DICARZ

What it is

DICARZ is a dual action cardiovascular agent; a vasodilating, non-selective beta-blocking agent with antioxidant properties. DICARZ is available as tablets containing 3.125, 6.25, 12.5 and 25 mg of carvedilol.

Approved indications

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

Dosing overview

Key safety warnings

Beta blockers can cause worsening heart failure. Since DICARZ has beta-blocking properties, care must be taken during initiation and up-titration of the drug in heart failure patients, as worsening heart failure has been observed in this phase of treatment. To minimise the risk of these events, it is critical to carefully follow the recommended dosing for DICARZ 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. When discontinuing DICARZ in patients with angina pectoris the dosage should be gradually reduced over a period of about 2 weeks and the patient should be carefully observed. DICARZ caused bradycardia in about 2% of hypertensive patients and 9% of congestive heart failure patients. If pulse rate drops below 55 beats per minute, the dosage should be reduced. Hypotension and postural hypotension occurred in 9.7% and syncope in 3.4% of congestive heart failure patients receiving DICARZ 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. To decrease the likelihood of syncope or excessive hypotension, treatment should be initiated with 3.125 mg twice daily for congestive heart failure patients, with dosage increased slowly according to recommendations and the drug taken with food.

Contraindications

DICARZ must not be used in patients with New York Heart Association 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 (less than 45 to 50 beats per minute) or sick sinus syndrome unless a permanent pacemaker is in place; shock; second and third degree atrioventricular block; known hypersensitivity to carvedilol; hepatic impairment with clinically manifest liver dysfunction; or severe hypotension with systolic blood pressure less than 85 mmHg.

Regulatory history

DICARZ carvedilol was first registered on the ARTG on 15 July 2005, with registrations for 3.125 mg and 25 mg tablets in blister pack and bottle formats. Additional registrations for 6.25 mg and 12.5 mg tablets in blister pack and bottle formats followed on 24 April 2007.