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Carcinogenesis, Mutagenesis, Impairment of Fertility: The carcinogenic potential of desloratadine was assessed using loratadine studies.
Information for Patients: Desloratadine should be used with caution in patients with medical record or having historical family in seizures. Children are susceptible to seizures, during Desloratadine treatment. Physician must stopped treatment immediately if patients has a seizure during treatment with Desloratadine. Patients should be instructed to use Desloratadine as directed. As there are no food effects on bioavailability, patients can be instructed that Desloratadine may be taken without regard to meals. Patients should be advised not to increase the dose or dosing frequency as studies have not demonstrated increased effectiveness at higher doses and somnolence may occur.
Drug Abuse and Dependence: There is no information to indicate that abuse or dependency occurs with Desloratadine.
Use in Pregnancy: Pregnancy Category C: No adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, desloratadine should be used during pregnancy only if clearly needed.
Use in Lactation: Desloratadine passes into breast milk, therefore a decision should be made whether to discontinue nursing or to discontinue desloratadine, taking into account the importance of the drug to the mother.
Use in Children: The safety and effectiveness of Desloratadine in pediatric patients under 12 years of age have not been established.
Use in the Elderly: In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
