DESCRIPTION
id: ad340996-e5da-4b1c-88bf-6855bdbedb98
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Glyburide and metformin hydrochloride tablets USP contain two 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 USP 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 glyburide USP used in glyburide and metformin hydrochloride tablets USP has a particle size distribution of 25% undersize value not more than 6 µm, 50% undersize value not more than 7 to 10 µm, and 75% undersize value not more than 21 µm. The structural formula is represented below:
C23H28ClN3O5S M.W. 494.01
Metformin hydrochloride USP is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride USP ( 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 USP is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin USP is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride USP is 6.68. The structural formula is as shown:
C4H12ClN5 (monohydrochloride) M.W. 165.63
Each glyburide and metformin hydrochloride tablet USP, 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, or 5 mg glyburide USP with 500 mg metformin hydrochloride USP. In addition, each tablet contains the following inactive ingredients: copovidone, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, talc, and titanium dioxide. The 1.25 mg/250 mg strength also contains D&C Yellow #10 aluminum lake and FD&C Red #40 aluminum lake; the 2.5 mg/500 mg strength also contains FD&C Red #40 aluminum lake and FD&C Yellow #6 aluminum lake; and the 5 mg/500 mg strength also contains D&C Yellow #10 aluminum lake and FD&C Yellow #6 aluminum lake.
INDICATIONS AND USAGE
id: 7b0e5efd-bff2-4e03-90e8-97a0a15190a2
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
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.
CONTRAINDICATIONS
id: 202a79fe-034e-4d7c-b42f-298e39db0410
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Glyburide and Metformin Hydrochloride Tablets are contraindicated in patients with:
- Renal disease or renal dysfunction (e.g., 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.
Glyburide and metformin should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function (see also PRECAUTIONS).
HOW SUPPLIED
id: edcbdda0-ce6b-4838-8514-539954494c5f
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Glyburide and Metformin Hydrochloride Tablets USP, 2.5/500 mg are available as light orange, oval-shaped, beveled-edged, film-coated tablets, debossed
and “5711” on one side and “2.5/500” on the other side containing 2.5 mg glyburide USP and 500 mg metformin hydrochloride USP packaged in bottles of 100 and 500 tablets and unit-dose boxes of 100 tablets.
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Manufactured In India By:
EMCURE PHARMACEUTICALS LTD.
Hinjwadi, Pune, India
Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. H 12/2010
Repackaged by:
REBEL DISTRIBUTORS CORP
Thousand Oaks, CA 91320
PATIENT INFORMATION ABOUT GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS USP
id: 1aeb67a4-208e-4e7f-90ba-5bd0abc07a99
displayName: SPL PATIENT PACKAGE INSERT SECTION
FDA Article Code: 42230-3
Rx only
PRINCIPAL DISPLAY PANEL
id: b914a6f9-2d28-4974-a036-79bc1c846b5f
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
