function such as Dehydration, severe infection, intravascular administration of iodinated contrast agents etc.
- 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.
- Lactation.
PrecautionsView
For Glimepiride: In the initial weeks of treatment, the risk of hypoglycemia may be increased and necessitates especially careful monitoring. If risk factors for hypoglycemia are present, it may be necessary to adjust the dosage of glimepiride or the entire therapy. This also applies whenever illness occurs during therapy or the patient's life-style changes. It is known from other sulfonylureas that, despite initially successful countermeasures, hypoglycaemia may recur. Patients must, therefore, remain under close observation. Severe hypoglycaemia further requires immediate treatment and follow-up by a physician and, in some circumstances, in-patient hospital care. Treatment of patients with G6PD-defciency with sulfonylurea agents can lead to hemolytic anaemia. Since glimepiride belongs to the class of sulfonylurea agents, caution should be used in patients with G6PD-defciency and a non-sulfonylurea alternative should be considered.
For Metformin: Regular monitoring of thyroid-stimulating hormone (TSH) levels is recommended in patients withhypothyroidism. Long-term treatment with metformin has been associated with a decrease in vitamin B12 serumlevels which may cause peripheral neuropathy. Monitoring of the vitamin B12 level is recommended.
For Metformin: Regular monitoring of thyroid-stimulating hormone (TSH) levels is recommended in patients withhypothyroidism. Long-term treatment with metformin has been associated with a decrease in vitamin B12 serumlevels which may cause peripheral neuropathy. Monitoring of the vitamin B12 level is recommended.
InteractionsView
For Glimepiride:
- Glimepiride is metabolized by cytochrome P450 2C9 (CYP2C9). This should be taken into account when glimepiride is coadministered with inducers (e.g. rifampicin) or inhibitors (e.g. fuconazole) of CYP 2C9.
- Potentiation of the blood-glucose-lowering efect and, thus, in some instances hypoglycaemia may occur when one of the following drugs is taken, for example: insulin and other, oral antidiabetics; ACE inhibitors; anabolic steroids and male sex hormones; chloramphenicol; coumarin derivatives; cyclophosphamide; disopyramide; fenfuramine; fenyramidol; fbrates; fuoxetine; guanethidine; ifosfamide; MAO inhibitors; miconazole; fuconazole; para-aminosalicylic acid; pentoxifylline (high dose parenteral); phenylbutazone; azapropazone; oxyphenbutazone; probenecid; quinolones; salicylates; sulfnpyrazone; clarithromycin; sulfonamide antibiotics; tetracyclines; tritoqualine; trofosfamide.
- Weakening of the blood-glucose-lowering efect and, thus raised blood glucose levels may occur when one of the following drugs is taken, for example: acetazolamide; barbiturates; corticosteroids; diazoxide; diuretics; epinephrine (adrenaline) and other sympathomimetic agents; glucagon; laxatives (after protracted use); nicotinic acid (in high doses); oestrogens and progestogens; phenothiazines; phenytoin; rifampicin; thyroid hormones.
- H2 receptor antagonists, beta-blockers, clonidine and reserpine may lead to either potentiation or weakening of the blood-glucose-lowering efect. Under the infuence of sympatholytic drugs such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation to hypoglycaemia may be reduced or absent.
- Both acute and chronic alcohol intake may potentiate or weaken the blood-glucose-lowering action of glimepiride in an unpredictable fashion.
- The efect of coumarin derivatives may be potentiated or weakened.
- Bile acid sequestrant: Colesevelam binds to glimepiride and reduces glimepiride absorption from the gastrointestinal tract. Glimepiride should be administered at least 4 hours prior to colesevelam.
- Alcohol: Alcohol intoxication is associated with an increased risk of lactic acidosis, particularly in case of fasting, malnutrition or hepatic insufciency. Avoid consumption of alcohol and alcohol-containing medications
- Iodinated contrast agents: Metformin must be discontinued prior to, or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable.
- Combinations requiring precautions for use: Some medicinal products can adversely afect renal function which may increase the risk of lactic Acidosis. When starting or using such products in combination with metformin, close monitoring of renal function is necessary. Glucocorticoids, beta-2-agonists, and diuretics have intrinsic hyperglycemic activity. Inform the patient and perform more frequent blood glucose monitoring. ACE-inhibitors may decrease the blood glucose levels. Metformin may decrease the anticoagulant efect of phenprocoumon. Therefore, a close monitoring of the INR is recommended. Levothyroxine can reduce the hypoglycemic efect of metformin. Monitoring of blood glucose levels is recommended, especially when thyroid hormone therapy is initiated or stopped, and the dosage of metformin must be adjusted if necessary.
- Inhibitors of OCT1 (such as verapamil) may reduce efcacy of metformin.
- Inducers of OCT1 (such as rifampicin) may increase gastrointestinal absorption and efcacy of metformin.
- Inhibitors of OCT2 (such as cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole) may decrease the renal elimination of metformin and thus lead to an increase in metformin plasma concentration.
- Inhibitors of both OCT1 and OCT2 (such as crizotinib, olaparib) may alter efcacy and renal elimination of metformin.
Pregnancy & lactationView
Pregnancy-
- For Glimepiride: Glimepiride must not be taken during pregnancy. Otherwise, there is risk of harm to the child. The patient must change over to insulin during pregnancy. Patients planning a pregnancy must inform their physician. It is recommended that such patients change over to insulin.
