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Pseudoephedrine / triprolidine Pregnancy and Breastfeeding Warnings

Pseudoephedrine / triprolidine is also known as: A-Phedrin, Actedril, Actifed, Allercon, Allerfrim, Allerphed, Aphedrid, Aprodine, Atridine, Atrofed, Atrogen, Ed A-Hist PSE, Genac, Hist-PSE, Hista-Tabs, LA Nasal Decongestant, Pediatex TD, Ridifed, Tri-Sudo, Triafed, Triofed, Triphed, Triposed, Triptifed, Zymine-D

Medically reviewed on Apr 13, 2018

Pseudoephedrine / triprolidine Pregnancy Warnings

Pseudoephedrine-triprolidine has not been formally assigned to a pregnancy category by the FDA. There are no controlled data in human pregnancy. Pseudoephedrine-triprolidine is only recommended for use during pregnancy when benefit outweighs risk.

Pseudoephedrine has not been formally assigned to a pregnancy category by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Based on available data, pseudoephedrine is not thought to be teratogenic.

Triprolidine has been assigned to pregnancy category C by the FDA. There are no controlled data in human pregnancy.

A case-controlled surveillance study reported an elevated relative risk (3.2) of gastroschisis with first-trimester pseudoephedrine use in 76 cases. Relative risks for other drugs were 1.6 for salicylates, 1.7 for acetaminophen, 1.3 for ibuprofen, and 1.5 for phenylpropanolamine (not significant). The authors hypothesized vascular disruption was the etiology of gastroschisis. A second group of 416 infants with heterogeneous defects suspected to have a vascular etiology were reviewed. There was no increased risk associated with salicylates, ibuprofen, pseudoephedrine, phenylpropanolamine or other decongestants. These data require independent confirmation.

In a review of 229,101 deliveries to Michigan Medicaid patients, 940 first-trimester exposures to pseudoephedrine were recorded and 1919 exposures anytime during pregnancy. A total of 37 birth defects were reported with first trimester exposure (40 expected) and included (observed/expected) 3/9 cardiovascular defects, 2 oral clefts, and 3/2 polydactyly. These researchers reviewed nine cases of abdominal wall defects in the 1980-1983 Medicaid data. Seven of the nine cases occurred in 3752 woman who had taken pseudoephedrine for a relative risk of 1.8. Only one of these cases was a surgically treated abdominal wall defect. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994).

The Collaborative Perinatal Project monitored 50,282 mother-child pairs. Only 39 first-trimester exposures to pseudoephedrine were recorded, with one birth defect observed. For use anytime during pregnancy, 194 exposures were recorded with 3 birth defects observed (3.22 expected).

The effect of pseudoephedrine on uterine and fetal blood was studied in 12 healthy pregnant women between 26 and 40 weeks gestation. Following a single 60 mg dose of pseudoephedrine, no significant effect was seen on fetal heart rate, uterine blood flow, or fetal aortic blood flow.

See references

Pseudoephedrine / triprolidine 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.

There are no data on the excretion of pseudoephedrine-triprolidine into human milk. Pseudoephedrine is excreted into human milk. The effects in the nursing infant are unknown. The American Academy of Pediatrics considers pseudoephedrine to be compatible with breast-feeding.

See references

References for pregnancy information

  1. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
  2. "Product Information. Actifed (pseudoephedrine-triprolidine)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  3. Werler MM, Mitchell AA, Shapiro S "First trimester maternal medication use in relation to gastroschisis." Teratology 45 (1992): 361-7
  4. 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

References for breastfeeding information

  1. 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
  2. "Product Information. Actifed (pseudoephedrine-triprolidine)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  3. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.