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Ceftibuten Pregnancy and Breastfeeding Warnings

Ceftibuten is also known as: Cedax

Ceftibuten 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.

US FDA pregnancy category: B

See references

Ceftibuten Breastfeeding Warnings

Use is considered acceptable; caution is recommended.

Excreted into human milk: Yes (in small amounts)

Comments:
-Low levels in milk are not expected to cause harmful effects in the nursing infant.
-Disruption of infant's gastrointestinal flora (resulting in diarrhea or thrush) reported occasionally with cephalosporins, but such effects have not been adequately evaluated.
-Other cephalosporins have been considered compatible with breastfeeding by the American Academy of Pediatrics.

After a single 200 mg oral dose in 6 women, this drug was undetectable (less than 1 mg/L) at any time up to 24 hours after dosing.

See references

References for pregnancy information

  1. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  2. "Product Information. Cedax (ceftibuten)." Schering-Plough, Liberty Corner, NJ.

References for breastfeeding information

  1. "Product Information. Cedax (ceftibuten)." Schering-Plough, Liberty Corner, NJ.
  2. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  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 -]):
  4. Owens RC, Nightingale CH, Nicolau DP "Ceftibuten: an overview." Pharmacotherapy 17 (1997): 707-20

Further information

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

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