- For Metformin: When the patient plans to become pregnant and during pregnancy, diabetes should not be treated with metformin but insulin should be used to maintain blood glucose levels as close to normal as possible in order to lower the risk of fetal malformations associated with abnormal blood glucose levels.
- For Glimepiride: To prevent possible ingestion with the breast milk and possible harm to the child, glimepiride must not be taken by breast-feeding women. If necessary the patient must change over to insulin, or must stop breastfeeding.
- For Metformin: Metformin is excreted into milk in lactating rats. Similar data is not available in humans and a decision should be made whether to discontinue nursing or to discontinue metformin, taking into account the importance of the compound to the mother.
Pediatric usageView
Children: Data is insufficient to recommend pediatric use of this tablet.
Renal impairment: A GFR should be assessed before initiation of treatment with metformin-containing products and at least annually thereafter. In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months. The maximum daily dose of metformin should preferably be divided into 2-3 daily doses. Factors that may increase the risk of lactic acidosis should be reviewed before considering the initiation of metformin in patients with GFR<60 mL/min. If no adequate strength of this tablet is available, individual monocomponents should be used instead of the fixed dose combination.
GFR 60-89 ml/min:
Renal impairment: A GFR should be assessed before initiation of treatment with metformin-containing products and at least annually thereafter. In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months. The maximum daily dose of metformin should preferably be divided into 2-3 daily doses. Factors that may increase the risk of lactic acidosis should be reviewed before considering the initiation of metformin in patients with GFR<60 mL/min. If no adequate strength of this tablet is available, individual monocomponents should be used instead of the fixed dose combination.
GFR 60-89 ml/min:
- Metformin: Maximum daily dose is 3000 mg. Dose reduction may be considered in relation to declining renal function.
- Glimepiride: The highest recommended dose per day should be 8 mg of glimepiride.
- Metformin: Maximum daily dose is 2000 mg. The starting dose is at most half of the maximum dose.
- Metformin: Maximum daily dose is 1000 mg. The starting dose is at most half of the maximum dose.
- Metformin: Metformin is contraindicated
- Glimepiride: Change-over to insulin is indicated, not least to achieve optimal metabolic control.
Overdose effectsView
For Glimepiride: Acute overdosage, as well as long-term treatment with too high a dose of glimepiride, may lead to severe life-threatening hypoglycaemia. As soon as an overdose of glimepiride has been discovered, a physician must be notifed without delay. The patient must immediately take sugar, if possible in the form of glucose unless a physician has already undertaken responsibility for treating the overdose. Careful monitoring is essential until the physician is confdent that the patient is out of danger. It must be remembered that hypoglycaemia may recur after initial recovery. Admission to hospital may sometimes be necessary even as a precautionary measure. In particular, signifcant overdoses and severe reactions with signs such as loss of consciousness or other serious neurological disorders are medical emergencies and require immediate treatment and admission to hospital. If, for example, the patient is unconscious, an intravenous injection of concentrated glucose solution is indicated (for adults starting with 40 ml of 20% solution, for example). Alternatively in adults, administration of glucagon, e.g. in doses of 0.5 to 1 mg i.v., s.c. or i.m., may be considered. In particular when treating hypoglycaemia due to accidental intake of glimepiride in infants and young children, the dose of glucose given must be very carefully adjusted in view of the possibility of producing dangerous hyperglycaemia, and must be controlled by close monitoring of blood glucose. Patients who have ingested life-threatening amounts of glimepiride require detoxifcation (e.g. by gastric lavage and medicinal charcoal). After acute glucose replacement has been completed it is usually necessary to give an intravenous glucose infusion in lower concentration so as to ensure that the hypoglycaemia does not recur. The patient's blood glucose level should be carefully monitored for at least 24 hours. In severe cases with a protracted course, hypoglycaemia, or the danger of slipping back into hypoglycaemia, may persist for several days.
For Metformin: Hypoglycaemia has not been seen with metformin doses of up to 85 g, although Lactic acidosis has occurred in such circumstances. High overdose or concomitant risks of metformin may lead to lactic acidosis Lactic acidosis is a medical emergency and must be treated in hospital. The most efective method to remove lactate and metformin is haemodialysis. Pancreatitis may occur in the context of a metformin overdose.
For Metformin: Hypoglycaemia has not been seen with metformin doses of up to 85 g, although Lactic acidosis has occurred in such circumstances. High overdose or concomitant risks of metformin may lead to lactic acidosis Lactic acidosis is a medical emergency and must be treated in hospital. The most efective method to remove lactate and metformin is haemodialysis. Pancreatitis may occur in the context of a metformin overdose.
StorageView
Store in a cool (not exceeding 25°C) and dry place, protected from light.
Amason
Dexamethasone
Amason
Dexamethasone
Indication detailsView
Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis and serum sickness.
Collagen disease: Like lupus erythematosus, rheumatoid arthritis etc.
Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus and severe erythema multiforme (Stevens-Johnson syndrome).
Endocrine disorders: Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, hypercalcemia associated with cancer and nonsuppurative thyroiditis.
Gastrointestinal diseases: Regional enteritis and ulcerative colitis.
Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults and selected cases of secondary thrombocytopenia.
Neoplastic diseases: Leukemias and lymphomas.
