资料单张
INDICATIONS [/za_1030.html#1]
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CONTRA-INDICATIONS [/za_1030.html#1]
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DOSAGE [/za_1030.html#1]
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SIDE-EFFECTS [/za_1030.html#1]
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PREGNANCY [/za_1030.html#1]
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OVERDOSE [/za_1030.html#1]
IDENTIFICATION [/za_1030.html#1]
[/za_1030.html#1] PATIENT INFORMATION
FASTWAY 120 (TABLETS)
FASTWAY 180 (TABLETS)
SCHEDULING STATUS:
S2
PROPRIETARY NAME
(and dosage form):
FASTWAY 120 (TABLETS)
FASTWAY 180 (TABLETS)
COMPOSITION:
FASTWAY 120: Each tablet contains 120 mg
FEXOFENADINE
hydrochloride
FASTWAY 180: Each tablet contains 180 mg fexofenadine hydrochloride
PHARMACOLOGICAL CLASSIFICATION
A 5.7.1 Antihistaminics
PHARMACOLOGICAL ACTION
Fexofenadine hydrochloride is a pharmacologically active metabolite of terfenadine and is a non-sedating, selective
histamine H
1
-receptor antagonist. Fexofenadine exhibits an antihistaminic effect beginning within one hour, achieving
maximum effect at 6 hours and lasting 24 hours.
PHARMACOKINETICS
Fexofenadine is absorbed into the body following oral administration, with T max occurring at approximately 1-3 hours
post dose. The mean Cmax value was approximately 427 ng/mL and 494 ng/mL following the administration of a
120 mg and 180 mg dose once daily, respectively. The volume of distribution is5,4-5,8 L/kg. Fexofenadine does not
cross the blood brain barrier.
Fexofenadine is 60-70% plasma protein bound. Fexofenadine undergoes negligible metabolism (about 5% of the total
dose is metabolised, mostly by the intestinal mucosa, with only 0,5-1,5% of the dose undergoing hepatic
biotransformation), as it was the only major compound identified in urine and faeces of animals and man. The plasma
concentration profiles of fexofenadine follow
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