Dilatrend Dosage/Direction for Use

Hypertension: The recommended dose for initiation of therapy is 12.5 mg once a day for the first two days. Thereafter, the recommended dosage is 25 mg once a day. If necessary, the dosage may subsequently be increased at intervals of at least two weeks to the recommended maximum daily dose of 50 mg, given once or twice daily.
Coronary Heart Disease: The recommended dose for initiation of therapy is 12.5 mg twice a day for the first two days. Thereafter the recommended dosage is 25 mg twice a day. If necessary, the dosage may thereafter be increased at intervals of at least two weeks, up to the recommended maximum daily dose of 100 mg given in divided doses (twice daily).
Chronic Heart Failure: Dosage must be tailored to suit the individual, and closely monitored by a physician during up-titration. For those patients receiving digitalis, diuretics and ACE inhibitors, dosing of these drugs should be stabilised before initiation of carvedilol treatment.
The recommended dose for initiation of therapy is 3.125 mg twice daily for two weeks. If this dose is tolerated, the dose may thereafter be increased, at intervals of not less than two weeks, to 6.25 mg, 12.5 mg and 25 mg twice daily. Doses 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 vasodilation or worsening heart failure. Transient worsening of heart failure or fluid retention should be treated with increased doses of diuretics. Occasionally, it may be necessary to lower the dose of carvedilol and, in rare cases, temporarily discontinue carvedilol treatment.
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 in line with the above dosing recommendation.
Symptoms of vasodilation may be managed initially by a reduction in the dose of diuretics. If symptoms persist, the dose of ACE inhibitor (if used) may be reduced, followed by a reduction in the dose of carvedilol if necessary. Under these circumstances, the dose of carvedilol should not be increased until symptoms of worsening heart failure or vasodilation have been stabilised.
Left ventricular dysfunction following acute myocardial infarction: Dosage must be individualised and closely monitored by a physician during up-titration.
Treatment may be started as an inpatient or outpatient when the patient is haemodynamically stable and fluid retention has been minimised.
Prior to initiating carvedilol: Haemodynamically stable patients should have received an ACE inhibitor for at least 48 hours, given at a stable dose during at least the preceding 24 hours.
Carvedilol can then be started between day 3 and day 21 after the myocardial infarction.
First dose of carvedilol: The initial recommended dose is 6.25 mg. Patients should remain under close medical supervision for at least 3 hours following the initial dose (see Precautions).
Subsequent doses of carvedilol: If the patient has tolerated the first dose (i.e. heart rate >50 beats/minute, systolic blood pressure >80 mm Hg, and absence of clinical signs of intolerance), the dose should be increased to 6.25 mg twice daily and maintained for 3 to 10 days.
The dose should be reduced to 3.125 mg twice daily if the patient develops signs of intolerance during this period, in particular bradycardia <50 beats/minute, systolic blood pressure <80 mmHg or fluid retention. If this dose is not tolerated, treatment should be stopped.
If it is well tolerated, it should be increased again to 6.25 mg twice daily after 3 to 10 days.
Subsequent up-titration: If the dose of 6.25 mg twice daily is well tolerated, the dose should be increased at intervals of 3 to 10 days to 12.5 mg twice daily and then to 25 mg twice daily. The maintenance dose is the maximum dose tolerated by the patient. The maximum recommended dose is 25 mg twice daily, irrespective of the patient's weight.
Special Dosage Instructions: Renal Impairment: Available pharmacokinetic data (see Pharmacology: Pharmacokinetics: Special Populations under Actions) and published clinical studies (see Pharmacology: Pharmacodynamics: Renal Impairment under Actions) in patients with varying degrees of renal impairment (including renal failure) suggest no changes in carvedilol
dosing recommendations are warranted in patients with moderate to severe renal insufficiency.
Hepatic Impairment: Carvedilol is contraindicated in patients with clinical manifestations of liver dysfunction (see Contraindications).
Elderly: There is no evidence to support dose adjustment.
Children: The safety and efficacy of carvedilol in children and adolescents (<18 years) has not been established (see Pharmacology: Pharmacokinetics: Special Populations under Actions).
Method of Administration: The tablets are to be swallowed with sufficient fluid.
Duration of treatment: Treatment with carvedilol is a long-term therapy. As with all β-blockers, treatment should not be stopped abruptly but rather gradually reduced at weekly intervals. This is particularly important in the case of patients with concomitant coronary heart disease.