Aerius

Aerius Special Precautions

desloratadine

Manufacturer:

Organon

Distributor:

Zuellig Pharma
Full Prescribing Info
Special Precautions
This medication may cause drowsiness in some patients. Individual response should be determined that it does not cause drowsiness before driving, operating machines or working in areas with risk of falling. In clinical trials, this medication was no more likely than placebo to cause drowsiness.
Be careful in patients with renal disease. In the case of severe renal insufficiency (GFR<30 mL/min), AERIUS should be used as alternate day dosage until the physicians can determine the individual patient's response.
Desloratadine should be administered with caution in patients with a medical or family history of seizures. In particular, young children may be more susceptible to developing new seizures under desloratadine treatment. Healthcare providers may consider discontinuing desloratadine in patients who experience a seizure while on treatment.
Tablet/Syrup: Serum levels of this medication may be increased when using with macrolides antimicrobials such as erythromycin or imidazole antifungal such as ketoconazole. No clinically relevant changes in desloratadine plasma concentrations were observed in multiple-dose ketoconazole and erythromycin interaction trials.
Effects on ability to drive and use machines: No effects on the ability to drive and use machines have been observed (see Pharmacology: Pharmacodynamics under Actions).
Oral solution: Desloratadine showed no mutagenic effects in in vitro and in vivo mutagenicity studies.
Use in Pregnancy & Lactation: Oral solution: No teratogenic effects were observed in animal studies with desloratadine.
Since no clinical data on exposure during pregnancy are available with desloratadine, the safe use of desloratadine during pregnancy has not been established. Desloratadine should not be used during pregnancy unless the potential benefit outweighs the risks. Desloratadine passes into breast milk; therefore, breastfeeding is not recommended in lactating women taking desloratadine.
Use in Children: Tablet/Syrup: Efficacy and safety of AERIUS tablets in children under 12 years of age, and AERIUS syrup in children under 6 months of age have not been established.
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