GLIPIZIDE AND METFORMIN HYDROCHLORIDE- glipizide and metformin hydrochloride 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:

REMEDYREPACK INC.

INN (International Name):

GLIPIZIDE

Composition:

GLIPIZIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 mL/min/1.73 m 2 ) (see WARNINGS and PRECAUTIONS). - 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.

Product summary:

Glipizide and Metformin Hydrochloride Tablets, USP are available containing 2.5 mg glipizide, USP with 250 mg metformin hydrochloride, USP; 2.5 mg glipizide, USP with 500 mg metformin hydrochloride, USP; or 5 mg glipizide, USP with 500 mg metformin hydrochloride, USP. The 2.5 mg/250 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and G31 on the other side. They are available as follows: NDC 0378-3131-01 bottles of 100 tablets The 2.5 mg/500 mg tablets are white, film-coated, oval, unscored tablets debossed with M on one side of the tablet and G32 on the other side. They are available as follows: NDC 0378-3132-01 bottles of 100 tablets The 5 mg/500 mg tablets are peach, film-coated, modified capsule-shaped, unscored tablets debossed with M on one side of the tablet and G33 on the other side. They are available as follows: NDC 0378-3133-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Patient Information Leaflet with each prescription.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLIPIZIDE AND METFORMIN HYDROCHLORIDE- GLIPIZIDE AND METFORMIN
HYDROCHLORIDE TABLET, FILM COATED
REMEDYREPACK INC.
REFERENCE LABEL SET ID: 8046A29F-F7C3-4B45-960A-314216C8E27B
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DESCRIPTION
Glipizide and metformin hydrochloride tablets, USP 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, USP is
white to almost white crystalline powder with a molecular formula of C
H
N
O
S, a molecular
weight of 445.54 and a pK
of 5.9. It is practically insoluble in water and in ethanol, sparingly
soluble
in acetone; soluble in chloroform. It dissolves in dilute solutions of
alkali hydroxides. The structural
formula is represented below.
Metformin hydrochloride is an oral antihyperglycemic drug used in the
management of type 2 diabetes.
Metformin hydrochloride (1,1 Dimethylbiguanide monohydrochloride) is
not chemically or
pharmacologically related to sulfonylureas, thiazolidinediones, or
α-glucosidase inhibitors. Metformin
hydrochloride, USP is a white crystalline powder with a molecular
formula of C
H
N
• HCl and a
molecular weight of 165.62. Metformin hydrochloride is very soluble in
water, slightly soluble in
ethanol, practically insoluble in ether and in chloroform. 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:
Glipizide and metformin hydrochloride 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, or 5 mg glipizide with 500 mg metformin hydrochloride.
In addition, each film-coated
tablet contains the following inactive ingredients: croscarmellose
sodium, hypromellose, magnesium
stearate, microcrystalline cellulose, polydextrose, polyethyl