Tablet: As with other broad-spectrum antibiotics, cefuroxime axetil should be prescribed with caution in individuals with history of colitis. Prolonged administration of cefuroxime axetil may also result in overgrowth of nonsusceptible microorganisms. If superinfection occurs during therapy, appropriate measures should be taken.
Cephalosporins, including cefuroxime axetil, should be given with caution to patients receiving concurrent treatment with potent diuretics are suspected of adversely affecting renal function.
Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment of 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.
Injection: In case of pronounced renal insufficiency, the dosage of Cefumax has to be reduced according to the renal function test.
The concomitant administration with other nephrotoxic drug (kanamycin, streptomycin, colistin, viomycin, polymixin, neomycin, gentamycin, etc) increases the renal toxicity. Consequently, the renal function has to be observed cautiously.
The long-term administration of Cefumax may cause the development of nonsusceptible bacteria, therefore, appropriate therapeutic measures must be taken in such cases.
The administration of cephalosporins may interfere with the results of some laboratory tests, causing false-positive reaction of the glycosuria according to the methods of Benedict's, Fehling's and Clinitest, but not in accordance with enzyme-based tests. During treatment with cephalosporins, a false-positive result may occur in the direct Coombs' test.
Use in pregnancy: Pregnancy Category B: Reproduction studies have been performed on mice at doses up to 3200 mg/kg/day (14 times the recommended maximum human dose based on mg/m2) and in rats at doses up to 1000 mg/kg/day (9 times the recommended maximum human dose based on mg/m2) and have revealed no evidence of impaired fertility or harm to the fetus due to cefuroxime axetil. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Cefumax should be used during pregnancy only if clearly needed.
Use in lactation: Because cefuroxime is excreted in human milk, consideration should be given to discontinuing nursing temporarily during treatment with cefuroxime axetil.
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