Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
REPAGLINIDE (UNII: 668Z8C33LU) (REPAGLINIDE - UNII:668Z8C33LU)
Padagis US LLC
REPAGLINIDE
REPAGLINIDE 0.5 mg
ORAL
PRESCRIPTION DRUG
Repaglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitation of Use: Repaglinide tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Repaglinide tablets are contraindicated in patients with: 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 clinical dose, based on body surface area. No adverse developmental effects were observed in offspring of rats administered repaglinide during late gestation and lactatio
Repaglinide Tablets, USP are supplied as round tablets with beveled edges on both sides available in 0.5 mg (white, debossed with “P240” on one side), 1 mg (yellow, debossed with “P241” on one side) and 2 mg (pink, debossed with “P242” on one side) strengths. Bottles of 500 Bottles of 1000 Bottles of 500 Bottles of 1000 Bottles of 500 Bottles of 1000 Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from moisture. Keep bottles tightly close. Dispense in tight containers with safety closures.
Abbreviated New Drug Application
REPAGLINIDE- REPAGLINIDE TABLET PADAGIS US LLC ---------- 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 are 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 • • • 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 PADAGIS AT 1-866-634-9120 OR FDA AT 1- 800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • • • The recommended starting dose is 0.5 mg orally before each meal if HbA is less than 8%; and 1 or 2 mg orally before each meal if HbA is 8% or greater. (2.1) 1c 1c 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 modific Les hele dokumentet