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Generic Name
Mefloquine, Sulfadoxine and Pyrimethamine
Trade Name
Fansimef
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 C for Pyrimethamine.
The Risk category is D for Sulfadoxine (if used near term).
FDA Pregnancy Risk Categories

Place (not click) your mouse cursor over the bold words in the text below to receive description

Indication
Indication
  • antimalarial.
  • Fetal Risk
    Fetal Risk
  • Pyrimethamine is teratogenic in animals causing cleft palate, limb defects, neural tube defects and chromosomal aberrations (trisomy and chromosomal mosaicism).
  • Considered relatively safe in pregnancy but should be avoided in 1st trimester and Folic acid supplementation should be given during therapy.
  • Reported single case of congenital malformation (abdominal and thoracic wall defects).
  • Sulfonamides including sulfa doxine are teratogenic in animals.
  • No adequate human data, suggested possible association between 1st trimester exposure and congenital anomalies including tracheoesophageal fistula, cataract, oral clefts, urethral obstruction limb defects, persistent ductus arteriosus atrophy of the adrenals and benign tumors.
  • If used close to delivery sulfonamides can cause neonatal jaundice, hemolytic anemia, and kernicterus. Mefloquine is teratogenic and embryotoxic in animals. No adequate human data but the drug should be used with caution in the 1st trimester because of possible fetotoxicity.
  • Therapeutic doses in the last two trimesters seem to have no fetal adverse effects.
  • Breast Feeding
    Breast Feeding
  • Pyrimethamine is excreted into milk safe in breast feeding.
  • Sulfonamides are excreted into milk in low concentrations safe in breast feeding but should be avoided in premature infants, infants with hyperbilirubinemia or glucose-6 - phosphate dehydrogenase deficiency.
  • Reported diarrhea and skin rash in exposed infants.
  • Malfoguine is excreted into milk.
  • No data available.
  • 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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