DILATREND

What it is

Dilatrend is carvedilol, supplied as tablets. Each tablet contains 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol as the active ingredient. Carvedilol is a dual action cardiovascular agent that is a vasodilating, non-selective beta-blocking agent with antioxidant properties.

Approved indications

— Treatment of hypertension. — Treatment of patients with symptomatic mild to severe (NYHA class II to IV) congestive heart failure (CHF) as an adjunct to conventional treatments such as diuretics, digoxin, ACE inhibitors and vasodilators.

Dosing overview Dilatrend tablets are intended for oral administration.

Key safety warnings

Beta-blockers can cause worsening heart failure. Since carvedilol has beta-blocking properties, care must be taken during initiation and up-titration of the drug in heart failure patients, since worsening heart failure has been observed in this phase of treatment. It is critical to carefully follow the recommended dosing for carvedilol in patients with congestive heart failure. In patients with heart failure, ischaemic heart disease or angina pectoris, abrupt cessation of therapy may lead to deterioration. There have been reports of severe exacerbation of angina, and of myocardial infarction or ventricular arrhythmias occurring following abrupt discontinuation of beta-blocker therapy. Therefore, when discontinuing carvedilol in patients with angina pectoris the dosage should be gradually reduced over a period of about two weeks and the patient should be carefully observed. Hypotension and postural hypotension occurred in 9.7% and syncope in 3.4% of congestive heart failure patients receiving carvedilol compared to 3.6% and 2.5% of placebo patients, respectively. The risk for these events was highest during the first 30 days of dosing, corresponding to the up-titration period. Mild hepatocellular injury, confirmed by rechallenge, has occurred rarely with carvedilol therapy. In controlled studies of congestive heart failure, the incidence of liver function abnormalities reported as adverse experiences was 5.0% in patients receiving carvedilol and 4.6% in those receiving placebo. Three patients receiving carvedilol and two patients receiving placebo withdrew for abnormal hepatic function.

Contraindications

Carvedilol must not be used in patients with NYHA Class IV decompensated heart failure requiring intravenous inotropic support; bronchial asthma or related bronchospastic conditions including chronic obstructive pulmonary disease with a bronchospastic component; allergic disorders which may suggest a predisposition to bronchospasm; severe sinus bradycardia or sick sinus syndrome unless a permanent pacemaker is in place; shock including cardiogenic and hypovolaemic shock; second and third degree atrioventricular block; known hypersensitivity to carvedilol; hepatic impairment; or severe hypotension with systolic blood pressure less than 85 mmHg.

PBS listing

Dilatrend is listed on the PBS in tablets of 6.25 mg, 12.5 mg and 25 mg with restricted access. The ex-manufacturer price is A$4.00 for the 6.25 mg and 12.5 mg strengths and A$4.79 for the 25 mg strength.

Regulatory history

Dilatrend carvedilol 6.25 mg, 12.5 mg and 25 mg tablets were first listed on the ARTG on 21 January 1998.