Active Ingredient: Carvedilol
Carvedilol tablets are 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.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that patient weight is ≤ 85 kg, oral, 3.125 milligrams carvedilol, 2 times daily to meals, over the duration of 2 weeks. Afterwards, in case that patient weight is ≤ 85 kg, oral, 6.25 milligrams carvedilol, 2 times daily to meals, over the duration of 2 weeks. Afterwards, in case that patient weight is ≤ 85 kg, oral, 12.5 milligrams carvedilol, 2 times daily to meals, over the duration of 2 weeks. Afterwards, in case that patient weight is ≤ 85 kg, oral, 25 milligrams carvedilol, 2 times daily to meals. The maximum allowed total dose is 50 milligrams carvedilol daily.
Regimen B: In case that patient weight is ≥ 85 kg, oral, 3.125 milligrams carvedilol, 2 times daily to meals, over the duration of 2 weeks. Afterwards, in case that patient weight is ≥ 85 kg, oral, 6.25 milligrams carvedilol, 2 times daily to meals, over the duration of 2 weeks. Afterwards, in case that patient weight is ≥ 85 kg, oral, 12.5 milligrams carvedilol, 2 times daily to meals, over the duration of 2 weeks. Afterwards, in case that patient weight is ≥ 85 kg, oral, 25 milligrams carvedilol, 2 times daily to meals, over the duration of 2 weeks. Afterwards, in case that patient weight is ≥ 85 kg, oral, 50 milligrams carvedilol, 2 times daily to meals. The maximum allowed total dose is 100 milligrams carvedilol daily.
The dosage must be titrated to individual requirements and monitored during up-titration.
For those patients receiving diuretics and/or digoxin and/or ACE inhibitors, dosing of these other medicinal products should be stabilised prior to initiation of carvedilol treatment.
The recommended dose for the initiation of therapy is 3.125 mg twice a day for two weeks. If this dose is tolerated, the dosage should be increased subsequently, at intervals of not less than two weeks, to 6.25 mg twice daily, followed by 12.5 mg twice daily and thereafter 25 mg twice daily. Dosing should be increased to the highest level tolerated by the patient.
The maximum recommended dose is 25 mg twice daily for all patients with severe CHF and for patients with mild to moderate CHF weighing less than 85 kg (187 lbs). In patients with mild or moderate CHF weighing more than 85 kg, the maximum recommended dose is 50 mg twice daily.
Before each dose increase the patient should be evaluated by the physician for symptoms of worsening heart failure or vasodilation. Transient worsening of heart failure, vasodilation or fluid retention may be treated with increased doses of diuretics or ACE inhibitors or by modifying or temporarily discontinuing carvedilol treatment. Under these circumstances, the dose of carvedilol should not be increased until symptoms of worsening heart failure or vasodilation have been stabilised.
If carvedilol treatment is discontinued for more than one week, therapy should be recommenced at a lower dose level (twice daily) and up-titrated in line with the above dosing recommendation.
If carvedilol is discontinued for more than two weeks, therapy should be recommenced at 3.125 mg twice daily and up-titrated in line with the above dosing recommendation.
It is recommended that heart failure patients take their carvedilol medication with food to allow the absorption to be slower and the risk of orthostatic hypotension to be reduced.
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