Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
REPAGLINIDE (UNII: 668Z8C33LU) (REPAGLINIDE - UNII:668Z8C33LU)
Breckenridge Pharmaceutical, Inc.
REPAGLINIDE
REPAGLINIDE 0.5 mg
ORAL
PRESCRIPTION DRUG
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 contraindicated in patients with: - Concomitant use of gemfibrozil [see Drug Interactions (7.1)] - Known hypersensitivity to repaglinide or any inactive ingredients Risk Summary Limited available data from case reports and case series with Repaglinide Tablets use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations ). Teratogenicity was not observed in rats and rabbits administered repaglinide during organogenesis at approximately 60 and 1 times the maximum daily
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. Store at 20o to 25o C (68o to 77o F) [see USP Controlled Room Temperature]. Protect from moisture. Keep bottles tightly closed. Dispense in tight containers with child resistant closure.
Abbreviated New Drug Application
REPAGLINIDE- REPAGLINIDE TABLET BRECKENRIDGE PHARMACEUTICAL, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE REPAGLINIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR REPAGLINIDE TABLETS. REPAGLINIDE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1997 INDICATIONS AND USAGE 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 • • • • • • • DOSAGE FORMS AND STRENGTHS Tablets: 0.5 mg, 1 mg, 2 mg (3) CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • Hypoglycemia: Repaglinide Tablets may cause hypoglycemia. Skip the scheduled dose of Repaglinide Tablets if a meal is skipped to reduce the risk of hypoglycemia. Reduce the dose of Repaglinide Tablets if hypoglycemia occurs. (5.1) • Serious Cardiovascular Adverse Reactions with Concomitant NPH-insulin: Repaglinide Tablets is not indicated for use in combination with NPH-insulin. (5.2) • Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Repaglinide Tablets. (5.3) ADVERSE REACTIONS The most common adverse reactions (5% or greater incidence) among patients treated with Repaglinide Tablets were: hypoglycemia, upper respiratory infection, headache, sinusitis, arthralgia, nausea, diarrhea, and back pain. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BRECKENRIDGE PHARMACEUTICAL, INC. AT 1-800-367-3395 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS Clopidogrel: Avoid concomitant use; if used concomitantly initiate at 0.5 mg before each meal and limit total daily dose to 4 mg (7) Cyclosporine: Limit daily dose of Repaglinide Tablets to 6 mg and increase frequency of glucose monitoring when co- administered (7) CYP2C8 and CYP3A4 Inhibitors and Drugs Belgenin tamamını okuyun