Glucophage Powder

Company: Merck Serono.
Legal Category: Prescription. GMS. Sport permitted.
Active ingredient: Metformin (HCl) 500mg.
Description: White, odourless powder for oral solution.
Presentation: 500mg-30 sachets, €2.23.
Indications: Treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control (alone or with other oral antidiabetic agents or insulin).

Pharmacology: Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It may act via 3 mechanisms: Reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis; by increasing insulin sensitivity in muscle, improving peripheral glucose uptake and utilization; by delaying intestinal glucose absorption. Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase and increases the transport capacity of all types of membrane glucose transporters known to date. Independently of its action on glycaemia, metformin has favourable effects on lipid metabolism and reduces total cholesterol, LDL cholesterol and triglyceride levels at therapeutic doses.
Dosage: Adults: Usual starting dose is 500mg or 850mg 2 or 3 times daily with or after meals. Adjust dose after 10 to 15 days on basis of blood glucose measurements. Maximum recommended dose is 3g daily. In combination with insulin, adjust insulin dosage on basis of blood glucose measurements. Elderly: Adjust dose based on renal function (assess regularly). Children: 10 years and older, usual starting dose is 500mg or 850mg once daily with or after meals. Adjust dose after 10 to 15 days on basis of blood glucose measurements. Maximum recommended dose is 2g daily, taken as 2 or 3 divided doses.
Contraindications: Hypersensitivity to metformin HCl or any of the excipients. Diabetic ketoacidosis, diabetic pre-coma, renal failure or dysfunction, acute conditions which may alter renal function (e.g., dehydration, severe infection), diseases which may cause tissue hypoxia (e.g., cardiac or respiratory failure, recent myocardial infarction, shock), hepatic insufficiency, acute alcohol intoxication, alcoholism. Pregnancy, lactation.
Special precautions: Discontinue immediately and hospitalise patient if lactic acidosis is suspected. Impaired renal function. Determine serum creatinine levels at least annually if normal renal function, or 2 to 4 times annually in elderly or if serum creatinine at ULN. Do not administer within 48 hours pre- or post surgery. Children (especially between 10-12 years). Contains aspartame.
Drug interactions: Contra: Iodinated contrast agents. Not recommended: Alcohol. Caution: Insulin, sulfonylureas, repaglinide, glucocorticoids, β₂-agonists, ACE inhibitors, NSAIDs, diuretics, antihypertensives.
Adverse drug reactions: Taste disturbance, GI disorders.
Full prescribing information and references available from Merck Serono. Telephone: (01) 4687590.