Telfast Overdosage

Information regarding acute overdosage is limited to experience from clinical trials conducted during the development of Telfast. 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 1 month (3 normal volunteers at this dose level) were administered without the development of clinically significant adverse events.
No deaths occurred in mature mice and rats at oral doses of fexofenadine HCl up to 5000 mg/kg (approximately 170 and 340 times, respectively, the maximum recommended daily oral dose in adults on a mg/m² basis). The median oral lethal dose in newborn rats was 438 mg/kg (approximately 30 times the maximum recommended daily oral dose in adults on a mg/m² basis). In dogs, no evidence of toxicity was observed at oral doses up to 2000 mg/kg (approximately 450 times the maximum recommended daily oral dose on a mg/m² basis).
Symptoms: Tablet: In large doses, sympathomimetics may give rise to giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tenseness, anxiety, restlessness and insomnia. Many patients can present a toxic psychosis with delusions and hallucinations. Some may develop cardiac arrhythmias, circulatory collapse, convulsions, coma and respiratory failure.
Oral suspension: Most of the fexofenadine hydrochloride overdose reports presented restricted information. However, dizziness, drowsiness and dry mouth were reported. In adults a single dose of up to 800 mg and doses of up to 690 mg, twice a day for one month or 240 mg daily, for 1 year, were studied in healthy volunteers without the emergence of any clinically significant adverse events compared to the placebo. The maximum tolerated dose of TELFAST (ORAL SUSPENSION) has not been established.
There were no deaths of mice that received oral doses of fexofenadine hydrochloride of up to 5000 mg/kg (110 times the maximum daily oral dose for adults and children on a mg/m² basis) and in rats with oral doses of up to 5000 mg/kg (230 times the maximum recommended daily oral dose for adults and 210 times the maximum recommended daily oral dose for children on a mg/m² base). Additionally, no clinical signals of toxicity were observed; nor were there any significant pathologic findings. In dogs, no evidence of toxicity was observed with oral doses of up to 2000 mg/kg (300 times the maximum daily oral dose for adults and 280 times the maximum oral dose for children on a mg/m² basis).
Treatment: 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.
Oral suspension: In case of overdose, it is recommended that the usual symptomatic and support measures be taken to remove the non-absorbed drug from the body.
Hemodialysis does not effectively remove fexofenadine hydrochloride from the blood.