Nervous system: Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury.
Ophthalmic diseases: Temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
Renal diseases: To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.
Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
Miscellaneous: Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.
Collagen disease: Like lupus erythematosus, rheumatoid arthritis etc.
Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus and severe erythema multiforme (Stevens-Johnson syndrome).
Endocrine disorders: Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, hypercalcemia associated with cancer and nonsuppurative thyroiditis.
Gastrointestinal diseases: Regional enteritis and ulcerative colitis.
Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults and selected cases of secondary thrombocytopenia.
Neoplastic diseases: Leukemias and lymphomas.
Nervous system: Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury.
Ophthalmic diseases: Temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
Renal diseases: To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.
Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
Miscellaneous: Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.
PharmacologyView
Dexamethasone is a synthetic glucocorticoid which decreases inflammation by inhibiting the migration of leukocytes and reversal of increased capillary permeability. It suppresses normal immune response.
DosageView
In general, glucocorticoid dosage depends on the severity of the condition and the response of the patient. If no favourable response is noted within a couple of days, continuation of glucocorticoid therapy is undesirable. In chronic conditions requiring long-term therapy the lowest dosage that provides adequate, but not necessarily complete, relief should be used.
For tablet:
For tablet:
- In adult patients, daily oral dosages vary from 1 mg to 10 mg and in children from 0.03-0.20 mg/kg body weight,according to the individual response.
- In some patients higher dosages may be temporarily required,to control the disease. As soon as circumstances permit,dosage should be decreased.
- For a short dexamethasone suppression test 1 mg dexamethasone is given at 11 p.m. and plasmacortisol measured the next morning.
- Patients who do not show a decrease in cortisol can be exposed to a longer test: 0.5 mg dexamethasone is given at 6-hour intervals
- for 48 hours followed by 2 mg every 6 hours for a further 48 hours. 24-hour urine collections are made before, during and at the end of the test for the determination of 17 alpha-hydroxycorticoids.
- Dexamethasone can be given by intravenous (IV), intramuscular (IM) or local injection. Dexamethasone injections can also be diluted with an infusion fluid or be injected directly into the infusion line.
- Intravenous injections of massive doses should be given slowly, over a period of several minutes.
- Intramuscular administration should be given by deep intramuscular injection,to prevent atrophy of the subcutaneous adipose tissues.
- Intra-articular injections should be given under strictly aseptic conditions as glucocorticoids decrease the resistance to infection. When diluted with these infusion fluids, Dexamethasone will keep its potency for at least 24 hours (at room temperature and in daylight conditions). As infusion fluids, Sodium chloride 0.9%, Anhydrous glucose 5%, Invert sugar 10%, Sorbitol 5%, Ringer's solution, Hartman's solution (Ringer-lactate) etc.can be used.
- The dosage of Dexamethasone depends on the severity of the condition and the response of the patient.
- For systemic therapy in adults, daily doses of 0.05-0.20 mg/kg body weight are usually sufficient. For emergencies (e.g. anaphylaxis, acute severe asthma, cerebral edema) substantially higher doses are required. An initial dose of 10-20 mg IV is followed by 6 mg IV or IM every 6 hours,until a satisfactory result has been obtained. Thereafter the dosage has to be tapered off gradually.
- Intra-articularly: 2-4 mg in large and 0.8-1 mg in small joints
- Intrabursally: 2-4 mg;in tendon sheaths:0.4-1 mg
- The frequency of these injections may vary from every 3-5 days to every 2-3 weeks
Side effectsView
The following adverse reactions have been associated with prolonged systemic glucocorticoid therapy.
Endocrine and metabolic disturbances: Cushing-like syndrome, hirsutism, menstrual irregularities, premature epiphyseal closure, secondary adrenocortical and pituitary unresponsiveness, decreased glucose tolerance, negative nitrogen and calcium balance.
Fluid and electrolyte disturbances: Sodium and fluid retention, hypertension, potassium loss, hypokalaemic alkalosis.
Musculo-skeletal effects: Myopathy, abdominal distension, osteoporosis, aseptic necrosis of femoral and humeral heads.
Gastro-intestinal effects: Gastric and duodenal ulceration, perforation and haemorrhage.
Dermatological effects: Impaired wound healing, skin atrophy, striae, petechiae and ecchymoses, bruising, facial erythema, increased sweating, acne.
Central Nervous System effects: Psychic disturbances ranging from euphoria to frank psychotic manifestations,convulsions,in children pseudotumor cerebri (benign intracranial hypertension) with vomiting and papilloedema.
Ophthalmic effects: Glaucoma, increased intraocular pressure, posterior subcapsular cataracts.
Immunosuppressive effects: Increased susceptibility to infections, decreased responsiveness to vaccination and skin tests.
Endocrine and metabolic disturbances: Cushing-like syndrome, hirsutism, menstrual irregularities, premature epiphyseal closure, secondary adrenocortical and pituitary unresponsiveness, decreased glucose tolerance, negative nitrogen and calcium balance.
Fluid and electrolyte disturbances: Sodium and fluid retention, hypertension, potassium loss, hypokalaemic alkalosis.
Musculo-skeletal effects: Myopathy, abdominal distension, osteoporosis, aseptic necrosis of femoral and humeral heads.
Gastro-intestinal effects: Gastric and duodenal ulceration, perforation and haemorrhage.
