INDICATIONS
Congestive Heart Failure
Coreg is indicated for the treatment of mild or moderate
(NYHA class II or III) heart failure of ischemic or cardiomyopathic
origin, in conjunction with digitalis, diuretics, and
ACE inhibitor, to reduce the progression of disease as
evidenced by cardiovascular death, cardiovascular hospitalization,
or the need to adjust other heart failure medications.
Coreg may be used in patients unable to tolerate an ACE
inhibitor. Coreg may be used in patients who are or are
not receiving digitalis, hydralazine or nitrate therapy.
Hypertension
Coreg (carvedilol) is also indicated for the management
of essential hypertension. It can be used alone or in combination
with other antihypertensive agents, especially thiazide-type
diuretics (see DRUG INTERACTIONS).
DOSAGE AND ADMINISTRATION
Congestive Heart Failure
DOSAGE MUST BE INDIVIDUALIZED AND CLOSELY MONITORED BY
A PHYSICIAN DURING UP-TITRATION. Prior to initiation of
Coreg, the dosing of digitalis, diuretics and ACE inhibitors
(if used) should be stabilized. The recommended starting
dose of Coreg is 3.125 mg twice daily for two weeks. If
this dose is tolerated, it can then be increased to 6.25
mg twice daily. Dosing should then be doubled every 2
weeks to the highest level tolerated by the patient. At
initiation of each new dose, patients should be observed
for signs of dizziness or light-headedness for one hour.
The maximum recommended dose is 25 mg twice daily in patients
weighing less than 85 kg (187 lbs) and 50 mg twice daily
in patients weighing more than 85 kg. Coreg (carvedilol)
should be taken with food to the rate of absorption and
reduce the incidence of orthostatic effects.
Before each dose increase the patient should be seen
in the office and evaluated for symptoms of worsening
heart failure, vasodilation (dizziness, light-headedness,
symptomatic hypotension) or bradycardia, in order to determine
tolerability of Coreg. Transient worsening of heart failure
may be treated with increased doses of diuretics although
occasionally it is necessary to lower the dose of Coreg
or temporarily discontinue it. Symptoms of vasodilation
often respond to a reduction in the dose of diuretics
or ACE inhibitor. If these changes do not relieve symptoms,
the dose of Coreg may be decreased. The dose of Coreg
should not be increased until symptoms of worsening heart
failure or vasodilation have been stabilized. Initial
difficulty with titration should not preclude later attempts
to introduce Coreg. If congestive heart failure patients
experience bradycardia (pulse rate below 55 beats/min),
the dose of Coreg should be reduced.
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 to14 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. Coreg should be taken with
food to the rate of absorption and reduce the incidence
of orthostatic effects.
Addition of a diuretic to Coreg, or Coreg to a diuretic
can be expected to produce additive effects and exaggerate
the orthostatic component of Coreg action.
Coreg (carvedilol) should not be given to patients with
severe hepatic impairment (see CONTRA
INDICATIONS
).
HOW SUPPLIED
Tablets: White, oval film-coated tablets: 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
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