Film-coated tablet: Pregnancy: A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformative nor foeto/neonatal toxicity of desloratadine.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Toxicology: Preclinical safety data under Actions). As a precautionary measure, it is preferable to avoid the use of desloratadine during pregnancy.
Breast-feeding: Desloratadine has been identified in breastfed newborns/infants of treated women. The effect of desloratadine on newborns/infants is unknown. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from desloratadine therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: There are no data available on male and female fertility.
Syrup: No overall effect on rat fertility was observed with desloratadine at an exposure that was 34 times higher than the exposure in humans at the recommended clinical dose. No teratogenic or mutagenic effects were observed in animal trials with desloratadine. Since no clinical data on exposed pregnancies are available with desloratadine, the safe use of DESTA SYRUP during pregnancy has not been established. DESTA SYRUP is not to be used during pregnancy unless the potential benefits outweigh the risks.
Desloratadine is excreted into breast milk, therefore the use of DESTA SYRUP is not recommended in breast-feeding women.
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