Recommended Topic Related To:

Coreg CR

"What are beta blockers?

The class of drugs called beta blockers were given their name because this class of medications counteracts the stimulatory effects of epinephrine (adrenaline) on the so-called beta-adrenergic receptors found"...

Coreg CR

Indications
Dosage
How Supplied

INDICATIONS

Heart Failure

COREG CR 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 CR 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 CR 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].

DOSAGE AND ADMINISTRATION

COREG CR is an extended-release capsule intended for once-daily administration. Patients controlled with immediate-release carvedilol tablets alone or in combination with other medications may be switched to COREG CR extended-release capsules based on the total daily doses shown in Table 1.

Table 1: Dosing Conversion

Daily Dose of Immediate-Release Carvedilol Tablets Daily Dose of COREG CR Capsules*
6.25 mg (3.125 mg twice daily) 10 mg once daily
12.5 mg (6.25 mg twice daily) 20 mg once daily
25 mg (12.5 mg twice daily) 40 mg once daily
50 mg (25 mg twice daily) 80 mg once daily
* When switching from carvedilol 12.5 mg or 25 mg twice daily, a starting dose of COREG CR 20 mg or 40 mg once daily, respectively, may be warranted for elderly patients or those at increased risk of hypotension, dizziness, or syncope. Subsequent titration to higher doses should, as appropriate, be made after an interval of at least 2 weeks.

COREG CR should be taken once daily in the morning with food. COREG CR should be swallowed as a whole capsule. COREG CR and/or its contents should not be crushed, chewed, or taken in divided doses.

Alternative Administration

The capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The applesauce should not be warm because it could affect the modified-release properties of this formulation. The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use. Absorption of the beads sprinkled on other foods has not been tested.

Heart Failure

DOSAGE MUST BE INDIVIDUALIZED AND CLOSELY MONITORED BY A PHYSICIAN DURING UP-TITRATION. Prior to initiation of COREG CR, it is recommended that fluid retention be minimized. The recommended starting dose of COREG CR is 10 mg once daily for 2 weeks. Patients who tolerate a dose of 10 mg once daily may have their dose increased to 20, 40, and 80 mg over successive intervals of at least 2 weeks. Patients should be maintained on lower doses if higher doses are not tolerated.

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. Thus during these periods they 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 CR from that of the ACE inhibitor or to reduce temporarily the dose of the ACE inhibitor. The dose of COREG CR 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 CR should be reduced if patients experience bradycardia (heart rate < 55 beats/minute).

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

Left Ventricular Dysfunction Following Myocardial Infarction

DOSAGE MUST BE INDIVIDUALIZED AND MONITORED DURING UP-TITRATION. Treatment with COREG CR 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 CR be started at 20 mg once daily and increased after 3 to 10 days, based on tolerability, to 40 mg once daily, then again to the target dose of 80 mg once daily. A lower starting dose may be used (10 mg once 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 CR is 20 mg once daily. If this dose is tolerated, using standing systolic pressure measured about one hour after dosing as a guide, the dose should be maintained for 7 to 14 days, and then increased to 40 mg once 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 80 mg once daily if tolerated and needed. Although not specifically studied, it is anticipated the full antihypertensive effect of COREG CR would be seen within 7 to 14 days as had been demonstrated with immediate-release carvedilol. Total daily dose should not exceed 80 mg.

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

Hepatic Impairment

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

Geriatric Use

When switching elderly patients (65 years of age or older) who are taking the higher doses of immediate-release carvedilol tablets (25 mg twice daily) to COREG CR, a lower starting dose (40 mg) of COREG CR is recommended to minimize the potential for dizziness, syncope, or hypotension. Patients who have switched and who tolerate COREG CR should, as appropriate, have their dose increased after an interval of at least 2 weeks [see Use in Specific Populations].

HOW SUPPLIED

Dosage Forms And Strengths

The hard gelatin capsules are filled with white to off-white microparticles and are available in the following strengths:

  • 10 mg – white and green capsule shell printed with GSK COREG CR and 10 mg
  • 20 mg – white and yellow capsule shell printed with GSK COREG CR and 20 mg
  • 40 mg – yellow and green capsule shell printed with GSK COREG CR and 40 mg
  • 80 mg – white capsule shell printed with GSK COREG CR and 80 mg

Storage And Handling

The hard gelatin capsules are available in the following strengths:

10 mg – white and green capsule shell printed with GSK COREG CR and 10 mg

20 mg – white and yellow capsule shell printed with GSK COREG CR and 20 mg

40 mg – yellow and green capsule shell printed with GSK COREG CR and 40 mg

80 mg – white capsule shell printed with GSK COREG CR and 80 mg

10 mg 30's: NDC 0007-3370-13
10 mg 90's: NDC 0007-3370-59
20 mg 30's: NDC 0007-3371-13
20 mg 90's: NDC 0007-3371-59
40 mg 30's: NDC 0007-3372-13
40 mg 90's: NDC 0007-3372-59
80 mg 30's: NDC 0007-3373-13
80 mg 90's: NDC 0007-3373-59

Store at 25°C (77°F); excursions 15° to 30°C (59° to 86°F). Dispense in a tight, light-resistant container.

GlaxoSmithKline, Research Triangle Park, NC 27709. February 2011

Last reviewed on RxList: 8/19/2011
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
A A A

Coreg CR - User Reviews

Coreg CR User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Coreg CR sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Hypertension

Get tips on handling your hypertension.