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Chlorcyclizine / codeine / pseudoephedrine Pregnancy and Breastfeeding Warnings

Brand names: Notuss-NXD, Poly-Tussin D, Statuss Green

Chlorcyclizine / codeine / pseudoephedrine Pregnancy Warnings

Codeine has been shown to be embryolethal and fetotoxic in the hamster, rat, and mouse at doses of approximately 2 to 4 times the maximum recommended human dose. Maternally toxic doses (7 times the maximum recommended human dose) were associated with evidence of resorptions and incomplete ossification, including meningioencephalocele and cranioschisis. In the rabbit model, embryotoxicity and fetotoxicity were not observed. 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. Animal data is not available on chlorcyclizine or pseudoephedrine. There are no controlled data in human pregnancy.

Chronic use of opioids may cause reduced fertility; it is unknown whether these effects are reversible.

Benefit should outweigh risk

US FDA pregnancy category: Not formally assigned a pregnancy category

Comments: Prolonged use of opioids during pregnancy can result in physical dependence in the neonate; women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available.

See references

Chlorcyclizine / codeine / pseudoephedrine Breastfeeding Warnings

Use is not recommended

Excreted into human milk: Yes (codeine); Yes (pseudoephedrine); Unknown (chlorcyclizine)

Comments: Breastfeeding is not recommended when taking codeine due to the risk of serious adverse reactions in breastfed infants.

The US FDA recommends against use of prescription codeine pain and cough medicines in breastfeeding women. This is due to serious reactions in breastfed infants including excess sleepiness, difficultly breastfeeding, or serious breathing problems that could result in death. The US FDA is considering additional regulatory action for OTC combination cough and cold products containing codeine.

Codeine is present in breast milk and for women with normal codeine metabolism (normal CYP450 2D6 activity) the amount of codeine secreted is low and dose-dependent; however, in women who are ultra-rapid metabolizers of codeine (those with a specific CYP2D6 genotype) higher-than-expected serum levels of morphine, codeine's active metabolite, may be present in their breast milk which may lead to dangerously high serum morphine levels in their breastfed infants. In most cases, a person's specific CYP2D6 genotype is unknown. Several small series and 1 small retrospective study suggest that codeine may be causative in episodes of apnea, bradycardia, and cyanosis in the first week of life. A death of a breastfeed infant due to respiratory depression has been reported; the mother was found to be a CYP450 2D6 ultrarapid metabolizer.

See references

References for pregnancy information

  1. Product Information. Calcidrine (codeine). Abbott Pharmaceutical. 2002;PROD.
  2. Product Information. Sudafed (pseudoephedrine). Glaxo Wellcome. 2001;PROD.
  3. Product Information. Notuss-NXD (chlorcyclizine/codeine/pseudoephedrine). SJ Pharmaceuticals formerly Stewart-Jackson Pharmacal Inc. 2010.

References for breastfeeding information

  1. US Food and Drug Administration (FDA). FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women. https://www.fda.gov/Drugs/DrugSafety/ucm549679.htm 2017.

Further information

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

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