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Metomin (Metformin Hydrochloride BP)

Composition:

Metomin Tablet: Each film coated tablet contains Metformin Hydrochloride BP 850 mg.

Metomin 500 Tablet: Each film coated tablet contains Metformin Hydrochloride BP 500 mg.

Pharmacology:

Metformin Hydrochloride is an oral hypoglycemic agent that enhances insulin stimulated glucose transport in skeletal muscle and increases peripheral glucose uptake due to improved insulin sensitivity. It decreases the hepatic glucose output as well as the rate of gluconeogenesis and glycolysis. After an oral administration Metformin Hydrochloride, Tmax is reached in 2.5 hours and absolute bioavailability is approximately 50-60% in healthy subjects. Plasma protein binding is negligible. It is excreted unchanged in the urine. Renal clearance is > 40 ml/minute, including that it is eliminated by glomerular filtration & tubular secretion. Following an oral dose, the apparent terminal half-life is approximately 6.5 hours.

Indication:

Non-insulin dependent adult diabetes mellitus, when overweight or obesity is not responding to dietary therapy. Metomin tablet can be given alone as initial therapy or can be administered in combination with a sulphonylurea. In insulin dependent diabetes Metomin tablet may be given as an adjuvant to patients whose symptoms are not well controlled and who are often obese.

Dosage and Administration:

Diabetes mellitus: The usual starting dose is 500 mg twice daily or 850 mg once a day, given with meals. Dosage increase should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. Patients can also be treated from 500 mg twice a day to 850 mg twice a day after 2 weeks. For those patients requiring additional glycemic control, Metomin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated when given three times a day with meals.

Polycystic Ovary Syndrome: Initially 500 mg with breakfast for 1 week, then 500 mg with breakfast and evening meal for 1 week, then 1.5 - 1.7 g daily in 2 - 3 divided doses.

Contraindications:

Individual hypersensitive to Metformin, renal impairment, predisposition to lactic acidosis, heart failure, severe infection or trauma, dehydration, alcohol dependence.

Precautions:

Metomin is inappropriate for patients with diabetic coma and ketoacidosis, or for those with severe infections, stress, trauma. It should not be given to patients with impairment of renal or hepatic function. Metomin 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.

Side effects:

Anorexia, nausea, vomiting, diarrhoea (usually transient), abdominal pain, taste disturbance, rarely lactic acidosis (withdraw treatment), decreased vitamin-B12 absorption, erythema, pruritus and urticaria; hepatitis also reported.

Use in pregnancy and lactation:

Metformin is a US FDA pregnancy category B drug. No evidence of risk in human has been found in using Metformin in pregnancy and lactation. Nevertheless Metformin should be used during pregnancy and lactation only if clearly needed.

Drug interactions:

In general fewer drug interactions have been reported with metformin such as Cimetidine, Ketotifen, Alcohol etc. It may enhance the effect of anticoagulants.

Packaging:

Metomin Tablet: Each box contains 5x10s tablets in blister pack.

Metomin 500 Tablet: Each box contains 10x10s tablets in blister pack.

 

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