GLUCOVANCE 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)

Available from:

Bristol-Myers Squibb Company

INN (International Name):

glyburide

Composition:

glyburide 2.5 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

GLUCOVANCE- GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED
BRISTOL-MYERS SQUIBB COMPANY
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GLUCOVANCE
(GLYBURIDE AND METFORMIN HCL) TABLETS
2.5 mg/500 mg
5 mg/500 mg
DESCRIPTION
GLUCOVANCE (Glyburide and Metformin HCl) Tablets contain 2 oral
antihyperglycemic drugs used
in the management of type 2 diabetes, glyburide and metformin
hydrochloride.
Glyburide 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 is a
white to off-white crystalline compound with a molecular formula of C
H ClN O S and a molecular
weight of 494.01. The glyburide used in GLUCOVANCE has a particle size
distribution of 25%
undersize value not more than 6 μm, 50% undersize value not more than
7 to 10 μm, and 75% undersize
value not more than 21 μm. 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 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:
GLUCOVANCE is available for oral administration in tablets containing,
2.5 mg glyburide with 500 mg
metformin hydrochloride, and 5 mg glyburide with 500 mg metformin
hydrochloride. In addition, each
tablet contains the following inactive ingredients: microcrystalline
cellulose, povidone, croscarmellose
sodium, and magnesium stearate. The tablets are film coated, which
provides color differentiation.
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CLINI