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Doripenem Pregnancy and Breastfeeding Warnings

Doripenem is also known as: Doribax

Doripenem Pregnancy Warnings

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

AU TGA pregnancy category: B2
US FDA pregnancy category: B

Animal studies have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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.

See references

Doripenem Breastfeeding Warnings

Caution is recommended; according to some experts, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and the benefit of breastfeeding to the infant.

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

Comments:
-The effects in the nursing infant are unknown.
-Most likely has similar excretion into breast milk as imipenem and meropenem (low levels); side effects in nursing infants are not expected at these levels.
-Disruption of infant's gastrointestinal flora (resulting in diarrhea or thrush) reported occasionally with beta-lactams, but such effects have not been adequately evaluated.

See references

References for pregnancy information

  1. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. Available from: URL: http://www.tga.gov.au/docs/pdf/medpreg.pdf." ([1999]):
  2. Cerner Multum, Inc "Malaysia product information." O 0 (2015):
  3. "Product Information. Doribax (doripenem)." Ortho McNeil Pharmaceutical, Raritan, NJ.
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."

References for breastfeeding information

  1. Cerner Multum, Inc "Malaysia product information." O 0 (2015):
  2. "Product Information. Doribax (doripenem)." Ortho McNeil Pharmaceutical, Raritan, NJ.
  3. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. 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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