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Generic Name
Paracetamol (acetaminophen), Meprobamate and Caffeine
Trade Name
Paxidal
Manufacturer
Wallace
Risk Category
D*
  • Positive evidence of human fetal risk exists.
  • Potential benefits may warrant use of the drug in pregnant women despite potential risks (e.g. life threatening situations or serious illness).
The risk category is C according to manufacturer-Roche laboratories.
FDA Pregnancy Risk Categories

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Indication
Indication
  • sedative analgesic for painful muscle spasm.
  • Fetal Risk
    Fetal Risk
  • Reported association between meprobamate use in pregnancy and congenital defects including heart defects, down’s syndrome, deafness, limb defects and polydactyly.
  • Caffeine is teratogenic in animals at maternal toxic doses. No adequate human data but suggested association between high maternal caffeine intake and decreased fertility, increased abortion rate, low birth weight, growth retardation and preterm delivery.
  • maternal ingestion of more than 500mg/day of caffeine may cause neonatal cardiac arrythmias as a feature of drug withdrawal and change in fetal behavior (frequent body movements, irregular heart rate and breathing activity).
  • No adequate human data for paracetamol but reported that maternal toxic doses can cause fetal liver toxicity, kidney abnormalities and intrauterine death, suggested possible association with 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 in breast feeding but reported single case of maculopapular rash in exposed infant.
  • Heavy amounts of caffeine may cause irritability and poor sleeping in nursing infants.
  • Usual amounts are safe. Unknown effects of meprobamate on nursing infants.
  • 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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