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 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 are available as follows: 5 mg/500 mg —    Each blue, capsule-shaped, film coated tablet imprinted with and 753 on one side and plain on the other side contains 5 mg of glyburide, USP and 500 mg of metformin hydrochloride, USP. Tablets are supplied in bottles of: Bottle of 30 - 68788-9128-3 Bottle of 60 - 68788-9128-6 Bottle of 90 - 68788-9128-9 Bottle of 100 - 68788-9128-1 Bottle of 120 - 68788-9128-8 Store at temperatures up to 25°C (77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Brands listed are the trademarks of their respective owners. Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 40-9179 Revised — May 2017

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.
----------
GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS, USP
40-9179
Revised – May 2017
RX ONLY
DESCRIPTION
Glyburide and metformin hydrochloride tablets, USP contain two oral
antihyperglycemic drugs used in
the management of type 2 diabetes, glyburide and metformin
hydrochloride.
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 with a molecular
formula of C
H ClN O S and a
molecular weight of 494.00. 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 with a
molecular formula of C H N •HCl
and a molecular weight of 165.62. Metformin hydrochloride, USP 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:
23
28
3
5
4
11
5
a
Glyburide and metformin hydrochloride tablets, USP are available for
oral administration in tablets
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 tablet contains the following
inactive ingredients: ammonio
methacrylate copolymer (type B), croscarmellose sodium, hypromellose,
magnesium stearate,
microcrystalline cellulose, polydextrose, polyethylene glycol,
povidone, sodium hydroxide,