CARDIZEM

What it is

Diltiazem Sandoz CD contains a blend of beads with controlled dissolution characteristics for once-a-day administration. The capsules are available as either 180 mg, 240 mg or 360 mg diltiazem hydrochloride in sustained release form. Diltiazem is a calcium channel blocker, benzothiazepine derivative.

Approved indications

— Treatment of hypertension — Management of 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; treatment with doses exceeding 360 mg per day is not recommended.

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 (risk of exacerbation) or with a first degree AV block detected on the electrocardiogram (risk of exacerbation and rarely, of complete block). Cases of acute renal failure have been reported in patients using diltiazem at therapeutic dosages; patients at greater risk appear to have reduced left ventricular function, severe bradycardia or severe hypotension. Mild elevations of transaminases with and without concomitant elevation in alkaline phosphatase and bilirubin have been observed in clinical studies, usually transient and frequently resolved even with continued diltiazem treatment; in rare instances, significant elevations in enzymes and acute hepatic injury have been noted, tending to occur early after therapy initiation (1 to 8 weeks) and been reversible upon discontinuation of drug therapy. Diltiazem should be used with caution in patients suffering from diabetes; like other calcium channel blockers, diltiazem influences insulin secretion and its peripheral action by inhibiting calcium influx into cells, so careful monitoring is necessary in patients with latent or manifest diabetes mellitus due to a possible increase in blood glucose. The use of diltiazem may induce bronchospasm, including asthma aggravation, especially in patients with pre-existing bronchial hyper-reactivity; cases have also been reported after dose increase, and patients should be monitored for signs and symptoms of respiratory impairment during diltiazem therapy.

Contraindications

— 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 — Concomitant use of ivabradine — Idiosyncrasy or hypersensitivity to diltiazem or any of the excipients — Breastfeeding — Left ventricular failure with pulmonary congestion — Acute myocardial infarction and pulmonary congestion documented by X-ray on admission

PBS listing

Capsule (controlled delivery) containing diltiazem hydrochloride 180 mg is listed with 2 PBS items, with an ex-manufacturer price of A$6.92. Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg is listed with 2 PBS items, with an ex-manufacturer price of A$8.82. Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg is listed with 2 PBS items, with an ex-manufacturer price of A$12.84. Tablet containing diltiazem hydrochloride 60 mg is listed with 2 PBS items, with an ex-manufacturer price of A$9.17.

Regulatory history

Cardizem CD diltiazem hydrochloride 180 mg capsule was first listed on the Australian Register of Therapeutic Goods on 10 November 1993. Cardizem CD diltiazem hydrochloride 240 mg capsule was first listed on 10 November 1993. Cardizem diltiazem hydrochloride 60 mg tablet was first listed on 24 February 2000. Cardizem CD diltiazem hydrochloride 360 mg capsule was first listed on 20 July 2000. The product information was first approved on 26 February 2007 and last revised on 7 May 2025.