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Brompheniramine / codeine Pregnancy and Breastfeeding Warnings

Brand names: BroveX CB, BroveX CBX, EndaCof-AC, Nalex AC

Brompheniramine / codeine Pregnancy Warnings

Brompheniramine-codeine has been assigned to pregnancy category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Brompheniramine-codeine is only recommended for use during pregnancy when benefit outweighs risk.

See references

Brompheniramine / codeine Breastfeeding Warnings

There are no data on the excretion of brompheniramine into human milk. Many H1-antagonists are excreted in human milk and in general, these medications are not recommended for use during breast-feeding. Side effects in breast-feeding infants may manifest as irritability, disturbed sleeping patterns, drowsiness, hyperexcitability, or excessive crying.

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.

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. EndaCof-AC (brompheniramine-codeine). Larken Laboratories Inc. 2009.

References for breastfeeding information

  1. Findlay JW, DeAngelis RL, Kearney MF, et al. Analgesic drugs in breast milk and plasma. Clin Pharmacol Ther. 1981;29:625-33.
  2. 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. 1989;84:924-36.
  3. Mortimer EA, Jr. Drug toxicity from breast milk? . Pediatrics. 1977;60:780-1.
  4. Product Information. Dimetane (brompheniramine). Wyeth-Ayerst Laboratories. 2002.
  5. Committee on Drugs, 1992 to 1993. The transfer of drugs and other chemicals into human milk. Pediatrics. 1994;93:137-50.
  6. Product Information. EndaCof-AC (brompheniramine-codeine). Larken Laboratories Inc. 2009.

Further information

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