COMPOSITION:
GLIMIFIX-M 1
Each Uncoated bilayer tablet contains
Glimepiride………………………………1 mg
Metformin (Sustain-Release)……… 500 mg
GLIMIFIX-M 2
Each Uncoated bilayer tablet contains
Glimepiride…………………………… 2 mg
Metformin (Sustain-Release)…… 500 mg
DESCRIPTION:
GLIMIFIX-M contains two oral anti-hyperglycemic drugs glimepiride and metformin hydrochloride sustained release used in the management of type 2 diabetes (NIDDM). The primary mechanism of action of glimepiride in lowering blood glucose appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. Metformin hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Hence, the combination of glimepiride and metformin sustain release complements each other and provides better glycaemic control in the management of type 2 diabetes and probably in the prevention of its associated macrovascular and microvascular complications.
INDICATIONS:
GLIMIFIX-M is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes who are already treated with a combination of glimepiride and metformin or whose diabetes is not adequately controlled with metformin alone, or for those patients who have initially responded to glimepiride alone and require additional glycaemic control.
DOSAGE & ADMINISTRATION:
General
Dosage should be individualized on the basis of both effectiveness and tolerance. The combination should be given once daily (1-2 mg daily) with meals and should be started at a low dose. The initial recommended dose is one tablet once daily with breakfast or the first main meal of the day and gradually titrated after assessing the adequacy of the therapeutic response.
CONTRAINDICATIONS:
1. Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels 1.5 mg/dL [males], 1.4 mg/dL [females] or abnormal creatinine clearance), which may also result from condition s such as cardiovascular collapse (shock), acute myocardial infarction, and septicaemia.
2. Congestive heart failure requiring pharmacologic treatment.
3. Known hypersensitivity to this product or any of its components.
4. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
5. Patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because the use of such products may result in acute alteration of renal function.