SINGLE-DOSE TREATMENT OF ACUTE CYSTITIS WITH FOSFOMYCIN TROMETHAMINE

OBJECTIVE: TO review the clinical pharmacology of fosfomycin trometham ine, a new antimicrobial agent for the treatment of uncomplicated lowe r urinary tract infections (UTIs). DATA SOURCE: Publications in Englis h on fosfomycin, fosfomycin tromethamine, and fosfomycin trometamol (M EDLINE, 1970-1997), as well as unpublished studies submitted to the Fo od and Drug Administration (FDA), were reviewed. STUDY SELECTION: Comp arative, randomized, controlled studies were used to analyze the effic acy and safety of fosfomycin tromethamine. DATA SYNTHESIS: Fosfomycin tromethamine is an oral antimicrobial indicated for the treatment of u ncomplicated lower UTIs. This agent is active in the urine against com mon uropathogens that are associated with cystitis in women, including organisms resistant to other antibiotics. A single dose of fosfomycin tromethamine is well absorbed and produces therapeutic concentrations in the urine for 2-4 days, Comparative clinical trials suggest that a single dose of fosfomycin tromethamine 3.0 g is as clinically effecti ve as 7- to 10-day treatment regimens of standard agents used to treat UTIs, such as nitrofurantoin, norfloxacin, and trimethoprim/sulfameth oxazole. Fosfomycin tromethamine is well tolerated and appears safe to use during pregnancy. CONCLUSIONS: Fosfomycin tromethamine is the onl y antimicrobial to be approved by the FDA for single-dose therapy in w omen with acute cystitis. It is as effective and safe as multidose com parators and appears safe to use during pregnancy. The acquisition cos t of this new drug will need to be weighed against the improved compli ance and convenience associated with its use in the treatment of uncom plicated UTIs.