A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Seldane Online, Description, Chemistry, Ingredients - Terfenadine (Removed from market 1998)
Seldane Online, Description, Chemistry, Ingredients - Terfenadine (Removed from market 1998)
DESCRIPTION
WARNING
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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).
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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.
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