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Generic Name
Chlorzoxazone, Paracetamol and Prednisolone
Trade Name
Predniflex
Manufacturer
Cilag – Chemie
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 prednisolone.
FDA Pregnancy Risk Categories

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Indication
Indication
  • Muscle relaxant with analgesic and corticosteroid.
  • Fetal Risk
    Fetal Risk
  • corticosteroids in general are teratogenic in animals causing cleft palate is a split in roof of the mouth, due to failure of two sides to fuse during embryonic development. Could also be a cleft lip, which is a split in the lip">cleft palate.
  • No well – controlled human data, but association between corticosteroid therapy and fetal malformations (cleft palate is a split in roof of the mouth, due to failure of two sides to fuse during embryonic development. Could also be a cleft lip, which is a split in the lip">cleft palate), growth retardation, neonatal cataract and adrenal suppression have been reported.
  • No adequate data for prednisolone in pregnancy but increased incidence of congenital anomalies, neonatal cataract, and increased still birth rate have been reported when the drug used throughout pregnancy.
  • No animal data for chlorzoxazone, limited human data but no association with congenital defects has been reported in 1st trimester exposure.
  • No adequate data for paracetamol reported that maternal toxic doses can cause fetal liver toxicity, kidney abnormalities and death.
  • Suggested possible association with congenital dislocation of the hip and club foot if used anytime in pregnancy.
  • Breast Feeding
    Breast Feeding
  • Paracetamol is excreted into milk in small amounts.
  • Safe, reported single case of maculopapular rash in exposed infant, no data for chlorzoxazone.
  • Prednisolone is excreted into milk.
  • 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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