Cetirizine / pseudoephedrine Pregnancy and Breastfeeding Warnings
Cetirizine / pseudoephedrine Pregnancy Warnings
Cetirizine-pseudoephedrine has been assigned to pregnancy category C by the FDA. High dose animal studies have revealed evidence of developmental toxicity. There are no controlled data in human pregnancy. Cetirizine-pseudoephedrine is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk. .
Cetirizine / pseudoephedrine Breastfeeding Warnings
Cetirizine is excreted into human milk. Cetirizine is considered contraindicated during breast-feeding by the manufacturer. 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. Pseudoephedrine is considered compatible with breast-feeding by the American Academy of Pediatrics.
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