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Chlorpheniramine / codeine Pregnancy and Breastfeeding Warnings

Chlorpheniramine / codeine is also known as: Codar AR, Codeprex, Cotab A, Cotab AX, Endacof-C, Lexuss 210, Notuss-AC, TL-Hist CM, Tuxarin ER, Tuzistra XR, Z-Tuss AC, Zodryl AC

Chlorpheniramine / codeine Pregnancy Warnings

Codeine has been shown to be embryolethal and fetotoxic in rats at maternally toxic doses. In the rabbit model, embryotoxicity and fetotoxicity were not observed. Prolonged use of opioids during pregnancy has resulted in babies being born physically dependent. Opioids administered to mothers shortly before delivery may result in some degree of newborn respiratory depression, especially with higher doses. Animal studies using chlorpheniramine at doses approximately 9 times the maximum recommended human daily dose have shown embryolethality. A small, but statistically significant association between maternal chlorpheniramine use and inguinal hernia and eye or ear anomalies in children was observed in a retrospective study, however, other studies have not shown this. There are no adequate and well-controlled studies in pregnant women. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is not recommended unless the benefit outweighs the risk to the fetus US FDA pregnancy category: C Comment: 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

Chlorpheniramine / codeine Breastfeeding Warnings

Use is not recommended Excreted into human milk: Yes (chlorpheniramine); Yes (codeine) Comments: Breastfeeding is not recommended when taking codeine due to the risk of serious adverse reactions in breastfed infants.

Codeine is present in breast milk. 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 CYP450 2D6 genotype) higher-than-expected serum levels of morphine (codeine's active metabolite) may be present in breast milk which may lead to dangerously high serum morphine levels in their breastfed infants. In most cases, a person's specific CYP450 2D6 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. 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. The anticholinergic effect of chlorpheniramine may suppress lactation if taken prior to nursing.

See references

References for pregnancy information

  1. "Product Information. Tuzistra XR (chlorpheniramine-codeine)." Vernalis Pharmaceuticals Inc, Morristown, NJ.
  2. "Product Information. Zodryl AC Adult (chlorpheniramine-codeine)." codaDOSE Incorporated, Flowery Branch [Atlanta], GA.

References for breastfeeding information

  1. "Product Information. Tuzistra XR (chlorpheniramine-codeine)." Vernalis Pharmaceuticals Inc, Morristown, NJ.
  2. "Product Information. Zodryl AC Adult (chlorpheniramine-codeine)." codaDOSE Incorporated, Flowery Branch [Atlanta], GA.
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

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