Each tablet contains: Glimepiride 2 mg.
Pharmacology: Pharmacokinetics: Glimepiride is completely absorbed from the gastrointestinal tract. Peak plasma concentrations occur in 2 to 3 hours, and it is highly protein bound. It is extensively metabolized into two main metabolites, a hydroxyl derivative and a carboxy derivative. The half-life after multiple doses is about 9 hours. About 6% of a dose is eliminated in the urine and 40% in the faeces.
For concomitant use with insulin for the treatment of noninsulin-dependent (type II) diabetes mellitus; for the treatment of hyperglycemia that cannot be controlled by diet and exercise in conjunction with an oral hypoglycemic agent.
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. Those patients who may be more sensitive to hypoglycemic drugs should be started at 1 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 no more based upon the patient's blood glucose response.
Overdosage of Glimepiride can produce hypoglycemia. Mild hypoglycemia symptoms without loss of consciousness or neurologic finding should be treated aggressively with oral glucose and adjustment in drug dosage and/or meal patterns. Severe hypoglycemic reactions with coma, seizures, or other neurologic impairment occur infrequently, but constituted medical hospitalization.
Glimepiride is contraindicated in patients with known hypersensitivity to the drug.
Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.
Hypoglycemia: All sulfonylurea drugs are capable of producing severe hypoglycemia.
Patients with impaired renal function may be more sensitive to the glucose-lowering effect of Glimepiride, as starting dose of 1 mg once daily followed by appropriate dose titration is recommended in those with adrenal pituitary, or hepatic insufficiency are particularly susceptible to the hypoglycemic action of glucose-lowering drugs.
Loss of control of blood glucose: When a patient stabilized in any diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, a loss of control may occur.
Caution: Caution is needed in the elderly and those with mild to moderate hepatic and renal impairment because of the hazard of hypoglycemia. Careful monitoring of blood glucose concentration is essential among these patients with renal or hepatic dysfunction; care is required to choose the smallest possible dose that produces adequate control of blood glucose.
Use in Children: The profile of adverse reactions in pediatric patients treated with Glimepiride was similar to that observed in adults.
Elderly patients are particularly susceptible to hypoglycemic action of glucose lowering drugs. In elderly, debilitated, or malnourished patients, or in patients with renal and hepatic insufficiency, hypoglycemia may be difficult to recognize in the elderly and in people who are taking beta-adrenergic blocking drugs or other sympatholytic agents.
Use in Pregnancy: A Glimepiride tablet is not recommended for use in pregnancy.
Use in Lactation: A Glimepiride tablet is not recommended for use in nursing mothers.
Vomiting. gastrointestinal pain, diarrhea, impairment of liver function (e.g., with cholestasis and jaundice) hepatic and liver failure.
Pruritus, erythema, urticaria, morbilliform or maculopapular eruptions, porphyria cutanea tarda, photosensitivity reactions, and allergic vasculitis have been reported.
Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, and pancytopenia.
Hepatic porphyria reactions and disulfiram-like reactions have been reported with Glimepiride. The syndromes of inappropriate antidiuretic hormone (SIADH) secretion has been reported with Glimepiride.
Changes in occur with the use of Glimepiride. Dizziness, Asthenia, Headache and Nausea.
The hypoglycemic action of sulfonylureas may be potentiated by certain drugs, including nonsteroidal anti-inflammatory drugs and other drugs that are highly protein bound, such as salicylates, sulfonamide, chloramphenicol, coumarins, probenecid, monoamine oxidase, inhibitors, and beta adrenergic blocking agents.
Certain drugs tend to produce hyperglycemia and may lead to loss of control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympthomimetics, and isoniazid. Co-administration of either cimetidine (800 mg once daily) or ranitidine (150 mg bid) with a single 4 mg oral dose of (150 mg bid) with a significantly alter the absorption of Glimepiride, and no difference were seen in hypoglycemic symptomology.
Beta-blocker are used, caution should be exercised and patients should be warned about the potential for hypoglycemia.
Glimepiride treatment did result in a slight, but statistically significant, decrease in the pharmacodynamic response to warfarin.
Type 2 diabetes showed no evidence of 2 clinically significant decrease in the pharmacodynamic response to warfarin.
Type 2 diabetes showed no evidence of clinically significant adverse interactions with uncontrolled concurrent administration of ACE inhibitor. A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported. There is a potential interaction of Glimepiride with inhibitors (e.g., fluconazole) and inducers (e.g., rifampicin) of cytochrome P4502C9.
Significant adverse interactions with uncontrolled concurrent administration of calcium-channel blockers, estrogens, fibrates, NSAIDS, HMG CoA reductase inhibitors, sulfonamides, or thyroid hormone.
Store at temperatures not exceeding 30°C.
A10BB12 - glimepiride ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.