Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C), METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)
Zydus Pharmaceuticals USA Inc.
GLIPIZIDE
GLIPIZIDE 2.5 mg
ORAL
PRESCRIPTION DRUG
Glipizide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glipizide and metformin hydrochloride tablets are contraindicated in patients with: - Severe renal impairment (eGFR below 30 mlL/min/1.73 m2 ) - Known hypersensitivity to glipizide or metformin hydrochloride. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
Glipizide and Metformin Hydrochloride Tablets, 2.5 mg/250 mg are pink-colored, biconvex, modified capsule-shaped, film-coated tablet, debossed with "ZE68" on one side and plain on other side and are supplied as follows: NDC 68382-184-16 in bottle of 90 tablets with child-resistant closure NDC 68382-184-01 in bottle of 100 tablets NDC 68382-184-10 in bottle of 1000 tablets NDC 68382-184-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Glipizide and Metformin Hydrochloride Tablets, 2.5 mg/500 mg are white-colored, biconvex, modified capsule-shaped, film-coated tablet, debossed with "ZE67" on one side and plain on other side and are supplied as follows: NDC 68382-185-16 in bottle of 90 tablets with child-resistant closure NDC 68382-185-01 in bottle of 100 tablets NDC 68382-185-10 in bottle of 1000 tablets NDC 68382-185-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Glipizide and Metformin Hydrochloride Tablets, 5 mg/500 mg are pink-colored, biconvex, modified capsule-shaped, film-coated tablet, debossed with "ZE66" on one side and plain on other side and are supplied as follows: NDC 68382-186-16 in bottle of 90 tablets with child-resistant closure NDC 68382-186-01 in bottle of 100 tablets NDC 68382-186-10 in bottle of 1000 tablets NDC 68382-186-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets
Abbreviated New Drug Application
GLIPIZIDE AND METFORMIN HYDROCHLORIDE- GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED GLIPIZIDE AND METFORMIN HYDROCHLORIDE- GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED ZYDUS PHARMACEUTICALS USA INC. ---------- GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLETS, USP DESCRIPTION Glipizide and metformin hydrochloride tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes, glipizide and metformin hydrochloride. Glipizide is an oral antihyperglycemic drug of the sulfonylurea class. The chemical name for glipizide is 1-cyclohexyl-3-[[_p_-[2-(5-methylpyrazinecarboxamido)ethyl]phenyl] sulfonyl]urea. Glipizide, USP is a white to almost white; crystalline powder with a molecular formula of C H N O S, a molecular weight of 445.55 and a pK of 5.9. The structural formula is represented below. Metformin hydrochloride, USP is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (_N,N_- dimethylimidodicarbonimidic diamide monohydrochloride) is not chemically or pharmacologically related to sulfonylureas, thiazolidinediones, or α-glucosidase inhibitors. It is white crystalline compound with a molecular formula of C H ClN (monohydrochloride) and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride. The pK of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is as shown: Each glipizide and metformin hydrochloride tablet intended for oral administration contains glipizide, 2.5 mg or 5 mg and metformin hydrochloride, 250 mg or 500 mg. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide. Additionally each 2.5 mg/250 mg and 21 27 5 4 a 4 12 5 a 5 mg/500 mg tablet contains iron oxide red and ea Läs hela dokumentet