Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)
Teva Pharmaceuticals USA, 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 500 mg, are available as white to off-white film-coated oval-shaped tablets, debossed with “93” on one side and “48” on the other side. They are available in bottles of 100 (NDC 0093-1048-01) and 1000 (NDC 0093-1048-10). Metformin Hydrochloride Tablets USP 850 mg, are available as white to off-white film-coated oval-shaped tablets, debossed with “93” on one side and “49” on the other side. They are available in bottles of 100 (NDC 0093-1049-01) and 1000 (NDC 0093-1049-10). Metformin Hydrochloride Tablets USP 1000 mg, are available as white to off-white film-coated oval-shaped tablets, scored on two sides, debossed with “9” on the left side of the score and “3” on the right side of the score on one side and “72” on the left side of the score and “14” on the right side of the score on the other side. They are available in bottles of 100 (NDC 0093-7214-01) and 1000 (NDC 0093-7214-10). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Czech Republic By: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic Manufactured For: North Wales, PA 19454 Rev. AO 4/2017
Abbreviated New Drug Application
METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED TEVA PHARMACEUTICALS USA, INC. ---------- METFORMIN HYDROCHLORIDE TABLETS USP 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: C H N •HCl M.W. 165.63 Metformin hydrochloride, USP is a white to off-white crystalline compound. 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 contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, polyethylene glycol, povidone 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 hyd Lue koko asiakirja