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Acetaminophen / dextromethorphan / pseudoephedrine Pregnancy and Breastfeeding Warnings

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Acetaminophen / dextromethorphan / pseudoephedrine Pregnancy Warnings

Acetaminophen/dextromethorphan/pseudoephedrine has not been formally assigned to a pregnancy category by the FDA.

Acetaminophen has not been formally assigned to pregnancy category by the FDA. It is routinely used for short-term pain relief and fever in all stages of pregnancy. Acetaminophen is believed to be safe in pregnancy when used intermittently for short durations.

Dextromethorphan has been assigned to pregnancy category C by the FDA. A teratogenic effect has been demonstrated in chicken embryos. There are no controlled data in human pregnancy.

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. Acetaminophen/dextromethorphan/pseudoephedrine is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

See references

Acetaminophen / dextromethorphan / pseudoephedrine Breastfeeding Warnings

There are no data on the excretion of acetaminophen/dextromethorphan/phenylephrine into human milk.

Acetaminophen is excreted into human milk in small concentrations. One case of a rash has been reported in a nursing infant. Acetaminophen is considered compatible with breast-feeding by the American Academy of Pediatrics.

There are no data on the excretion of dextromethorphan 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

See also

References for pregnancy information

  1. Rayburn W, Shukla U, Stetson P, Piehl E (1986) "Acetaminophen pharmacokinetics: comparison between pregnant and nonpregnant women." Am J Obstet Gynecol, 155, p. 1353-6
  2. Goldberg M (1982) "Analgesic nephropathy in 1981: which drug is responsible?" JAMA, 247, p. 64-5
  3. Roberts I, Robinson MJ, Mughal MZ, Ratcliffe JG, Prescott LF (1984) "Paracetamol metabolites in the neonate following maternal overdose." Br J Clin Pharmacol, 18, p. 201-6
  4. Galinsky RE, Levy G (1984) "Absorption and metabolism of acetaminophen shortly before parturition." Drug Intell Clin Pharm, 18, p. 977-9
  5. Levy G, Garrettson LK, Soda DM (1975) "Evidence of placental transfer of acetaminophen." Pediatrics, 55, p. 895
  6. Rudolph AM (1981) "Effects of aspirin and acetaminophen in pregnancy and in the newborn." Arch Intern Med, 141, p. 358-63
  7. O'Brien WF, Krammer J, O'Leary TD, Mastrogiannis DS (1993) "The effect of acetaminophen on prostacyclin production in pregnant women." Am J Obstet Gynecol, 168, p. 1164-9
  8. Beaulac-Baillargeon L, Rocheleau S (1994) "Paracetamol pharmacokinetics during the first trimester of human pregnancy." Eur J Clin Pharmacol, 46, p. 451-4
  9. (2001) "Product Information. Benylin DM (dextromethorphan)." Warner Lambert Consumer Healthcare
  10. Andaloro VJ, Monaghan DT, Rosenquist TH (1998) "Dextromethorphan and other N-methyl-D-aspartate receptor antagonists are teratogenic in the avian embryo model." Pediatr Res, 43, p. 1-7
  11. Briggs GG, Freeman RK, Yaffe SJ.. (1998) "Drugs in Pregnancy and Lactation." Baltimore, MD: Williams & Wilkins
  12. Einarson A, Lyszkiewicz D, Koren G (2001) "The safety of dextromethorphan in pregnancy - Results of a controlled study." Chest, 119, p. 466-9
  13. Debus O, Kurlemann G, Gehrmann J, Krasemann T (2001) "Dextromethorphan in pregnancy." Chest, 120, p. 1038-40

References for breastfeeding information

  1. Findlay JW, DeAngelis RL, Kearney MF, et al. (1981) "Analgesic drugs in breast milk and plasma." Clin Pharmacol Ther, 29, p. 625-33
  2. Notarianni LJ, Oldham HG, Bennett PN (1987) "Passage of paracetamol into breast milk and its subsequent metabolism by the neonate." Br J Clin Pharmacol, 24, p. 63-7
  3. Roberts RJ, Blumer JL, Gorman RL, et al. (1989) "American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk." Pediatrics, 84, p. 924-36
  4. Findlay JW, Butz RF, Sailstad JM, Warren JT, Welch RM (1984) "Pseudoephedrine and triprolidine in plasma and breast milk of nursing mothers." Br J Clin Pharmacol, 18, p. 901-6
  5. Matheson I, Lunde PK, Notarianni L (1985) "Infant rash caused by paracetamol in breast milk." Pediatrics, 76, p. 651-2
  6. Committee on Drugs, 1992 to 1993 (1994) "The transfer of drugs and other chemicals into human milk." Pediatrics, 93, p. 137-50
  7. (2001) "Product Information. Benylin DM (dextromethorphan)." Warner Lambert Consumer Healthcare
  8. Briggs GG, Freeman RK, Yaffe SJ.. (1998) "Drugs in Pregnancy and Lactation." Baltimore, MD: Williams & Wilkins

Further information

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