Heart Failure

COREG is indicated for 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 [see Clinical Studies].

Left Ventricular Dysfunction Following Myocardial Infarction

COREG is 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 ≤40% (with or without symptomatic heart failure) [see Clinical Studies].

Hypertension

COREG is indicated for the management of essential hypertension [see Clinical Studies].It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions].

COREG should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects.

Heart Failure

DOSAGE MUST BE INDIVIDUALIZED AND CLOSELY MONITORED BY A PHYSICIAN DURING UP-TITRATION. Prior to initiation of COREG, it is recommended that fluid retention be minimized. The recommended starting dose of COREG is 3.125 mg twice daily for 2 weeks. If tolerated, patients may have their dose increased to 6.25, 12.5, and 25 mg twice daily over successive intervals of at least 2 weeks. Patients should be maintained on lower doses if higher doses are not tolerated. A maximum dose of 50 mg twice daily has been administered to patients with mild-to-moderate heart failure weighing over 85 kg (187 lbs).

Patients should be advised that initiation of treatment and (to a lesser extent) dosage increases may be associated with transient symptoms of dizziness or lightheadedness (and rarely syncope) within the first hour after dosing. During these periods, patients should avoid situations such as driving or hazardous tasks, where symptoms could result in injury. Vasodilatory symptoms often do not require treatment, but it may be useful to separate the time of dosing of COREG from that of the ACE inhibitor or to reduce temporarily the dose of the ACE inhibitor. The dose of COREG should not be increased until symptoms of worsening heart failure or vasodilation have been stabilized.

Fluid retention (with or without transient worsening heart failure symptoms) should be treated by an increase in the dose of diuretics.

The dose of COREG should be reduced if patients experience bradycardia (heart rate < 55 beats/minute).

Episodes of dizziness or fluid retention during initiation of COREG can generally be managed without discontinuation of treatment and do not preclude subsequent successful titration of, or a favorable response to, carvedilol.

Left Ventricular Dysfunction Following Myocardial Infarction

DOSAGE MUST BE INDIVIDUALIZED AND MONITORED DURING UP-TITRATION. Treatment with COREG may be started as an inpatient or outpatient and should be started after the patient is hemodynamically stable and fluid retention has been minimized. It is recommended that COREG be started at 6.25 mg twice daily and increased after 3 to 10 days, based on tolerability, to 12.5 mg twice daily, then again to the target dose of 25 mg twice daily. A lower starting dose may be used (3.125 mg twice daily) and/or the rate of up-titration may be slowed if clinically indicated (e.g., due to low blood pressure or heart rate, or fluid retention). Patients should be maintained on lower doses if higher doses are not tolerated. The recommended dosing regimen need not be altered in patients who received treatment with an IV or oral β-blocker during the acute phase of the myocardial infarction.

Hypertension

DOSAGE MUST BE INDIVIDUALIZED. The recommended starting dose of COREG is 6.25 mg twice daily. If this dose is tolerated, using standing systolic pressure measured about 1 hour after dosing as a guide, the dose should be maintained for 7 to 14 days, and then increased to 12.5 mg twice daily if needed, based on trough blood pressure, again using standing systolic pressure one hour after dosing as a guide for tolerance. This dose should also be maintained for 7 to 14 days and can then be adjusted upward to 25 mg twice daily if tolerated and needed. The full antihypertensive effect of COREG is seen within 7 to 14 days. Total daily dose should not exceed 50 mg.

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

Hepatic Impairment

COREG should not be given to patients with severe hepatic impairment [see Contraindications].

Dosage Forms And Strengths

The white, oval, film-coated tablets are available in the following strengths: 3.125 mg-engraved with 39 and SB, 6.25 mg-engraved with 4140 and SB, 12.5 mg-engraved with 4141 and SB, and 25 mg-engraved with 4142 and SB.

AND STORAGE AND HANDLING

The white, oval, film-coated tablets are available in the following strengths: 3.125 mg- engraved with 39 and SB, in bottles of 100; 6.25 mg-engraved with 4140 and SB, in bottles of 100; 12.5 mg-engraved with 4141 and SB, in bottles of 100; 25 mg-engraved with 4142 and SB, in bottles of 100. The 6.25 mg, 12.5 mg, and 25 mg tablets are TILTAB tablets.

• 3.125 mg 100's:   NDC 0007-4139-20
• 6.25 mg 100's:     NDC 0007-4140-20
• 12.5 mg 100's:     NDC 0007-4141-20
• 25 mg 100's:        NDC 0007-4142-20

Store below 30°C (86°F). Protect from moisture. Dispense in a tight, light-resistant container.

Patient Counseling Information

See FDA-approved Patient Labeling

Patient Advice

Patients taking COREG should be advised of the following:

• Patients should take COREG with food.
• Patients should not interrupt or discontinue using COREG without a physician's advice.
• Patients with heart failure should consult their physician if they experience signs or symptoms of worsening heart failure such as weight gain or increasing shortness of breath.
• Patients may experience a drop in blood pressure when standing, resulting in dizziness and, rarely, fainting. Patients should sit or lie down when these symptoms of lowered blood pressure occur.
• If experiencing dizziness or fatigue, patients should avoid driving or hazardous tasks.
• Patients should consult a physician if they experience dizziness or faintness, in case the dosage should be adjusted.
• Diabetic patients should report any changes in blood sugar levels to their physician.
• Contact lens wearers may experience decreased lacrimation.

GlaxoSmithKline., Research Triangle Park, NC 27709
©Year GlaxoSmithKline. All rights reserved.
FDA rev date: 2/23/2007

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