Pregnancy of Ticarcillin/ clavulanate in details
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.
Ticarcillin/ clavulanate breastfeeding
After single 1 g IM doses of Ticarcillin (Ticarcillin/ Clavulanate (Ticarcillin/ clavulanate)) in 3 women in 1 study and 5 women in another early study, only trace amounts were detected for 6 hours. After Ticarcillin (Ticarcillin/ Clavulanate (Ticarcillin/ clavulanate)) 5 g IV 3 times a day in 10 women, milk levels averaged 2 to 2.5 mg/L; Ticarcillin (Ticarcillin/ Clavulanate (Ticarcillin/ clavulanate)) 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 (Ticarcillin/ Clavulanate (Ticarcillin/ clavulanate)) in small amounts); No (Clavulanate (Ticarcillin/ 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 (Ticarcillin/ Clavulanate (Ticarcillin/ clavulanate)) is considered compatible with breastfeeding by the American Academy of Pediatrics.
References
- PubMed Health. "Ticarcillin (By injection): This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).
- Human Metabolome Database (HMDB). "Ticarcillin: The Human Metabolome Database (HMDB) is a freely available electronic database containing detailed information about small molecule metabolites found in the human body.". http://www.hmdb.ca/metabolites/HMDB0... (accessed September 17, 2018).
- FDA Pharm Classes. "FDA Pharmacological Classification: FDA published a final rule that amended the requirements for the content and format of approved labeling (prescribing information) for human prescription drug and biological products in January 2006.". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
