KEFUROX IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for KEFUROX IN PLASTIC CONTAINER (KEFUROX IN PLASTIC CONTAINER).
Cefuroxime is a second-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), specifically PBP-3 and PBP-1a/1b, leading to inhibition of transpeptidase activity and autolysin-mediated cell death.
| Metabolism | Cefuroxime is not metabolized to a significant extent; it is primarily eliminated unchanged by the kidneys via glomerular filtration and tubular secretion. |
| Excretion | Renal: 80-90% unchanged by glomerular filtration and tubular secretion. Biliary: <2% excreted in bile. Fecal: <1%. |
| Half-life | 1.2-1.6 hours in adults with normal renal function. Extended to 15-22 hours in end-stage renal disease. |
| Protein binding | 33-50%; primarily to serum albumin. |
| Volume of Distribution | 0.13-0.23 L/kg; indicates distribution primarily into extracellular fluid. |
| Bioavailability | IM: 100% (well absorbed); Oral (cefuroxime axetil): 30-50% when taken with food. |
| Onset of Action | IV: Immediate; IM: 15-30 minutes for therapeutic serum levels. |
| Duration of Action | 6-8 hours after IV/IM administration; prolonged in renal impairment. |
750 mg to 1.5 g IV every 8 hours; for severe infections, up to 3 g IV every 8 hours.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl 10-30 mL/min: 750 mg IV every 12 hours; CrCl <10 mL/min: 750 mg IV every 24 hours. |
| Liver impairment | No dose adjustment required for hepatic impairment as drug is primarily renally eliminated. |
| Pediatric use | Children >3 months: 50-100 mg/kg/day IV divided every 6-8 hours; maximum 3 g/day. |
| Geriatric use | Adjust dose based on renal function; no specific age-related dose changes beyond renal considerations. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for KEFUROX IN PLASTIC CONTAINER (KEFUROX IN PLASTIC CONTAINER).
| Breastfeeding | Cefuroxime is excreted into human breast milk in low concentrations (M/P ratio approximately 0.01-0.03). It is considered compatible with breastfeeding; however, potential for disruption of infant gut flora and allergic sensitization should be considered. Use with caution in nursing mothers. |
| Teratogenic Risk | Cefuroxime is a cephalosporin antibiotic classified as FDA Pregnancy Category B. Animal studies have not demonstrated teratogenic effects. There are no adequate and well-controlled studies in pregnant women. Cefuroxime crosses the placenta. First trimester: no known teratogenic risk. Second and third trimesters: considered safe when clinically indicated; no known fetal risk. |
■ FDA Black Box Warning
None
| Serious Effects |
["Absolute: Hypersensitivity to cefuroxime or any component of the formulation; prior history of immediate-type anaphylactic reaction to other beta-lactam antibiotics (e.g., penicillins, carbapenems)","Relative: Use with caution in patients with history of severe allergic reactions to penicillins or other cephalosporins; caution in patients with gastrointestinal disease (especially colitis)"]
| Precautions | ["Serious hypersensitivity reactions (anaphylaxis) reported, especially in patients with a history of penicillin or other beta-lactam allergy; cross-sensitivity may occur","Clostridioides difficile-associated diarrhea (CDAD) can occur and may range from mild diarrhea to fatal colitis; evaluate if diarrhea occurs during or after treatment","Dosage adjustment required in patients with renal impairment (creatinine clearance <30 mL/min); prolonged half-life may lead to accumulation and increased toxicity","Cefuroxime may cause a false-positive direct Coombs test; monitor hematologic parameters during prolonged therapy","Increased risk of seizures in patients with renal impairment when high doses are used; reduce dose accordingly","Superinfection with non-susceptible organisms, including fungi, may occur with prolonged use","Drug-induced immune hemolytic anemia (rare) has been reported"] |
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| Fetal Monitoring | No specific monitoring required beyond routine prenatal care. Monitor for maternal allergic reactions (e.g., rash, anaphylaxis). Assess for diarrhea in mother indicating C. difficile colitis. No need for fetal monitoring specifically related to cefuroxime. |
| Fertility Effects | No known adverse effects on human fertility. Animal studies have not shown impaired fertility. |