国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
metformin hydrochloride (UNII: 786Z46389E) (metformin - UNII:9100L32L2N)
Provident Pharmaceutical, Inc
Metformin Hydrochloride
TABLET, FILM COATED
500 mg
ORAL
PRESCRIPTION DRUG
Metformin hydrochloride tablets, as monotherapy, are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Metformin hydrochloride is indicated in patients 10 years of age and older. Metformin hydrochloride may be used concomitantly with a sulfonylurea or insulin to improve glycemic control in adults (17 years of age and older). Metformin hydrochloride 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 hydrochloride. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. Metformin hydrochloride should be temporarily discontinued in
Metformin Hydrochloride Tablets 500 mg Bottles of 100 NDC 20091-531-01 500 mg Bottles of 500 NDC 20091-531-05 500 mg Bottles of 1000 NDC 20091-531-10 850 mg Bottles of 100 NDC 20091-533-01 850 mg Bottles of 500 NDC 20091-533-05 850 mg Bottles of 1000 NDC 20091-533-10 1000 mg Bottles of 100 NDC 20091-535-01 1000 mg Bottles of 500 NDC 20091-535-05 1000 mg Bottles of 1000 NDC 20091-535-10 Metformin Hydrochloride 500 mg tablets are white colored, round shape, film coated tablets debossed with "P531" on one side and "500" on the other side. Metformin Hydrochloride 850 mg tablets are white colored, round shape, film coated tablets debossed with "P533" on one side and "850" on the other side. Metformin Hydrochloride 1000 mg tablets are white colored, oval shape, film coated tablets debossed with "P" bisect "535" on one side and "10" bisect "00" on the other side. Store at 20° - 25° C (68° - 77° F); excursion permitted to 15° - 30° C (59° - 86° F). Dispense in tight, light-resistant container with child-resistant closure as defined in the USP.
METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED PROVIDENT PHARMACEUTICAL, INC ---------- METFORMIN HYDROCHLORIDE TABLETS, USP RX ONLY 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 pK of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, for oral administration, contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients carnauba wax, crospovidone, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide, and triacetin. 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 A 阅读完整的文件