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Seldane Indications, Dosage, Storage, Stability - Terfenadine (Removed from market 1998)

INDICATIONS

Terfenadine is indicated for the relief of symptoms associated with seasonal allergic rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation.

Clinical studies conducted to date have not demonstrated effectiveness of terfenadine in the common cold.

DOSAGE AND ADMINISTRATION

One tablet (60 mg) twice daily for adults and pediatric patients 12 years and older.

USE OF DOSES IN EXCESS OF 60 MG B.I.D. IS NOT RECOMMENDED BECAUSE OF THE INCREASED POTENTIAL FOR QT INTERVAL PROLONGATIONS AND ADVERSE CARDIAC EVENTS. (See BOXED WARNING).USE OF TERFENADINE IN PATIENTS WITH SIGNIFICANT HEPATIC DYSFUNCTION AND IN PATIENTS TAKING KETOCONAZOLE, ITRACONAZOLE, CLARITHROMYCIN, ERYTHROMYCIN OR TROLEANDOMYCIN IS CONTRAINDICATED. (See CONTRA

INDICATIONS

, WARNINGS, and DRUG INTERACTIONS).

HOW SUPPLIED

Removed from market 1998

60 mg tablets in bottles of 100.

60 mg tablets in bottles of 500.

Tablets are round, white, and debossed "SELDANE". Store tablets at controlled room temperature (59-86°F) (15-30°C). Protect from exposure to temperatures above 104°F (40°C) and moisture.

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