Carvedilol

Full Title

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 for oral use Initial U.S. Approval: 1995INDICATIONS AND USAGE Carvedilol tablets are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: • mild to severe chronic heart failure (1.1) • left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2) • hypertension (1.3) DOSAGE AND ADMINISTRATION Take with food. Individualize dosage and monitor during up-titration. (2) • 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) DOSAGE FORMS AND STRENGTHS Tablets: 3.125 mg, 6.25 mg, 12.5 mg, 25 mg (3) CONTRAINDICATIONS • 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 hepatic impairment. (2.4, 4) • History of serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to any component of this medication or other medications containing carvedilol. (4) WARNINGS AND PRECAUTIONS • Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue. (5.1) • Bradycardia, hypotension, worsening heart failure/fluid retention may occur. Reduce the dose as needed. (5.2, 5.3, 5.4) • Non-allergic bronchospasm (e.g., chronic bronchitis and emphysema): Avoid β-blockers. (4) However, if deemed necessary, use with caution and at lowest effective dose. (5.5) • Diabetes: Monitor glucose as β-blockers may mask symptoms of hypoglycemia or worsen hyperglycemia. (5.6) ADVERSE REACTIONS Most common adverse events (6.1): • Heart failure and left ventricular dysfunction following myocardial infarction (≥ 10%): Dizziness, fatigue, hypotension, diarrhea, hyperglycemia, asthenia, bradycardia, weight increase • Hypertension (≥ 5%): Dizziness 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. DRUG INTERACTIONS • CYP P450 2D6 enzyme inhibitors may increase and rifampin may decrease carvedilol levels. (7.1, 7.5) • Hypotensive agents (e.g., reserpine, MAO inhibitors, clonidine) may increase the risk of hypotension and/or severe bradycardia. (7.2) • Cyclosporine or digoxin levels may increase. (7.3, 7.4) • Both digitalis glycosides and β-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. (7.4) • Amiodarone may increase carvedilol levels resulting in further slowing of the heart rate or cardiac conduction. (7.6) • Verapamil- or diltiazem-type calcium channel blockers may affect ECG and/or blood pressure. (7.7) • Insulin and oral hypoglycemics action may be enhanced. (7.8) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 9/2019