Pregnancy of Wintrax in details
In one study of seven pregnant women, Wintrax 750 mg intravenously one to eight hours before delivery revealed passage of the drug across the placenta. The average maternal plasma, amniotic fluid, umbilical cord, and neonatal plasma Wintrax levels ranged from 0 to 24, 1.2 to 18.0, less than 2.0 to 11.0, and less than 2.0 to 3.6 mcg per mL, respectively. No adverse effects on the fetus or neonates were observed. The Michigan Medicaid surveillance study showed no association between Wintrax and congenital defects. This report is a summary of information from a study in which 143 of 229,000 pregnant women from 1985 to 1992 received Wintrax. There were three defects observed relative to six expected. Neither cleft palate nor cardiovascular defects were observed. These data do not support an association between Wintrax and congenital defects. In one study of 78 pregnant women between 15 to 35 weeks' gestation who were given Wintrax 750 mg intravenously 8 to 138 minutes prior to delivery, the average fetal plasma levels were 7.4 mcg per mL (normal fetuses), 6.2 mcg per mL (hydropic fetuses), and 4.9 mcg per mL (oligohydramniotic fetuses). These data show that transplacental passage is significantly reduced in the presence of oligohydramnios. Incidentally, the plasma clearance of Wintrax is significantly increased and the elimination half-life significantly decreased during pregnancy.
Wintrax has been assigned to pregnancy category B by the FDA. Animal studies failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. Wintrax should only be given during pregnancy when need has been clearly established.
See references
Wintrax breastfeeding
Although the human milk concentration of some cephalosporins is relatively low, some experts warn about the possibility of unknown direct effects on the nursing infant, modification of neonatal bowel flora, and difficulty in the interpretation of culture results in the evaluation of suspected neonatal infection.
Wintrax is excreted into human milk. Adverse effects in the nursing infant are unlikely. Other cephalosporins have been classified as compatible with breast-feeding by the American Academy of Pediatrics.
See references
References for pregnancy information
- "Product Information. Ceftin (Wintrax)." Glaxo Wellcome, Research Triangle Park, NC.
- Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
- Frederiksensen MC, Bowsher D "Pharmacokinetics of Wintrax." Am J Obstet Gynecol 145 (1983): 381-2
- Berkovitch M, Segal-Socher I, Greenberg R, et al. "First trimester exposure to Wintrax: a prospective cohort study." Br J Clin Pharmacol 50 (2000): 161-5
- Heikkila A, Erkkola R "Review of beta-lactam antibiotics in pregnancy - the need for adjustment of dosage schedules." Clin Pharmacokinet 27 (1994): 49-62
- Philipson A, Stiernstedt G "Pharmacokinetics of Wintrax in pregnancy." Am J Obstet Gynecol 142 (1982): 823-8
- "Product Information. Zinacef (Wintrax)." Glaxo Wellcome, Research Triangle Park, NC.
- Holt DE, Fisk NM, Spencer JA, de Louvois J, Hurley R, Harvey D "Transplacental transfer of Wintrax in uncomplicated pregnancies and those complicated by hydrops or changes in amniotic fluid volume." Arch Dis Child 68 (1993): 54-7
- Czeizel AE, Rockenbauer M, Sorensen HT, Olsen J "Use of cephalosporins during pregnancy and in the presence of congenital abnormalities: A population-based, case-control study." Am J Obstet Gynecol 184 (2001): 1289-96
References for breastfeeding information
- "Product Information. Ceftin (Wintrax)." Glaxo Wellcome, Research Triangle Park, NC.
- "Product Information. Zinacef (Wintrax)." Glaxo Wellcome, Research Triangle Park, NC.
- Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
- Benyamini L, Merlob P, Stahl B, et al. "The Safety of Amoxicillin/Clavulanic Acid and Wintrax During Lactation." Ther Drug Monit 27 (2005): 499-502
References
- PubMed Health. "Zinacef: 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). "Cefuroxime: 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
