দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)
Lake Erie Medical DBA Quality Care Products LLC
METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE 500 mg
ORAL
PRESCRIPTION DRUG
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 extended-release tablets 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. 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 acu
Metformin Hydrochloride Extended - Release Tablets, USP Metformin hydrochloride extended release tablets, USP 500 mg are white to off-white, capsule shaped, uncoated tablets debossed with "142" on one side and plain on the other side. Metformin hydrochloride extended release tablets, USP 750 mg are red colored, biconvex, capsule shaped, uncoated tablets debossed with "143" on one side and plain on the other side. 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.] Dispense in light-resistant containers.
Abbreviated New Drug Application
METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP DESCRIPTION Metformin hydrochloride extended - release tablets 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 C4H11N5•HCl and a molecular weight of 165.63. Metformin hydrochloride 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 is 6.68. Metformin hydrochloride extended - release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride USP as the active ingredient. Metformin hydrochloride extended - release tablets 500 mg contain the inactive ingredients xanthan gum, hypromellose, sodium carbonate, povidone, talc, colloidal silicon dioxide and magnesium stearate. Metformin hydrochloride extended - release tablets 750 mg contain the inactive ingredients xanthan gum, hypromellose, sodium carbonate, povidone, talc, colloidal silicon dioxide, magnesium stearate and ferric oxide (red). Metformin hydrochloride extended - release tablets meet USP dissolution test 10. SYSTEM COMPONENTS AND PERFORMANCE-Metformin hydrochloride extended - release tablets comprises a hydrophilic polymer matrix system. Metformin hydrochloride is combined with a drug release controlling polymers to form a monophasic matrix system. 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 p সম্পূর্ণ নথি পড়ুন