Support for the use of COREG CR® extended-release capsules for the treatment of mild-to-severe heart failure and for patients with left ventricular dysfunction following myocardial infarction is based on the equivalence of pharmacokinetic and pharmacodynamic (β1‑blockade) parameters between COREG CR and immediate-release carvedilol. Visit DailyMed for the full Clinical Pharmacology Data.
Select Safety Information for COREG CR®
Do not abruptly stop taking COREG CR, as it may lead to acute exacerbation of coronary artery disease upon cessation of therapy. Bradycardia, hypotension, worsening heart failure/fluid retention may occur. Discuss these symptoms with your doctor. Tell your doctor about all the medications you take. Certain other medications may affect how COREG CR works.
IMPORTANT SAFETY INFORMATION AND INDICATIONS
Do not abruptly stop taking COREG CR®, as it may lead to acute exacerbation of coronary artery disease upon cessation of therapy.
Bradycardia, hypotension, worsening heart failure/fluid retention may occur. Discuss these symptoms with your doctor.
Tell your doctor about all the medications you take. Certain other medications may affect how COREG CR® works.
Do not take COREG CR® if you have any of the following:
- Bronchial asthma or related bronchospastic conditions.
- Second- or third-degree AV block.
- Sick sinus syndrome.
- Severe bradycardia (unless permanent pacemaker in place).
- Patients in cardiogenic shock or decompensated heart failure requiring the use of IV inotropic therapy.
- Severe hepatic (liver) impairment.
- History of serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to carvedilol or any of the components of COREG CR®.
SIDE EFFECTS
The most commonly reported side effects were:
- Heart failure and left ventricular dysfunction following myocardial infarction (≥10%): Dizziness, fatigue, hypotension, diarrhea, hyperglycemia, asthenia, bradycardia, weight increase.
- Hypertension (≥5%): Dizziness.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
These highlights do not include all the information needed to use COREG CR safely and effectively. See full prescribing information for COREG CR.
Please read the accompanying Medication Guide for COREG CR, including the information about birth defects if taken during pregnancy, and discuss it with your doctor. The physician Prescribing Information also is available.