Drug Catalog - Product Detail
REPAGLINIDE TB 0.5MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 51991-0853-01 | BRECKENRIDGE | 100 | 0.5MG | TABLET |
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Description
11 DESCRIPTION Repaglinide Tablets, USP (repaglinide) are an oral blood glucose-lowering drug of the glinide class. Repaglinide, S(+)2-ethoxy-4(2((3-methyl-1-(2-(1-piperidinyl) phenyl)-butyl) amino)-2-oxoethyl) benzoic acid, is chemically unrelated to the oral sulfonylurea insulin secretagogues. Structural Formula of Repaglinide Repaglinide is a white to off-white powder with molecular formula C 27 H 36 N 2 O 4 and a molecular weight of 452.6. Repaglinide Tablets, USP contain 0.5 mg, 1 mg, or 2 mg of repaglinide. In addition each tablet contains the following inactive ingredients: microcrystalline cellulose, polacrilin potassium, povidone K30, magnesium stearate, poloxamer (lutrol micro), and dibasic calcium phosphate anhydrous. The 1 mg and 2 mg tablets contain iron oxides (yellow and red, respectively) as coloring agents. Fig. 1 - Structural Formula of Repaglinide Tablets
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Repaglinide Tablets, USP (repaglinide) are supplied as round tablets and colored to indicate strength, available in 0.5 mg (white), 1 mg (light yellow) and 2 mg (light red) strengths. Tablets are engraved with "B853" for 0.5 mg, "B854" for 1 mg, and "B855" for 2 mg tablets on the face of the tablet and blank on the back of the tablet. 0.5 mg tablets (white) Bottles of 100 NDC 51991-853-01 1 mg tablets (light yellow) Bottles of 100 NDC 51991-854-01 2 mg tablets (light red) Bottles of 100 NDC 51991-855-01 Store at 20 o to 25 o C (68 o to 77 o F) [see USP Controlled Room Temperature]. Protect from moisture. Keep bottles tightly closed. Dispense in tight containers with child resistant closure.
Indications & Usage
1 INDICATIONS AND USAGE Repaglinide Tablets, USP (repaglinide) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitation of Use: Repaglinide Tablets, USP (repaglinide) should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Repaglinide Tablets is a glinide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1) Limitation of Use: Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION • The recommended starting dose is 0.5 mg orally before each meal if HbA 1c is less than 8%; and 1 or 2 mg orally before each meal if HbA 1c is 8% or greater. ( 2.1 ) • The recommended dose range is 0.5 mg to 4 mg before meals, with a maximum daily dose of 16 mg. ( 2.1 ) • The patient's dose should be doubled up to 4 mg with each meal until satisfactory glycemic control is achieved. At least one week should elapse to assess response after each dose adjustment. ( 2.1 ) • Instruct patients to skip the dose of Repaglinide Tablets if a meal is skipped. In patients who experience hypoglycemia, the dose of Repaglinide Tablets should be reduced. ( 2.1 ; 5.1 ) • Instruct patients to take Repaglinide Tablets within 30 minutes before meals. ( 2.1 ) • In patients with severe renal impairment (CrCl = 20 – 40 mL/min), recommended starting dose is 0.5 mg orally before each meal. ( 2.2 ) • Dose modifications are required when used concominantly with some medications. ( 2.3 , 7 ) 2.1 Recommended Dosage and Administration The recommended starting dose for patients whose HbA 1c is less than 8% is 0.5 mg orally before each meal. For patients whose HbA 1c is 8% or greater the starting dose is 1 or 2 mg orally before each meal. The recommended dose range is 0.5 mg to 4 mg before meals, with a maximum daily dose of 16 mg. The patient's dose should be doubled up to 4 mg with each meal until satisfactory glycemic control is achieved. At least one week should elapse to assess response after each dose adjustment. Instruct patients to take Repaglinide Tablets within 30 minutes before meals. Repaglinide Tablets may be dosed 2, 3, or 4 times a day in response to changes in the patient's meal pattern. In patients who skip meals, instruct patients to skip the scheduled dose of Repaglinide Tablets to reduce the risk of hypoglycemia. In patients who experience hypoglycemia, the dose of Repaglinide Tablets should be reduced [see Warnings and Precautions ( 5.1 )]. 2.2 Patients with Severe Renal Impairment In patients with severe renal impairment (CrCl = 20 – 40 mL/min) initiate Repaglinide Tablets 0.5 mg orally before each meal. Gradually titrate the dose, if needed to achieve glycemic control. 2.3 Dose Modifications for Drug Interactions Dosage adjustments are recommended in patients taking concomitant strong CYP3A4 or CYP2C8 inhibitors or strong CYP3A4 or CYP2C8 inducers [see Drug Interactions (7.1) , Clinical Pharmacology (12.3) ]. Concomitant use with gemfibrozil is contraindicated [see Contraindications (4) ]. Avoid concomitant use of Repaglinide Tablets with clopidogrel. If concomitant use can not be avoided, initiate Repaglinide Tablets at 0.5 mg before each meal and do not exceed a total daily dose of 4 mg [see Drug Interactions (7.1) , Clinical Pharmacology (12.3) ]. Do not exceed a total daily dose of 6 mg of Repaglinide Tablets in patients receiving cyclosporine [see Drug Interactions (7.1) , Clinical Pharmacology (12.3) ].