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Chlorpheniramine / codeine / pseudoephedrine Pregnancy and Breastfeeding Warnings

Chlorpheniramine / codeine / pseudoephedrine is also known as: Co-Histine DH, Codahistine-DH Elixir, Codehist DH, Decohistine DH, Dihistine DH, Novadyne DH, Phenylhistine DH, Phenylhistine DH Expectorant, Ryna-C, Tricode AR, Zodryl DAC

Chlorpheniramine / codeine / pseudoephedrine Pregnancy Warnings

Chlorpheniramine/codeine/pseudoephedrine has been not been formally assigned to a pregnancy category by the FDA. Codeine is the only narcotic analgesic that has shown a statistically significant association with teratogenicity (involving respiratory tract malformations) at the time of this writing. Like other narcotics, codeine rapidly crosses the placenta. Neonatal codeine withdrawal has occurred even in infants whose mothers were taking codeine at cough suppressant doses for as little as ten days prior to delivery. Chlorpheniramine/codeine/pseudoephedrine is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

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Chlorpheniramine / codeine / pseudoephedrine Breastfeeding Warnings

There are no data on the excretion of chlorpheniramine into human milk. Codeine is excreted into human milk in small amounts. Several small series and one small retrospective study suggest that codeine may be causative in episodes of apnea, bradycardia and cyanosis in the first week of life. Codeine is nevertheless considered compatible with breast-feeding by the American Academy of Pediatrics. 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. Bracken MB, Holford TR "Exposure to prescribed drugs in pregnancy and association with congenital malformations." Obstet Gynecol 58 (1981): 336-44
  2. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
  3. Mangurten HH, Benawra R "Neonatal codeine withdrawal in infants of nonaddicted mothers." Pediatrics 65 (1980): 159-60
  4. Koren G, Pastuszak A, Ito S "Drugs in pregnancy." N Engl J Med 338 (1998): 1128-37
  5. 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
  6. Werler MM, Mitchell AA, Shapiro S "First trimester maternal medication use in relation to gastroschisis." Teratology 45 (1992): 361-7
  7. "Product Information. Ryna-C Liquid (chlorpheniramine-pseudoephedrine)" Wallace Laboratories, Cranbury, NJ.

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. "Product Information. Chlortrimeton (chlorpheniramine)." Schering-Plough, Liberty Corner, NJ.
  4. Findlay JW, DeAngelis RL, Kearney MF, et al "Analgesic drugs in breast milk and plasma." Clin Pharmacol Ther 29 (1981): 625-33
  5. 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

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