Indications
Treatment of type 2 diabetes mellitus in adults. Metformin may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control.
Contraindications
Known hypersensitivity to any of the active substance or excipients.
Pregnancy.
Acute catabolic states, infection, trauma (diabetes should be treated with insulin).
Decreased kidney function in renal disease or renal dysfunction (serum creatinine greater than or equal to 1.5 mg/dl in males, or greater than or equal to 1.4 mg/dl in females) or result from other diseases.
Acute or chronic metabolic acidosis with or without coma (including diabetic ketoacidosis).
Patients with severe hepatic disease, severe 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; gangrene, alcoholism, malnutrition.
Temporarily withheld in patients undergoing radiologic studies involving the parenteral administration of iodinated contrast materials.
Compositon/Ingredients
Metformin 1000mg
Dosage and administration
Monotherapy and combination with other oral antidiabetic agents:
Maximum recommended dose of 2 MR tablets per day with meal (if glycaemic control is not achieved: consider schedule one MR tablet x 2 times/day at the time of the morning and evening meals; if glycaemic control is still not achieved: switch to standard tablets to a maximum dose of 3000 mg daily);
Currently treated with either 1000 mg or 2000 mg of metformin: maintain the daily dose of MR tablet equivalent to the current daily dose;
Treated with a dose above 2000 mg metformin daily: not recommend switching to Metformin STELLA 1000 mg;
New to metformin hydrochloride or transfer from another oral antidiabetic agent: initial 500 mg once daily (using other suitable preparation) with the evening meal, after 10 to 15 days, dosage is adjusted on the basis of blood glucose measurements.
Combination with insulin: initial 500 mg once daily (using other suitable preparation) with the evening meal, insulin dosage is adjusted on the basis of blood glucose measurements. After titration, consider switching to Metformin STELLA 1000 mg.
Metformin STELLA 1000 mg should not be used in children.
Elderly: doses adjustment bases on renal function.
Precaution
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).
Storage
Store at temperature below 30°C, protect from light.
