Trigenna Special Precautions

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 because these 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.
Use in pregnancy: US FDA Pregnancy Category B: Reproduction studies have been performed in mice at doses up to 3200 mg/kg/day (14 times the recommended maximum human dose based in 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, Trigenna 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.