VOLIROP

What it is

VOLIROP is carvedilol, a medicine available as tablets. Each tablet contains 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. 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

VOLIROP tablets are intended for oral administration. Dosing differs by indication.

For hypertension in adults, the recommended initial dose is 12.5 mg once daily for the first two days, then 25 mg once daily. The dosage may be increased at intervals of at least two weeks up to a maximum of 50 mg given once daily or twice daily. For congestive heart failure, dosage must be individualised and closely monitored by the physician during up-titration. It is recommended that carvedilol be taken with food to slow the rate of absorption and to reduce the risk of orthostatic effects. The recommended starting dose is 3.125 mg twice daily for two weeks; if tolerated, the dosage may be increased at intervals of not less than two weeks to 6.25 mg twice daily, then 12.5 mg twice daily, then 25 mg twice daily.

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. In patients with heart failure, ischaemic heart disease or angina pectoris, abrupt cessation of therapy may lead to deterioration, with reports of severe exacerbation of angina and myocardial infarction or ventricular arrhythmias; therefore, when discontinuing carvedilol in patients with angina pectoris the dosage should be gradually reduced over a period of about two weeks. 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; the risk for these events was highest during the first 30 days of dosing. Mild hepatocellular injury 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 carvedilol patients and 4.6% in placebo patients. Rarely, use of carvedilol in patients with congestive heart failure has resulted in deterioration of renal function, particularly in those with low blood pressure, ischaemic heart disease and diffuse vascular disease, and/or underlying renal insufficiency.

Contraindications

VOLIROP must not be used in patients with NYHA Class IV decompensated heart failure requiring intravenous inotropic support; bronchial asthma or related bronchospastic conditions including COPD 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 including cardiogenic and hypovolaemic 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

VOLIROP was first listed on the ARTG on 11 November 2011, with registrations for 3.125 mg, 6.25 mg, 12.5 mg and 25 mg tablet strengths in various pack types.