Stop for serious allergy and assess renal dosing.
Cephalosporin/beta-lactam allergy, kidney accumulation and severe delayed diarrhea require attention. Breathing difficulty, swelling, severe blistering rash or seizures need urgent care. Severe watery/bloody diarrhea can beC. difficile even months later; do not treat it as an ordinary nuisance.
Warnings and precautionsIndications
Site, susceptible organism, route and age determine use.
Oral tablet indications
Selected label: susceptible mild/moderate pharyngitis/tonsillitis, maxillary sinusitis, chronic-bronchitis bacterial exacerbation, uncomplicated skin/UTI, uncomplicated gonorrhea and early Lyme. Most adult/adolescent uses ≥13; pediatric otitis/sinusitis tablets require ability to swallow whole. Sinusitis evidence is limited to S. pneumoniae / non-beta-lactamase H. influenzae; not every organism or viral URI. Rheumatic-fever prevention unestablished.
Injection and guideline context
Selected IV/IM label includes designated susceptible respiratory/urinary/skin infections, sepsis, meningitis, gonococcal and bone/joint infections and surgical prophylaxis. This does not make it preferred empiric treatment for every serious infection. CDC explicitly does not recommend oral cefuroxime for gonorrhea; IDSA erythema migrans guidance uses 14 days cefuroxime rather than label 20 days. Use current specialist/procedure guidance; no universal preference inferred from label.
Dosage and administration
Oral, IV/IM and suspension schedules are distinct.
Current tablet label regimens
| Population / indication | Label regimen and clinical context |
|---|---|
| ≥13 years pharyngitis/sinusitis | 250 mg every 12 hours 10 days. |
| ≥13 years bronchitis exacerbation/skin | 250 or 500 mg every 12 hours 10 days; no universal first-line guideline claim. |
| ≥13 years uncomplicated UTI | 250 mg every 12 hours 7–10 days. |
| Early Lyme≥13 | Label 500 mg every 12 hours 20 days; current-served IDSA erythema migrans recommendation 14 days. Prescriber selects disease-specific course. |
| Gonorrhea≥13 | Label 1,000 mg single oral dose; CDC does not recommend oral cefuroxime. This label comparator is not current treatment advice. |
| Below 13, can swallow whole | Label 250 mg every 12 hours 10 days for otitis/sinusitis; do not crush or extrapolate to children unable to swallow. |
Tablet administration and renal intervals
Swallow whole with/without food; crushing gives persistent bitterness. Tablets and oral suspension are not bioequivalent/mg-for-mg substitutable. Adult CrCl ≥30 mL/min no adjustment; 10 to<30 standard individual dose every 24 hours; <10 without HD every 48 hours. Hemodialysis adds one standard dose after each session. This adult table is not an unverified pediatric renal algorithm.
Current injection dose contexts
| Population / condition | Selected label regimen |
|---|---|
| Adults, usual susceptible infection | 750 mg–1.5 g every 8 hours, usually 5–10 days; 750 mg for specified uncomplicated infections, 1.5 g for severe/bone-joint. Life-threatening/less-susceptible infection may require 1.5 g every 6 hours; meningitis≤3 g every 8 hours. Clinical/source control review essential. |
| Pediatric table above 3 months | Most infections 50–100 mg/kg/day divided every 6–8 hours; severe 100 mg/kg/day≤maximum adult. Bone/joint 150 mg/kg/day divided every 8 hours≤maximum adult; meningitis 200–240 mg/kg/day IV divided every 6–8 hours. Below 3 months unestablished; exact 3-month boundary needs product/prescriber review. |
| Adult renal dosing | CrCl >20: 750 mg–1.5 g every 8 hours; 10–20: 750 mg every 12 hours; <10: 750 mg every 24 hours. Further dose after HD. Pediatric renal insufficiency: modify frequency consistently with adult recommendations through clinical team, no extra formula. |
| Other label uses | Uncomplicated gonorrhea label 1.5 g IM once at 2 sites plus 1 g oral probenecid is legacy regimen context, not contemporary CDC recommendation. Surgical prophylaxis: 1.5 g IV 30–60 minutes preincision, 750 mg every 8 hours if prolonged; special cardiac label 1.5 g induction/every 12 hours total 6 g. Current procedure-specific prophylaxis review required; no blanket prolonged prophylaxis advice. |
Injection administration and legacy liquid
Selected direct IV over 3–5 minutes; separate from aminoglycoside solutions, no sodium-bicarbonate diluent. Qualified aseptic preparation using exact vial/diluent instructions, not oral-tablet substitution. Legacy Ranbaxy suspension label (clinical 2007, API 2013) describes 125/250 mg per 5 mL, food/shake-before-use and pediatric 3 months–12 years 20 mg/kg/day divided BID (max 500 mg/day) for pharyngitis; 30 mg/kg/day divided BID (max 1,000 mg/day) for otitis/sinusitis/impetigo, 10 days. Historical comparison only: no verified latest package/current stock, obtain current formulation review before prescribing/preparing; do not extrapolate tablet renal table.
