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Tablet: Careful inquiry should be made prior to cefuroxime therapy to determine whether the patient has had previous hypersensitivity reactions to cefuroxime, other cephalosporins, penicillins, or other drugs. Use with caution in penicillin-sensitive patients since cross-sensitivity among beta-lactam antibiotics has been clearly documented and may occur in patients with a history of allergy to penicillin. In case of an allergic reaction to cefuroxime, the drug should be discontinued.
Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures including oxygen, intravenous fluids, corticosteroids, pressor amines, and airway management, as clinically indicated.
Clostridium difficile-associated diarrhea (CDAD) and colitis have been reported with the use of nearly all antibacterial agents, including cefuroxime, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Cefuroxime should not be used in patients with a history of cephalosporin-associated hemolytic anemia since the recurrence of hemolysis is much more severe.
If a patient develops anemia anytime during, or within 2 to 3 weeks subsequent to the administration of cefuroxime, the diagnosis of cephalosporin-associated anemia should be considered and the drug discontinued until the etiology is determined.
Periodic monitoring for signs and symptoms of hemolytic anemia, including measurement of hematological parameters of drug-induced antibody testing is recommended in patients treated with cefuroxime.
As with other broad-spectrum antibacterial agents, cefuroxime should be used with caution in patients with a history of gastrointestinal disease, particularly colitis.
Cephalosporins, including cefuroxime, have been associated with the development of seizures, particularly in patients with renal impairment, in whom dosage of the drug was not reduced. If seizures due to cefuroxime develop, the drug should be discontinued and treatment with an anticonvulsant be given as clinically indicated.
Cephalosporins may be associated with a fall in prothrombin activity. Patients who are at risk are those with renal or hepatic impairment or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous Vitamin K administered as indicated.
The patient's renal function should be carefully monitored when cefuroxime is given concurrently with aminoglycosides and/or diuretics because adverse renal effects may occur [see Interactions].
The Jarisch-Herxheimer reaction, a transient immunological reaction lasting 1 to 2 days, has been observed following cefuroxime treatment of Lyme disease. Patients should be reassured that this is a common and usually a self-limiting consequence of antibiotic treatment of Lyme disease.
Cefuroxime has been used safely in a few patients with porphyria although data are insufficient and experimental evidence of porphyrinogenicity are conflicting.
Prescribing cefuroxime in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of antibiotic resistance.
As with other antibacterial agents, long term or repeated use may result in overgrowth of non-susceptible organisms, including fungi.
Carcinogenesis, Mutagenesis, Impairment of Fertility: The carcinogenic potential of cefuroxime has not been evaluated in long-term animal studies.
No evidence of mutagenicity was observed with cefuroxime in various in vitro and in vivo test systems, including the mouse lymphoma assay, micronucleus test, and bacterial mutation tests. Cefuroxime produced positive results in the in vitro chromosome aberration assay.
There are no adequate and controlled studies using cefuroxime in pregnant women. Cefuroxime axetil has not been studied for use during labor and delivery. Since cefuroxime is distributed into milk, cefuroxime axetil should be used with caution in breastfeeding women.
Effects on Ability to Drive and Use Machines: Since cefuroxime may cause dizziness, patients should be advised to avoid performing tasks which require complete mental alertness such as driving and operating machinery.
Renal Impairment: The safety and efficacy of oral cefuroxime axetil in patients with renal impairment have not been established. Since cefuroxime is renally eliminated, its half-life will be prolonged in patients with reduced renal function.
Use in Children: The safety and efficacy of cefuroxime axetil in children younger than 3 months old have not been established.
Use in the Elderly: There are no apparent differences in efficacy and safety of cefuroxime between the elderly and younger adults. However, since elderly patients have increased risk of renal impairment, dose adjustment and renal function monitoring may be necessary.
Powder for Injection: A thorough inquiry about the patient's previous hypersensitivity history should be made. Cefuroxime, like other cephalosporins, penicillins and other drugs, may cause serious hypersensitivity reactions and should be used with caution in any patient who has demonstrated some allergy to any drug. Although it has not been established, allergic reactions to antibiotics may occur more frequently in atopic individuals.
Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures including oxygen, intravenous fluids and intravenous antihistamines, corticosteroids, pressor amines, and airway management as clinically indicated.
Clostridium difficile-associated diarrhea (CDAD) has been reported with the use of nearly an antibacterial agents, including cefuroxime, and may range in severity from mild diarrhea to fatal colitis. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality. Careful medical history is necessary because CDAD can occur over two months after administration of antibacterial agents. If CDAD is suspected or confirmed, discontinue ongoing antibiotic use not directed against C. difficile. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
General: As with other broad-spectrum antibiotics, cefuroxime should be given with caution in individuals with a history of colitis. The safety and efficacy of cefuroxime have not been established in patients with gastrointestinal malabsorption.
Cephalosporins may be associated with a fall in prothrombin activity. Patients who are at risk are those with kidney or liver impairment or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous Vitamin K administered as indicated.
Prescribing cefuroxime in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of antibiotic resistance.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies have not been performed to date to evaluate the carcinogenic potential of cefuroxime.
No evidence of mutagenicity was observed with cefuroxime in various in vitro and in vivo test systems, including the mouse lymphoma assay, micronucleus test, bacterial mutation tests. Cefuroxime produced positive results in the in vitro chromosome aberration assay.
Reproduction studies in mice and rabbits using cefuroxime sodium in dosages up to 14 and 9 times the usual human dosage, respectively, based on mg/m2 have not revealed evidence of impaired fertility.
Use in Children: Cefuroxime's serum half-life is inversely proportional to age when given in children and neonates.
