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Fexofenadine / pseudoephedrine Pregnancy and Breastfeeding Warnings

Fexofenadine / pseudoephedrine is also known as: Allegra-D 12 Hour, Allegra-D 12 Hour Allergy & Congestion, Allegra-D 24 Hour, Allegra-D 24 Hour Allergy & Congestion

Fexofenadine / pseudoephedrine Pregnancy Warnings

Fexofenadine-pseudoephedrine has been assigned to pregnancy category C by the FDA. Reproductive studies in rats and rabbits have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy. Fexofenadine-pseudoephedrine should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Fexofenadine / pseudoephedrine Breastfeeding Warnings

There are no data on the excretion of fexofenadine into human milk. Pseudoephedrine is excreted into human milk. 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. There are no reports of adverse effects in infants who were exposed to pseudoephedrine in breast milk. The American Academy of Pediatrics considers pseudoephedrine to be compatible with breast-feeding.

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