GLIPIZIDE AND METFORMIN HCL tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C), METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)

Available from:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

INN (International Name):

GLIPIZIDE

Composition:

GLIPIZIDE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Glipizide and Metformin HCl Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glipizide and Metformin HCl Tablets are contraindicated in patients with: 1. Severe renal impairment (eGFR below 30 mL/min/1.73 m2 ) (see WARNINGS and PRECAUTIONS ). 2. Known hypersensitivity to glipizide or metformin hydrochloride. 3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.

Product summary:

Glipizide and Metformin HCl Tablets USP Glipizide and Metformin HCl Tablet 2.5 mg/250 mg is a pink coloured, capsule shape, film-coated tablet with "U 787" debossed on one side and plain on the other side. Glipizide and Metformin HCl Tablet 2.5 mg/500 mg is a white to off white, capsule shape, film-coated tablet with "U 785" debossed on one side and plain on the other side. Glipizide and Metformin HCl Tablet 5 mg/500 mg is a pink coloured, capsule shape, film-coated tablet with "U 786" debossed on one side and plain on the other side. Store at 20°-25° C (68°-77° F); excursions permitted to 15°-30° C (59°-86° F). [See USP Controlled Room Temperature.] GLUCOPHAGE ® is a registered trademark of Merck Sant¡SR S.A.S., an associate of Merck KGaA of Darmstadt, Germany. Licensed to Bristol-Myers Squibb Company. GLUCOTROL ® is a registered trademark of Pfizer Inc. Manufactured by: USV Private Limited Daman - 396210, India Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Revised: 12/2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLIPIZIDE AND METFORMIN HCL- GLIPIZIDE AND METFORMIN HCL TABLET, FILM
COATED
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
----------
RX ONLY
DESCRIPTION
Glipizide and Metformin HCl Tablets contain 2 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 is a
whitish, odorless powder with a molecular formula of C
H N O S, a molecular weight of 445.55
and a pK of 5.9. It is insoluble in water and alcohols, but soluble in
0.1 N NaOH; it is freely soluble in
dimethylformamide. The structural formula is represented below.
Metformin hydrochloride 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 a white to off-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 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. The structural formula is
as shown:
Glipizide and Metformin HCl Tablets are available for oral
administration in tablets containing 2.5 mg
glipizide with 250 mg metformin hydrochloride, 2.5 mg glipizide with
500 mg metformin
hydrochloride, and 5 mg glipizide with 500 mg metformin hydrochloride.
In addition, each tablet
contains the following inactive ingredients: Sodium Starch Glycolate,
Corn Starch, Povidone,
Magnesium Stearate, Colloidal Silicon Dioxide, Hypromellose, Talc,
Titanium Dioxide, Polyethylene
Glycol 6000, Propylene Glycol and Iron Oxide Red. The tablets are film
coated, which p