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Cefuroxime Pregnancy and Breastfeeding Warnings

Cefuroxime is also known as: Ceftin, Kefurox, Zinacef

Cefuroxime Pregnancy Warnings

Animal studies have failed to reveal evidence of fetal harm or impaired fertility. This drug crosses the placental barrier into cord blood and amniotic fluid. There are no controlled data in human pregnancy. This drug reaches therapeutic levels in cord blood and amniotic fluid after IM or IV maternal dose. In a study of 7 pregnant women, 750 mg IV dose 1 to 8 hours before delivery revealed passage of the drug across the placenta. The average maternal plasma, amniotic fluid, umbilical cord, and neonatal plasma drug levels ranged from 0 to 24, 1.2 to 18, less than 2 to 11, and less than 2 to 3.6 mcg/mL, respectively. No adverse effects on the fetus or neonates were observed. The US Michigan Medicaid surveillance study showed no association between this drug 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 this drug. There were 3 defects observed relative to 6 expected. Neither cleft palate nor cardiovascular defects were observed. These data do not support an association between this drug and congenital defects. In a study of 78 pregnant women between 15 to 35 weeks gestation who were given a 750 mg IV dose 8 to 138 minutes prior to delivery, the average fetal plasma levels were 7.4 mcg/mL (normal fetuses), 6.2 mcg/mL (hydropic fetuses), and 4.9 mcg/mL (oligohydramniotic fetuses). These data show that transplacental passage is significantly reduced in the presence of oligohydramnios. Incidentally, the plasma clearance of this drug is significantly increased and the elimination half-life significantly decreased during 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

See references

Cefuroxime Breastfeeding Warnings

According to limited data, maternal doses up to 2.25 g/day via injection produce low levels in breast milk. After a single 750 mg IM injection in 8 women with endometritis, milk drug levels increased from 0.34 mg/L at 30 minutes after dosing to 1.45 mg/L at 8 hours after dosing. After 750 mg IM 3 times a day, peak milk levels averaged 1.2 mg/L at 6 hours after dosing. This drug was detectable at 30 minutes after dosing (0.36 mg/L); by 8 hours after dosing, milk level decreased to 1.06 mg/L. After a single 750 mg IV dose in 5 women, peak drug level in milk averaged 0.37 mg/L at 3 hours after dosing; at 2 to 4 hours after dosing, individual peak levels were 0.33 to 0.5 mg/L. After 750 mg IV 3 times a day for 2 days after cesarean section, 2 women provided milk samples an hour after dosing. Milk drug levels were 0.34 and 0.39 mg/L. A mother received 500 mg orally 3 times a day for acute mastitis of the left breast (after incision and drainage of the lesion); milk samples were collected from each breast 30 minutes after dosing on the first day of therapy. The drug concentration was 90 mcg/L in the unaffected breast and 590 mcg/L in the breast with mastitis. On the second day of therapy, milk samples collected 90 minutes after dosing contained 57 mcg/L in the right breast and 59 mcg/L in the left breast. On the third day, milk samples collected 90 minutes after dosing contained 27 mcg/L in the unaffected breast and 1.07 mg/L in the affected breast. In a prospective controlled study (through an information service), mothers using this drug were asked about side effects in their breastfed infants. A case of diarrhea was reported, which was 2.6% of cefuroxime-exposed infants.

Use is considered acceptable; caution is recommended. Benefit to mother should outweigh risk to the infant. -According to some manufacturers: A decision should be made to discontinue breastfeeding or discontinue the parenteral drug, taking into account the importance of the drug to the mother and the benefit of breastfeeding for the infant. Excreted into human milk: Yes (in small amounts) Comments: -Low levels in milk are not expected to cause harmful effects in the nursing infant. -Disruption of infant's gastrointestinal flora (resulting in diarrhea or thrush) reported occasionally with cephalosporins, but such effects have not been adequately evaluated; possibility of sensitization should be considered. -This drug is considered compatible with breastfeeding by some experts; other cephalosporins have been considered compatible with breastfeeding by the American Academy of Pediatrics.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Ceftin (cefuroxime)." Glaxo Wellcome, Research Triangle Park, NC.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  5. Frederiksensen MC, Bowsher D "Pharmacokinetics of cefuroxime." Am J Obstet Gynecol 145 (1983): 381-2
  6. Berkovitch M, Segal-Socher I, Greenberg R, et al. "First trimester exposure to cefuroxime: a prospective cohort study." Br J Clin Pharmacol 50 (2000): 161-5
  7. Melbourne: Therapeutic Guidelines Limited "eTG complete [Online] Available from: URL: http://online.tg.org.au/complete/desktop/tgc.htm." ([2014, Nov -]):
  8. Heikkila A, Erkkola R "Review of beta-lactam antibiotics in pregnancy - the need for adjustment of dosage schedules." Clin Pharmacokinet 27 (1994): 49-62
  9. Philipson A, Stiernstedt G "Pharmacokinetics of cefuroxime in pregnancy." Am J Obstet Gynecol 142 (1982): 823-8
  10. "Product Information. Zinacef (cefuroxime)." Glaxo Wellcome, Research Triangle Park, NC.
  11. Holt DE, Fisk NM, Spencer JA, de Louvois J, Hurley R, Harvey D "Transplacental transfer of cefuroxime in uncomplicated pregnancies and those complicated by hydrops or changes in amniotic fluid volume." Arch Dis Child 68 (1993): 54-7
  12. 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. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Ceftin (cefuroxime)." Glaxo Wellcome, Research Triangle Park, NC.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Zinacef (cefuroxime)." Glaxo Wellcome, Research Triangle Park, NC.
  5. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  6. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  7. Benyamini L, Merlob P, Stahl B, et al. "The Safety of Amoxicillin/Clavulanic Acid and Cefuroxime During Lactation." Ther Drug Monit 27 (2005): 499-502
  8. Melbourne: Therapeutic Guidelines Limited "eTG complete [Online] Available from: URL: http://online.tg.org.au/complete/desktop/tgc.htm." ([2014, Nov -]):

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