Country: United States
Language: English
Source: NLM (National Library of Medicine)
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)
Solco healthcare U.S., LLC
METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE 500 mg
ORAL
PRESCRIPTION DRUG
Metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. Metformin hydrochloride tablets are 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), which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see WARNINGS and PRECAUTIONS ). - Known hypersensitivity to metformin hydrochloride. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. Metformin hydrochloride tablets should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. (See also PREC
Metformin hydrochloride tablets, USP Metformin hydrochloride tablets, 850 mg are white to off white, capsule shaped, biconvex, film coated tablets debossed with ‘I46’ on one side and plain on other side. Metformin hydrochloride tablets, 1000 mg are white to off white, oval shaped, biconvex, film coated tablets debossed with ‘I’ and ‘47’ separated by a breakline on one side and the breakline on the other side.
Abbreviated New Drug Application
METFORMIN HYDROCHLORIDE - METFORMIN HYDROCHLORIDE TABLET, FILM COATED SOLCO HEALTHCARE U.S., LLC ---------- RX ONLY METFORMIN HYDROCHLORIDE TABLETS (METFORMIN HYDROCHLORIDE TABLETS, USP) DESCRIPTION Metformin hydrochloride tablets are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (_N,N_-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown : Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C H N • HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients Sodium Starch Glycolate, Povidone, Corn Starch, Colloidal Silicon Dioxide and Magnesium Stearate. In addition, the coating for the 500 mg, 850 mg and 1000 mg tablets contains Opadry White which contains : Hypromellose, Talc, Polyethylene glycol and Titanium dioxide. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects (except in special circumstances, see PRECAUTIONS) and does not cause hyperinsulinemia. With metformin therapy, insulin secretion remains uncha Read the complete document