Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)
REMEDYREPACK INC.
METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE 500 mg
ORAL
PRESCRIPTION DRUG
Metformin hydrochloride 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 hydrochloride tablets are contraindicated in patients with: 1. Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) (see WARNINGS and PRECAUTIONS ). 2. Known hypersensitivity to metformin hydrochloride tablets, USP. 3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
Metformin hydrochloride tablets, USP 500 mg Bottles of 90 NDC57664-397-59 500 mg Bottles of 100 NDC57664-397-51 500 mg Bottles of 500 NDC57664-397-53 500 mg Bottles of 1000 NDC57664-397-58 850 mg Bottles of 90 NDC57664-435-59 850 mg Bottles of 100 NDC57664-435-51 850 mg Bottles of 500 NDC57664-435-53 850 mg Bottles of 1000 NDC57664-435-58 1000 mg Bottles of 90 NDC57664-474-59 1000 mg Bottles of 100 NDC57664-474-51 1000 mg Bottles of 500 NDC57664-474-53 1000 mg Bottles of 1000 NDC57664-474-58 Metformin hydrochloride 500 mg tablets, USP are round, white to off-white, film coated tablets debossed with “397” on one side and plain on the other side. Metformin hydrochloride 850 mg tablets, USP are round, white to off-white, film coated tablets debossed with “435” on one side and plain on the other side. Metformin hydrochloride 1000 mg tablets, USP are white to off-white colored, oval shaped, film coated tablets debossed with “C” & “474” on one side and scored on both sides. Storage Store at controlled room temperature 15°-30°C (59°-86°F). Dispense in tight, light resistant container as defined in the USP.
Abbreviated New Drug Application
METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET REMEDYREPACK INC. ---------- METFORMIN HYDROCHLORIDE TABLETS, USP RX ONLY DESCRIPTION Metformin hydrochloride, USP is an oral antihyperglycemic drug 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, 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 4 11 5 is practically insoluble in acetone, ether and chloroform. The pKa of metformin is 12.4. The pH of a 1% a aqueous solution of metformin hydrochloride, USP is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg and 1000 mg of metformin hydrochloride, USP. Each tablet contains the inactive ingredients povidone, polyethylene glycol and magnesium stearate. In addition the coating for 500 mg, 850 mg and 1000 mg contains: lactose monohydrate, hypromellose, 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 hydrochloride 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. PHAR Կարդացեք ամբողջական փաստաթուղթը