Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)
American Health Packaging
METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE 500 mg
ORAL
PRESCRIPTION DRUG
Metformin HCl extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin HCl, extended-release tablets are contraindicated in patients with: - Severe renal impairment (eGFR below 40 mL/min/1.73 m 2 ) (see WARNINGS and PRECAUTIONS ). - Known hypersensitivity to metformin HCl. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
Metformin HCl Extended-Release Tablets, USP 500 mg are white, capsule shaped, biconvex tablets debossed "IP 178" on one side and plain on the other side. They are available as follows: Unit dose packages of 100 (10 x 10) NDC 68084-072-01 Storage Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Abbreviated New Drug Application
METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE AMERICAN HEALTH PACKAGING ---------- METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP 8207201/0817 RX ONLY DESCRIPTION Metformin hydrochloride (HCl) extended-release tablets, USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin HCl, 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 HCl, 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 HCl, 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 HCl, USP is 6.68. Metformin HCl extended-release tablets, USP contain 500 mg or 750 mg of metformin HCl, USP as the active ingredient. Metformin HCl extended-release tablets, USP 500 mg contain the inactive ingredients; colloidal silicon dioxide, hypromellose, magnesium stearate and microcrystalline cellulose. Metformin HCl extended-release tablets, USP 750 mg contain the inactive ingredients; colloidal silicon dioxide, hypromellose and magnesium stearate. Dissolution Method: Test 10 SYSTEM COMPONENTS AND PERFORMANCE – Metformin HCl extended-release tablets comprise a dual hydrophilic polymer matrix system. Metformin HCl is combined with a drug release controlling polymer to form an "inner" phase, which is then incorporated as discrete particles into an "external" phase of a second polymer. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tr Prečítajte si celý dokument