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Metformin HCl

I-Max®




FORMULATION:
Each tablet contains:
Metformin hydrochloride ..................................... 500 mg

INDICATIONS:
Metformin is a biguanide hypoglycaemia agent used in the treatment of non-insulin dependent diabetes mellitus (NIDDM) not responding to dietary modifications. It is used as a monotherapy or in combination with a sulfonylurea product. In Type 1 diabetic patients or insulin deficient patients, who are not adequately controlled, metformin may be combined with insulin.

ACTIONS:
Metformin acts primarily by reducing hepatic glucose production and increasing peripheral glucose uptake. Insulin production is not affected and so hypoglycaemia as a side effect does not occur. Metformin does not cause weight gain and so is the treatment of choice for obese patients. Metformin HCl is equally effective in the non-obese. It induces comparable effects on fasting plasma glucose (FPG) glycosylated haemoglobin (HbA) levels to the sulphonylureas. Metformin HCl has a favorable effect on plasma lipids and the homeostatic mechanism.

Metformin HCl does not stimulate insulin release but does require that some insulin be present for it to exert a hypoglycemic effect. Possible mechanisms of action include delay in the absorption of glucose from the gastro-intestinal tract, an increased in insulin sensitivity and inhibition of hepatic gluconeogenesis. Metformin HCl does not usually lower blood-glucose concentrations in non-diabetic subjects.

ABSORPTION AND FATE:
Metformin hydrochloride is absorbed from the gastro-intestinal tract. It has a plasma half-life of about 3 hours and is not bound to plasma proteins. Metformin HCl is excreted, unchanged, in the urine. Its hypoglycemic action lasts 6-8 hours.

ADVERSE EFFECT:
Gastro-intestinal adverse effects including anorexia, nausea and diarrhea may occur and is dose dependent. These effects can be limited by administering with food and starting with low dose (500 mg once or twice a day), then slowly titrating the dose upwards according to the clinical response.

Patients may experience a metallic taste and there ma be weight loss. Absorption of various substances including Vitamin B12 may be impaired. Hypoglycelia is less of a problem with metformin than with sulphonylureas.

Lactic acidosis is rare and occurs predominantly in patients with renal impairment.

CAUTION:
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.

CONTRAINDICATIONS:
Metformin HCl is contraindicated in renal impairment and liver failure, because of an increased risk of hypoglycemia. Renal impairment may also predispose patients to lactic acidosis. Regular renal and hepatic monitoring is essential.

Metformin HCl should also not be given to patients with heart failure, recent myocardial infarction, dehydration, alcoholism or any other condition likely to predispose to lactic acidosis.

Drug interactions involve drugs also excreted by the renal tubular pathway (e.g. amiloride, cimitidine, digoxin, morphine, procainmide, quinidine, vancomycin, trimethoprim). Cimitidine may increase metformin levels by up to 50%

PREGNANCY AND LACTATION:
Use of metformin HCl is not recommended.

DOSAGE AND ADMINISTRATION:
Initial dose of 500mg three times daily with or after meals, gradually increased if necessary to a maximum of 3 g daily.

AVAILABILITY:
Box of 60 tablets in blisters.

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