Cefuroxime AXETIL 250 MG TABLET Pregnancy

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Pregnancy of Cefuroxime AXETIL 250 MG TABLET in details

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In one study of seven pregnant women, Cefuroxime AXETIL 250 MG TABLET 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 Cefuroxime AXETIL 250 MG TABLET 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 Cefuroxime AXETIL 250 MG TABLET 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 Cefuroxime AXETIL 250 MG TABLET. 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 Cefuroxime AXETIL 250 MG TABLET and congenital defects. In one study of 78 pregnant women between 15 to 35 weeks' gestation who were given Cefuroxime AXETIL 250 MG TABLET 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 Cefuroxime AXETIL 250 MG TABLET is significantly increased and the elimination half-life significantly decreased during pregnancy.

Cefuroxime AXETIL 250 MG TABLET 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. Cefuroxime AXETIL 250 MG TABLET should only be given during pregnancy when need has been clearly established.

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Cefuroxime AXETIL 250 MG TABLET breastfeeding

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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.

Cefuroxime AXETIL 250 MG TABLET 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

  1. "Product Information. Ceftin (Cefuroxime AXETIL 250 MG TABLET)." Glaxo Wellcome, Research Triangle Park, NC.
  2. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  3. Frederiksensen MC, Bowsher D "Pharmacokinetics of Cefuroxime AXETIL 250 MG TABLET." Am J Obstet Gynecol 145 (1983): 381-2
  4. Berkovitch M, Segal-Socher I, Greenberg R, et al. "First trimester exposure to Cefuroxime AXETIL 250 MG TABLET: a prospective cohort study." Br J Clin Pharmacol 50 (2000): 161-5
  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
  6. Philipson A, Stiernstedt G "Pharmacokinetics of Cefuroxime AXETIL 250 MG TABLET in pregnancy." Am J Obstet Gynecol 142 (1982): 823-8
  7. "Product Information. Zinacef (Cefuroxime AXETIL 250 MG TABLET)." Glaxo Wellcome, Research Triangle Park, NC.
  8. Holt DE, Fisk NM, Spencer JA, de Louvois J, Hurley R, Harvey D "Transplacental transfer of Cefuroxime AXETIL 250 MG TABLET in uncomplicated pregnancies and those complicated by hydrops or changes in amniotic fluid volume." Arch Dis Child 68 (1993): 54-7
  9. 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

  1. "Product Information. Ceftin (Cefuroxime AXETIL 250 MG TABLET)." Glaxo Wellcome, Research Triangle Park, NC.
  2. "Product Information. Zinacef (Cefuroxime AXETIL 250 MG TABLET)." Glaxo Wellcome, Research Triangle Park, NC.
  3. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  4. Benyamini L, Merlob P, Stahl B, et al. "The Safety of Amoxicillin/Clavulanic Acid and Cefuroxime AXETIL 250 MG TABLET During Lactation." Ther Drug Monit 27 (2005): 499-502


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References

  1. 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).
  2. 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).
  3. 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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