TGP Glimepiride

TGP Glimepiride

glimepiride

Manufacturer:

ACME

Distributor:

TGP Pharma

Marketer:

Euro Generics
Full Prescribing Info
Contents
Glimepiride.
Description
Each tablet contains Glimepiride USP 2 mg.
Glimepiride is an oral hypoglycemic drug belonging to the sulfonylurea group. It stimulates the release of insulin from functioning pancreatic β-cells. It also can increase sensitivity of peripheral tissues to insulin.
Action
Pharmacology: Pharmacodynamics: Glimepiride is an orally active hypoglycaemic substance belonging to the sulphonylurea group. It may be used in non-insulin dependent (type 2) diabetes mellitus. Glimepiride acts mainly by stimulating insulin release from pancreatic beta cells. As with other sulfonylureas this effect is based on an increase of responsiveness of the pancreatic beta cells to the physiological glucose stimulus. In addition, glimepiride seems to have pronounced extrapancreatic effects also postulated for other sulfonylureas.
Pharmacokinetics: Glimepiride is completely absorbed from the gastrointestinal tract. Peak plasma concentrations occur in 2 to 3 hours, and it is highly protein bound. The drug is extensively metabolized to two main metabolites, a hydroxyl derivative and a carboxyl derivative. The half-life after multiple doses is about 9 hours. Approximately 60% of a dose is eliminated in the urine and 40% in the feces.
Indications/Uses
Glimepiride is indicated in type 2 diabetes mellitus when dietary modification has failed in adequate glycemic control.
Dosage/Direction for Use
Usual Starting Dose: The usual starting dose of Glimepiride as initial therapy is 1-2 mg once daily, administered with breakfast or the first main meal. The patients who are more sensitive to hypoglycemic drugs should be started at 1 mg once daily. The maximum starting dose of Glimepiride should be not more than 2 mg.
Usual Maintenance Dose: The usual maintenance dose is 1 - 4 mg once daily. The maximum recommended dose is 8 mg once daily. After reaching a dose of 2 mg, dosage increases should be made in increments of not more than 2 mg at 1-2 week intervals based upon the patient's blood glucose response.
OR AS DIRECTED BY THE PHYSICIAN.
Overdosage
Symptoms: After ingestion of an overdosage hypoglycaemia 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, co-ordination problems, sleepiness, coma and convulsions.
Treatment: 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) overdosage 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 a 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 hypoglycaemia 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.
Contraindications
Glimepiride is contraindicated in patients with known hypersensitivity to the drug. It is also contraindicated in diabetic ketoacidosis, with or without coma.
Special Precautions
Caution is needed in the elderly and in those with mild to moderate hepatic & renal impairment.
Use in Children: Safety and effectiveness in children have not been established.
Use in the Elderly: There are no significant differences in pharmacokinetics between the elderly and adults.
Use In Pregnancy & Lactation
Glimepiride should not be given during pregnancy and lactation.
Adverse Reactions
Hypoglycemia, gastrointestinal disturbances such as nausea, vomiting, abdominal pain, diarrhea and constipation may occur.
Drug Interactions
The hypoglycemic action of Glimepiride may be potentiated by certain drugs, include NSAIDs and other drugs that are highly protein bound such as salicylates, sulfonamides, chloramphenicol, coumarin derivatives, probenecid, monoamine oxidase inhibitors, and beta adrenergic blocking agents. Thiazides and other diuretics, corticosteroids, phenothiazines, estrogens, oral contraceptives, nicotinic acid, sympathomimetics, thyroid hormones and isoniazid tend to reduce the hypoglycemic effect of glimepiride, when administered with it.
Storage
Store at temperatures not exceeding 30°C. Protect from light.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BB12 - glimepiride ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.
Presentation/Packing
Form
TGP Glimepiride tab 2 mg
Packing/Price
40's
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