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Monurol (Fosfomycin Tromethamine) - Summary

 



MONUROL SUMMARY

MONUROL®
[mon' ur ol]
(fosfomycin tromethamine)
SACHET

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.)


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NEWS HIGHLIGHTS

Media Articles Related to Monurol (Fosfomycin)

Urinary Tract Infection (UTI In Adults)
Source: MedicineNet Benign Prostatic Hyperplasia Specialty [2009.10.30]
Title: Urinary Tract Infection (UTI In Adults)
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 10/30/2009

Study Suggests Increased Risk of Birth Defects With UTI Treatments (CME/CE)
Source: MedPage Today OB/Gyn [2009.11.02]
Although most antibiotics are safe for pregnant women, two preferred classes of drugs for urinary tract infections were associated with significant, life-threatening birth defects, according to a CDC study.

Prophylactic Antibiotics May Prevent Recurring UTIs in Children (CME/CE)
Source: MedPage Today Pediatrics [2009.10.28]
Long-term prophylaxis with oral antibiotics produced a modest decrease in the number of recurrent urinary tract infections in children, a randomized trial showed.

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Published Studies Related to Monurol (Fosfomycin)

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.

Protective effects of fosfomycin on cisplatin-induced nephrotoxicity in patients with lung cancer. [2001.03]
CONCLUSION: High-dose cisplatin induced reversible elevation of urinary NAG and concurrent administration of low-dose fosfomycin for 5 days had no effect on the enzymuria. In the prevention of cisplatin nephrotoxicity, a further study using dose escalation (8 to 12 g/d) of fosfomycin administered 2 to 3 days prior to cisplatin are required to demonstrate its nephroprotective effects.

Distribution and antimicrobial activity of fosfomycin in the interstitial fluid of human soft tissues. [2000.10]
Fosfomycin is a broad-spectrum antibiotic which is established as therapy for uncomplicated lower urinary tract infections...

Comparison of single-dose fosfomycin and a 7-day course of nitrofurantoin in female patients with uncomplicated urinary tract infection. [1999.11]
This multicenter clinical trial compared single-dose fosfomycin tromethamine with a 7-day course of nitrofurantoin for the treatment of acute uncomplicated lower urinary tract infection (UTI) in female patients. Healthy females with symptoms of acute uncomplicated UTI were enrolled in a double-masked, randomized clinical trial.

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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.

Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis [Not yet recruiting]

Study Evaluating Fosfomycin/Tobramycin for Inhalation in Cystic Fibrosis Patients With Pseudomonas Aeruginosa Lung Infection [Recruiting]
The purpose of this study is to evaluate the safety and efficacy of 2 dose combinations of fosfomycin/tobramycin for inhalation (FTI), following a 28-day course of Aztreonam for Inhalation (AZLI) in patients with cystic fibrosis and Pseudomonas aeruginosa lung infection.

Epidemiology of Acute Bacterial Uncomplicated Cystitis in General Practice [Recruiting]
Acute uncomplicated bacterial cystitis is common in general practice. Cystitis is at the second raw of antibiotic treatment indications. It has been now recommended not to perform any urine culture for more than 20 years; hence, the bacterial epidemiology of acute uncomplicated cystitis is surprisingly relatively unknown. The available bacteriological data mainly describe the epidemiology of complicated urinary tract infections or upper urinary tract infections, but the causative bacteria and the resistance rates might differ from those of uncomplicated cystitis. As an example, it is unknown to what extent Staphylococcus saprophyticus is the causative agent of uncomplicated cystitis.

Moreover, the urine dipstick test have been evaluated in laboratories. But their interpretation in current practice might not be so easy: in particular, the nitrite detection depends on the bacterial concentration. The nitrite detection, produced in enterobacteriaceae related infections might have therapeutical consequences: trométamol-fosfomycine is almost constantly active on enterobacteriaceae, but ineffective on staphylococci. Knowing the increasing prevalence of fluoroquinolone-resistant enterobacteriaceae, the use of fosfomycin in nitrite positive uncomplicated cystitis might preserve the susceptibility of fluoroquinolones during pyelonephritis.

This study will describe:

- the bacterial epidemiology of acute uncomplicated cystitis in general practice,

- the correlation in between urine dipstick and urine culture in general practice,

- the prediction of enterobacterial infection by the nitrite detection, AND

- the antibiotics prescribed by the practitioners for uncomplicated acute cystitis.

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Page last updated: 2009-11-02

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