Fosfomycin

1): − complicated urinary tract infections − infective endocarditis − bone and joint infections − hospital-acquired pneumonia, including ventilator-associated pneumonia − complicated skin and soft tissue infection − bacterial meningitis − complicated intra-abdominal infections − bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above Consideration should be given to official guidance on the appropriate use of antibacterial agents.

MONUROL® (fosfomycin tromethamine) is indicated for the treatment of acute uncomplicated lower urinary tract infections (acute cystitis) in women of 18 years of age and older caused by the following susceptible pathogens: Escherichia coli, Enterococcus faecalis.

MONUROL is not indicated for the treatment of pyelonephritis or perinephric abscess. To reduce the development of drug-resistant bacteria and maintain the effectiveness of MONUROL and other antibacterial drugs, MONUROL should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.

When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

1 Pediatrics Pediatrics (< 18 years old): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Evidence from clinical studies and experience suggests that use in the geriatric population is not associated with differences in safety or effectiveness.