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Drug Catalog - Product Detail

GLYBURIDE MICRONIZED & METFORMIN HCL TB 2.5/500MG 500

NDC Mfr Size Str Form
00228-2752-50 ACTAVIS MID ATLANTIC 500 2.5-500MG TABLET
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Description
11 DESCRIPTION Glyburide and metformin hydrochloride tablets, USP for oral use contain glyburide, USP and metformin hydrochloride, USP. Glyburide, USP is a sulfonylurea and its chemical name 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 23 H 28 ClN 3 O 5 S and a molecular weight of 494.00. The structural formula is represented below. Metformin hydrochloride, USP is a biguanide in hydrochloride salt form and its chemical name is N,N -dimethylimidodicarbonimidic diamide monohydrochloride. It is a white to off-white crystalline compound with a molecular formula of C 4 H 11 N 5 ·HCl (monohydrochloride) 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 a 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 in film coated tablets containing: 1.25 mg glyburide, USP and 250 mg metformin hydrochloride, USP (equivalent to 194.97 mg metformin); 2.5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin); 5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin). 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 triacetin. The 2.5 mg/500 mg tablet also contains: black iron oxide, D&C Yellow #10 Aluminum Lake, and yellow iron oxide. The 5 mg/500 mg tablet also contains: black iron oxide, FD&C Blue #2/Indigo Carmine Aluminum Lake, and FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake. Glyburide Structural Formula Metformin Hydrochloride Structural Formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 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 0228-2751-11). 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 0228-2752-11) and 500 (NDC 0228-2752-50). 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 0228-2753-11) and 500 (NDC 0228-2753-50). 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. image 3 imprinted 4 imprinted 5
Indications & Usage
1 INDICATIONS AND USAGE Glyburide and metformin hydrochloride tablets 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 a combination of glyburide, a sulfonylurea, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Adult Dosage: Give glyburide and metformin hydrochloride tablets in divided doses, twice daily, with meals. ( 2.1 ) For patients not treated with either glyburide (or another sulfonylurea) or metformin HCl, initiate treatment with another formulation with a dose of 1.25 mg glyburide and 250 mg metformin HCl orally, once or twice daily with meals. ( 2.1 ) For patients not adequately controlled on either glyburide (or another sulfonylurea) or metformin HCl alone, the recommended starting dose is 2.5 mg/500 mg or 5 mg/500 mg orally twice daily with meals. ( 2.1 ) For patients previously treated with a combination therapy of glyburide (or another sulfonylurea) and metformin HCl, the starting dose should not exceed the daily dose of glyburide (or equivalent dose of another sulfonylurea) and metformin HCl already being taken. ( 2.1 ) Increase the dose gradually on the basis of glycemic control and tolerability, up to a maximum to a maximum dose of 20 mg glyburide/2000 mg metformin HCl daily. ( 2.1 ) Renal Impairment: Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) ( 2.4 ) Do not use in patients with eGFR below 30 mL/minute/1.73 m 2 ( 2.4 ) Initiation is not recommended in patients with eGFR between 30 to 45 mL/minute/1.73 m 2 ( 2.4 ) Assess risk/benefit if eGFR falls below 45 mL/minute/1.73 m 2 ( 2.4 ) Discontinue if eGFR falls below 30 mL/minute/1.73 m 2 ( 2.4 ) Discontinuation for Iodinated Contrast Imaging Procedures: Glyburide and metformin hydrochloride tablets may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures ( 2.4 ) 2.1 Dosage Give glyburide and metformin hydrochloride tablets in divided doses, twice daily, with meals. For patients not treated with either glyburide (or another sulfonylurea) or metformin hydrochloride (HCl), initiate treatment with another formulation of glyburide and metformin HCl at a starting dose of 1.25 mg glyburide and 250 mg metformin HCl orally, once or twice daily with meals. For patients not adequately controlled on either glyburide (or another sulfonylurea) or metformin HCl alone, the recommended starting dose of glyburide and metformin hydrochloride tablets is 2.5 mg/500 mg or 5 mg/500 mg orally twice daily with meals. For patients previously treated with a combination therapy of glyburide (or another sulfonylurea) and metformin HCl, the starting dose of glyburide and metformin hydrochloride tablets should not exceed the daily dose of glyburide (or equivalent dose of another sulfonylurea) and metformin HCl already being taken. Increase the dose gradually on the basis of glycemic control and tolerability, up to a maximum to a maximum dose of 20 mg glyburide/2000 mg metformin HCl daily. 2.2 Patients Receiving Colesevelam Administer glyburide and metformin hydrochloride tablets at least 4 hours prior to colesevelam for patients taking both drugs concomitantly [see Drug Interactions ( 7 )] . 2.3 Recommendations for Use in Renal Impairment Assess renal function prior to initiation of glyburide and metformin hydrochloride tablets and periodically thereafter. Glyburide and metformin hydrochloride tablets are contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m 2 . Initiation of glyburide and metformin hydrochloride in patients with an eGFR between 30 to 45 mL/minute/1.73 m 2 is not recommended. In patients taking glyburide and metformin hydrochloride whose eGFR later falls below 45 mL/min/1.73 m 2 , assess the benefit risk of continuing therapy. Discontinue glyburide and metformin hydrochloride tablets if the patient’s eGFR later falls below 30 mL/minute/1.73 m 2 [see Warnings and Precautions ( 5.1 )] . 2.4 Discontinuation for Iodinated Contrast Imaging Procedures Discontinue glyburide and metformin hydrochloride tablets at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m 2 ; in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart glyburide and metformin hydrochloride tablets if renal function is stable.