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.
See Also...
- desloratadine/pseudoephedrine sustained-release tablets Consumer Information
- Pregnancy Support Group
- FDA Pregnancy Categories
- Medicine use during Pregnancy
- Medicine use while Breastfeeding
- Safe Medications during Breastfeeding
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