Pregnancy of Vancomycin Abipharm in details
Vancomycin Abipharm crosses the placenta and can be detected in fetal serum, amniotic fluid, and cord blood (Bourget 1991; Reyes 1989). Adverse fetal effects, including sensorineural hearing loss or nephrotoxicity, have not been reported following maternal use during the second or third trimesters of pregnancy.
The pharmacokinetics of Vancomycin Abipharm may be altered during pregnancy and pregnant patients may need a higher dose of Vancomycin Abipharm. Maternal half-life is unchanged, but the volume of distribution and the total plasma clearance may be increased (Bourget 1991). Individualization of therapy through serum concentration monitoring may be warranted.
Vancomycin Abipharm is recommended for the treatment of Clostridioides (formerly Clostridium) difficile infections in pregnant women (ACG [Surawicz 2013]). Vancomycin Abipharm is recommended as an alternative agent to prevent the transmission of group B streptococcal (GBS) disease from mothers to newborns (ACOG 782 2019). In patients colonized with MRSA, Vancomycin Abipharm is recommended as part of the antibiotic regimen for prophylactic use prior to cesarean delivery (ACOG 199 2018).
[US Boxed Warning]: The formulation of Vancomycin Abipharm injection containing the excipients polyethylene glycol (PEG 400) and N-acetyl D-alanine (NADA) is not recommended for use during pregnancy. PEG 400 and NADA have caused fetal malformations in animal reproduction studies. If use of Vancomycin Abipharm is needed during pregnancy, use other available formulations of Vancomycin Abipharm.
Vancomycin Abipharm breastfeeding
Vancomycin Abipharm is excreted into human milk following intravenous administration. It is not known whether oral Vancomycin Abipharm is excreted in human milk. However, oral Vancomycin Abipharm is generally poorly absorbed and systemic concentrations are very low. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
See references
References for pregnancy information
- "Product Information. Vancocin (Vancomycin Abipharm)." Lilly, Eli and Company, Indianapolis, IN.
References for breastfeeding information
- Reyes MP, Ostrea EM, Cabinian AE, Schmitt C, Rintelmann W "Vancomycin Abipharm during pregnancy: does it cause hearing loss or nephrotoxicity in the infant?" Am J Obstet Gynecol 161 (1989): 977-81
- "Product Information. Vancocin (Vancomycin Abipharm)." Lilly, Eli and Company, Indianapolis, IN.
References
- PubMed Health. "Vancocin HCl: 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). "Vancomycin: 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
