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Product Monograph PrCEFTIN® PrCEFTIN® - GlaxoSmithKline

Product Monograph PrCEFTIN® PrCEFTIN® - GlaxoSmithKline

Product Monograph PrCEFTIN® PrCEFTIN® - GlaxoSmithKline

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anemia, including fatalities, have been reported in both adults and children. If a patient<br />

develops anemia anytime during, or within 2-3 weeks subsequent to the administration<br />

of CEFTIN, the diagnosis of a cephalosphorin-associated amenia should be considered<br />

and the drug discontinued until the etiology is determined.<br />

Patients may benefit from periodic monitoring for signs and symptoms of hemolytic<br />

anemia, including measurement of hematological parameters or drug-induced antibody<br />

testing, where appropriate (see PRECAUTIONS and ADVERSE REACTIONS).<br />

General<br />

Precautions<br />

Broad-spectrum antibiotics including CEFTIN ® (cefuroxime axetil) should<br />

be administered with caution to individuals with a history of gastrointestinal disease,<br />

particularly colitis.<br />

The concomitant administration of aminoglycosides and some cephalosporins has<br />

caused nephrotoxicity. There is no evidence that CEFTIN ® , when administered alone, is<br />

nephrotoxic, although transient elevations of BUN and serum creatinine have been<br />

observed in clinical studies. However, the effect of administering CEFTIN ®<br />

concomitantly with aminoglycosides is not known.<br />

Studies suggest that the concomitant use of potent diuretics, such as furosemide and<br />

ethacrynic acid, may increase the risk of renal toxicity with cephalosporins.<br />

As with other antibiotics, use of CEFTIN ® may result in the overgrowth of Candida.<br />

Prolonged use may also result in the overgrowth of other non-susceptible organisms<br />

(e.g. enterococci and Clostridium difficile), which may require interruption of treatment.<br />

November 30, 2010<br />

Page 6 of 43

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