Clavulanate / ticarcillin Pregnancy and Breastfeeding Warnings
Brand names: 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.
Clavulanate / ticarcillin Breastfeeding Warnings
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.
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.
See also
References for pregnancy information
- (2001) "Product Information. Timentin (ticarcillin-clavulanate)." SmithKline Beecham
- Briggs GG, Freeman RK, Yaffe SJ.. (1998) "Drugs in Pregnancy and Lactation." Baltimore, MD: Williams & Wilkins
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee (2007) Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. http://www.tga.gov.au/docs/pdf/medpreg.pdf
- Cerner Multum, Inc. "Australian Product Information."
- Melbourne: Therapeutic Guidelines Limited (2015) eTG complete [Online] http://online.tg.org.au/complete/desktop/tgc.htm
References for breastfeeding information
- von Kobyletzki D, Dalhoff A, Lindemeyer H, Primavesi CA (1983) "Ticarcillin serum and tissue concentrations in gynecology and obstetrics." Infection, 11, p. 144-9
- Roberts RJ, Blumer JL, Gorman RL, et al. (1989) "American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk." Pediatrics, 84, p. 924-36
- (2001) "Product Information. Timentin (ticarcillin-clavulanate)." SmithKline Beecham
- Committee on Drugs, 1992 to 1993 (1994) "The transfer of drugs and other chemicals into human milk." Pediatrics, 93, p. 137-50
- Briggs GG, Freeman RK, Yaffe SJ.. (1998) "Drugs in Pregnancy and Lactation." Baltimore, MD: Williams & Wilkins
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- Cerner Multum, Inc. "Australian Product Information."
- United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
- Melbourne: Therapeutic Guidelines Limited (2015) eTG complete [Online] http://online.tg.org.au/complete/desktop/tgc.htm
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
