Metformin STELLA 500 mg

Rx

Indications:

Non-insulin-dependent diabetes mellitus (type II): Monotherapy when hyperglycemia cannot be managed on diet alone or in combination with sulfonylurea when diet and metformin or sulfonylurea alone does not result in adequate glycemic control.

Dosage:

• Patients new to metformin: Initiate at 500 mg once daily, if the patient does not have any gastrointestinal adverse reactions and needs to increase dose, an addition of 500 mg metformin may be given at 1 – 2 weeks intervals, maximum 2000 mg/day.
• Adults: Initiate at 500 mg twice daily (given with the morning and evening meals); an addition of one tablet/day every other week, up to a maximum of 5 tablets/day.
• Children from 10 years of age and adolescents: Start at 1 tablet once daily, after 10 to 15 days, the dose should be adjusted on the basis of blood glucose measurements, maximum 2 g daily, taken as 2 or 3 divided doses.
• Elderly: Should not be titrated to the maximum dose of metformin.
• Renal impairment: Not recommended (if eGFR = 30 – 45 ml/minute/1.73 m²), assess the benefit and risk of continuing therapy (if eGFR < 45 ml/minute/1.73 m²), discontinue (if eGFR < 30 ml/minute/1.73 m²)
• Hepatic impairment: Metformin should not be used.
• Discontinue metformin at the time of, or prior to, an iodinated contrast imaging procedure: in patients with an eGFR = 30 – 60 ml/minute/1.73 m²; in patients with a history of liver disease, alcoholism, or heart failure; in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart metformin if renal function is stable.

Usage:

Metformin STELLA 500 mg is orally administered with or after meals.

• Known hypersensitivity to any of the active substance or excipients.
• Acute catabolic states, infection, trauma which should be treated with insulin.
• Decreased kidney function in renal disease or renal dysfunction (ClCr ≥ 1.5 mg/dl in males, or ≥ 1.4 mg/dl in females) or result from other diseases.
• Severe renal impairment (eGFR < 30 mL/minute/1.73 m²).
• Metabolic acidosis, including diabetic ketoacidosis.
• Severe hepatic/cardiovascular disease, severe respiratory disease with hypoxaemia.
• Congestive heart failure, cardiovascular collapse, acute myocardial infarction.
• Chronic hypoxic lung disease.
• Severe infection, septicemia.
• In acute symptoms of metabolic decompensation.
• Pregnancy.
• Temporarily withheld in patients undergoing radiologic studies involving the parenteral administration of iodinated contrast materials.
• Gangrene, alcoholism, malnutrition.

Common: Anorexia, nausea, vomiting, diarrhoea, epigastric fullness, constipation, heartburn; rash, urticaria, photosensitivity; decreased vitamin B₁₂ levels.

• Risks of lactic acidosis (increase by the severity of renal impairment, age, alcohol intake).
• Therapy with metformin should be discontinued for any surgical procedures.
• Oral antidiabetic drugs increase cardiovascular mortality as compared to the treatment with diet alone or the combination of insulin with diet.
• A decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.
• Patients should be aware of how they react to drug before driving or operating machinery (if metformin is used in combination with other antidiabetic agents).