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

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Preferred Pharmaceuticals Inc.

INN（国際名）:

GLYBURIDE

構図:

GLYBURIDE 2.5 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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:

製品概要:

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. Bottles of 30            NDC 68788-6426-3 Bottles of 60            NDC 68788-6426-6 Bottles of 90            NDC 68788-6426-9 Bottles of 100          NDC 68788-6426-1 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.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

GLYBURIDE AND METFORMIN HYDROCHLORIDE- GLYBURIDE AND METFORMIN
HYDROCHLORIDE TABLET, FILM COATED
PREFERRED 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.
Meets USP Dissolution Test 2
CLINICAL PHARMACOLOG