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Bronchial asthma or related bronchospastic conditions. Deaths from status asthmaticus have been reported following single doses of immediate-release carvedilol.
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Second‑ or third‑degree AV block.
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Sick sinus syndrome.
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Severe bradycardia (unless a permanent pacemaker is in place).
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Patients with cardiogenic shock or who have decompensated heart failure requiring the use of intravenous inotropic therapy. Such patients should first be weaned from intravenous therapy before initiating COREG CR.
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Patients with severe hepatic impairment.
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Patients with a history of a serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to carvedilol or any of the components of COREG CR.
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5 WARNINGS AND PRECAUTIONS
In clinical trials of COREG CR in subjects with hypertension (338 subjects) and in subjects with left ventricular dysfunction following a myocardial infarction or heart failure (187 subjects), the profile of adverse events observed with carvedilol phosphate was generally similar to that observed with the administration of immediate‑release carvedilol. Therefore, the information included within this section is based on data from controlled clinical trials with COREG CR as well as immediate‑release carvedilol.
5.1 Cessation of Therapy
Patients with coronary artery disease, who are being treated with COREG CR, should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported in patients with angina following the abrupt discontinuation of therapy with β‑blockers. The last 2 complications may occur with or without preceding exacerbation of the angina pectoris. As with other β‑blockers, when discontinuation of COREG CR is planned, the patients should be carefully observed and advised to limit physical activity to a minimum. COREG CR should be discontinued over 1 to 2 weeks whenever possible. If the angina worsens or acute coronary insufficiency develops, it is recommended that COREG CR be promptly reinstituted, at least temporarily. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue therapy with COREG CR abruptly even in patients treated only for hypertension or heart failure.
5.2 Bradycardia
In clinical trials with immediate‑release carvedilol, bradycardia was reported in about 2% of hypertensive subjects, 9% of subjects with heart failure, and 6.5% of subjects with myocardial infarction and left ventricular dysfunction. Bradycardia was reported in 0.5% of subjects receiving COREG CR in a trial of subjects with heart failure and subjects with myocardial infarction and left ventricular dysfunction. There were no reports of bradycardia in the clinical trial of COREG CR in hypertension. However, if pulse rate drops below 55 beats per minute, the dosage of COREG CR should be reduced.
5.3 Hypotension
In clinical trials of primarily mild‑to‑moderate heart failure with immediate‑release carvedilol, hypotension and postural hypotension occurred in 9.7% and syncope in 3.4% of subjects receiving carve