Clarinex

[Desloratadine]

Overdosage & Contraindications
CONTRAINDICATIONS

CLARINEX Tablets 5 mg are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients, or to loratadine.

OVERDOSAGE

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Information regarding acute overdosage is limited to experience from clinical trials conducted during the development of the CLARINEX product. In a dose ranging trial, at doses of 10 mg and 20 mg/ day somnolence was reported. Single daily doses of 45 mg were given to normal male and female volunteers for 10 days. All ECGs obtained in this study were manually read in a blinded fashion by a cardiologist.

In CLARINEX-treated subjects, there was an increase in mean heart rate of 9.2 bpm relative to placebo. The QT interval was corrected for heart rate (QTc) by both the Bazett and Fridericia methods. Using the QTc (Bazett) there was a mean increase of 8.1 msec in CLARINEX-treated subjects relative to placebo. Using QTc (Fridericia) there was a mean increase of 0.4 msec in CLARINEX-treated subjects relative to placebo.

No clinically relevant adverse events were reported. In the event of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Desloratadine and 3-hydroxydesloratadine are not eliminated by hemodialysis.

Lethality occurred in rats at oral doses of 250 mg/ kg or greater (estimated desloratadine and desloratadine metabolite exposures were approximately 120 times the AUC in humans at the recommended daily oral dose). The oral median lethal dose in mice was 353 mg/ kg (estimated desloratadine exposures were approximately 290 times the human daily oral dose on a mg/ m 2 basis).

No deaths occurred at oral doses up to 250 mg/ kg in monkeys (estimated desloratadine exposures were approximately 810 times the human daily oral dose on a mg/ m 2 basis).