Pregnancy of Rolisporin in details
Animal studies have failed to reveal evidence of embryotoxicity, fetotoxicity, or teratogenicity. This drug crosses the placenta. There are no controlled data in human pregnancy. AU TGA pregnancy category B1: 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 have not shown 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.
This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk. AU TGA pregnancy category: B1 US FDA pregnancy category: B
Use is considered acceptable; caution is recommended. -UK: 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 for the child. Excreted into human milk: Yes (small amounts) Comments: -The effects in the nursing infant are unknown; low levels in milk not expected to cause harmful effects in the nursing infant. -This drug is considered compatible with breastfeeding by the American Academy of Pediatrics.
After 1 g IM or IV on day 3 postpartum to 20 women, peak milk levels averaged about 0.7 and 0.5 mg/L, respectively, at about 4 hours after the dose. Levels decreased very slowly over 24 hours with half-lives of 13 to 17 hours. Amounts in milk correspond to infant dose of about 0.5% of the maternal weight-adjusted dose. With usual doses, only a few mg of this drug expected to be ingested per day by the infant. Disruption of infant's gastrointestinal flora (resulting in diarrhea or thrush) reported occasionally with cephalosporins; such effects have not been adequately evaluated. Risk of diarrhea and mucous membrane fungal infections cannot be excluded; possible sensitization should be considered.
- Human Metabolome Database (HMDB). "Ceftriaxone: 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/HMDB00153... (accessed September 18, 2017).
- 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/DataStan... (accessed September 18, 2017).
Information checked by Dr. Sachin Kumar, MD Pharmacology