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Ciprofloxacin / dexamethasone otic Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Mar 21, 2023.

Ciprofloxacin / dexamethasone otic is also known as: Ciprodex

Ciprofloxacin / dexamethasone otic Pregnancy Warnings

Animal reproduction studies of ciprofloxacin have revealed evidence of abortion at doses that produced maternal gastrointestinal disturbances and weight loss. Corticosteroids have revealed evidence of teratogenicity and changes to the testes, epididymis, sperm duct, prostate, seminal vesicle, Cowper's and accessory glands after dermal administration. There are no controlled data for either drug in human pregnancy.

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.

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

US FDA pregnancy category: C

See references

Ciprofloxacin / dexamethasone otic Breastfeeding Warnings

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comment: The effects in the nursing infant are unknown.

Ciprofloxacin and corticosteroids, such as dexamethasone, are excreted into breastmilk when administered orally. Excreted dexamethasone may result in growth suppression, interference with endogenous corticosteroid production, and/or other effects in the infant.

See references

See also

References for pregnancy information

  1. "Product Information. Ciprodex (ciprofloxacin-dexamethasone otic)." Alcon Laboratories Inc (2003):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Ciprodex (ciprofloxacin-dexamethasone otic)." Alcon Laboratories Inc (2003):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT" (2013):

Further information

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