United States of America - The manufacturer of itraconazole capsules, injection and oral solution has revised the labelling as a result of ongoing research, monitoring and evaluation of these products. Itraconazole capsules should not be administered to patients with evidence of ventricular dysfunction or a history of congestive heart failure. Rare cases of congestive heart failure and pulmonary oedema have been reported during postmarketing surveillance. If signs or symptoms of congestive heart failure occur during administration of itraconazole capsules these should be discontinued. In the event of injection or oral solution, continued use of itraconazole should be reassessed.
Other revisions to the labelling include a contraindication for use with dofetilide (a class III anti-arrhythmic), a precaution of use with erythromycin, and modifications to the calcium channel blocker drug interaction statement. A complete discussion of the changes is set out in the package insert for each dosage form.
Reference: Letter from Janssen Pharmaceutica, New Jersey, USA, dated May 2001.