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Generic Name
Codeine phosphate, ephedrine hydrochloride and papaverine hydrochloride
Trade Name
R+N pharm
Risk Category
  • 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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  • antitussive, decongestant, vasodilator.
  • Fetal Risk
    Fetal Risk
  • No well-controlled data for codeine but suggested possible association with respiratory, genito-urinary malformations, downs syndrome, umbilical and inguinal hernias, pyloric stenosis and hydrocephaly.
  • Opiates in general are suggested to produce cleft hip/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 for sympathomimetic drugs in general, has been reported association with minor congenital anomalies, inguinal hernia and clubfoot if used in 1st trimester, no fetal adverse effects when used in the last two trimesters.
  • No human or animal data for papaverine.
  • Breast Feeding
    Breast Feeding
  • Codeine is safe in breast feeding.
  • Ephedrine is considered safe, but reported single case of irritability and poor sleeping in nursing infant.
  • Unknown excretion of papverine into milk, but no adverse effects have been reported.
  • 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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