GLYBURIDE AND METFORMIN HYDROCHLORIDE tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Zydus Lifesciences Limited

INN (Международно Name):

GLYBURIDE

Композиция:

GLYBURIDE 1.25 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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 (eg, 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 iodinated contrast materials, becau

Каталог на резюме:

Glyburide and Metformin Hydrochloride Tablets USP, 1.25 mg/250 mg are white to off white colored, capsule shaped, biconvex coated tablets, debossed with "653" on one side and plain on the other side and are supplied as follows: NDC 65841-824-06 in bottles of 30 tablets NDC 65841-824-16 in bottles of 90 tablets NDC 65841-824-01 in bottles of 100 tablets NDC 65841-824-05 in bottles of 500 tablets NDC 65841-824-10 in bottles of 1000 tablets NDC 65841-824-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Glyburide and Metformin Hydrochloride Tablets USP, 2.5 mg/500 mg are tan to scarlet yellow colored, capsule shaped, biconvex coated tablets debossed with "654" on one side and plain on the other side and are supplied as follows: NDC 65841-825-06 in bottles of 30 tablets NDC 65841-825-16 in bottles of 90 tablets NDC 65841-825-01 in bottles of 100 tablets NDC 65841-825-05 in bottles of 500 tablets NDC 65841-825-10 in bottles of 1000 tablets NDC 65841-825-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Glyburide and Metformin Hydrochloride Tablets USP, 5 mg/500 mg are pale yellow colored, capsule shaped, biconvex coated tablets, debossed with "655" on one side and plain on the other side and are supplied as follows: NDC 65841-826-06 in bottles of 30 tablets NDC 65841-826-16 in bottles of 90 tablets NDC 65841-826-01 in bottles of 100 tablets NDC 65841-826-05 in bottles of 500 tablets NDC 65841-826-10 in bottles of 1000 tablets NDC 65841-826-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets STORAGE Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container (USP). GLUCOPHAGE® is a registered trademark of Merck SantÉ S.A.S., an associate of Merck KGaA of Darmstadt, Germany. Licensed to Bristol-Myers Squibb Company. Micronase® is a registered trademark of Pharmacia & Upjohn Company. Manufactured  by: Cadila Healthcare Ltd. Baddi, India Rev.: 03/16 Revision Date: 11/03/16

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

GLYBURIDE AND METFORMIN HYDROCHLORIDE - GLYBURIDE AND METFORMIN
HYDROCHLORIDE TABLET
ZYDUS LIFESCIENCES LIMITED
----------
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 or almost white, crystalline
powder with a molecular
formula of C
H
ClN O S and a molecular weight of 494. The glyburide used in
glyburide and metformin hydrochloride tablets, USP has a particle size
at least 20% are
less than 2 micron, at least 80% are less than 10 micron and 100% are
less than 40
micron. 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 crystals with a molecular formula of C H
ClN
(monohydrochloride) and a molecular weight of 165.62. Metformin
hydrochloride, USP is
freely soluble in water, slightly soluble in ethanol (95%),
practically insoluble in acetone
and in methylene chloride. The structural formula is as shown:
Each glyburide and metformin hydrochloride tablet, USP intended for
oral administration
contains 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: calcium carbonate, croscarmellose sodium,
magnesium stearate,
microcrystalline cellulose and povidone.
Additionally, 1.25 mg/250 mg tablet