ZIPROX

What it is

ZIPROX contains ziprasidone hydrochloride monohydrate and is available as capsules in strengths of 20 mg, 40 mg, 60 mg or 80 mg. The capsules should be taken with food and swallowed whole without chewing, crushing or opening.

Approved indications —

Treatment of schizophrenia, related psychoses, prevention of relapse and maintenance of clinical improvement during continuation therapy — Short-term treatment of acute manic or mixed episodes associated with bipolar I disorder, as monotherapy

Dosing overview

Key safety warnings

ZIPROX causes a mild to moderate prolongation of the QT interval. Certain circumstances may increase the risk of torsade de pointes and sudden death, including bradycardia, electrolyte imbalances (especially hypokalaemia or hypomagnesaemia), concomitant use of other drugs that prolong the QTc interval, and presence of congenital prolongation of the QT interval. Patients being considered for ZIPROX treatment who are at risk for significant electrolyte disturbances should have baseline serum potassium and magnesium measurements. ZIPROX should be discontinued in patients who are found to have persistent QTc measurements greater than 500 msec. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared with placebo, with analyses of seventeen placebo-controlled trials revealing a risk of death in drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. ZIPROX is not approved for the treatment of elderly patients with dementia-related psychosis. Neuroleptic malignant syndrome, a potentially fatal complex, has been reported in association with antipsychotic drugs, including ZIPROX, with clinical manifestations including hyperthermia, muscle rigidity, altered mental status and signs of autonomic instability; if a patient develops signs and symptoms indicative of neuroleptic malignant syndrome, all antipsychotic drugs including ZIPROX should be discontinued. Drug reaction with eosinophilia and systemic symptoms and other severe cutaneous adverse reactions such as Stevens-Johnson syndrome have been reported with ZIPROX exposure, and ZIPROX should be discontinued if severe cutaneous adverse reactions occur. ZIPROX may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients syncope, especially during the initial dose-titration period; syncope was reported in 0.6% of patients treated with ZIPROX in schizophrenia clinical trials.

Contraindications

ZIPROX is contraindicated in patients with known hypersensitivity to any ingredient of the product; recent acute myocardial infarction; uncompensated heart failure; QT-interval prolongation or history of QT prolongation; congenital long QT syndrome; use with other drugs known to increase the QT interval; and arrhythmias treated with Class IA and III antiarrhythmic drugs.

PBS listing

ZIPROX is listed on the PBS in capsule strengths of 20 mg, 40 mg, 60 mg and 80 mg (as hydrochloride), with one item per strength, all with streamlined restriction. Ex-manufacturer prices are A$27.51 (20 mg), A$55.12 (40 mg), A$82.37 (60 mg) and A$109.98 (80 mg).

Regulatory history

ZIPROX was first registered on the ARTG on 13 August 2013, with registrations for capsules in 20 mg, 40 mg, 60 mg and 80 mg strengths plus a titration pack.