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Dosing Considerations: Dosage must be individualized and patients closely monitored during initiation and up-titration by a physician experienced in the treatment of heart failure.
All patients in whom pms-CARVEDILOL therapy is to be considered must be clinically stable for 4 weeks prior to initiation of pms-CARVEDILOL.
Prior to initiation of pms-CARVEDILOL therapy, patients should be on stable doses of diuretics and angiotensin converting enzyme inhibitors, with or without digitalis. In clinical trials, all patients shown to have benefit were on the previously mentioned regimen unless they were intolerant to an ACE inhibitor.
Recommended Dose and Dosage Adjustment: The recommended starting dose of pms-CARVEDILOL is 3.125 mg twice daily for two weeks. If this dose is tolerated, it can then be increased to 6.25, 12.5 and 25 mg twice daily over successive intervals of at least 2 weeks. Patients should be maintained on the highest tolerated dose. The maximum recommended dose is 25 mg twice daily. The dose of pms-CARVEDILOL should not be increased until symptoms of worsening heart failure or vasodilation have stabilized.
Patients should be advised that initiation of treatment and, to a lesser extent, dosage increases may be associated with transient symptoms of dizziness or light-headedness, and rarely syncope, within the first 2 hours after dosing. During these periods, they should avoid situations such as driving or dangerous tasks where symptoms could result in injury. In addition, pms-CARVEDILOL should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects, especially during up-titration. Symptoms of hypotension do not often require treatment, but it may be useful to separate the time of dosing of pms-CARVEDILOL from that of the ACE inhibitor, or to reduce temporarily the dose of the ACE inhibitor.
The risk/benefit of carvedilol therapy in clinically stable heart failure patients with a heart rate lower than 68 beats per minute should be carefully considered prior to initiation of pms-CARVEDILOL since carvedilol has not been studied in these patients (see Precautions).
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 pms-CARVEDILOL. Transient worsening of heart failure may be treated with increased doses of diuretics, lowering the dose of pms-CARVEDILOL or, if necessary, discontinuation of pms-CARVEDILOL. Symptoms of vasodilation such as dizziness, light-headedness or decreasing blood pressure may respond to a reduction in the dose of diuretics. If these changes do not relieve symptoms, the dose of pms-CARVEDILOL should be decreased. If the dose of pms-CARVEDILOL was decreased, it should not be increased again until symptoms of worsening heart failure or vasodilation have been stabilized for 2 weeks. Initial difficulty with titration may not preclude later attempts to re-introduce or resume titration of pms-CARVEDILOL; however, caution is required in these circumstances. If congestive heart failure patients experience bradycardia (pulse rate below 55 beats/min.), the dose of pms-CARVEDILOL should be reduced, or may require discontinuation.
Elderly: The frequency and pattern of adverse reactions in patients ≥ 65 years was similar to that in younger patients. However, plasma levels of carvedilol are higher in older patients compared to younger patients (see Precautions). Therefore, after initiating pms-CARVEDILOL at the same dose in the elderly as in younger patients, up-titration should be done more cautiously in the elderly. A lower total daily dose may be reached at the end of up-titration in such patients compared to younger patients.
Hepatic Insufficiency: pms-CARVEDILOL is contraindicated in patients with clinically manifest liver disease (see Contraindications). In patients with milder hepatic impairment, there is a potential for increased manifestations of vasodilation and beta-blockade (see Pharmacology: Pharmacokinetics under Actions; and Precautions). Therefore, after initiating pms-CARVEDILOL at the same dose in patients with hepatic impairment as in other patients, up-titration should be done more cautiously in patients with hepatic impairment. A lower total daily dose may be reached at the end of up-titration in such patients compared to other patients.
Renal Insufficiency: Acute, reversible renal failure has been seen in some patients treated with Carvedilol; particularly those with underlying renal impairment (see Precautions). Therefore, after initiating pms-CARVEDILOL at the same dose in patients with renal impairment as in other patients, up-titration should be done more cautiously in patients with renal impairment. Renal function (BUN and creatinine) should be checked in such patients as appropriate. If renal function has deteriorated, the dose of pms-CARVEDILOL may need to be reduced or discontinued.
Discontinuation: pms-CARVEDILOL should be gradually reduced over a period of about 2 weeks, if possible, and the patient should be carefully observed (see General: Abrupt Cessation of Therapy under Precautions).
