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Glimepiride STADA® 2/4 mg

Glimepiride STADA

® 2/4mg

 
Packaging: 

Blister of 10 tablets. Box of 3 blisters.

Blister of 10 tablets. Box of 6 blisters.

Composition:

Each Glimepiride Stada® 2 mg tablet contains:

Glimepiride         2 mg
Excipients q.s     1 tablet

Each Glimepiride Stada® 4 mg tablet contains:  

Glimepiride          4 mg

Excipients q.s      1 tablet

Indications:

  • Glimepiride is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin-dependent (type 2) diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled by diet and exercise alone.

Dosage:

Glimepiride Stada® is orally taken. The drug usually is administered as a single daily dose given each morning with breakfast or with the first main meal.

  • Initial dosage in previously untreated patients: The usual initial adult dosage of glimepiride is 1-2 mg once daily. In debilitated, malnourished, or geriatric patients and in patients with hepatic or renal impairment and other patients at increased risk of hypoglycemia, the initial dosage of glimepiride should be 1 mg once daily.

  • Initial dosage in patients transferred from other antidiabetic agents: The initial dosage of glimepiride should be 1 - 2 mg once daily. The maximum dosage should not exceed 2 mg daily.

  • Maintenance dosage: The usual maintenance dosage of glimepiride from 1 - 4 mg once daily. In patients receiving 1 mg of glimepiride daily, the dosage may be increased to 2 mg daily if adequate glycemic control has not been achieved after 1 - 2 weeks. After reaching the 2 mg dosage, subsequent dosage should be adjusted according to the patient’s tolerance and therapeutic response, increasing the dosage in increments of no more than 2 mg daily at 1- to 2-week intervals.The maximum recommended dosage of glimepiride is 8 mg daily.

Contraindications:

  • Hypersensitivity to glimepiride, other sulfonylureas or sulfonamides or excipients in the tablet.

  • Insulin dependent diabetes, diabetic coma, ketoacidosis.

  • Severe renal or hepatic function disorders: a change over to insulin is required.

  • Pregnancy and lactation.

Drug interactions:

  • Coadministrations tend to produce hypoglycemia: sulfonylureas and nonsteroidal anti-inflammatory drugs and other drugs that are highly protein bound, such as salicylates, sulfonamides, chloramphenicol, coumarin, probenecid, monoamine oxidase inhibitors, and beta adrenergic blocking agents.

  • Coadministrations tend to produce hyperglycemia and may lead to loss of control: sulfonylureas and the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics and isoniazid.

  • A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported.

  • There is potential interaction of glimepiride with inhibitors (e.g. fluconazole) and inducers (e.g. rifampicin) of cytochrome P450 2C9.

Pregnancy and Lactation:

  • Glimepiride should not be used during pregnancy and lactation.

Adverse effects:

  • Hypoglycemia, dizziness, asthenia, headache, nausea.

  • Gastrointestinal reactions: vomiting, gastrointestinal pain, and diarrhea. In rare cases, there may be an elevation of liver enzyme levels. In isolated instances, impairment of liver function (e.g. with cholestasis and jaundice), as well as hepatitis.

  • Dermatologic reactions: porphyria cutanea tarda, photosensitivity reactions, and allergic vasculitis.

  • Hematologic reactions: Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia and pancytopenia.

  • Metabolic reactions: hepatic porphyria reactions and disulfiram-like reactions, hyponatremia, syndrome of inappropriate antidiuretic hormone (SIADH).

  • Other reactions: changes in accommodation and/or blurred vision. 

Shelf - Life:

24 months from the date of manufacturing.