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Generic Name
Promethazine hydrochloride, Codeine phosphate and Ephedrine hydrochloride
Trade Name
Phensedyl
Manufacturer
Rhone Poulenc Rorer
Risk Category
C
  • Studies on animals show adverse effect and toxicity on fetus.
  • No adequate and well controlled studies done on pregnant women.
  • Drugs should be given only if the potential benefit outweighs the potential risk to the fetus.
FDA Pregnancy Risk Categories

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Indication
Indication
  • antihistamine, narcotic analgesic.
  • sympathomimetic for treatment of cough.
  • Fetal Risk
    Fetal Risk
  • Promethazine crosses human placenta. No adequate data but suggested possible association with cardiovascular defects in 1st trimester exposure. Reported to cause neonatal respiratory depression and platelet.
  • No well – controlled data for codeine, but suggested possible association with respiratory, genito- urinary malformations, down’s syndrome, umbilical and inguinal hernias, pyloric stenosis and hydrocephaly. For opiates in general, possibly associated with cleft lip/palate, heart, musculoskeletal, gastrointestinal malformations and inguinal hernias.
  • High doses of codeine at term can cause neonatal withdrawal and respiratory depression.
  • Ephedrine is teratogenic in animals.
  • No adequate human data but sympathomimetic agents in general are possible associated with minor malformations inguinal hernia and clubfoot if used in 1st trimester.
  • Ephedrine can cause fetal tachycardia.
  • Breast Feeding
    Breast Feeding
  • No data available for promethazine, unknown effects on nursing infants.
  • Ephedrine is considered safe in breast feeding, reported single case of irritability and poor sleeping in nursing infant.
  • Codeine is safe in breast feeding.
  • Other Trade Names
     
    The information on this Web site is not intended as a substitute for the advice and care of your doctor or other health-care provider. Always consult your doctor if you have any questions about exposures during pregnancy and lactation, and before you take any medications. Please read the Terms and Conditions before using this website.
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