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Dexamethasone / tobramycin ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: TobraDex, Tobradex ST

Medically reviewed by Drugs.com. Last updated on Nov 20, 2023.

Dexamethasone / tobramycin ophthalmic Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: C

Comments:
-Treatment especially during the first three months of pregnancy, should only take place after a careful benefit-risk assessment.
-Women should inform their healthcare provider if pregnancy occurs.

Animal studies have shown this drug to be teratogenic. There are no adequate and well-controlled studies in pregnant women.

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

Dexamethasone / tobramycin ophthalmic Breastfeeding Warnings

Use is not recommended.

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

Comments: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects.

See references

References for pregnancy information

  1. (2001) "Product Information. Tobradex (dexamethasone-tobramycin ophthalmic)." Alcon Laboratories Inc
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."

References for breastfeeding information

  1. (2001) "Product Information. Tobradex (dexamethasone-tobramycin ophthalmic)." Alcon Laboratories Inc
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."

Further information

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