DILATREND TABLET 12.5 MG [SIN10335P]

Product Info

DILATREND TABLET 12.5 MG

[SIN10335P]

2.1 Therapeutic Indication(s)
Hypertension
Dilatrend is indicated for the management of essential hypertension.
It can be used alone or in combination with other antihypertensive agents (e.g. calcium channel blockers, diuretics).

Angina pectoris
Carvedilol has demonstrated anti-ischemic and anti-anginal properties in patients with coronary heart disease.

Symptomatic chronic heart failure
Dilatrend is indicated for the treatment of symptomatic chronic heart failure (CHF) to reduce mortality and cardiovascular hospitalisations, improve patient well-being and slow the progression of the disease.
Dilatrend may be used as adjunct to standard therapy, but may also be used in those patients unable to tolerate an ACE inhibitor, or those who are not receiving digitalis, hydralazine or nitrate therapy.

2.2 Dosage and Administration
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.

Hypertension
The recommended dose for initiation of therapy is 12.5 mg once a day for the first 2 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.

Angina pectoris
The recommended dose for initiation of therapy is 12.5 mg twice a day for the first 2 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).

Symptomatic 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 stabilized before initiation of Dilatrend treatment.
The recommended dose for initiation of therapy is 3.125 mg twice daily for 2 weeks. If this dose is tolerated, the dose may thereafter be increased, at intervals of not less than two weeks, to 6.25 mg (half of a 12.5 mg tablet), 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 Dilatrend and, in rare cases, temporarily discontinue Dilatrend treatment.
If Dilatrend 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 Dilatrend 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 stabilized.

2.2.1 Special Dosage Instructions
Renal impairment
Available pharmacokinetic data and published clinical studies in patients with varying degrees of renal impairment (including renal failure) suggest no changes in Dilatrend dosing recommendations are warranted in patients with moderate to severe renal insufficiency.

Hepatic impairment
Dilatrend is contraindicated in patients with clinical manifestations of liver dysfunction (see section 2.3).

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 section 2.5.3 and section 3.2.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

2.3 Contraindications
Dilatrend must not be used in patients with:

• hypersensitivity to carvedilol or any component of the product

• unstable/decompensated heart failure

• clinically manifest liver dysfunction

As with other β-blockers, Dilatrend must not be used in patients with:

• 2nd and 3rd degree atrioventricular (AV) block (unless a permanent pacemaker is in place)

• Severe bradycardia (< 50 bpm)

• Sick sinus syndrome (including sino-atrial block)

• Severe hypotension (systolic blood pressure < 85 mmHg)

• Cardiogenic shock

• History of bronchospasm or asthma