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Acetaminophen / chlorpheniramine Pregnancy and Breastfeeding Warnings

Acetaminophen / chlorpheniramine is also known as: Congestant, Coricidin HBP Cold & Flu

Acetaminophen / chlorpheniramine Pregnancy Warnings

Acetaminophen has not been formally assigned to a 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. Chlorpheniramine has been assigned to pregnancy category B by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Acetaminophen-chlorpheniramine is only recommended for use during pregnancy when benefit outweighs risk.

Two cases of acetaminophen overdose in late pregnancy have been reported. In both cases neither the neonate nor the mother suffered hepatic toxicity. Investigations have revealed conflicting results with regards to the pharmacokinetic disposition of acetaminophen in pregnant women. One study has suggested that the oral clearance of acetaminophen is 58% higher and the elimination half-life is 28% longer in pregnant women compared to nonpregnant women. Another study has suggested that the elimination half-life is not different in patients who are pregnant. That study also suggested that the volume of distribution of acetaminophen may be higher in pregnant women. One study has suggested that acetaminophen in typical oral doses may result in a reduced production of prostacyclin in pregnant women. That study also suggested that acetaminophen does not affect thromboxane production. The Collaborative Perinatal Project monitored 1,070 first trimester exposures and 3,931 exposures which occurred anytime during pregnancy. No evidence was found to suggest a relationship to large categories of malformations. Antihistamine exposure in the first trimester in general was not associated with an increased risk of malformations.

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Acetaminophen / chlorpheniramine Breastfeeding Warnings

One small study has reported that following a 1000 mg dose of acetaminophen to nursing mothers, nursing infants receive less than 1.85% of the weight-adjusted maternal oral dose.

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 chlorpheniramine into human milk. Because other antihistamines are excreted into human milk in low concentrations, the manufacturer recommends that caution be used when administering chlorpheniramine to nursing women.

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References for pregnancy information

  1. Beaulac-Baillargeon L, Rocheleau S "Paracetamol pharmacokinetics during the first trimester of human pregnancy." Eur J Clin Pharmacol 46 (1994): 451-4
  2. Galinsky RE, Levy G "Absorption and metabolism of acetaminophen shortly before parturition." Drug Intell Clin Pharm 18 (1984): 977-9
  3. Levy G, Garrettson LK, Soda DM "Evidence of placental transfer of acetaminophen." Pediatrics 55 (1975): 895
  4. Rudolph AM "Effects of aspirin and acetaminophen in pregnancy and in the newborn." Arch Intern Med 141 (1981): 358-63
  5. Roberts I, Robinson MJ, Mughal MZ, Ratcliffe JG, Prescott LF "Paracetamol metabolites in the neonate following maternal overdose." Br J Clin Pharmacol 18 (1984): 201-6
  6. Nelson MA, Forfar JO "Associations between drugs administered during pregnancy and congenital abnormalities of the fetus." Br Med J 1 (1971): 523-7
  7. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
  8. "Product Information. Chlortrimeton (chlorpheniramine)." Schering-Plough, Liberty Corner, NJ.
  9. Miners JO, Robson RA, Birkett DJ "Paracetamol metabolism in pregnancy." Br J Clin Pharmacol 22 (1986): 359-62
  10. O'Brien WF, Krammer J, O'Leary TD, Mastrogiannis DS "The effect of acetaminophen on prostacyclin production in pregnant women." Am J Obstet Gynecol 168 (1993): 1164-9
  11. "Product Information. Coricidin (acetaminophen-chlorpheniramine)." Schering-Plough Healthcare Products, Memphis, TN.
  12. Byer AJ, Traylor TR, Semmer JR "Acetaminophen overdose in the third trimester of pregnancy." JAMA 247 (1982): 3114-5

References for breastfeeding information

  1. Roberts RJ, Blumer JL, Gorman RL, et al "American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk." Pediatrics 84 (1989): 924-36
  2. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  3. Matheson I, Lunde PK, Notarianni L "Infant rash caused by paracetamol in breast milk." Pediatrics 76 (1985): 651-2
  4. "Product Information. Coricidin (acetaminophen-chlorpheniramine)." Schering-Plough Healthcare Products, Memphis, TN.
  5. "Product Information. Chlortrimeton (chlorpheniramine)." Schering-Plough, Liberty Corner, NJ.
  6. Notarianni LJ, Oldham HG, Bennett PN "Passage of paracetamol into breast milk and its subsequent metabolism by the neonate." Br J Clin Pharmacol 24 (1987): 63-7
  7. Findlay JW, DeAngelis RL, Kearney MF, et al "Analgesic drugs in breast milk and plasma." Clin Pharmacol Ther 29 (1981): 625-33

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