International Nonproprietary Name

Metformin

Pharmacotherapeutic Group

• Digestive tract and metabolism

• Antidiabetic medicinal products

• Blood glucose-lowering drugs, excluding insulin

• Biguanides

Trade Name

Glucophage® X

Indications

• Prevention and risk reduction of type 2 diabetes in adult patients with overweight, impaired glucose tolerance, fasting hyperglycemia, and/or elevated glycated hemoglobin

• High-risk patients for developing type 2 diabetes

• Progression of type 2 diabetes despite active lifestyle changes over 3–6 months

• Treatment of type 2 diabetes in adults, especially in overweight patients, when diet therapy and physical exercise alone do not provide adequate glycemic control

• Can be used as monotherapy or in combination with other oral hypoglycemic agents or insulin

Contraindications

• Hypersensitivity to metformin or any of the excipients

• Any type of metabolic acidosis (lactic acidosis, diabetic ketoacidosis)

• Diabetic precoma

• Severe renal insufficiency (glomerular filtration <30 mL/min)

• Renal impairment (creatinine clearance <30 mL/min)

• Acute conditions that may impair renal function (dehydration, severe infection, shock)

• Acute or chronic diseases associated with tissue hypoxia (heart or respiratory failure, recent myocardial infarction, shock)

• Hepatic insufficiency, acute alcohol intoxication, alcoholism

Dosage Regimen

Adults with normal renal function (glomerular filtration rate ≥ 90 mL/min):

• Prevention of type 2 diabetes risk only if lifestyle modification over 3–6 months does not provide adequate glycemic control

• Therapy is initiated with 500 mg once daily with dinner

• Glycemic levels should be assessed 10–15 days after therapy initiation (glucose tolerance test, fasting glucose, glycated hemoglobin)

• Gradual dose increase may improve gastrointestinal tolerance

• Maximum recommended daily dose: 2000 mg with dinner

• Regular monitoring of glycemic status (glucose tolerance test, fasting glucose, glycated hemoglobin) every 3–6 months is recommended

• Decision on continuation and dose adjustment should be based on successful lifestyle and dietary modification

Overdose Measures

• Use of 85 g of metformin does not typically cause hypoglycemia but may induce lactic acidosis

• Treatment: lactic acidosis is a medical emergency requiring hospitalization

• Hemodialysis is the most effective method for removing lactate and metformin from the body

Shelf Life

3 years
Do not use after the expiration date

Storage Conditions

• Store at a temperature not exceeding 25°C

• Keep out of reach of children

Dispensing Conditions

• Pharmaceutical product group II

• Dispensed as form №3 with prescription (can be supplied without prescription in emergencies)

Manufacturer Information

• Merck Healthcare KGaA, Germany