Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)
Amneal Pharmaceuticals
METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE 500 mg
ORAL
PRESCRIPTION DRUG
Metformin HCl Tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. Metformin HCl, USP 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) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see WARNINGS and PRECAUTIONS ). - Known hypersensitivity to metformin HCl, USP. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. Metformin HCl, USP 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 PRECAUTIONS .)
Metformin HCl Tablets, USP 500 mg are white to off-white, round, biconvex, film-coated tablets debossed “IP175” on obverse and “500” on the reverse. They are available as follows: Bottles of 100: NDC 65162-175-10 Bottles of 500: NDC 65162-175-50 Bottles of 1000: NDC 65162-175-11 Metformin HCl Tablets, USP 850 mg are white to off-white, round, biconvex, film-coated tablets debossed “IP176” on obverse and “850” on the reverse. They are available as follows: Bottles of 100: NDC 65162-174-10 Bottles of 500: NDC 65162-174-50 Bottles of 1000: NDC 65162-174-11 Metformin HCl Tablets, USP 1000 mg are white to off-white, oval, biconvex, bisected, film-coated tablets debossed “IP177” on obverse and “1000” on the reverse. They are available as follows: Bottles of 100: NDC 65162-177-10 Bottles of 500: NDC 65162-177-50 Bottles of 1000: NDC 65162-177-11 Storage Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F) [See USP Controlled Room Temperature.] Dispense in light-resistant containers.
Abbreviated New Drug Application
METFORMIN HYDROCHLORIDE - METFORMIN TABLET AMNEAL PHARMACEUTICALS ---------- METFORMIN HYDROCHLORIDE TABLETS, USP DESCRIPTION Metformin Hydrochloride (HCl) Tablets, USP is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin HCl, USP (_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 HCl, USP is a white to off-white crystalline compound with a molecular formula of C H N • HCl and a molecular weight of 165.62. Metformin HCl, USP 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 HCl, USP is 6.68. Metformin HCl Tablets, USP, contains 500 mg, 850 mg, or 1000 mg of metformin HCl, USP. Each tablet contains the inactive ingredients povidone, microcrystalline cellulose, croscarmellose sodium and magnesium stearate. In addition, the coating for the 500 mg, 850 mg and 1000 mg tablets contain polyethylene glycol, polyvinyl alcohol, titanium dioxide and talc. 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 BIOAV Lees het volledige document