Dermatological effects: Impaired wound healing, skin atrophy, striae, petechiae and ecchymoses, bruising, facial erythema, increased sweating, acne.
Central Nervous System effects: Psychic disturbances ranging from euphoria to frank psychotic manifestations,convulsions,in children pseudotumor cerebri (benign intracranial hypertension) with vomiting and papilloedema.
Ophthalmic effects: Glaucoma, increased intraocular pressure, posterior subcapsular cataracts.
Immunosuppressive effects: Increased susceptibility to infections, decreased responsiveness to vaccination and skin tests.
ContraindicationsView
- Gastric and duodenal ulcers.
- Systemic and ophthalmic fungal infections.
- Viral infections, e.g. varicella and herpes genitalis infections. Viral infections of the eye.
- Glaucoma.
- Hypersensitivity to corticosteroids
PrecautionsView
General: The lowest possible dose of corticosteroids should be used to control the condition under treatment.The reduction should be gradual.
Cardio-renal: These agents should be used with caution in patients with congestive heart failure,hypertension, or renal insufficiency.
Endocrine: Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage.
Gastrointestinal: Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.
Musculoskeletal: Special consideration should be given to patients at increased risk of osteoporosis (e.g.,postmenopausal women) before initiating corticosteroid therapy.
Neuro-psychiatric: An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with myasthenia gravis or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). Psychic derangements may appear ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations.
Cardio-renal: These agents should be used with caution in patients with congestive heart failure,hypertension, or renal insufficiency.
Endocrine: Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage.
Gastrointestinal: Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.
Musculoskeletal: Special consideration should be given to patients at increased risk of osteoporosis (e.g.,postmenopausal women) before initiating corticosteroid therapy.
Neuro-psychiatric: An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with myasthenia gravis or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). Psychic derangements may appear ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations.
InteractionsView
- Diuretics and/or cardiac glycosides, since potassium loss may be enhanced.This is a particular risk in patients using cardiac glycosides; since hypokalaemia increases the toxicity of these drugs.
- Antidiabetics, since glucocorticoids may impair glucose tolerance, thereby increasing the need for antidiabetic drugs.
- Non-steroidal anti-inflammatory drugs, since the incidence and/or severity of gastro-intestinal ulceration may increase.
- Oral anti-coagulants since glucocorticoids may alter the need for these drugs.
- Glucocorticoids may be less effective when used concomitantly with liver enzyme inducing drugs,such as rifampicin, ephedrine, barbiturates, phenytoin and primidone.
- If patients undergoing long-term therapy with glucocorticoids are concomitantly given salicylates, any reduction in glucocorticoid dosage should be made with caution, since salicylate intoxication has been reported in such cases.
- Antacids;especially those containing magnesium trisilicate,have been reported to impair the gastro-intestinal absorption of glucocorticoids. Therefore, doses of one agent should be spaced as far as possible from the other.
Pregnancy & lactationView
Pregnancy Category C.There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Glucocorticoids appear in breast milk.Mothers taking high dosages of corticosteroids should be advised not to breast-feed
Pediatric usageView
In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose.
Overdose effectsView
Overdosage is unlikely, however, treatment of overdosage is by supportive and symptomatic therapy
StorageView
Tablet: Store in a cool & dry place, protected from light & moisture.
Injection: Store below 30° C, protected from light.Do not freeze. Keep medicines out of the reach of children
Injection: Store below 30° C, protected from light.Do not freeze. Keep medicines out of the reach of children
Ambeecal
Calcium Carbonate
Ambeecal
Calcium Carbonate
Indication detailsView
250 mg or 500 mg tablet: This is used for the treatment or prevention of calcium depletion in patients in whom dietary measures are inadequate. Conditions that may be associated with calcium deficiency include hypoparathyroidism, achlorhydria, chronic diarrhea, vitamin D deficiency, steatorrhea, sprue, pregnancy and lactation, menopause, pancreatitis, renal failure, alkalosis, and hyperphosphataemia. Calcium Carbonate is being used increasingly often to treat hyperphosphataemia in chronic renal failure as well as those on continuous ambulatory peritoneal dialysis (CAPD) and haemodialysis. Many patients are unable to tolerate sufficient doses for complete phosphate control and require additional measures such as stringent dietary phosphate restriction or relatively small doses of aluminium hydroxide. Calcium Carbonate containing preparations can provide short-term relief of dyspeptic systems but are no longer recommended for long-term treatment of peptic ulceration.
1000 mg tablet: This is indicated for the management of conditions associated with hyperidity and for fast relief of acid indigestion, heartburn, sour stomach and upset stomach.
1000 mg tablet: This is indicated for the management of conditions associated with hyperidity and for fast relief of acid indigestion, heartburn, sour stomach and upset stomach.
Therapeutic classView
Minerals in bone formation, Specific mineral preparations
PharmacologyView
Calcium carbonate reacts with gastric acid to produce a salt and water. For calcium carbonate the postulated chemical reaction is: CaCO3+2HCl = CaCl2+H2O+CO2. Two grams of calcium carbonate will readily bring 100 ml of hydrochloric acid to a pH above 6. The increase in gastric pH diminishes the activity of pepsin in the gastric secretion. Up to 30% of the oral calcium load may be absorbed.
