Each film coated tablet contains:
Metformin Hydrochloride BP 500 mg
Colour: Titanium Dioxide BP
Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce
It may act via 3 mechanisms:
(1) Reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis
(2) In muscle, by increasing insulin sensitivity, improving peripheral glucose uptake and utilization
(3) And delay of intestinal glucose absorption.
Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase. It increase the transport capacity of all types of membrane glucose transporters (GLUT).
Therapeutic category: Blood glucose lowering drug
i) Treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycemic control.
ii) In adults, Metformin film-coated tablets may be used as monotherapy or in combination with other oral anti-diabetic agents or with insulin.
iii) In children from 10 years of age and adolescents, Metformin hydrochloride film-coated tablets may be used as monotherapy or in combination with insulin.
iv) A reduction of diabetic complications has bean shown in overweight type 2 diabetic adult patients treated with metformin hydrochloride as first-line therapy after diet failure.
Posology and Method Administration:
Route of Administration: Oral
Monotherapy and combination with other oral antidiabetic agents:
The usual starting dose is 500 mg or 850 mg Metformin hydrochloride 2 or 3 times daily given during or after meals.
Altar 10 to 15 days the dose should be adjusted on the basis of blood glucose measurement. A slow increase of dose may improve gastrointestinal tolerability.
The maximum recommended dose of is 3 g daily, taken as 3 divided doses.
i) Hypersensitivity to Metformin orto any of the excipients.
ii) Diabetic ketoacidosis, diabetic pre-coma.
iii) Renal failure or renal dysfunction (creatinine clearance < 60 ml/min)
iv) Acute conditions with the potential to alter renal function such as:
– Severe Infection,
v) Acute or chronic disease which may cause tissue hypoxia such as:
– Cardiac or respiratory failure,
– Recent myocardial infarction,
vi) Hepatic insufficiency, acute alcohol intoxication, alcoholism