Chlorcyclizine / codeine / pseudoephedrine Pregnancy and Breastfeeding Warnings
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.
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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