DosageView
250 mg or 500 mg tablet: Calcium Carbonate is always used orally and when used as an antacid the recommended doses for adults are equivalent to 540-2000 mg Calcium Carbonate per day, doses for children being half of those for adults. As a dietary supplement, such as for the prevention of osteoporosis, 1250-3750 mg Calcium Carbonate (500-1500 mg calcium) daily is recommended in general, but again this will need to be tailored to the individual patient depending on any specific disease such as Calcium deficiency, malabsorption or parathyroid function. In pregnancy and lactation the recommended daily dose of calcium is 1200-1500 mg. In chronic renal failure the doses used vary from 2.5-9.0 gm Calcium Carbonate per day and need to be adjusted according to the individual patient. To maximize effective phosphate binding in this context the Calcium Carbonate should be given with meals.
1000 mg tablet: 2000-3000 mg tablet when symptoms occur; may be repeated hourly if needed or as directed by the physician.
1000 mg tablet: 2000-3000 mg tablet when symptoms occur; may be repeated hourly if needed or as directed by the physician.
Side effectsView
Orally administered Calcium Carbonate may be irritating to the GI tract. It may also cause constipation. Hypercalcaemia is rarely produced by administration of calcium alone, but may occur when large doses are given to patients with chronic renal failure.
ContraindicationsView
- Hypercalcaemia and hyperparathyroidism
- Hypercalciuria and nephrolithiasis
- Zollinger-Ellison syndrome
- Concomitant digoxin therapy (requires careful monitoring of serum calcium level)
InteractionsView
Calcium Carbonate may enhance the cardiac effects of digoxin and other cardiac glycosides, if systemic hypercalcaemia occurs. Calcium Carbonate may interfere with the absorption of concomitantly administered tetracycline preparations and in chronic renal failure modification of vitamin D therapy may be required to avoid hypercalcaemia when Calcium Carbonate is used as the primary phosphate binder.
Pregnancy & lactationView
Calcium containing drugs have been widely used in pregnancy by way of oral calcium supplementation or antacid therapy. Calcium Carbonate can be used in lactating women too.
Pediatric usageView
Use in children: Calcium carbonate has been extensively studied in children and infants with chronic renal failure and is both safe and effective.
Use in elderly: In case of elderly patients with renal failure when calcium carbonate is taken constipation may be troublesome one for this group. For this reason, monitoring of serum calcium and phosphate is of course indicated for elderly patients.
Use in elderly: In case of elderly patients with renal failure when calcium carbonate is taken constipation may be troublesome one for this group. For this reason, monitoring of serum calcium and phosphate is of course indicated for elderly patients.
StorageView
Store in a cool, dry place in controlled room temperature.
Ambeecal-D
Calcium Carbonate [Elemental source] + Vitamin D3
Ambeecal-D
Calcium Carbonate [Elemental source] + Vitamin D3
Indications
Rickets
Indication detailsView
This combination is used for treatment of osteoporosis, osteomalacia, rickets, tetany and in parathyroid disease. Calcium supplements are often used to ensure adequate dietary intake in conditions such as pregnancy & lactation, osteogenesis and tooth formation (adjunct with definite treatment) and therapy with anti-seizure medications. It is also used as routine supplement and phosphate binder in chronic renal failure.
Therapeutic classView
Specific mineral & vitamin combined preparations
PharmacologyView
This is the preparation of Calcium Carbonate and Vitamin D3 (Cholecalciferol). Calcium is necessary for many normal functions of our body, especially bone formation and maintenance. Vitamin D3 helps for the absorption & reabsorption of Calcium. Vitamin D3 also stimulates bone formation. Clinical studies showed that Calcium and Vitamin D3 all together helps in bone growth, and in prevention of osteoporosis & bone fracture.
DosageView
Calcium 500 mg and Vitamin D3 200 IU Tablet: 2 tablets daily or 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.
Calcium 500 mg and Vitamin D3 400 IU Tablet: 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.
Calcium 500 mg and Vitamin D3 400 IU Tablet: 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.
Side effectsView
It is generally well tolerated. If there is experience like nausea, vomiting, stomach cramps, dry mouth, increased thirst, increased urination while taking, noticed to physicians. Constipation may occur.
ContraindicationsView
It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.
PrecautionsView
If there is any pre-existing heart disease or kidney disease, precautions should be taken.
InteractionsView
It has possible interaction with calcium, aluminium or magnesium containing antacids & other calcium supplements, calcitriol & other vitamin D3 supplements; digoxin, tetracycline, doxycycline, minocycline or oxytetracycline.
Pregnancy & lactationView
This combination should be used as directed by physician during pregnancy or while breast-feeding.
