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Seldane D Indications, Dosage, Storage, Stability - Pseudoephedrine Hydrochloride; Terfenadine
INDICATIONS
Seldane-D is indicated for the relief of symptoms associated with seasonal allergic rhinitis such as sneezing, rhinorrhea, pruritus, lacrimation, and nasal congestion. It should be administered when both the antihistaminic properties of Seldane (terfenadine) and the nasal decongestant activity of pseudoephedrine hydrochloride are desired.
Seldane-D has not been studied for effectiveness in relieving symptoms of the common cold.
DOSAGE AND ADMINISTRATION
Adults and pediatric patients 12 years and older: one tablet swallowed whole, morning and night.
USE OF DOSES IN EXCESS OF ONE TABLET B.I.D. IS NOT RECOMMENDED BECAUSE OF THE INCREASED POTENTIAL FOR QT INTERVAL PROLONGATION AND ADVERSE CARDIAC EVENTS. USE OF SELDANE-D IN PATIENTS WITH SIGNIFICANT HEPATIC DYSFUNCTION AND IN PATIENTS TAKING KETOCONAZOLE, ITRACONAZOLE, CLARITHROMYCIN, ERYTHROMYCIN, OR TROLEANDOMYCIN IS CONTRAINDICATED.
HOW SUPPLIED
(Removed
from market 1998)
Seldane-D Tablets containing 60 mg
of terfenadine and 10 mg of pseudoephedrine hydrochloride
in an outer press-coat for immediate release and 110 mg
of pseudoephedrine hydrochloride
in an extended- release core.
Tablets are white to off-white, biconvex capsule-shaped; debossed "Seldane-D".
Store at controlled room temperature (59-86°F) (15-30°C). Protect from moisture.
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