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Generic Name
Dextromethorphan hydrobromide, Pseudoephedrine and Paracetamol (acetaminophen)
Trade Name
Pretuval
Manufacturer
Roche
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.
The risk category is B for paracetamol.
FDA Pregnancy Risk Categories

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Indication
Indication
  • antitussive, decongestant, analgesic.
  • Fetal Risk
    Fetal Risk
  • Limited human data for dextromethorphan, but considered to be safe in pregnancy. No animal data.
  • No adequate data for pseudoephedrine but suggested possible association with gastroschisis in 1st trimester exposure and for sympathomimetic agents in general, they are teratogenic in animals possibly associated with minor malformations, club foot and inguinal hernias in human pregnancy.
  • No adequate data for paracetamol, but reported that maternal toxic doses can cause fetal liver toxicity kidney abnormalities and intrauterine death.
  • Suggested possible association with congenital dislocation of the hip and club foot if used any time during pregnancy.
  • Breast Feeding
    Breast Feeding
  • Paracetamol and pseudoephedrine are excreted into milk, both safe in breast feeding, but single case of maculopapular rash in nursing infant exposed to paracetamol has been reported.
  • No data for Dextromethorphan.
  • 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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