HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use COREG CR safely and effectively. See full prescribing information for COREG CR.
COREG CR (carvedilol phosphate) extended-release capsules for oral use
Initial U.S. Approval: 1995
INDICATIONS AND USAGE
COREG CR is an alpha-/beta-adrenergic blocking agent indicated for the treatment of:
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mild to severe chronic heart failure. ( 1.1)
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left ventricular dysfunction following myocardial infarction in clinically stable patients. ( 1.2)
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hypertension. ( 1.3)
DOSAGE AND ADMINISTRATION
Take with food. Do not crush or chew capsules. Individualize dosage and monitor during up-titration. (2)
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Heart failure: Start at 10 mg once daily and increase to 20, 40, and then 80 mg once daily over intervals of at least 2 weeks. Maintain lower doses if higher doses are not tolerated. ( 2.1)
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Left ventricular dysfunction following myocardial infarction: Start at 20 mg once daily and increase to 40 mg then 80 mg once daily after intervals of 3 to 10 days. A lower starting dose or slower titration may be used. ( 2.2)
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Hypertension: Start at 20 mg once daily and increase if needed for blood pressure control to 40 mg then 80 mg once daily over intervals of 1 to 2 weeks. ( 2.3)
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Elderly patients (>65 years of age): When switching from higher doses of immediate-release carvedilol to COREG CR, a lower starting dose should be considered to reduce the risk of hypotension and syncope. ( 2.5)
DOSAGE FORMS AND STRENGTHS
Capsules: 10 mg, 20 mg, 40 mg, 80 mg (3)
CONTRAINDICATIONS
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Bronchial asthma or related bronchospastic conditions. ( 4)
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Second- or third-degree AV block. ( 4)
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Sick sinus syndrome. ( 4)
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Severe bradycardia (unless permanent pacemaker in place). ( 4)
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Patients in cardiogenic shock or decompensated heart failure requiring the use of IV inotropic therapy. ( 4)
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Severe hepatic impairment. ( 2.4, 4)
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History of serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to carvedilol or any of the components of COREG CR. ( 4)
WARNINGS AND PRECAUTIONS
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Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue. ( 5.1)
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Bradycardia, hypotension, worsening heart failure/fluid retention may occur. Reduce the dose as needed. ( 5.2, 5.3, 5.4)
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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)
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Diabetes: Monitor glucose as β‑blockers may mask symptoms of hypoglycemia or worsen hyperglycemia. ( 5.6)
ADVERSE REACTIONS
The safety profile of COREG CR was similar to that observed for immediate-release carvedilol. Most common adverse events seen with immediate-release carvedilol (6.1):
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Heart failure and left ventricular dysfunction following myocardial infarction (≥10%): Dizziness, fatigue, hypotension, diarrhea, hyperglycemia, asthenia, bradycardia, weight increase.
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Hypertension (≥5%): Dizziness.
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS