Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)
REMEDYREPACK INC.
METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE 500 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED REMEDYREPACK INC. ---------- DESCRIPTION Metformin hydrochloride tablets, USP are 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 to off-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 contain 500 mg, 850 mg or 1000 mg of metformin hydrochloride. Each tablet contains the following inactive ingredients: artificial blackberry flavor, magnesium stearate, polyethylene glycol, 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 Lees het volledige document