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Crotamiton topical Pregnancy and Breastfeeding Warnings

Brand names: Crotan, Eurax

Medically reviewed by Drugs.com. Last updated on Aug 4, 2023.

Crotamiton topical Pregnancy Warnings

Use is not recommended during pregnancy, especially in the first trimester; use is contradicted in some countries.

AU TGA pregnancy category: B2
US FDA pregnancy category: C

Animal reproduction studies have not been conducted with this drug. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Crotamiton topical Breastfeeding Warnings

Use while breastfeeding is not recommended unless directed by a physician.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-Nursing mothers should not apply this drug to the nipple area.
-The effects in the nursing infant are unknown.

See references

See also

References for pregnancy information

  1. (2002) "Product Information. Eurax (crotamiton topical)." Ranbaxy Pharmaceuticals
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."

References for breastfeeding information

  1. (2002) "Product Information. Eurax (crotamiton topical)." Ranbaxy Pharmaceuticals
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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