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Generic Name
Paracetamol (acetaminophen), Phenylpropanolamine hydrochloride and Chlopheniramine maleate
Trade Name
Michaelon
Manufacturer
Amoun
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 and Chlorpheniramine maleate.
FDA Pregnancy Risk Categories

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Indication
Indication
  • decongestant, antipyretic.
  • Fetal Risk
    Fetal Risk
  • No well – controlled human data for chlorpheniramine, suggested possible association with congenital malformations including polydactyly, eye, ear defects inguinal hernia, gastrointestinal and genital defects, dislocation of the hip.
  • Use of antihistamines in the last two weeks of pregnancy reported to cause retrolental fibroplasia in premature infants. No adequate data for paracetamol, reported that maternal toxic doses can cause liver toxicity kidney abnormalities and intrauterine death.
  • Suggested possible association with dislocation of the hip and club foot if used any time during pregnancy.
  • Limited human data for phenylpropranol-amine but as sympathomimetic agent reported to be teratogenic producing, eye, ear defects hypospadias, polydactyly, cataract and pectus excavatum in 1st trimester exposure and with dislocation of the hip when used anytime in pregnancy.
  • It may induce constriction of uterine vesseles causing fetal hypoxia and bradycardia.
  • Breast Feeding
    Breast Feeding
  • No data for Chlorpheniramine and phenylproponolamine in breast feeding.
  • Paracetamol is excreted into milk. Safe during lactation.
  • Reported single case of maculopapular rash in nursing infant.
  • 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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