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Nedocromil ophthalmic Pregnancy and Breastfeeding Warnings

Nedocromil ophthalmic is also known as: Alocril

Medically reviewed on Sep 3, 2018

Nedocromil ophthalmic Pregnancy Warnings

Animal studies failed to reveal evidence of teratogenicity or fetal harm when this drug was administered subcutaneously at doses more than 1600 times the maximum human daily ocular dose on a mg/kg basis. There are no controlled data in human pregnancy.

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.

This drug should be used during pregnancy only if clearly needed.

US FDA pregnancy category: B

See references

Nedocromil ophthalmic Breastfeeding Warnings

Caution is recommended.

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

Comments:
-This drug was detected in the milk of lactating rats following IV administration.
-Less than 4% of an ophthalmic dose is expected to be absorbed systemically.

Although no published data exist on the use of this drug during lactation, maternal milk levels are likely to be very low and it is expected to be poorly absorbed from the infant's gastrointestinal tract.

See references

References for pregnancy information

  1. "Product Information. Alocril (nedocromil ophthalmic)" Allergan Inc, Irvine, CA.
  2. 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. "Product Information. Alocril (nedocromil ophthalmic)" Allergan Inc, Irvine, CA.
  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 -]):

Further information

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

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