Cefuroxime axetil
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
Dosage in Patients with Impaired Renal Function A dosage interval adjustment is required for patients whose creatinine clearance is less than 30 mL/min, as listed in Table 4 below, because cefuroxime is eliminated primarily by the kidney [see Clinical Pharmacology ]. [See table below.]
| Creatinine Clearance (mL/min) | Recommended Dosage |
| ≥30 | No dosage adjustment |
| 10 to <30 | Standard individual dose given every 24 hours |
| <10 (without hemodialysis) | Standard individual dose given every 48 hours |
| Hemodialysis | A single additional standard dose should be given at the end of each dialysis |
Preparation and administration
Important Administration Instructions Cefuroxime axetil tablets and cefuroxime axetil for oral suspension are not bioequivalent and are therefore not substitutable on a milligram-per-milligram basis [see Clinical Pharmacology ] . Administer cefuroxime axetil tablets as described in the appropriate dosage guidelines [see Dosage and Administration ].
Administer cefuroxime axetil tablets with or without food. Pediatric patients (aged 13 years and older) who cannot swallow the cefuroxime axetil tablets whole should receive cefuroxime axetil for oral suspension because the tablet has a strong, persistent bitter taste when crushed [see Dosage and Administration ].
Drug interactions
Check cefuroxime axetil against a medication listLabel text (4 paragraphs)
Drugs that reduce gastric acidity may lower the bioavailability of cefuroxime axetil. ( 7.1 ) Coadministration with probenecid increases systemic exposure to cefuroxime axetil and is therefore not recommended. ( 7.2 )
7.1 Drugs that Reduce Gastric Acidity Drugs that reduce gastric acidity may result in a lower bioavailability of cefuroxime axetil compared with administration in the fasting state. Administration of drugs that reduce gastric acidity may negate the food effect of increased absorption of cefuroxime axetil when administered in the postprandial state. Administer cefuroxime axetil at least 1 hour before or 2 hours after administration of short-acting antacids. Histamine-2 (H 2 ) antagonists and proton pump inhibitors should be avoided.
7.2 Probenecid Concomitant administration of probenecid with cefuroxime axetil tablets increases serum concentrations of cefuroxime [see Clinical Pharmacology (12.3) ]. Coadministration of probenecid with cefuroxime axetil is not recommended.
7.3 Drug/Laboratory Test Interactions A false-positive reaction for glucose in the urine may occur with copper reduction tests (e.g., Benedict's or Fehling's solution), but not with enzyme-based tests for glycosuria. As a false-negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase method be used to determine blood/plasma glucose levels in patients receiving cefuroxime axetil. The presence of cefuroxime does not interfere with the assay of serum and urine creatinine by the alkaline picrate method.
Supplement interactions
Dietary supplement interactions
1 noted- Antibiotics can destroy vitamin K-producing bacteria in the gut, potentially decreasing vitamin K status. This effect might be more pronounced with cephalosporin antibiotics, such as cefoperazone (Cefobid), because these antibiotics might also inhibit the action of vitamin K in the body.
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 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for cefuroxime axetil. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
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 organogenesis (Gestation Days 7 through 16) at doses up to 3,200 mg/kg/day (14 times the MRHD based on body surface area); and in rats dosed during organogenesis and lactation (Gestation Days 7 through 16 and Gestation Days 17 through Lactation Day 21, respectively) at doses up to 1,000 mg/kg/day (9 times the MRHD based on body surface area) have revealed no adverse developmental outcomes.
Breastfeeding (LactMed)
Limited information indicates that cefuroxime produces low levels in milk that are not expected to cause severe adverse effects in breastfed infants. Cefuroxime does not appear to alter the flora of breastmilk when used alone, but it can alter the infant’s fecal flora. Occasionally, diarrhea or thrush have been reported with cephalosporins, but these effects have not been adequately evaluated. Cefuroxime is acceptable in nursing mothers.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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