OVERDOSE
Information regarding acute overdosage is limited to
experience from clinical trials conducted during the development
of fexofenadine HCl. Single doses of fexofenadine HCl
up to 800 mg (6 normal volunteers at this dose level),
and doses up to 690 mg twice daily for one month (3 normal
volunteers at this dose level), were administered without
the development of clinically significant adverse events.
In the event of overdose, consider standard measures
to remove any unabsorbed drug. Symptomatic and supportive
treatment is recommended.
Hemodialysis did not effectively remove fexofenadine
from blood (up to 1.7% removed) following terfenadine
administration.
No deaths occurred at oral doses of fexofenadine HCl
up to 5000 mg/kg in mice (170 times the maximum recommended
human daily oral dose based on mg/m2) and up to 5000 mg/kg
in rats (330 times the maximum recommended human daily
oral dose based on mg/m2). Additionally, no clinical signs
of toxicity or gross pathological findings were observed.
In dogs, no evidence of toxicity was observed at oral
doses up to 2000 mg/kg (450 times the maximum recommended
human daily oral dose based on mg/m2).
CONTRAINDICATIONS
Fexofenadine HCl is contraindicated in patients with known
hypersensitivity to any of its ingredients.
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