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Monurol (Fosfomycin Tromethamine) - Summary



[mon' ur ol]
(fosfomycin tromethamine)

MONUROL (fosfomycin tromethamine) sachet contains fosfomycin tromethamine, a synthetic, broad-spectrum, bactericidal antibiotic for oral administration. It is available as a single-dose sachet which contains white granules consisting of 5.

MONUROL is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. MONUROL is not indicated for the treatment of pyelonephritis or perinephric abscess.

If persistence or reappearance of bacteriuria occurs after treatment with MONUROL, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES section.)

See all Monurol indications & dosage >>


Media Articles Related to Monurol (Fosfomycin)

Urinary Tract Infections in Children
Source: MedicineNet Bedwetting Specialty [2017.08.03]
Title: Urinary Tract Infections in Children
Category: Diseases and Conditions
Created: 2/1/2010 12:00:00 AM
Last Editorial Review: 8/3/2017 12:00:00 AM

Urinary Tract Infection Quiz
Source: MedicineNet Hydronephrosis Specialty [2017.07.20]
Title: Urinary Tract Infection Quiz
Category: MedicineNet Quiz
Created: 6/10/2010 12:00:00 AM
Last Editorial Review: 7/20/2017 7:26:55 PM

Urinary Tract Infections (UTIs)
Source: MedicineNet Bedwetting Specialty [2017.06.12]
Title: Urinary Tract Infections (UTIs)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 6/12/2017 12:00:00 AM

Urinary Tract Infection (UTI) Symptoms, Diagnosis, Medication
Source: MedicineNet trimethoprim Specialty [2016.08.01]
Title: Urinary Tract Infection (UTI) Symptoms, Diagnosis, Medication
Category: Slideshows
Created: 12/4/2008 12:00:00 AM
Last Editorial Review: 8/1/2016 12:00:00 AM

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Published Studies Related to Monurol (Fosfomycin)

A randomized comparative study of single-dose fosfomycin and 5-day ciprofloxacin in female patients with uncomplicated lower urinary tract infections. [2010.12]
Uncomplicated lower urinary tract infections (UTIs) are the most frequent infections in females... It was concluded that the use of FMT as a first-line treatment in the empirical treatment of uncomplicated UTIs might have a positive impact on the problem of resistance to other antibiotics.

Fosfomycin versus other antibiotics for the treatment of cystitis: a meta-analysis of randomized controlled trials. [2010]
other antibiotics for the treatment of patients with cystitis... CONCLUSIONS: In the era of high drug resistance rates, reported even among

Fosfomycin in a single dose versus a 7-day course of amoxicillin-clavulanate for the treatment of asymptomatic bacteriuria during pregnancy. [2009.12]
The purpose of this paper was to compare the efficacy of a single dose of 3 g of fosfomycin to that of a 7-day regimen of amoxicillin-clavulanate in the treatment of asymptomatic bacteriuria during pregnancy. A randomised, prospective, interventional, analytical, longitudinal study was undertaken, in which the efficacy of two antibiotic regimens (one short and the other long) in the treatment of pregnant women with asymptomatic bacteriuria is compared...

Intravenous and intramuscular pharmacokinetics of a single-daily dose of disodium-fosfomycin in cattle, administered for 3 days. [2007.02]
Pharmacokinetic parameters of fosfomycin in cattle were determined after administration of buffered disodium fosfomycin either intravenously (i.v.) or intramuscularly (i.m.) at a dose of 20 mg/kg/day for 3 days. Calculated concentrations at time zero and maximum serum concentrations were 34.42 and 10.18 mug/mL, respectively.

Prevention of recurrent lower urinary tract infections by long-term administration of fosfomycin trometamol. Double blind, randomized, parallel group, placebo controlled study. [2005]
Three hundred and seventeen non pregnant females, suffering of recurrent lower urinary tract infections (UTIs; at least three episodes in the preceding 12 months) were enrolled in a double blind, randomized placebo (PL) controlled, parallel group clinical study, addressed to evaluate the efficacy and safety of fosfomycin trometamol (CAS 78964-85-9, FT, Monuril) in the prevention of infectious recurrences of lower urinary tract.

