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Codeine / diphenhydramine / phenylephrine Pregnancy and Breastfeeding Warnings

Codeine / diphenhydramine / phenylephrine is also known as: Airacof, Endal CD (old formulation)

Codeine / diphenhydramine / phenylephrine Pregnancy Warnings

Codeine-diphenhydramine-phenylephrine 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-diphenhydramine-phenylephrine is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

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Codeine / diphenhydramine / phenylephrine Breastfeeding Warnings

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 ultra-rapid 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. Small amounts of phenylephrine are secreted in breast milk. Diphenhydramine is excreted into human milk. Diphenhydramine may also inhibit lactation. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

See references

References for pregnancy information

  1. "Product Information. Endal CD (codeine/diphenhydramine/phenylephrine)." Tiber Laboratories, Suwanee, GA.

References for breastfeeding information

  1. "Product Information. Endal CD (codeine/diphenhydramine/phenylephrine)." Tiber Laboratories, Suwanee, GA.

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