GLYBURIDE AND METFORMIN HYDROCHLORIDE- glyburide and metformin hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

GLYBURIDE

Composition:

GLYBURIDE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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: 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: 55700-469-30 55700-469-60 55700-469-90 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: 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 Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 Rev.: 03/16 Revision Date: 11/03/16

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLYBURIDE AND METFORMIN HYDROCHLORIDE- GLYBURIDE AND METFORMIN
HYDROCHLORIDE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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 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, 1.2