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Loperamide / simethicone Pregnancy and Breastfeeding Warnings

Brand names: Anti-Diarrheal + Anti-Gas, Imodium Multi-Symptom Relief

Loperamide / simethicone Pregnancy Warnings

This drug is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs the risk, especially during the first trimester.

AU TGA pregnancy category: Not formally assigned to a pregnancy category. This class of drugs is generally exempt from pregnancy classification.
US FDA pregnancy category: Not formally assigned to a pregnancy category. Not formally assigned to a pregnancy category.

Animal studies have failed to reveal evidence of teratogenicity or embryofetal toxicity. There are no controlled data in human pregnancy.

See references

Loperamide / simethicone Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Yes (loperamide); No (simethicone)

Comments:
-Loperamide is excreted into human milk in small amounts.
-Simethicone is not orally absorbed.
-The American Academy of Pediatrics considers loperamide compatible with breastfeeding.

See references

References for pregnancy information

  1. (2006) "Product Information. Imodium Advanced (loperamide-simethicone)." Johnson and Johnson/Merck
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. Briggs GG, Freeman RK. (2015) "Drugs in Pregnancy and Lactation." Philadelphia, PA: Wolters Kluwer Health

References for breastfeeding information

  1. (2006) "Product Information. Imodium Advanced (loperamide-simethicone)." Johnson and Johnson/Merck
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
  5. Briggs GG, Freeman RK. (2015) "Drugs in Pregnancy and Lactation." Philadelphia, PA: Wolters Kluwer Health

Further information

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