RARE CASES OF SERIOUS CARDIOVASCULAR ADVERSE EVENTS, INCLUDING DEATH, CARDIAC ARREST, TORSADES DE POINTES, AND OTHER VENTRICULAR ARRHYTHMIAS, HAVE BEEN OBSERVED IN THE FOLLOWING CLINICAL SETTINGS, FREQUENTLY IN ASSOCIATION WITH INCREASED TERFENADINE LEVELS WHICH LEAD TO ELECTROCARDIOGRAPHIC QT PROLONGATION:

CONCOMITANT ADMINISTRATION OF KETOCONAZOLE (NIZORAL) OR ITRACONAZOLE (SPORANOX)

OVERDOSE, INCLUDING SINGLE DOSES AS LOW AS 360 MG

CONCOMITANT ADMINISTRATION OF CLARITHROMYCIN, ERYTHROMYCIN, OR TROLEANDOMYCIN

SIGNIFICANT HEPATIC DYSFUNCTION

TERFENADINE IS CONTRAINDICATED IN PATIENTS TAKING KETOCONAZOLE, ITRACONAZOLE, OR ERYTHROMYCIN, CLARITHROMYCIN, OR TROLEANDOMYCIN, AND IN PATIENTS WITH SIGNIFICANT HEPATIC DYSFUNCTION.

DO NOT EXCEED RECOMMENDED DOSE.

IN SOME CASES, SEVERE ARRHYTHMIAS HAVE BEEN PRECEDED BY EPISODES OF SYNCOPE, SYNCOPE IN PATIENTS RECEIVING TERFENADINE SHOULD LEAD TO DISCONTINUATION OF TREATMENT AND FULL EVALUATION OF POTENTIAL ARRHYTHMIAS.

(See CONTRAINDICATIONS, WARNINGS, CLINICAL PHARMACOLOGY, and DRUG INTERACTIONS).