Description
Generic
Metformin Hydrochloride
Indications
RadimetTM (Metformin Hydrochloride tablet) is indicated as an adjunct to diet and exercise to improve glycemic control in children and adults with type 2 diabetes mellitus. RadimetTM XR (Metformin Hydrochloride extended release tablet) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Pharmacology
Metformin is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and generally it does not produce hypoglycemia. Metformin Hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Dosage & Administration
Adults : Usual Starting dose of RadimetTM (Metformin Hydrochloride tablet) is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases 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. Starting dose of RadimetTM XR (Metformin Hydrochloride extended release tablet) is 500 mg once daily with the evening meal. Dosage increases should be made in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal.
Pediatrics : Usual Starting dose of RadimetTM (Metformin Hydrochloride tablet) is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.
Interaction
No information is available about the interaction of Metformin and Furosemide when co-administered chronically. Nifedipine appears to enhance the absorption of Metformin. Metformin had minimal effects on Nifedipine. Cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin) that are eliminated by renal tubular secretion theoretically have the potential for interaction with Metformin by competing for common renal tubular transport systems. Metformin had no effect on Cimetidine pharmacokinetics. Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid.
Contraindications
Metformin Hydrochloride is contraindicated in patients with:
- Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels > 1.5 mg/dL [males], > 1.4 mg/dL [females] or abnormal creatinine clearance).
- Known hypersensitivity to Metformin Hydrochloride.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
Side Effects
The most common side effects of Metformin are diarrhoea, nausea, vomiting, abdominal bloating, flatulence, and anorexia. Lactic acidosis also rarely occurs.
Pregnancy & Lactation
Both Metformin immediate and extended release tablets should not be used during pregnancy unless clearly needed as there are no adequate and well-controlled studies in pregnant women with Metformin. Metformin was not teratogenic in rats and rabbits at doses up to 600 mg/kg/day. The potential for hypoglycemia in nursing infants may exist, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Precautions & Warnings
Metformin is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Thus, patients with serum creatinine levels above the upper limit of normal for their age should not receive Metformin. In patients with advanced age, Metformin should be carefully titrated to establish the minimum dose for adequate glycemic effect, because aging is associated with reduced renal function.
Therapeutic Class
Antidiabetic
Storage Conditions
Store in a cool & dry place at below 30°C, protect from light & moisture. Keep the medicine out of the reach of children.
Pharmaceutical Name
Radiant Pharmaceuticals Ltd.
