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Clavulanate / ticarcillin Pregnancy and Breastfeeding Warnings

Clavulanate / ticarcillin is also known as: Timentin

Clavulanate / ticarcillin Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk. AU TGA pregnancy category: B2 US FDA pregnancy category: B

Animal studies have failed to reveal evidence of fetal harm. 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

Clavulanate / ticarcillin Breastfeeding Warnings

After single 1 g IM doses of ticarcillin in 3 women in 1 study and 5 women in another early study, only trace amounts were detected for 6 hours. After ticarcillin 5 g IV 3 times a day in 10 women, milk levels averaged 2 to 2.5 mg/L; ticarcillin was undetectable in milk by 12 hours after last dose. Total daily intake of a breastfed infant would be negligible.

Use is considered acceptable; caution is recommended and benefit should outweigh risk. Excreted into human milk: Yes (ticarcillin in small amounts); No (clavulanate) Comments: -Low levels in milk are not expected to cause harmful effects in the nursing infant; according to some authorities, risk of sensitization/hypersensitivity reactions should be considered. -Disruption of infant's gastrointestinal flora (resulting in diarrhea or thrush) reported occasionally with penicillins, but such effects have not been adequately evaluated. -Ticarcillin is considered compatible with breastfeeding by the American Academy of Pediatrics.

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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. Timentin (ticarcillin-clavulanate)." SmithKline Beecham, Philadelphia, PA.
  3. Melbourne: Therapeutic Guidelines Limited "eTG complete [Online] Available from: URL: http://online.tg.org.au/complete/desktop/tgc.htm." ([2014, Nov -]):
  4. 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]):
  5. Cerner Multum, Inc. "Australian Product Information." O 0
  6. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Melbourne: Therapeutic Guidelines Limited "eTG complete [Online] Available from: URL: http://online.tg.org.au/complete/desktop/tgc.htm." ([2014, Nov -]):
  2. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  3. Roberts RJ, Blumer JL, Gorman RL, et al "American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk." Pediatrics 84 (1989): 924-36
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. Cerner Multum, Inc. "Australian Product Information." O 0
  6. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  7. "Product Information. Timentin (ticarcillin-clavulanate)." SmithKline Beecham, Philadelphia, PA.
  8. von Kobyletzki D, Dalhoff A, Lindemeyer H, Primavesi CA "Ticarcillin serum and tissue concentrations in gynecology and obstetrics." Infection 11 (1983): 144-9
  9. 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 -]):

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