ARYA Glimepiride 1mg Tablet 30's
RXDRUG-DR-XY33171
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
It is used for the treatment of type 2 diabetes mellitus.
Dosage/Direction for Use
Usual dose is 1-2 mg daily by mouth initially, may be increased if necessary to 4 mg daily for the maintenance or as prescribed by the physician.
Overdosage
After ingestion of an overdose hypoglycemia may occur, lasting from 12 to 72 hours, and may recur after an initial recovery. Symptoms may not be present for up to 24 hours after ingestion. In general observation in hospital is recommended. Nausea, vomiting and epigastric pain may occur. The hypoglycaemia may in general be accompanied by neurological symptoms like restlessness, tremor, visual disturbances, coordination problems, sleepiness, coma and convulsions.
Treatment primarily consists of preventing absorption by inducing vomiting and then drinking water or lemonade with activated charcoal (adsorbent) and sodium sulphate (laxative). If large quantities have been ingested, gastric lavage is indicated, followed by activated charcoal and sodium sulphate. In case of (severe) overdose hospitalisation in an intensive care department is indicated. Start the administration of glucose as soon as possible, if necessary by a bolus intravenous injection of 50 mL of 50% solution, followed by an infusion of a 10% solution with strict monitoring of blood glucose. Further treatment should be symptomatic.
In particular when treating hypoglycemia due to accidental intake of Glimepiride in infants and young children, the dose of glucose given must be carefully controlled to avoid the possibility of producing dangerous hyperglycaemia. Blood glucose should be closely monitored.
Treatment primarily consists of preventing absorption by inducing vomiting and then drinking water or lemonade with activated charcoal (adsorbent) and sodium sulphate (laxative). If large quantities have been ingested, gastric lavage is indicated, followed by activated charcoal and sodium sulphate. In case of (severe) overdose hospitalisation in an intensive care department is indicated. Start the administration of glucose as soon as possible, if necessary by a bolus intravenous injection of 50 mL of 50% solution, followed by an infusion of a 10% solution with strict monitoring of blood glucose. Further treatment should be symptomatic.
In particular when treating hypoglycemia due to accidental intake of Glimepiride in infants and young children, the dose of glucose given must be carefully controlled to avoid the possibility of producing dangerous hyperglycaemia. Blood glucose should be closely monitored.
Administration
Should be taken with food: Take immediately before the 1st main meal of the day. Do not skip meals.
Contraindications
Glimepiride must not be used in patients hypersensitive to glimepiride, other sulfonylureas and sulfonamide derivatives.
Special Precautions
Glimepiride should not be used in type 1 diabetes mellitus. Use in type 2 diabetes mellitus is contraindicated in patients with ketoacidosis and in those with severe infections, trauma or other severe conditions where the sulfonylurea is unlikely to control the hyperglycemia; insulin should be administered in such situations.
They should therefore be avoided in patients with impairment of renal or hepatic function, and a similar precaution would tend to apply in other groups with an increased susceptibility to this effect, such as the elderly, debilitated or malnourished patients, and those with adrenal or pituitary insufficiency.
They should therefore be avoided in patients with impairment of renal or hepatic function, and a similar precaution would tend to apply in other groups with an increased susceptibility to this effect, such as the elderly, debilitated or malnourished patients, and those with adrenal or pituitary insufficiency.
Use In Pregnancy & Lactation
Abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities and perinatal mortality. So the blood glucose level must be closely monitored during pregnancy in order to avoid the teratogenic risk. The use of insulin is required under such circumstances.
Patients who consider pregnancy should inform their physician.
There are no adequate data from the use of glimepiride in pregnant women. Animal studies have shown reproductive toxicity which likely related to the pharmacologic action (hypoglycaemia) of glimepiride.
Consequently, glimepiride should not be used during the whole pregnancy. In case of treatment by glimepiride, if the patient plans to become pregnant or if a pregnancy is discovered, the treatment should be switched as soon as possible to insulin therapy.
The excretion in human milk is unknown. Glimepiride is excreted in rat milk. As other sulfonylureas are excreted in human milk and because there is risk of hypoglycaemia in nursing infants, breast feeding is advised against during treatment with glimepiride.
Patients who consider pregnancy should inform their physician.
There are no adequate data from the use of glimepiride in pregnant women. Animal studies have shown reproductive toxicity which likely related to the pharmacologic action (hypoglycaemia) of glimepiride.
Consequently, glimepiride should not be used during the whole pregnancy. In case of treatment by glimepiride, if the patient plans to become pregnant or if a pregnancy is discovered, the treatment should be switched as soon as possible to insulin therapy.
The excretion in human milk is unknown. Glimepiride is excreted in rat milk. As other sulfonylureas are excreted in human milk and because there is risk of hypoglycaemia in nursing infants, breast feeding is advised against during treatment with glimepiride.
Adverse Reactions
The usual adverse effects with glimepiride are gastrointestinal disturbances such as nausea, vomiting, heartburn, anorexia, diarrhea and a metallic taste. Increased appetite and weight gain, skin rashes and pruritus may also occur.
Drug Interactions
An increased hypoglycaemic effect has occurred or might be expected with ACE inhibitors, alcohol, allopurinol, some analgesics (notably azapropazone, phenylbutazone, and the salicylates), azole antifungals (fluconazole, ketoconazole, and miconazole), chloramphenicol, cimetidine, clofibrate and related compounds coumarin anticoagulants, fluoroquinolones, heparin, MAOIs, octreotide (although this may also produce hyperglycaemia), ranitidine, sulfinpyrazone sulfonamides (including co-trimoxazole), tetracyclines, and tricyclic antidepressants.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Both in healthy persons and in patients with type 2 diabetes mellitus, glimepiride decreases blood glucose concentrations, mainly by stimulating insulin release from pancreatic beta cells.
Pharmacokinetics: Glimepiride is completely absorbed from the GIT. Peak plasma concentrations occur in 2-3 hours, and it is highly protein bound. The drug is extensively metabolized to two main metabolites, a hydroxy derivative and a carboxy derivative. The half-life after multiple doses is about 9 hrs. Approximately 60% of a dose is eliminated in the urine and 40% in the feces.
Pharmacokinetics: Glimepiride is completely absorbed from the GIT. Peak plasma concentrations occur in 2-3 hours, and it is highly protein bound. The drug is extensively metabolized to two main metabolites, a hydroxy derivative and a carboxy derivative. The half-life after multiple doses is about 9 hrs. Approximately 60% of a dose is eliminated in the urine and 40% in the feces.
MedsGo Class
Antidiabetic Agents
Features
Brand
Arya
Full Details
Dosage Strength
1mg
Drug Ingredients
- Glimepiride
Drug Packaging
Tablet 30's
Generic Name
Glimepiride
Dosage Form
Tablet
Registration Number
DR-XY33171
Drug Classification
Prescription Drug (RX)
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