GLYBURIDE and METFORMIN HYDROCHLORIDE TABLETS USP, Rx only, 5710, 5711, 5712

/GLYBURIDE and METFORMIN HYDROCHLORIDE TABLETS USP, Rx only, 5710, 5711, 5712
GLYBURIDE and METFORMIN HYDROCHLORIDE TABLETS USP, Rx only, 5710, 5711, 57122018-09-06T09:12:40+00:00

Prescription Drug Name:

GLYBURIDE and METFORMIN HYDROCHLORIDE TABLETS USP, Rx only, 5710, 5711, 5712

ID:

613f1eee-3018-45a8-a196-164c9d37a732

Code:

34391-3

DESCRIPTION


id: 65804a71-c903-447c-b028-2a6467bd721e
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: fe4c1aaa-7021-4f6f-811d-b33795def793
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: d25457d5-c25d-476d-bc7c-2a5e54f4b4b6
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: b4e266cb-1c42-4e89-8ff0-08bdeab21e2a
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Glyburide and Metformin Hydrochloride Tablets USP, 1.25/250 mg are available as light yellow, oval-shaped, beveled-edged, film-coated tablets, debossed and “5710” on one side and “1.25/250” on the other side containing 1.25 mg glyburide USP and 250 mg metformin hydrochloride USP packaged in

Bottles of 20 NDC 54868-5185-2
Bottles of 30 NDC 54868-5185-3
Bottles of 60 NDC 54868-5185-1
Bottles of 100f NDC 54868-5185-0
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 30 NDC 54868-5148-1
Bottles of 60 NDC 54868-5148-0
Bottles of 90 NDC 54868-5148-3
Bottles of 100 NDC 54868-5148-2
Bottles of 180 NDC 54868-5148-4
Glyburide and Metformin Hydrochloride Tablets USP, 5/500 mg are available as yellow, oval-shaped, beveled-edged, film-coated tablets, debossed and “5712” on one side and “5/500” on the other side containing 5 mg glyburide USP and 500 mg metformin hydrochloride USP packaged in
Bottles of 30 NDC 54868-5243-3
Bottles of 60 NDC 54868-5243-0
Bottles of 90 NDC 54868-5243-4
Bottles of 100 NDC 54868-5243-1
Bottles of 120 NDC 54868-5243-2
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 Relabeling and Repackaging by:

Physicians Total Care, Inc.
Tulsa, Oklahoma       74146

PATIENT INFORMATION ABOUT GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS USP


id: 3bec49a1-1e08-4f3f-beb5-681a5bb3893d
displayName: SPL PATIENT PACKAGE INSERT SECTION
FDA Article Code: 42230-3

Rx only

PRINCIPAL DISPLAY PANEL


id: 12774e91-68eb-44e1-a4ab-7cd9c5abe8cd
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP
1.25 mg/250 mg
PHARMACIST: PLEASE DISPENSE WITH PATIENT INFORMATION LEAFLET PROVIDED SEPARATELY Rx only Each tablet contains 1.25 mg glyburide, USP and 250 mg metformin hydrochloride, USP. Usual Dosage: See package insert for full prescribing information. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL


id: 486ea900-11f3-4594-affe-1bf5736db8fc
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP 2.5 mg/500 mg PHARMACIST: PLEASE DISPENSE WITH PATIENT INFORMATION LEAFLET PROVIDED SEPARATELY Rx only Each tablet contains 2.5 mg glyburide, USP and 500 mg metformin hydrochloride, USP. Usual Dosage: See package insert for full prescribing information. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL


id: c0b851df-e83f-48f8-84af-a88c6223a7f9
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP 5 mg/500 mg PHARMACIST: PLEASE DISPENSE WITH PATIENT INFORMATION LEAFLET PROVIDED SEPARATELY Rx only Each tablet contains 5 mg glyburide, USP and 500 mg metformin hydrochloride, USP. Usual Dosage: See package insert for full prescribing information. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.