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Generic Name
Mesalazine (Mesalamine)
Trade Name
Salofalk Tablets
Manufacturer
Minipharm
Risk Category
B
  • Controlled studies done on animals in reproduction do not indicate risk to the fetus.
  • No adequate and well-controlled studies done on pregnant women.
FDA Pregnancy Risk Categories

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Indication
Indication
  • It is 5-aminosalicylic acid, anti-inflammatory bowel agent.
  • Fetal Risk
    Fetal Risk
  • Only small amounts are absorbed from the colon into systemic circulation.
  • Crosses the placenta.
  • No well controlled human data, first trimester exposure resulted in no increase in congenital anomalies but single case of fetal renal toxicity leading to renal lesions and defects has been reported in second trimester exposure.
  • Breast Feeding
    Breast Feeding
  • Small amounts are excreted into milk.
  • Should be used with caution because of possible allergic reaction in nursing infant producing watery diarrhea.
  • 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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