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Azithromycin ophthalmic Pregnancy and Breastfeeding Warnings

Azithromycin ophthalmic is also known as: Azasite

Medically reviewed on January 8, 2018

Azithromycin ophthalmic Pregnancy Warnings

Animal studies have failed to reveal evidence of fetal harm. 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; use is considered acceptable.

US FDA pregnancy category: B

See references

Azithromycin ophthalmic Breastfeeding Warnings

Use is considered acceptable; caution is recommended.

Excreted into human milk: Yes

Comments: The effects in the nursing infant are unknown; however, harmful effects would not be expected.

Limited data indicate azithromycin is excreted into breast milk. Due to the low dose and low systemic availability, doses taken by neonates are considered negligible; therefore, breastfeeding is possible during therapy.

See references

References for pregnancy information

  1. "Product Information. AzaSite (azithromycin ophthalmic)." Inspire Pharmaceuticals Inc, Durham, NC.
  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. AzaSite (azithromycin ophthalmic)." Inspire Pharmaceuticals Inc, Durham, NC.

Further information

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

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