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Cromolyn Pregnancy and Breastfeeding Warnings

Cromolyn is also known as: Gastrocrom, Intal, Intal Inhaler

Medically reviewed on Sep 24, 2018

Cromolyn Pregnancy Warnings

Use is not recommended unless clearly needed.

AU TGA pregnancy category: B1
US FDA pregnancy category: B

Animal studies at doses 27, 17, and 98 times the maximum recommended inhalation dose have not demonstrated evidence of fetal malformations. At very high parenteral doses, increased resorption and decreased fetal weight have been observed. There are no controlled data in human pregnancy

AU TGA pregnancy category B1: 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 have not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Cromolyn Breastfeeding Warnings

Maternal systemic absorption of this drug is expected to be very low. While it is unknown if this drug is excreted into milk, if excreted it would be poorly absorbed from the infant's gastrointestinal tract.

This drug should be used only if clearly needed.

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

See references

References for pregnancy information

  1. "Product Information. Gastrocrom (cromolyn (sodium cromoglycate))." Celltech Pharmaceuticals Inc, Rochester, NY.
  2. "Product Information. Cromolyn Sodium (cromolyn (sodium cromoglycate))." Teva Pharmaceuticals (formerly IVAX), Miami, FL.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  4. "Product Information. Gastrocrom (cromolyn (sodium cromoglycate))." Celltech Pharmaceuticals Inc, Rochester, NY.
  5. "Product Information. Cromolyn Sodium (cromolyn (sodium cromoglycate))." Teva Pharmaceuticals (formerly IVAX), Miami, FL.

Further information

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

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