Seldane

(Generic versions may still be available.)

DRUG DESCRIPTION

WARNING

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.

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

    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.

    What are the possible side effects of terfenadine (Seldane)?

    If you experience any of the following serious side effects, stop taking terfenadine and call your doctor immediately or seek emergency medical attention.

    • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
    • an irregular heartbeat; or
    • seizures.

    If you experience any of the following less serious side effects, continue taking terfenadine and talk to your doctor:

    • drowsiness or dizziness;
    • headache;
    • ...

    Read All Potential Side Effects and See Pictures of Seldane


    Seldane Patient Information Including Side Effects

    Brand Names: Seldane

    Generic Name: terfenadine (Pronunciation: ter FEN a deen)

    • What is terfenadine (Seldane)?
    • What are the possible side effects of terfenadine (Seldane)?
    • What is the most important information I should know about terfenadine (Seldane)?
    • Who should not take terfenadine (Seldane)?
    • How should I take terfenadine (Seldane)?
    • What happens if I miss a dose (Seldane)?
    • What happens if I overdose (Seldane)?
    • What should I avoid while taking terfenadine (Seldane)?
    • What other drugs will affect terfenadine (Seldane)?
    • Where can I get more information?

    What is terfenadine (Seldane)?

    Terfenadine was withdrawn from the U.S. market in 1998.

    Terfenadine is an antihistamine. Antihistamines prevent sneezing, runny nose, itching and watering of the eyes, and other allergic symptoms.

    Terfenadine is used to treat allergies, hives (urticaria), and other allergic inflammatory conditions.

    Terfenadine may also be used for purposes other than those listed in this medication guide.

    What are the possible side effects of terfenadine (Seldane)?

    If you experience any of the following serious side effects, stop taking terfenadine and call your doctor immediately or seek emergency medical attention.

    • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
    • an irregular heartbeat; or
    • seizures.

    If you experience any of the following less serious side effects, continue taking terfenadine and talk to your doctor:

    • drowsiness or dizziness;
    • headache;
    • nervousness;
    • nausea, diarrhea, or abdominal discomfort;
    • dry mouth; or
    • dry skin or itchiness.

    Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

    What is the most important information I should know about terfenadine (Seldane)?

    Terfenadine was withdrawn from the U.S. market in 1998.

    Do not take terfenadine with any of the following medicines: the antifungal drugs ketoconazole (Nizoral) or itraconazole (Sporanox); the antibiotics erythromycin (E.E.S., E-Mycin, Ery-Tab), clarithromycin (Biaxin), or azithromycin (Zithromax); or the ulcer drug cimetidine (Tagamet, Tagamet HB). A dangerous drug interaction could occur.

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