GLYBURIDE AND METFORMIN HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals,Inc.

INN (International Name):

GLYBURIDE

Composition:

GLYBURIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: - Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females], or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (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. Glyburide and metformin hydrochloride tablets should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of

Product summary:

Glyburide and Metformin Hydrochloride Tablets USP, 5 mg/500 mg: Yellow, capsule shaped, biconvex, film-coated tablet with A debossed on one side and 48 on the other side. NDC 68071-1836-1 Bottles 100 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLYBURIDE AND METFORMIN HYDROCHLORIDE- GLYBURIDE AND METFORMIN
HYDROCHLORIDE TABLET, FILM COATED
NUCARE PHARMACEUTICALS,INC.
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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 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:
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.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Glybu