"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
(Generic versions may still be available.)
QT INTERVAL PROLONGATION/VENTRICULAR ARRHYTHMIA
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.
Seldane (terfenadine) is available as tablets for oral administration. Each tablet contains 60 mg terfenadine. Tablets also contain, as inactive ingredients: corn starch, gelatin, lactose, magnesium stearate, and sodium bicarbonate.
Terfenadine is a histamine H1-receptor antagonist with the chemical name alpha-[4-(1,1-Dimethylethyl) phenyl]-4- (hydroxydiphenylmethyl) -1-piperidine-butanol (±). The molecular weight is 471.68. The molecular formula is C32H41NO2.
Terfenadine occurs as a white to off-white crystalline powder. It is freely soluble in chloroform, soluble in ethanol, and very slightly soluble in water.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Seldane Information
- Seldane Drug Interactions Center: terfenadine oral
- Seldane Side Effects Center
- Seldane FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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