Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)
Blenheim Pharmacal, Inc.
METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE 500 mg
ORAL
PRESCRIPTION DRUG
Metformin hydrochloride tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride tablets, USP and metformin hydrochloride extended-release tablets, USP are 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. Me
Metformin hydrochloride tablets, USP are available as: Metformin hydrochloride 500 mg tablets, USP are round, white to off-white, film coated tablets debossed with “Andrx 674” on one side and “500” debossed on the other side. Metformin hydrochloride 850 mg tablets, USP are round, white to off-white, film coated tablets debossed with “Andrx 675” on one side and “850” debossed on the other side. Metformin hydrochloride 1000 mg tablets, USP are oval, white to off-white, film coated tablets with “Andrx 676” debossed on one side and bisected “1000” on the other side. Metformin hydrochloride extended-release tablets, USP are available as: Metformin hydrochloride extended-release 500 mg tablets, USP are white to off-white, capsule shaped tablets, debossed with the and “571” on one side and “500” on the other side. Metformin hydrochloride extended-release 750 mg tablets, USP are light yellow, capsule shaped tablets, debossed with and “577” on one side and “750” on opposite side. Store at controlled room temperature 20°-25°C (68°-77°F). [See USP.] Dispense in light-resistant containers. Metformin hydrochloride tablets, USP are manufactured by: Patheon Puerto Rico, Inc. Caguas, Puerto Rico 00725, USA Distributed by: Watson Pharma, Inc. Metformin hydrochloride extended-release tablets, USP are manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA Distributed by: Watson Pharma, Inc. Rev. date 05/09 190733
Abbreviated New Drug Application
METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE BLENHEIM PHARMACAL, INC. ---------- METFORMIN HYDROCHLORIDE, USP TABLETS AND METFORMIN HYDROCHLORIDE, USP EXTENDED-RELEASE TABLETS METFORMIN HYDROCHLORIDE TABLETS, USP AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP RX ONLY 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, USP given under fasting conditions is approximately 50-60%. Studies using single oral doses of metformin hydrochloride tablets, USP of 500 mg to 1500 mg, and 850 mg to 2550 mg, indicate that there is a lack of dose proportionality with increasing doses, which is due to decreased absorption rather than an alteration in elimination. Food decreases the extent and slightly delays the absorption of metformin, as shown by approximately a 40% lower mean peak plasma concentration (C ), a 25% lower area under the plasma concentration versus time curve (AUC), and a 35 minute prolongation of time to peak plasma concentration (T ) following administration of a single 850 mg tablet of metformin with food, compared to the same tablet strength administered fasting. The clinica Soma hati kamili