Overdose effectsView
Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache, constipation.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Ambeeclox
Cloxacillin Sodium
Ambeeclox
Cloxacillin Sodium
Indications
UTI caused by Staphylococcus Aureus
Indication detailsView
গ্রাম-পজিটিভ জীবাণু দ্বারা সৃষ্ট সংক্রমণের চিকিৎসায় ক্লক্সাসিলিন নির্দেশিত। পেনিসিলিনেজ উৎপাদনক্ষম স্টেফাইলোকক্কাই জনিত সংক্রমণের চিকিৎসায়ও এটি নির্দেশিত। এ জাতীয় সংক্রমণের মধ্যে রয়েছেঃ
স্কিন ও সফ্ট টিস্যু সংক্রমণ: ফোঁড়া (boils), পূজাশয় (abscess), কার্বাংকল, ফারানকুলোসিস, সেলুলাইটিস, সংক্রমিত ক্ষত (infected wounds), সংক্রমিত পোড়া (infected burns), ত্বক প্রতিস্থাপন প্রতিরক্ষা (protection for skin grafts), ত্বকের বিভিন্ন সংক্রমণ যেমন আলসার, একজিমা ও একনি।
রেসপিরেটরী ট্র্যাক্ট, নাক, কান ও গলার সংক্রমণ: নিউমোনিয়া, ফুসফুসের পূজাশয় (lung abscess), এমপায়েমা, সাইনোসাইটিস, ফ্যারিনজাইটিস, টনসিলাইটিস, কুইনসি, অটাইটিস মিডিয়া ও এক্সটারণা।
ক্লক্সাসিলিন-সংবেদনশীল (sensitive), জীবাণু জনিত অন্যান্য সংক্রমণ: অসটিওমায়েলাইটিস, এনটেরাইটিস, এনডোকারডাইটিস, ইউরিনারী ট্র্যাক্ট সংক্রমণ ও সেপটিসেমিয়া।
স্কিন ও সফ্ট টিস্যু সংক্রমণ: ফোঁড়া (boils), পূজাশয় (abscess), কার্বাংকল, ফারানকুলোসিস, সেলুলাইটিস, সংক্রমিত ক্ষত (infected wounds), সংক্রমিত পোড়া (infected burns), ত্বক প্রতিস্থাপন প্রতিরক্ষা (protection for skin grafts), ত্বকের বিভিন্ন সংক্রমণ যেমন আলসার, একজিমা ও একনি।
রেসপিরেটরী ট্র্যাক্ট, নাক, কান ও গলার সংক্রমণ: নিউমোনিয়া, ফুসফুসের পূজাশয় (lung abscess), এমপায়েমা, সাইনোসাইটিস, ফ্যারিনজাইটিস, টনসিলাইটিস, কুইনসি, অটাইটিস মিডিয়া ও এক্সটারণা।
ক্লক্সাসিলিন-সংবেদনশীল (sensitive), জীবাণু জনিত অন্যান্য সংক্রমণ: অসটিওমায়েলাইটিস, এনটেরাইটিস, এনডোকারডাইটিস, ইউরিনারী ট্র্যাক্ট সংক্রমণ ও সেপটিসেমিয়া।
Therapeutic classView
Penicillinase-resistant penicillins
DosageView
প্রাপ্তবয়স্কদের প্রচলিত মাত্রা-
খাওয়ার জন্য: ৫০০ মিগ্রা দিনে চার বার আহারের আধা থেকে এক ঘন্টা আগে।
ইনজেকশন হিসেবে:
শিশুদের প্রচলিত মাত্রা-
খাওয়ার জন্য: ২ থেকে ১০ বৎসর পর্যন্ত- প্রাপ্তবয়স্ক মাত্রার অর্ধেক। ২ বৎসরের নীচে- প্রাপ্তবয়স্ক মাত্রার এক-চতুর্থাংশ।
ইনজেকশন হিসেবে:
খাওয়ার জন্য: ৫০০ মিগ্রা দিনে চার বার আহারের আধা থেকে এক ঘন্টা আগে।
ইনজেকশন হিসেবে:
- মাংসপেশীতে ইনজেকশন হিসেবে: ২৫০ মিগ্রা চার থেকে ছয় ঘন্টা পর পর।
- শিরাপথে ইনজেকশন হিসেবে: ৫০০ মিগ্রা চার থেকে ছয় ঘন্টা পর পর। প্রয়োজনবোধে উপরোল্লিখিত মাত্রাকে দ্বিগুণ করা যেতে পারে।
- প্লুরাল কেভিটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা দিনে এক বার।
- জয়েন্ট কেভিটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা দিনে এক বার।
শিশুদের প্রচলিত মাত্রা-
খাওয়ার জন্য: ২ থেকে ১০ বৎসর পর্যন্ত- প্রাপ্তবয়স্ক মাত্রার অর্ধেক। ২ বৎসরের নীচে- প্রাপ্তবয়স্ক মাত্রার এক-চতুর্থাংশ।
ইনজেকশন হিসেবে:
- মাংসপেশীতে ইনজেকশন হিসেবে: ২৫০ মিগ্রা এর সাথে ১.৫ মিলি কিংবা ৫০০ মিগ্রা এর সাথে ২ মিলি ওয়াটার ফর ইনজেকশন বিপি মিশিয়ে দ্রবীভূত করতে হবে।
- শিরাপথে ইনজকেশন হিসাবে: ৫০০ মিগ্রা এর সাথে ৫-১০ মিলি ওয়াটার ফর ইনজকেশন বিপি মিশিয়ে দ্রবীভূত করতে হবে। এরপর এই দ্রবণকে তিন থেকে চার মিনিট ধরে ধীরে ধীরে শরীরে প্রয়োগ করতে হবে। ক্লক্সাসিলিন ইনজকেশনকে ইনফিউশন উপযোগী যে কোন তরলে মিশিয়ে দেয়া যায় অথবা যথাযথ ভাবে হালকা করে ড্রপি টউিবে তিন থেকে চার মিনিট ধরে ধীরে ধীরে প্রয়োগ করা যায়।
