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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

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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.

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Disclosure

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit.

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    Gillian M. Keating

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The manuscript was reviewed by: R. Colgan, University of Maryland, Department of Family and Community Medicine, Baltimore, MD, USA; A. P. MacGowan, Department of Microbiology, Bristol Centre for Antimicrobial Research & Evaluation, Southmead Health Services NHS Trust, Bristol, UK; K. G. Naber, Technical University Munich, Munich, Germany; O. R. Sipahi, Department of Infectious Diseases and Clinical Microbiology, Ege University Faculty of Medicine, Bornova Izmir, Turkey.

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Keating, G.M. 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. Drugs 73, 1951–1966 (2013). https://doi.org/10.1007/s40265-013-0143-y

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