Hypertension: COREG CR is indicated for the management of essential hypertension. COREG CR can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. Starting dose for COREG CR: 20 mg QD. Uptitrate to 40 mg QD after 1-to 2-weeks, as needed for blood pressure control. The maximum/target dose is 80 mg QD, if required.

Left Ventricular Dysfunction Following Myocardial Infarction: COREG CR is indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of an MI and have a left ventricular ejection fraction (LVEF) ≤40% (with or without symptomatic heart failure [HF]). Starting dose for COREG CR: 20 mg QD. Uptitrate to 40 mg QD after 3-10 days as tolerated. The maximum/target dose is 80 mg QD. If clinically indicated, start at 10 mg QD and/or uptitrate more slowly. Patients should be maintained on lower doses if higher doses are not tolerated. No dosing alteration needed when started after IV or oral β-blocker MI treatment.

Heart Failure: COREG CR is indicated for the treatment of mild to severe HF of ischemic or cardiomyopathic origin, usually in addition to diuretics, angiotensin-converting enzyme (ACE) inhibitor, and digitalis, to increase survival and, also, to reduce the risk of hospitalization. Starting dose for COREG CR: 10 mg QD for 2 weeks. Uptitration to 20, 40, and 80 mg QD should occur over successive intervals of at least 2 weeks, based on tolerability. The maximum/target dose is 80 mg QD. Patients should be maintained on lower doses if higher doses are not tolerated.

For dosing information for Coreg® (carvedilol) and additional dosing information for COREG CR, please see Prescribing Information.

Important Safety Information
Patients taking COREG CR should avoid abrupt cessation of therapy. Following abrupt cessation of therapy with certain β-blocking agents, exacerbation of angina pectoris and, in some cases, MI and ventricular arrhythmias have occurred. The dosage should be reduced gradually over a 1- to 2-week period and the patient should be carefully monitored.

COREG CR is contraindicated in patients with bronchial asthma or related bronchospastic conditions, second- or third-degree AV block, sick sinus syndrome or severe bradycardia (unless a permanent pacemaker is in place); in patients with cardiogenic shock or decompensated heart failure (HF) requiring the use of intravenous inotropic therapy (such patients should first be weaned from intravenous therapy before initiating COREG CR); in patients with clinically manifest hepatic impairment; and in patients who are hypersensitive to any component of this product.

Like other β-blockers, COREG CR should be used with caution in patients with peripheral vascular disease, thyrotoxicosis, or who are undergoing major surgery. Caution should also be used in diabetic patients as β-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia. Worsening heart failure or fluid retention may occur during uptitration of COREG CR.

Differences in safety would not be expected based on the similarity in plasma levels for COREG CR and Coreg® (carvedilol).

For COREG, the most common side effects reported in the controlled trials in HF (reported in ≥10% of patients [both the mild-to-moderate and the severe populations studied] and more frequently on COREG) were dizziness, fatigue, weight increase, hypotension, and bradycardia. Worsening HF symptoms were also reported, but with equal or greater frequency in placebo-treated patients.

The most common side effects reported with COREG in the CAPRICORN trial were consistent with the profile of the drug in the US HF trials and the COPERNICUS trial, as well as the health status of patients. The only additional adverse events reported in >3% of patients and more frequently on COREG in CAPRICORN were dyspnea, lung edema, and anemia.

The most common side effects in hypertension trials with carvedilol were nasopharyngitis (COREG CR) and dizziness and fatigue (COREG), which were generally mild.