Indicated for:

Heart Failure:

• The treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization.

Left Ventricular Dysfunction Following Myocardial Infarction:

• Indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure).

Hypertension:

• Indicated for the management of essential hypertension. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.

Patients with coronary artery disease, who are being treated with COREG, 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 angina patients 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 is planned, the patients should be carefully observed and advised to limit physical activity to a minimum. COREG should be discontinued over 1 to 2 weeks whenever possible.

Patients with bronchospastic disease (e.g., chronic bronchitis and emphysema) should, in general, not receive β-blockers.

β-adrenergic blockade may mask clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of β-blockade may be followed by an exacerbation of the symptoms of hyperthyroidism or may precipitate thyroid storm.

Worsening heart failure or fluid retention may occur during up-titration of carvedilol. If such symptoms occur, diuretics should be increased and the carvedilol dose should not be advanced until clinical stability resumes.

Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients treated with alpha-1 blockers (COREG is an alpha/beta blocker).

β-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease.

Agents with non-selective β-blocking activity may provoke chest pain in patients with Prinzmetal’s variant angina.

COREG is contraindicated in the following conditions:

• Bronchial asthma or related bronchospastic conditions
• Deaths from status asthmaticus have been reported following single doses of COREG.Second-or third-degree AV block.Sick sinus syndrome
• Severe bradycardia (unless a permanent pacemaker is in place).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
• Patients with severe hepatic impairment

Concomitant administration with a diuretic can be expected to produce additive effects and exaggerate the orthostatic component of carvedilol action.

In patients with pheochromocytoma, an α-blocking agent should be initiated prior to the use of any β-blocking agent.

Patients taking a β-blocker and a drug that can deplete catecholamines (e.g., reserpine and monoamine oxidase inhibitors) should be observed closely for signs of hypotension and/or severe bradycardia.

Concomitant administration of clonidine with a β-blocker may cause hypotension and bradycardia.

Both digitalis glycosides and β-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.

Rifampin reduced plasma concentrations of carvedilol by about 70%.

Amiodarone and its metabolite desethylamiodarone, inhibitors of CYP2C9, and P glycoprotein increased concentrations of the S(-)-enantiomer of carvedilol by at least 2 fold.

The use of beta blockers during the third trimester of pregnancy may increase the risk of hypotension, bradycardia, hypoglycemia, and respiratory depression in the neonate. Animal studies: post-implantation loss, decreased fetal body weight, and increased frequency of delayed fetal skeletal development.

There are no data on the presence of carvedilol in human milk, the effects on the breastfed infant, or the effects on milk production. Carvedilol is present in the milk of lactating rats.

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• Use in patients under the age of 18. GoToSource 

• Oxidative stress related diseases. GoToSource

• Lower urinary tract symptoms and urine flow in hypertensive patients with benign prostatic hyperplasia. GoToSource

• Prevention of gastrointestinal bleeding resulting from portal hypertension. GoToSource

• Prevention of post-coronary artery bypass grafting atrial fibrillation. GoToSource

• Primary prophylaxis of variceal bleeding in cirrhotic patients. GoToSource

• Alzheimer’s disease. GoToSource

• Cocaine toxicity. GoToSource

Stevens-johnson syndrome (severe skin disorder). GoToSource

Toxic epidermal necrolysis (severe skin disorder). GoToSource

Diabetes. GoToSource

Interstitial pneumonitis (lung disease with thickening and scarring of lung tissue). GoToSource

Angioedema (swelling in deep layers of skin) and anaphylactic reactions. GoToSource

Thrombocytopenia (low blood platelet count). GoToSource

Erectile dysfunction. GoToSource

Acute generalized exanthematous pustulosis (severe skin reaction). GoToSource

Peyronie disease (scar tissue along the length of the penis). GoToSource

Intraoperative floppy iris syndrome. GoToSource

Lawsuits filed for stevens-johnson syndrome and toxic epidermal necrolysis.