País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)
Mylan Institutional Inc.
METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE 500 mg
ORAL
PRESCRIPTION DRUG
Metformin hydrochloride tablets are 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 should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such
Metformin Hydrochloride Tablets, USP are available containing 500 mg or 1000 mg of metformin hydrochloride, USP. The 500 mg tablets are white to off-white, film-coated, round, unscored tablets with blackberry scent debossed with MF over 1 on one side of the tablet and G on the other side. They are available as follows: NDC 51079-172-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 1000 mg tablets are white to off-white, film-coated, oblong, scored tablets with blackberry scent debossed with MF to the left side of the score and 3 to the right side of the score on one side of the tablet and G to the left side of the score and G to the right side of the score on the other side. They are available as follows: NDC 51079-174-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]
Abbreviated New Drug Application
METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED MYLAN INSTITUTIONAL INC. ---------- DESCRIPTION Metformin hydrochloride is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (1,1-Dimethylbiguanide monohydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown: Metformin hydrochloride, USP is a white crystalline powder with a molecular formula of C H N • HCl and a molecular weight of 165.62. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg or 1000 mg of metformin hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: artificial blackberry flavor, macrogol, magnesium stearate, polyvinyl alcohol, povidone, talc 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 unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease. PHARMACOKINETICS _ABSORPTION AND BIOAVAILABILITY_ The absolute bioavailability of a metformin hydrochloride 500 mg tablet given under fasting Llegiu el document complet