- প্লুরাল কেভেটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা এর সাথে ৫ থেকে ১০ মিলি ওয়াটার ফর ইনজকেশন বিপি মিশিয়ে দ্রবীভূত করে প্রয়োগ করতে হবে।
- জয়েন্টে কেভেটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা এর সাথে অনধকি ৫ মিলি ওয়াটার ফর ইনজকেশন বিপি অথবা ০.৫% লিগনোকেইন হাইড্রোক্লোরাইড দ্রবণ মিশিয়ে দ্রবীভূত করে প্রয়োগ করতে হবে।
Side effectsView
ক্লক্সাসিলিন এর পার্শ্ব-প্রতিক্রিয়া অন্যান্য পেনিসিলিনের মতই। এগুলো সাধারণতঃ মৃদু ও ক্ষণস্থায়ী হয়ে থাকে। এই সমস্ত পার্শ্ব-প্রতিক্রিয়ার মধ্যে রয়েছে জ্বর, ডায়রিয়া, অজীর্ণ (indigestion), র্যাশ-আরটিকারিয়েল অথবা ইরিথিমেটাস জাতীয়। যে কোন ধরণের র্যাশে রোগীকে এ ওষুধ দেয়া বন্ধ করতে হবে।
ContraindicationsView
পেনিসিলিনে অতি-সংবেদনশীল (hypersensitive) রোগীদের ক্ষেত্রে ক্লক্সাসিলিন প্রয়োগ নিষিদ্ধ।
PrecautionsView
যে সব রোগীর এলার্জির পূর্ব ইতিহাস আছে তাদের বেলায় ক্লক্সাসিলিন সতর্কতার সাথে ব্যবহার করতে হবে। ক্লক্সাসিলিন সাব-কনজাংটিভাল ইনজেকশন হিসেবে অথবা চোখের ড্রপস হিসেবে দেয়া যাবে না।
ক্লক্সাসিলিন সিরাপ ও ড্রপস ব্যবহরের আগে তাৎক্ষনিকভাবে তৈরী করে ঠাণ্ডা স্থানে (সম্ভব হলে রেফ্রিজারেটরে) রাখতে হবে। সংমিশ্রিত সিরাপ ও ড্রপস সাধারণ তাপমাত্রায় রাখলে পাঁচ দিনের মধ্যে অথবা রেফ্রিজারেটরে রাখলে সাত দিনের মধ্যে ব্যবহার করতে হবে। মাংসপেশীতে বা শিরাপথে প্রয়োগের জন্য প্রস্তুতকৃত ক্লক্সাসিলিন দ্রবণ তৈরীর ৩০ মিনিটের মধ্যে ব্যবহার করতে হবে। অবশ্য ক্লক্সাসিলিন এর জলীয় দ্রবণ স্বাভাবিক তাপমাত্রায় (২৫° সেঃ) অনধিক ২৪ ঘন্টা পর্যন্ত কার্যকর থাকে।
শিরাপথের প্রয়োগোপযোগী অধিকাংশ তরলের সাথেই ক্লক্সাসিলিন মেশানো যায়। তবে কখনোই আমিষ জাতীয় তরল (যেমন প্রোটিন হাইড্রোলাইসেটস) এর সাথে মেশানো যাবে না।
ক্লক্সাসিলিন সিরাপ ও ড্রপস ব্যবহরের আগে তাৎক্ষনিকভাবে তৈরী করে ঠাণ্ডা স্থানে (সম্ভব হলে রেফ্রিজারেটরে) রাখতে হবে। সংমিশ্রিত সিরাপ ও ড্রপস সাধারণ তাপমাত্রায় রাখলে পাঁচ দিনের মধ্যে অথবা রেফ্রিজারেটরে রাখলে সাত দিনের মধ্যে ব্যবহার করতে হবে। মাংসপেশীতে বা শিরাপথে প্রয়োগের জন্য প্রস্তুতকৃত ক্লক্সাসিলিন দ্রবণ তৈরীর ৩০ মিনিটের মধ্যে ব্যবহার করতে হবে। অবশ্য ক্লক্সাসিলিন এর জলীয় দ্রবণ স্বাভাবিক তাপমাত্রায় (২৫° সেঃ) অনধিক ২৪ ঘন্টা পর্যন্ত কার্যকর থাকে।
শিরাপথের প্রয়োগোপযোগী অধিকাংশ তরলের সাথেই ক্লক্সাসিলিন মেশানো যায়। তবে কখনোই আমিষ জাতীয় তরল (যেমন প্রোটিন হাইড্রোলাইসেটস) এর সাথে মেশানো যাবে না।
StorageView
ক্লক্সাসিলিন এর সকল ডোসেজ ফরমকে ঠান্ডা ও শুকনো স্থানে রাখতে হবে। ক্লক্সাসিলিন ইনজেকশন ভায়ালকে অনধিক ২৫° সেঃ তাপমাত্রায় সংরক্ষণ করুন।
Ambeet
Ambroxol Hydrochloride
Ambeet
Ambroxol Hydrochloride
Indications
Sore throat
Indication detailsView
This is indicated in-
- Productive cough
- Acute and chronic inflammatory disorders of upper and lower respiratory tracts associated with viscid mucus including acute and chronic bronchitis
- Inflammatory disease of rhinopharyngeal tract (laryngitis, pharyngitis, sinusitis and rhinitis) associated with viscid mucus
- Asthmatic bronchitis bronchial asthma with thick expectoration
- Bronchiectasis
- Chronic pneumonia etc.
