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Although increased plasma concentrations (Cmax and AUC0-24 hrs) of desloratadine and 3hydroxydesloratadine were observed (see Table 2) desloratadine, as assessed by electrocardiographic parameters (including the corrected QT interval) clinical laboratory tests, vital signs, and adverse 3-Hydroxydesloratadine Pharmacokinetics in Healthy Male and Female Volunteers 48 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 210 times the AUC in humans at the recommended daily oral dose) or in rabbits at doses up to 60 mg/kg/day (estimated desloratadine exposures were approximately 230 times the AUC in humans at the recommended daily oral dose) In a separate study, an increase in pre-implantation loss and a decreased number of implantations and fetuses were noted in female rats at 24 mg/kg (estimated desloratadine and desloratadine metabolite exposures were approximately 120 times the AUC in humans at the recommended daily oral dose) Reduced body weight and slow righting reflex were reported in pups at doses of 9 mg/kg/day or greater (estimated desloratadine and desloratadine metabolite exposures were approximately 50 times or greater than the AUC in humans at the recommended daily oral dose) Desloratadine had no effect on pup development at metabolite exposures were approximately 7 times the AUC in humans at the evaluated in over 2300 patients 12 to 75 years of age with seasonal allergic rhinitis. Desloratadine (clarinex) packing 5 mg 120 the amount of packaging.
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| Clinical data | |
|---|---|
| Trade names | Clarinex (US), Aerius, Dasselta, Deslordis (EU), others |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a602002 |
| License data | EU EMA: by INN, US FDA: Desloratadine |
| Pregnancy category | AU: B1 US: C (Risk not ruled out) |
| Routes of administration | Oral (tablets, solution) |
| ATC code | R06AX27 ( WHO ) |
| Legal status | |
| Legal status | AU: S2 (Pharmacy only) CA : OTC UK: POM (Prescription only) US: ℞-only |
| Pharmacokinetic data | |
| Bioavailability | Rapidly absorbed |
| Protein binding | 83 to 87% |
| Metabolism | UGT2B10, CYP2C8 |
| Metabolites | 3-Hydroxydesloratadine |
| Onset of action | within 1 hour |
| Elimination half-life | 27 hours |
| Duration of action | up to 24 hours |
| Excretion | 40% as conjugated metabolites into urine Similar amount into the feces |
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| Desloratadine about | |
|---|---|
| Pill name | Desloratadine |
| Desloratadine other name | clarinex reditabs, clarinex-d |
| Active substance | clarinex |
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