Fosfomycin Trometamol: A Review of Its Use as a Single-Dose Oral Treatment for Patients with Acute Lower Urinary Tract Infections and Pregnant Women with Asymptomatic Bacteriuria

Abstract

Fosfomycin trometamol (fosfomycin tromethamine) [Monuril(®), Monurol(®), Monural(®)] is approved in numerous countries worldwide, mainly for the treatment of uncomplicated urinary tract infections (UTIs). Fosfomycin has good in vitro activity against common uropathogens, such as Escherichia coli (including extended-spectrum β-lactamase-producing E. coli), Proteus mirabilis, Klebsiella pneumoniae and Staphylococcus saprophyticus, and the susceptibility of uropathogens to fosfomycin has remained relatively stable over time. A single oral dose of fosfomycin trometamol 3 g (the approved dosage) achieves high concentrations in urine. Results of recent randomized trials indicate that single-dose fosfomycin trometamol had similar clinical and/or bacteriological efficacy to 3- to 7-day regimens of ciprofloxacin, norfloxacin, cotrimoxazole or nitrofurantoin in women with uncomplicated lower UTIs. In addition, single-dose fosfomycin trometamol had similar bacteriological efficacy to a 5-day course of cefuroxime axetil or a 7-day course of amoxicillin/clavulanic acid in pregnant women with asymptomatic bacteriuria, and similar clinical and/or bacteriological efficacy to a 5-day course of cefuroxime axetil or amoxicillin/clavulanic acid or a 3-day course of ceftibuten in pregnant women with a lower UTI. Single-dose fosfomycin trometamol was generally well tolerated, with gastrointestinal adverse events (e.g. diarrhoea, nausea) reported most commonly. In conclusion, single-dose fosfomycin trometamol is an important option for the first-line empirical treatment of uncomplicated lower UTIs.

Overview on fosfomycin and its current and future clinical significance

“…In addition, single-dose fosfomycin trometamol has similar bacteriological efficacy to a 5-day course of cefuroxime axetil or a 7-day course of amoxicillin/clavulanic acid in pregnant women with asymptomatic bacteriuria, and similar clinical and/or bacteriological efficacy to a 5-day course of cefuroxime axetil or amoxicillin/clavulanic acid in pregnant women with lower urinary tract infections [23]. It should be noted that fosfomycin trometamol is recommended for the treatment of urinary tract infections during pregnancy, and belongs to the Food and Drug Administration category B [5].…”

“…Results of the clinical trials indicate that single-dose fosfomycin trometamol has similar clinical and/or bacteriological effects comparable to 3-7-day regimens of ciprofloxacin, norfloxacin, cotrimoxazole or nitrofurantoin in women with uncomplicated lower urinary tract infections [23]. In addition, single-dose fosfomycin trometamol has similar bacteriological efficacy to a 5-day course of cefuroxime axetil or a 7-day course of amoxicillin/clavulanic acid in pregnant women with asymptomatic bacteriuria, and similar clinical and/or bacteriological efficacy to a 5-day course of cefuroxime axetil or amoxicillin/clavulanic acid in pregnant women with lower urinary tract infections [23].…”

“…Resistance to fosfomycin is not widespread due to its limited usage, and the emergence of resistance to fosfomycin has been found to only occur in 2.3-6.7% of all cases in which this agent has been used for the treatment of infections other than uncomplicated cystitis, such as respiratory tract infections or osteomyelitis [22]. It should be noted that several mechanisms of resistance to fosfomycin have been described, including decreased drug uptake, modification of the target site and inactivation of the antibiotic [23].…”

Tackling antimicrobial resistance in lower urinary tract infections: treatment options

“…fosA, but also fosB, fosC, and fosX) [78,[87][88][89]. Uncommonly, the fosfomycin binding site Cys115 may also be changed via mutations in the genes encoding the hexose phosphate transport (UhpT) and glycerol-3-phosphate transport (GlpT) pathways [78,87].…”

Successful treatment of lower urinary tract infections with oral fosfomycin: a report of three cases

“…Therapeutic options against infections caused by KPCproducing K. pneumoniae are often limited (5) . Thus, new therapeutic strategies against these isolates are urgently needed (7) (8) .…”