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Clinical Trials Related to Monurol (Fosfomycin)

Single Dose Monurol for Treatment of Acute Cystitis [Recruiting]
Urinary tract infecton (UTI) is a very common problem in young healthy women, afflicting approximately one-half of women by their late 20's. One of the most common antibiotics used to treat UTIs is Trimethoprim-sulfa (TMP-SMX), usually for total of three days. However, concerns about increased antibiotic resistance have led to increased interest in studying other antibiotics for UTI. An alternative antibiotic which is also FDA approved for the treatment of UTIs is fosfomycin (Monurol). The effectiveness of fosfomycin in curing UTIs when given as a single dose is not well studied. The purpose of this research study is to determine what the cure rates are with a single dose of fosfomycin versus the more standard 3-day course of TMP-SMX.

Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative and / or Gram-positive Bacterial Colonization [Active, not recruiting]
To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin Fosfomycin Inhalation System (AFIS) versus aerosolized placebo in mechanically ventilated patients with Gram-negative and / or Gram-positive bacterial colonization.

Safety, Tolerability and PK 3-Period Crossover Study Comparing 2 Single Doses of ZTI-01 and Monurol« in Healthy Subjects [Completed]
The objective is to determine the safety, tolerability and pharmacokinetics (PK) of 2 single doses of ZTI-01 (1g and 8g infused over 1-hr) and a single dose of the Reference Label Drug, Monurol« (oral sachet, 3g). Subjects will be randomized to a treatment sequence prior to dosing on Day 1 of Period 1 prior to study screening.

Study Comparing Nitrofurantoin to Fosfomycin for Acute Urinary Tract Infection in Women [Recruiting]
Developed before the establishment of a structured process for drug assessment, nitrofurantoin is now being prescribed frequently given the rise in multi-resistant gram-negative pathogens. Doubts remain regarding fosfomycin's long-term clinical effectiveness. A randomized, controlled trial is needed to explore the clinical effectiveness and better define the side effect profiles of both nitrofurantoin and fosfomycin. This multi-center open trial will randomize 600 non-pregnant women at three international sites (200 each in Poland, Switzerland, and Israel) at increased risk for carriage of resistant uropathogens and with suspicion of uncomplicated lower urinary tract infection to receive either oral nitrofurantoin 100 mg three times daily for 5 days or a single 3g dose of oral fosfomycin. Patients will be followed for clinical and bacteriologic response at days 14 and 28 post therapy completion. The study hypothesis holds that nitrofurantoin will be superior to fosfomycin in clinical efficacy at final follow-up.

Fosfomycin Versus Meropenem or Ceftriaxone in Bacteriemic Infections Caused by Multidrug Resistance in E.Coli [Recruiting]
Enterobacterieaceae (and specially Escherichia coli) showing resistance due to multidrug-resistant Escherichia coli, plasmid mediated AmpC or quinolone resistance caused by chromosomal mechanisms have spread worldwide during the last decades. This is important because many of these isolates are also resistant to other first-line agents such as fluoroquinolones or aminoglycosides, leaving few available options for therapy, and this condition is associated with increased morbidity- mortality and length of hospital stay. While carbapenems are considered the drugs of choice for multidrug-resistant Escherichia coli and AmpC producers, recent data suggests that certain alternatives may be suitable for some types of infections. At the present time, finding therapeutic alternatives to carbapenems and cephalosporins for the treatment of invasive infections due to multidrug-resistant Escherichia coli is critical. Fosfomycin was discovered more than 40 years ago but was not investigated according to present standards, and thus is not used in clinical practice except in desperate situations. It is one of the so-considered neglected antibiotics with high potential interest for the future. With the aim of demonstrate the clinical non-inferiority of intravenous fosfomycin compared to meropenem or ceftriaxone in the treatment of bacteraemic urinary tract infections caused by multidrug-resistant Escherichia coli . The investigators propose a "real practise" randomised, controlled, multicentre phase III clinical trial to compare the clinical and microbiological efficacy and safety of intravenous fosfomycin (4 grammes every 6 hours) with meropenem (1 gramme every 8 hours) or ceftriaxone (1 gramme every 24 hours) as targeted therapy of the previously specified infection; change to oral therapy according to predefined options is allowed in both arms after 5 days. Follow-up for the study is planned up to 60 days.

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Page last updated: 2017-08-03

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