国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
REPAGLINIDE (UNII: 668Z8C33LU) (REPAGLINIDE - UNII:668Z8C33LU)
Sandoz Inc
REPAGLINIDE
REPAGLINIDE 0.5 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
REPAGLINIDE- REPAGLINIDE TABLET SANDOZ 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 RECENT MAJOR CHANGES Dosage and Administration (2.3) 2/2017 INDICATIONS AND USAGE 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 were: hypoglycemia, upper respiratory infection, headache, sinusitis, arthralgia, nausea, diarrhea, and back pain. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC. AT 1-800-525-8747 OR FDA AT 1-800-FDA- 1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • • Repaglinide 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: The recommended starting dose is 0.5 mg orally before each meal if HbA1c is less than 8%; and 1 or 2 mg orally before each meal if HbA1c 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 if a meal is skipped. In patients who experience hypoglycemia, the dose of repaglinide should be reduced. (2.1; 5.1) Instruct patients to take repaglinide 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 阅读完整的文件