GLYBURIDE AND METFORMIN HYDROCHLORIDE- glyburide and metformin hydrochloride tablet, film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

GLYBURIDE (UNII: SX6K58TVWC) (GLYBURIDE - UNII:SX6K58TVWC), METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)

Verfügbar ab:

NuCare Pharmaceuticals,Inc.

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Glyburide and metformin hydrochloride tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glyburide 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 metformin hydrochloride or glyburide. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. - Concomitant administration of bosentan.

Produktbesonderheiten:

Glyburide and Metformin Hydrochloride Tablets USP, 2.5 mg/500 mg: Light pink, capsule shaped, biconvex, film-coated tablet with A debossed on one side and 47 on the other side. NDC 68071-4109-3 Bottles of 30 NDC 68071-4109-6 Bottles of 60 NDC 68071-4109-9 Bottles of 90 NDC 68071-4109-8 Bottles of 180 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in light-resistant containers.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

GLYBURIDE AND METFORMIN HYDROCHLORIDE- GLYBURIDE AND METFORMIN
HYDROCHLORIDE TABLET, FILM COATED
NUCARE PHARMACEUTICALS,INC.
----------
GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Glyburide and metformin hydrochloride tablets, USP contain 2 oral
antihyperglycemic drugs used in the
management of type 2 diabetes, glyburide USP and metformin
hydrochloride USP.
Glyburide USP is an oral antihyperglycemic drug of the sulfonylurea
class. The chemical name for
glyburide is 1-[[ _p_-[2-(5-chloro-
_o_-anisamido)ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide
USP is a white to off-white crystalline compound. 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 a white to off-white crystalline compound. Metformin
hydrochloride is freely soluble in
water and is practically insoluble in acetone, ether, and 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:
a
Glyburide and metformin hydrochloride tablets, USP are available for
oral administration containing
1.25 mg glyburide USP with 250 mg metformin hydrochloride USP, 2.5 mg
glyburide USP with 500 mg
metformin hydrochloride USP, and 5 mg glyburide USP with 500 mg
metformin hydrochloride USP. In
addition, each film-coated tablet contains the following inactive
ingredients: microcrystalline cellulose,
croscarmellose sodium, povidone, magnesium stearate, hypromellose,
propylene glycol, polysorbate
80, talc, titanium dioxide and FD&C Yellow#6 aluminum lake. The 1.25
mg/250 mg and 5 mg/500 mg
strengths also contain D&C Yellow#10 aluminum lake; The 2.5 mg/500 mg
strength also contains
FD&C Red#40 aluminum lake.
Meets USP Dissolution Test 2
CLINICAL PHARMACOL