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

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Impax Generics

DCI (Denominação Comum Internacional):

GLYBURIDE

Composição:

GLYBURIDE 1.25 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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/1.73m2 ) (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. 

Resumo do produto:

Glyburide and Metformin Hydrochloride Tablets, USP are available as follows: 1.25 mg/250 mg —Each white to off-white, capsule-shaped, film coated tablet imprinted with  and 751 on one side and plain on the other side contains 1.25 mg of glyburide, USP and 250 mg of metformin hydrochloride, USP. Tablets are supplied in bottles of 100 (NDC 0115-1648-01) and 500 (NDC 0115-1648-02). 2.5 mg/500 mg —Each yellow, capsule-shaped, film coated tablet imprinted with and 752 on one side and plain on the other side contains 2.5 mg of glyburide, USP and  500 mg of metformin hydrochloride, USP. Tablets are supplied in bottles of 100 (NDC 0115-1649-01) and 500 (NDC 0115-1649-02). 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 100 (NDC 0115-1650-01) and 500 (NDC 0115-1650-02). 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: Impax Generics Hayward, CA 94544 40-9270 Revised — June 2017 LA-1757-02

Status de autorização:

Abbreviated New Drug Application

Características técnicas

GLYBURIDE AND METFORMIN HYDROCHLORIDE- GLYBURIDE AND METFORMIN
HYDROCHLORIDE TABLET, FILM COATED
IMPAX GENERICS
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GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS, USP
40-9270
Revised – June 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:
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, sorbic
acid, titanium dioxide and