Answer 13: What is the safety profile of the 750mg schedule?

20 June, 2018

 

 

In general the 750 mg dose is well tolerated and has a safety profile similar to the 500 mg dose. The most common adverse events with the 750 mg dose were headache (8.6%), nausea (8.6%), and insomnia (7.0%). In patients given the 500 mg dose, the most common adverse events were insomnia (10.6%), diarrhea (6.0%), headache (5.7%), and nausea (5.7%) (6). The discontinuation rate was similar for both regimens. The study by Shorr confirmed the safety profile of the 750 mg dose in elderly patients (8).The safety profile of 750 mg levofloxacin also compares favorably with the β-lactams which are associated with rashes and hypersensitivity and macrolides which can cause drug interactions and mild liver abnormalities. Recently, another fluoroquinolone, gatifloxacin, was removed from the US market because of an increased rate of serious adverse events due to glucose metabolism abnormalities. Similarly, there have been recent, rare reports of severe liver toxicity associated with the ketolide, telithromycin, which is of some concern, particularly if patients have had hepatitis while receiving other antibiotics.