Brompheniramine Pregnancy and Breastfeeding Warnings
Brand names: B-Vex, Bidhist, Bromaphen, Bromax, Brovex, Brovex CT, Codimal A, Cophene B, Dimetane Extentab, Dimetapp Allergy, Histaject, J-Tan, J-Tan PD, LoHist-12, Lodrane 12 Hour, Lodrane 24, ND-Stat, Nasahist B, P-Tex, Prop-A-Tane, Respa BR, Siltane, Tanacof-XR, VaZol, Veltane
Brompheniramine Pregnancy Warnings
Brompheniramine has been assigned to pregnancy category C by the FDA. Animal studies failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy. The Collaborative Perinatal Project monitored 65 first trimester exposures to brompheniramine. Malformations were reported in 10 infants, a statistically significant association. In another 6509 live births, 172 mothers were exposed to Dimetapp (brompheniramine, phenylephrine and phenylpropanolamine). Five infants were born with congenital abnormalities resulting in a somewhat higher frequency than normal. Brompheniramine is only recommended for use during pregnancy when benefit outweigh risk.
Brompheniramine 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. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or brompheniramine, taking into account the importance of the drug to the mother.
See also
References for pregnancy information
- Aselton P, Jick H, Milunsky A, Hunter JR, Stergachis A (1985) "First-trimester drug use and congenital disorders." Obstet Gynecol, 65, p. 451-5
- Heinonen O, Shapiro S; Kaufman DW ed., Slone D (1977) "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc., p. 297
- (2002) "Product Information. Dimetane (brompheniramine)." Wyeth-Ayerst Laboratories
References for breastfeeding information
- Roberts RJ, Blumer JL, Gorman RL, et al. (1989) "American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk." Pediatrics, 84, p. 924-36
- Mortimer EA, Jr (1977) "Drug toxicity from breast milk? ." Pediatrics, 60, p. 780-1
- (2002) "Product Information. Dimetane (brompheniramine)." Wyeth-Ayerst Laboratories
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.