Safety
Allergy, delayed colitis and renal accumulation can be severe.
Warnings and precautions
- Stop for serious allergy/anaphylaxis and institute urgent treatment. Review prior beta-lactam/other allergy before therapy; severe skin syndromes and allergic cardiac ischemia are reported.
- C. difficile diarrhea can occur during therapy or>2 months afterward. Severe watery/bloody stools, pain/fever need prompt evaluation, not unreviewed antidiarrheal treatment.
- Renal impairment requires correct interval/dose adjustment; excessive levels can cause seizures/encephalopathy. Injection renal-status monitoring particularly important with maximal doses/severe illness/nephrotoxic combinations.
- Prolonged use can promote resistant bacteria/fungal superinfection. Use susceptibility/disease information and reassess nonresponse.
- Injection: monitor prothrombin time if risk such as renal/hepatic impairment, malnutrition, prolonged therapy or anticoagulation; pediatric meningitis hearing loss/persistent CSF cultures reported. Do not infer preferred meningitis therapy.
Contraindications
Current selected tablet: known hypersensitivity to cefuroxime axetil or other beta-lactam antibacterials. Injection formal contraindication: known cephalosporin allergy; penicillin sensitivity requires caution/review per warnings. Preserve label distinctions rather than invent one formal list for every product.
Boxed warning · status
Selected current tablet/injection and legacy suspension labels have no boxed warning. Serious allergy, colitis and neurotoxicity/renal-adjustment risks remain significant.
Adverse reactions and overdose
Oral diarrhea, nausea/vomiting, liver-enzyme abnormalities and occasional blood/skin/allergic effects; Lyme treatment may cause Jarisch–Herxheimer reaction. Injection local phlebitis, GI symptoms, allergy, blood-count/liver/renal abnormalities reported. Severe blistering skin reaction, hemolysis/seizures are reported. Overdose can cause convulsions/encephalopathy; urgent professional assessment, with HD/peritoneal dialysis capable of lowering levels. No home dialysis or antidote protocol.
Drug interactions
Acid suppression can reduce oral absorption.
Oral interaction instructions
Tablets ≥1 hour before or ≥2 hours after short-acting antacids; avoid H2 antagonists/PPIs per selected label because reduced absorption may negate food benefit. Oral probenecid coadministration not recommended due to increased cefuroxime exposure; do not generalize legacy parenteral gonorrhea co-use into all regimens.
Injection and laboratory interactions
Potent diuretics/aminoglycosides increase renal-risk concern; monitor and administer aminoglycosides separately, not same solution. In-vitro chloramphenicol antagonism is laboratory evidence, not a quantified clinical dose rule. Copper-reduction urinary glucose tests can be falsely positive and ferricyanide blood glucose falsely negative; glucose oxidase/hexokinase methods recommended. Creatinine alkaline picrate assay not interfered with.
Use in specific populations
Renal tables differ by route.
Renal and hepatic considerations
Adult oral interval adjustment starts CrCl <30; parenteral table uses>20, 10–20, <10 ranges. Do not combine tables. Injection pediatric renal frequency adjusted consistently with adult recommendations by clinical team; oral pediatric PK renal extrapolation unsupported. No numerical hepatic adjustment supplied; monitor coagulation risk/organ status as clinically indicated.
Children and older adults
Current tablet below 13 otitis/sinusitis only if can swallow whole; oral axetil pediatric approval support 3 months–12 years does not establish every tablet indication or mg conversion. Injection below 3 months unestablished; dose table above 3 months. Legacy liquid dose/status separately bounded. Older adults may have reduced renal function; adjust actual function, no age-only routine reduction.
Pregnancy and lactation
Current oral observational cephalosporin pregnancy data have not identified associated major risks, but do not prove absence; injection human controlled data limited; use clearly needed. Cefuroxime enters human milk; current oral label balances breastfeeding benefit, maternal need / infant risk and notes limited infant-effect data; injection cautions. No absolute pregnancy guarantee or legacy automatic nursing interruptions transferred as universal current advice.
Clinical pharmacology
Bacterial cell-wall inhibition is the active cefuroxime action.
