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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.

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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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References for pregnancy information

  1. Werler MM, Mitchell AA, Shapiro S "First trimester maternal medication use in relation to gastroschisis." Teratology 45 (1992): 361-7
  2. Smith CV, Rayburn WF, Anderson JC, Duckworth AF, Appel LL "Effect of a single dose of oral pseudoephedrine on uterine and fetal Doppler blood flow." Obstet Gynecol 76 (1990): 803-6
  3. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
  4. "Product Information. Allegra-D (fexofenadine-pseudoephedrine)." Hoechst Marion-Roussel Inc, Kansas City, MO.

References for breastfeeding information

  1. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  2. "Product Information. Allegra-D (fexofenadine-pseudoephedrine)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  3. Findlay JW, Butz RF, Sailstad JM, Warren JT, Welch RM "Pseudoephedrine and triprolidine in plasma and breast milk of nursing mothers." Br J Clin Pharmacol 18 (1984): 901-6
  4. "Product Information. Allegra (fexofenadine)." Hoechst Marion-Roussel Inc, Kansas City, MO.

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