VASOCARDOL

What it is

VASOCARDOL CD is a modified release capsule containing diltiazem hydrochloride, registered in three strengths: 180 mg, 240 mg and 360 mg.

Approved indications

— Hypertension — Chronic stable angina (effort-associated angina) where there is no evidence of vasospastic or unstable angina

Dosing overview

There is limited clinical experience with doses above 360 mg, and treatment with doses exceeding 360 mg per day is not recommended. Preliminary results in elderly patients suggest that a lower dosage might be required in this age group.

Key safety warnings

Calcium channel blocking agents such as diltiazem may be associated with mood changes, including depression. Close observation is necessary in patients with reduced left ventricular function, bradycardia or with a first degree AV block detected on the electrocardiogram. Cases of acute renal failure have been reported in patients using diltiazem at therapeutic dosages, with patients at greater risk appearing to have reduced left ventricular function, severe bradycardia or severe hypotension. Mild elevations of transaminases have been observed in clinical studies and were usually transient, though in rare instances significant elevations in liver enzymes consistent with acute hepatic injury have been noted, tending to occur early after therapy initiation and being reversible upon discontinuation. The use of diltiazem may induce bronchospasm, including asthma aggravation, especially in patients with pre-existing bronchial hyper-reactivity, with cases reported after dose increase, and patients should be monitored for signs and symptoms of respiratory impairment during therapy. Diltiazem should be used with caution in patients suffering from diabetes, as it influences insulin secretion and peripheral action, and careful monitoring is necessary due to a possible increase in blood glucose.

Contraindications

VASOCARDOL is contraindicated in sick sinus syndrome except in the presence of a functioning ventricular pacemaker; second- or third-degree AV block except in the presence of a functioning ventricular pacemaker; hypotension (less than 90 mmHg systolic); congestive heart failure; severe bradycardia (below 40 bpm); concomitant use of dantrolene infusion or ivabradine; idiosyncrasy or hypersensitivity to diltiazem or any excipients; breastfeeding; left ventricular failure with pulmonary congestion; and acute myocardial infarction with pulmonary congestion documented by X-ray on admission.

PBS listing

No source document contains information regarding PBS listing for VASOCARDOL.

Regulatory history

VASOCARDOL CD 180 mg and 240 mg capsules were first listed on the ARTG on 3 June 1999, followed by VASOCARDOL 60 mg tablets on 9 May 2000 and VASOCARDOL CD 360 mg capsules on 20 July 2000. The sponsor is Sanofi-Aventis Australia Pty Ltd, with the first approval date recorded as 26 February 2007.