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Metformin HCl BP
|Insimet 500 XR
Insimet (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 it does not produce hypoglycemia. Insimet decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
Insimet 500 : Each film coated tablet contains Metformin Hydrochloride BP 500 mg. Insimet 850 : Each film coated tablet contains Metformin Hydrochloride BP 850 mg. Insimet XR 500: Each extended release tablet contains Metformin Hydrochloride BP 500 mg.
Indications And Uses
Insimet, as monotherapy, is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Insimet is also indicated for use in combination therapy with an oral hypoglycemic agent or insulin when diet and exercise plus the single agent do not result in adequate glycemic control.
Dosage And Administration
Dosage of Insimet or Insimet XR must be individualized on the basis of both effectiveness and tolerance. The maximum recommended daily dose of Insimet is 2550 mg in adults and 2000 mg in pediatric patients (10-16 years of age); the maximum recommended daily dose of Insimet XR in adults is 2000 mg. Insimet should be given in divided doses with meals while Insimet XR should generally be given once daily with the evening meal. Insimet XR tablet must be swallowed whole and never be crushed or chewed. Insimet or Insimet XR should be started at a low dose, with gradual dose escalation for adequate glycemic control of the patient.
Diarrhea (usually transient), nausea, vomiting, lactic acidosis (withdraw treatment), decreased vitamin B12 absorption.
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.
Use In Pregnancy Lactation
Pregnancy: Pregnancy Category B. Most experts recommend that insulin should be used during pregnancy to maintain blood glucose levels as close to normal as possible. Both Metformin immediate and extended release tablets should not be used during pregnancy unless clearly needed. Nursing Mother: Because 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.
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.
Store at cool and dry place and keep away from light. Keep out of reach of children.
Metformin hydrochloride is contraindicated in hepatic or renal impairment (withdraw if renal impairment is suspected), predisposition to lactic acidosis, heart failure, severe infection or trauma, dehydration, alcohol dependence, pregnancy, breast-feeding.
Insimet 500: Box contains 100 (10x10's) tablets in blister pack. Insimet 850: Box contains 50 (5x10's) tablets in blister pack. Insimet XR 500: Box contains 50 (5x10's) tablets in blister pack.