Mechanism and resistance
Bactericidal inhibition of cell-wall synthesis; some beta-lactamase stability does not mean ESBL/carbapenemase/MRSA coverage. Resistance can involve beta-lactamase hydrolysis, altered PBPs, permeability/efflux; local susceptibility varies. No universal organism coverage or old breakpoint copied.
Route-specific PK
Oral axetil rapidly hydrolyzed by esterases; tablet absorption increases with food, bioavailability 37% fasted to 52% fed, despite with / without food labeling. Adult postmeal half-life about 1.2–1.3 hours; cefuroxime excreted unchanged in urine. IV / IM half-life about 80 minutes, approximately 89% renal excretion within 8 hours. Renal impairment prolongs exposure; tablets/suspension not bioequivalent. No universal oral-to-IV switch calculation.
Monitoring and counseling
Assess organism response, allergy, renal function androute.
Monitoring priorities
Review allergy, site, culture, renal function and exact formulation, dose/course. Monitor response, superinfection and severe delayed diarrhea; injection renal status and risk-based prothrombin time. Assess CBC/liver/renal abnormalities if clinically indicated, not an invented universal lab schedule. Use current CDC for gonorrhea and IDSA erythema migrans guidance versus label comparators.
Counseling
Take exact prescribed course; do not share/use for viral illness. Swallow tablets whole, report inability to swallow and obtain verified alternative rather than crush. Review antacid/PPI/probenecid plan; no self-switch tablet to liquid/injection. Seek urgent care for allergy, severe rash, seizures or severe diarrhea even months later. Legacy liquid mixing/doses cannot identify current package.
Product identification
Prodrug and sodium salt are different products.
Representative oral tablets
- 250 mg
- Blue capsule-shaped biconvex film-coated, 204 debossed; 20-tablet bottle NDC 67877-215-20.
- 500 mg
- Similar blue tablet, 203 debossed; 20-tablet bottle NDC 67877-216-20.
- Strength basis
- Cefuroxime equivalent as axetil; Ascend/Alkem prescription tablet.
Dosage forms and strengths
- Injection
- Sagent 750 mg vial NDC 25021-118-10 or 1.5 g vial NDC 25021-119-20; cefuroxime equivalent as sodium, single-dose sterile powder. Sodium about 54.2 mg (2.4 mEq) per gram activity.
- Legacy oral suspension
- Ranbaxy 125/250 mg per 5 mL after reconstitution; historical 2007/2013 record, not latest availability verified. Not mg-for-mg tablet substitute. Selected label aspartame phenylalanine 4.5 mg per 5 mL.
- Scope
- Other brands, premixed frozen injection, intracameral/international/off-label uses and latest liquid status require separate exact source review. No current stock claim.
Storage and handling
Current tablets 20–25°C, close cap securely. Injection powder 20–25°C protected from light; qualified reconstitution: concentrated IV / IM 24 hours room temperature/48 hours refrigerated 5°C per label; diluted IV stability depends on exact diluent/concentration (up to 7 days refrigerated in listed conditions), not universal sterility/BUD authorization. Legacy liquid 2–8°C after mixing/discard 10 days, not applicable to unverified current package. No household mixing/freezing protocol.
References
Original sources for the clinical and product information.
- DailyMed / official U.S. product labelingCefuroxime axetil tablets · Ascend full label
Clinical PIJanuary 2025; SPL v 25 effective 20251003; API publication Nov 17, 2025. Clinical revision is distinct from publication. Checked October 1, 2026.
- DailyMed / official U.S. product labelingCefuroxime sodium injection · Sagent full label
Clinical PIJune 2021; APIApril 2026 publication distinct; SPL v 10 effective 20250327; API publication Apr 27, 2026. Clinical revision is distinct from publication. Checked October 1, 2026.
- DailyMed / official U.S. product labelingCefuroxime axetil suspension · legacy Ranbaxy label
Clinical footerSeptember 2007, SPL/APIAugust 2013; comparison only, latest package/availability unverified; SPL v 1 effective 20130819; API publication Aug 21, 2013. Clinical revision is distinct from publication. Checked October 1, 2026.
- Centers for Disease Control and PreventionCDC STI Treatment Guidelines · gonococcal infections
2021 guideline currently served; oral cefuroxime nonrecommendation full supporting section checked October 1, 2026.
- IDSA / AAN / ACRAAN/ACR/IDSA 2020 Lyme disease guideline
Current served 2020 primary guideline sectionsVI–VII and rationale checked October 1, 2026; erythema migrans duration distinct from product label.