GLIPIZIDE AND METFORMIN HYDROCHLORIDE tablet, film coated GLIPIZIDE AND METFORMIN HYDROCHLORIDE tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Zydus Pharmaceuticals USA Inc.

INN (Algemene Internationale Benaming):

GLIPIZIDE

Samenstelling:

GLIPIZIDE 2.5 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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.

Product samenvatting:

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

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

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.
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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