Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)
Major Pharmaceuticals
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 Extended-Release Tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride and Metformin hydrochloride extended-release tablets are contraindicated in patients with: Metformin hydrochloride and Metformin hydrochloride extended-release tablets should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function (see also PRECAUTIONS ).
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg are available for oral administration as white to off-white, capsule shaped, unscored tablets, imprinted “APO” on one side and “XR500” on the other side. They are supplied as follows: Carton of 100 tablets (10 tablets each blister pack x 10), NDC 0904-5794-61 Bottles of 500, NDC 0904-5794-40 Store at 20°-25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers [see USP]. APOTEX INC. METFORMIN HYDROCHLORIDE TABLETS, USP 500 mg, 850 mg and 1000 mg METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP 500 mg and 750 mg Manufactured by: Manufactured for: Apotex Inc. Apotex Corp. Toronto, Ontario Weston, Florida Canada M9L 1T9 USA 33326 Revised: January 2014 Rev. 7 Distributed By: MAJOR® PHARMACEUTICALS 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152
Abbreviated New Drug Application
METFORMIN HYDROCHLORIDE EXTENDED RELEASE- METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE MAJOR PHARMACEUTICALS ---------- METFORMIN HYDROCHLORIDE TABLETS, USP 500 MG, 850 MG AND 1000 MG METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP 500 MG AND 750 MG RX ONLY DESCRIPTION Metformin Hydrochloride Tablets, USP and Metformin Hydrochloride Extended-Release Tablets, USP are oral antihyperglycemic drugs 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 is a white to off-white crystalline compound with a molecular formula of C H N •HCI and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Each Metformin Hydrochloride Tablet, USP for oral administration, contains 500 mg, 850 mg or 1000 mg of metformin hydrochloride. In addition, each film-coated tablet also contains the following inactive ingredients: methylcellulose, microcrystalline cellulose, polyethylene glycol, colloidal silicon dioxide, magnesium stearate, hypromellose, hydroxypropyl cellulose and titanium dioxide. Each 500 mg Metformin Hydrochloride Extended-Release Tablet, USP for oral administration, contains 500 mg of metformin hydrochloride. In addition, each 500 mg tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate and methylcellulose. Each 750 mg Metformin Hydrochloride Extended-Release Tablet, USP for oral administration, contains 750 mg of metformin hydrochloride. In addition, each 750 mg tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose and magnesium stearate. Metformin Extended-Release Tablets, USP meet USP Dissolution Test Aqra d-dokument sħiħ