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Chlorcyclizine / codeine / pseudoephedrine Pregnancy and Breastfeeding Warnings

Chlorcyclizine / codeine / pseudoephedrine is also known as: Notuss-NXD, Poly-Tussin D, Statuss Green

Chlorcyclizine / codeine / pseudoephedrine Pregnancy Warnings

Chlorcyclizine 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. Codeine has been assigned to pregnancy category C by the FDA. Codeine is the only narcotic analgesic which 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. There are no controlled data in human pregnancy. Codeine is only recommended for use during pregnancy when there are no alternatives and 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. Pseudoephedrine is only recommended for use during pregnancy when benefit outweighs risk.

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Chlorcyclizine / codeine / pseudoephedrine Breastfeeding Warnings

There no data on the excretion of chlorcyclizine into human milk. Codeine is excreted into human milk in small amounts. The FDA issued a Public Health Advisory about a very rare, but serious, side effect in nursing infants whose mothers are taking codeine and are ultrarapid metabolizers of codeine. 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. The effects in the nursing infant are unknown. 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. Werler MM, Mitchell AA, Shapiro S "First trimester maternal medication use in relation to gastroschisis." Teratology 45 (1992): 361-7
  6. 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, DeAngelis RL, Kearney MF, et al "Analgesic drugs in breast milk and plasma." Clin Pharmacol Ther 29 (1981): 625-33
  2. 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
  3. 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
  4. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50

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