Cefuroxime Axetil

Contraindications

4 CONTRAINDICATIONS Cefuroxime axetil tablets are contraindicated in patients with a known hypersensitivity (e.g., anaphylaxis) to cefuroxime axetil tablets or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins). Known hypersensitivity (e.g., anaphylaxis) to cefuroxime axetil tablets or to other β-lactams (e.g., penicillins and cephalosporins). ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Available data from published epidemiologic studies, case series, and case reports over several decades with cephalosporin use, including cefuroxime axetil, in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . In studies in pregnant mice and rats administered oral cefuroxime axetil during organogenesis at 14 and 9 times the maximum recommended human dose (MRHD) based on body surface area, respectively, there were no adverse developmental outcomes (see Data). The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Maternal gonorrhea may be associated with preterm birth, low neonatal birth weight, chorioamnionitis, intrauterine growth restriction, small for gestational age, and premature rupture of membranes. Perinatal transmission of gonorrhea to the offspring can result in infant blindness, joint infections, and bloodstream infections. Data Human Data: While available studies cannot definitively establish the absence of risk, published data from epidemiologic studies, case series, and case reports over several decades have not identified an association with cephalosporin use (including cefuroxime axetil) during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. Animal Data: Studies performed with oral cefuroxime axetil administered to pregnant mice during organogene