Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
metformin hydrochloride (UNII: 786Z46389E) (metformin - UNII:9100L32L2N)
Breckenridge Pharmaceutical, 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: - Severe renal impairment (eGFR below 30 mL/min/1.73 m2 ) (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, USP Metformin Hydrochloride Tablets, USP, 500 mg are white to off-white, oval, biconvex, film coated tablets with "∧" debossed on one side and "101" debossed on the opposite side. Metformin Hydrochloride Tablets, USP, 850 mg are white to off-white, oval, biconvex, film coated tablets with "∧" debossed on one side and "102" debossed on the opposite side. Metformin Hydrochloride Tablets, USP, 1000 mg are white to off-white, oval, biconvex, film coated tablets with "∧ 103" debossed on one side and a bisect line on both sides. Store at 20°–25°C (68°–77°F); excursions permitted to 15°–30°C (59°–86°F). [See USP Controlled Room Temperature.] Dispense in tight, light-resistant containers as defined in the USP with a child-resistant closure.
Abbreviated New Drug Application
METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET BRECKENRIDGE PHARMACEUTICAL, INC. ---------- METFORMIN HYDROCHLORIDE [MET FOR' MIN HYE" DROE KLOR' IDE] TABLETS USP DESCRIPTION Metformin Hydrochloride Tablets, USP 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 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. Each tablet contains the inactive ingredients crospovidone, povidone, and stearic acid. In addition, the coating for the 500 mg, 850 mg and 1000 mg tablets contains hypromellose, maltodextrin and polyethylene glycol. 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. PHARMACOKI Прочитать полный документ