Glipizide and Metformin Hydrochloride Tablets, USP

/Glipizide and Metformin Hydrochloride Tablets, USP
Glipizide and Metformin Hydrochloride Tablets, USP2018-09-06T09:12:40+00:00

Prescription Drug Name:

Glipizide and Metformin Hydrochloride Tablets, USP

ID:

91506951-2b16-48a3-bc03-e764c646b4e6

Code:

34391-3

DESCRIPTION


id: 4b45b69d-3e48-4da8-b49b-e1af401d2e4c
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

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 C21H27N5O4S, a molecular weight of 445.55 and a pKa 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 C4H12ClN5 (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 pKa 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 5 mg/500 mg tablet contains iron oxide red and each 2.5 mg/500 mg tablet contains polysorbate 80.

INDICATIONS AND USAGE


id: 22100b00-7182-4b3e-a454-c30fcda8d82c
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

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.

CONTRAINDICATIONS


id: 743417fc-b105-4690-9b0a-a0bc623ed631
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

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.

HOW SUPPLIED


id: 9b93c6c7-de08-430f-83cc-59fbb617467c
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Product: 50090-2492 NDC: 50090-2492-0 180 TABLET, FILM COATED in a BOTTLE Product: 50090-2556 NDC: 50090-2556-0 180 TABLET, FILM COATED in a BOTTLE

STORAGE AND HANDLING


id: 2992dbbf-18ec-46d1-ae23-147a0326ba2d
displayName: STORAGE AND HANDLING SECTION
FDA Article Code: 44425-7

Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Dispense in a tight container. Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 Rev.: 01/17

Glipizide and Metformin Hydrochloride


id: d46cd162-cdee-4483-b775-8ccaa5d5a2c8
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Glipizide and Metformin Hydrochloride


id: dfe44d55-975d-4302-838b-a5fc844ba267
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4