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U.S. Department of Health and Human Services

Safety

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Asacol (mesalamine) delayed release tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – May 2010

 

Summary View

 

ASACOL

PRECAUTIONS

Pregnancy
  • Dibutyl phthalate (DBP) is an inactive ingredient in Asacol’s enteric coating. The human daily intake of DBP from the maximum recommended dose of Asacol tablets is about 21 mg
  • ... in animal studies at doses >190 times the human dose based on body surface area, maternal DBP was associated with external and skeletal malformations and adverse effects on the male reproductive system. Asacol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

 

ASACOL HD

USE IN SPECIFIC POPULATIONS

Pregnancy
  • Dibutyl phthalate (DBP) is an inactive ingredient in Asacol HD’s enteric coating. The human daily intake of DBP from the maximum recommended dose of Asacol HD tablets is about 48 mg.
  • ...in animal studies at doses >80 times the human dose based on body surface area, maternal DBP was associated with external and skeletal malformations and adverse effects on the male reproductive system. Asacol HD should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

 

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