Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)
Glenmark Pharmaceuticals Inc., USA
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:
Metformin Hydrochloride Tablets USP 500 mg Bottles of 90 NDC 68462-159-90 500 mg Bottles of 100 NDC 68462-159-01 500 mg Bottles of 180 NDC 68462-159-18 500 mg Bottles of 500 NDC 68462-159-05 500 mg Bottles of 1000 NDC 68462-159-10 850 mg Bottles of 90 NDC 68462-160-90 850 mg Bottles of 100 NDC 68462-160-01 850 mg Bottles of 180 NDC 68462-160-18 850 mg Bottles of 500 NDC 68462-160-05 850 mg Bottles of 1000 NDC 68462-160-10 1000 mg Bottles of 90 NDC 68462-161-90 1000 mg Bottles of 100 NDC 68462-161-01 1000 mg Bottles of 180 NDC 68462-161-18 1000 mg Bottles of 500 NDC 68462-161-05 1000 mg Bottles of 1000 NDC 68462-161-10 Metformin hydrochloride tablets USP 500 mg are white, round shaped, biconvex, film coated tablets debossed with “G 45” on one side & “500” on the other side. Metformin hydrochloride tablets USP 850 mg are white, round shaped, biconvex, film coated tablets debossed with “G 45” on one side & “850” on the other side. Metformin hydrochloride tablets USP 1000 mg are white, capsule shaped, biconvex, film coated tablets with breakline on both sides & debossed with “G/45” on one side and “1000” on the other side.
Abbreviated New Drug Application
METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET GLENMARK PHARMACEUTICALS INC., USA ---------- METFORMIN HYDROCHLORIDE TABLETS USP RX ONLY DESCRIPTION Metformin Hydrochloride Tablets USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride, 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 hydrochloride, USP 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, 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 hydrochloride, USP is 6.68. Metformin Hydrochloride Tablets USP, for oral administration, contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride, USP. Each tablet contains the inactive ingredients microcrystalline cellulose, magnesium stearate and povidone. In addition, the coating for the 500 mg, 850 mg and 1000 mg tablets contains Opadry YS-1R-7006 Clear. The components of Opadry YS-1R-7006 Clear are hydroxypropyl methylcellulose, polyethylene glycol 400 and polyethylene glycol 6000. USP Dissolution test 1 is used. 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 Pročitajte cijeli dokument