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Desloratadine / pseudoephedrine Pregnancy and Breastfeeding Warnings

Desloratadine / pseudoephedrine is also known as: Clarinex-D 12 Hour, Clarinex-D 24 Hour

Desloratadine / pseudoephedrine Pregnancy Warnings

Desloratadine-pseudoephedrine has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy. Desloratadine-pseudoephedrine is only recommended for use during pregnancy when benefit outweighs risk

Desloratadine / pseudoephedrine Breastfeeding Warnings

Three mothers given pseudoephedrine demonstrated milk concentrations consistently higher than plasma concentrations. Maximum milk concentrations were reached at 1 to 1.5 hours after dosing. In one woman, the milk:plasma concentration ratio at 1, 3, and 12 hours was 3.3, 3.9, and 2.6. The authors calculated that 1000 mL of breast milk consumed over 24 hours would provide an infant with 0.25 to 0.33 mg of pseudoephedrine or 0.5% to 0.7% of the dose ingested by the mother.

Desloratadine and pseudoephedrine are excreted into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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