Therapeutic classView
Cough expectorants & mucolytics
PharmacologyView
Ambroxol is the active metabolite of bromhexine and it has been proven that this metabolite possesses a greater bronchosecretolytic effect than bromhexine. It improves sputum rheology by hydrating mechanism leading to liquefaction of mucus in the lumen of respiratory tract, thus facilitating expectoration of mucus and reducing dyspnea. It stimulates production of phospholipids of surfactant by alveolar cells, thus contributing to the lowering of superficial tension in the alveoli. It also reduces bronchial hyperactivity. Ambroxol has anti inflammatory properties owing to the inhibitory effect on the production of cellular cytokines and arachidonic acid metabolites. In patients with COPD it traditionally improves airway patency.
DosageView
Average daily dose (preferably after meal):
Pediatric Drops:
Pediatric Drops:
- 0-6 months: 0.5 ml 2 times a day
- 6-12 months: 1 ml 2 times a day
- 1-2 years: 1.25 ml 2 times a day
- 2-5 years: 2.5 ml (1/2 teaspoonful) 2-3 times a day
- 5-10 years: 5 ml (1 teaspoonful) 2-3 times a day
- 10 years and adults: 10 ml (2 teaspoonful) 3 times a day.
Side effectsView
Gastrointestinal side effects like epigastric pain, stomach overfill feeling may occur occasionally. Rarely allergic responses such as eruption, urticaria or angioneurotic edema have been reported.
ContraindicationsView
Contraindicated in known hypersensitivity to Ambroxol or Bromhexine.
PrecautionsView
Ambroxol should be given cautiously to patients with gastric and duodenal ulceration or convulsive disorders. Patients with hepatic and renal insufficiency should take it with caution.
InteractionsView
Ambroxol should not be taken simultaneously with antitussives (e.g.Codeine) because phlegm, which has been liquefied by Ambroxol might not be expectorated.
Pregnancy & lactationView
Teratogenic and fetal toxicity studies have shown no harmful effect of Ambroxol. However, it is advised not to use it in pregnancy, especially during the1st trimester. Safety during lactation has not been established yet.
StorageView
Protect from direct light exposure, Store in a dry place at a temperature not exceeding 30°C, Keep out of the reach of children.
Ambeet
Ambroxol Hydrochloride
Ambeet
Ambroxol Hydrochloride
Indications
Sore throat
Indication detailsView
This is indicated in-
- Productive cough
- Acute and chronic inflammatory disorders of upper and lower respiratory tracts associated with viscid mucus including acute and chronic bronchitis
- Inflammatory disease of rhinopharyngeal tract (laryngitis, pharyngitis, sinusitis and rhinitis) associated with viscid mucus
- Asthmatic bronchitis bronchial asthma with thick expectoration
- Bronchiectasis
- Chronic pneumonia etc.
Therapeutic classView
Cough expectorants & mucolytics
PharmacologyView
Ambroxol is the active metabolite of bromhexine and it has been proven that this metabolite possesses a greater bronchosecretolytic effect than bromhexine. It improves sputum rheology by hydrating mechanism leading to liquefaction of mucus in the lumen of respiratory tract, thus facilitating expectoration of mucus and reducing dyspnea. It stimulates production of phospholipids of surfactant by alveolar cells, thus contributing to the lowering of superficial tension in the alveoli. It also reduces bronchial hyperactivity. Ambroxol has anti inflammatory properties owing to the inhibitory effect on the production of cellular cytokines and arachidonic acid metabolites. In patients with COPD it traditionally improves airway patency.
DosageView
Average daily dose (preferably after meal):
Pediatric Drops:
Pediatric Drops:
- 0-6 months: 0.5 ml 2 times a day
- 6-12 months: 1 ml 2 times a day
- 1-2 years: 1.25 ml 2 times a day
- 2-5 years: 2.5 ml (1/2 teaspoonful) 2-3 times a day
- 5-10 years: 5 ml (1 teaspoonful) 2-3 times a day
- 10 years and adults: 10 ml (2 teaspoonful) 3 times a day.
Side effectsView
Gastrointestinal side effects like epigastric pain, stomach overfill feeling may occur occasionally. Rarely allergic responses such as eruption, urticaria or angioneurotic edema have been reported.
ContraindicationsView
Contraindicated in known hypersensitivity to Ambroxol or Bromhexine.
PrecautionsView
Ambroxol should be given cautiously to patients with gastric and duodenal ulceration or convulsive disorders. Patients with hepatic and renal insufficiency should take it with caution.
InteractionsView
Ambroxol should not be taken simultaneously with antitussives (e.g.Codeine) because phlegm, which has been liquefied by Ambroxol might not be expectorated.
Pregnancy & lactationView
Teratogenic and fetal toxicity studies have shown no harmful effect of Ambroxol. However, it is advised not to use it in pregnancy, especially during the1st trimester. Safety during lactation has not been established yet.
StorageView
Protect from direct light exposure, Store in a dry place at a temperature not exceeding 30°C, Keep out of the reach of children.