Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
CARVEDILOL (UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2)
Unit Dose Services
CARVEDILOL
CARVEDILOL 3.125 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
CARVEDILOL- CARVEDILOL TABLET, FILM COATED UNIT DOSE SERVICES ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CARVEDILOL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CARVEDILOL TABLETS. CARVEDILOL TABLETS USP, FOR ORAL USE INITIAL U.S. APPROVAL: 1995 INDICATIONS AND USAGE Carvedilol tablets USP are an alpha/beta-adrenergic blocking agent indicated for the treatment of: (1) • • • DOSAGE AND ADMINISTRATION Take with food. Individualize dosage and monitor during up-titration. (2) (2) • • • DOSAGE FORMS AND STRENGTHS Tablets: 3.125 mg, 6.25 mg, 12.5 mg, 25 mg (3) CONTRAINDICATIONS • • • • • • • WARNINGS AND PRECAUTIONS • • • • ADVERSE REACTIONS Most common adverse events (6.1): (6) • • TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLENMARK PHARMACEUTICALS INC., USA AT 1(888)721- 7115 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. (6) DRUG INTERACTIONS mild to severe chronic heart failure (1.1) left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2) hypertension (1.3) Heart failure: Start at 3.125 mg twice daily and increase to 6.25, 12.5, and then 25 mg twice daily over intervals of at least 2 weeks. Maintain lower doses if higher doses are not tolerated. (2.1) Left ventricular dysfunction following myocardial infarction: Start at 6.25 mg twice daily and increase to 12.5 mg then 25 mg twice daily after intervals of 3 to 10 days. A lower starting dose or slower titration may be used. (2.2) Hypertension: Start at 6.25 mg twice daily and increase if needed for blood pressure control to 12.5 mg then 25 mg twice daily over intervals of 1 to 2 weeks. (2.3) Bronchial asthma or related bronchospastic conditions. (4) Second- or third-degree AV block. (4) Sick sinus syndrome. (4) Severe bradycardia (unless permanent pacemaker in place) (4) Patients in cardiogenic shock or decompensated heart failure requiring the use of IV inotropic therapy. (4) Severe hep Прочитайте повний документ