INDICATIONS AND USAGE

MONUROL (fosfomycin tromethamine) 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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
MONUROL is contraindicated in patients with known hypersensitivity to the drug.

Important Safety Information continued below

Hero

A One-Day, Single-Dose Treatment for Uncomplicated

Urinary Tract Infection in Women

A One-Day, Single-Dose Treatment for Uncomplicated

Urinary Tract Infection in Women

MONUROL® — Product Overview

IDSA Guidelines 

  • 2010 Update of the IDSA guidelines recommends MONUROL® 3-gram single dose as a treatment option for acute uncomplicated cystitis in women.1

MONUROL®  Product Overview

  • Antimicrobial Spectrum of Activity: MONUROL® has in vitro activity against designated microorganisms associated with uncomplicated UTIs (acute cystitis).2
  • MONUROL® is bactericidal in urine at therapeutic doses.2
  • Both in vitro and in clinical infections, MONUROL® has shown to be active against most strains of Escherichia coli and Enterococcus faecalis.2
    • Both in vitro and in clinical infections, MONUROL® has been shown to be active against most strains of Escherichia coli and Enterococcus faecalis.2
    • Generally, there is no cross-resistance between MONUROL® and other classes of antibacterial agents, such as beta-lactams and aminoglycosides.2
  • Data from a recent in vitro US study of 400 clinically obtained UTI isolates of Enterobacteriaceae.3

Antimicrobial Susceptibility of Organisms Tested3
  Antimicrobial
Organism Fosfomycin Ciprofloxacin Trimethoprim/sulfamethoxazole
E. coli 100% 77% 65.5%
E. faecalis 94% 56% a
aNo Clinical and Laboratory Standards Institute breakpoints exist for trimethoprim/sulfamethoxazole for E. faecalis, so percent susceptibility cannot be calculated.

In vitro activity does not necessarily correlate with clinical results. MONUROL® was not shown to be superior to ciprofloxacin or to trimethoprim/sulfamethoxazole in clinical trials.

  • Clinical Efficacy: The efficacy of a single dose of MONUROL® for the treatment of acute cystitis was compared to multi-day regimens of oral ciprofloxacin, trimethoprim/sulfamethoxazole, and nitrofurantoin in controlled, double-blind US studies.2 Click here to view the clinical efficacy of MONUROL®
  • Dosage and Administration: The recommended dosage of MONUROL® for women ≥18 years for uncomplicated urinary tract infection (acute cystitis) is2:
    • Pour the entire contents of a single-dose sachet of MONUROL® into 3 to 4 ounces of water (1/2 cup) and stir to dissolve. Do not use hot water.2
    • MONUROL® granules for oral solution may be taken with or without food.2

MONUROL® granules for oral solution  One 3-Gram Sachet for Uncomplicated UTI in Women

                                                                                                                              For illustration purposes only.

IDSA=Infectious Diseases Society of America; UTI=Urinary tract infection. 

 

INDICATIONS AND USAGE
 
MONUROL (fosfomycin tromethamine) 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.
 
IMPORTANT SAFETY INFORMATION
 
CONTRAINDICATIONS
MONUROL is contraindicated in patients with known hypersensitivity to the drug.
 
WARNINGS
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including MONUROL, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
 
PRECAUTIONS
Do not use more than one single dose of MONUROL to treat a single episode of acute cystitis. Repeated daily doses of MONUROL did not improve the clinical success or microbiological eradication rates compared to single dose therapy, but did increase the incidence of adverse events. Patients should be informed that if their symptoms do not improve in 2 to 3 days, they should contact their healthcare provider.
 
When coadministered with MONUROL, metoclopramide lowers the serum concentration and urinary excretion of fosfomycin. Other drugs that increase gastrointestinal motility may produce similar effects.
 
There are no adequate and well-controlled studies of MONUROL in pregnant women. Therefore, MONUROL should be used in pregnancy only if clearly needed.
 
It is not known whether fosfomycin tromethamine is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from MONUROL, a decision should be made whether to discontinue nursing or to not administer the drug, taking into account the importance of the drug to the mother.
 
Safety and effectiveness in children age 12 years and under have not been established in adequate and well-controlled studies.
 
ADVERSE REACTIONS
In clinical trials, the most frequently reported adverse events occurring in >1% of the MONUROL-treated patients (n=1233) were: diarrhea (9.0%), vaginitis (5.5%), nausea (4.1%), headache (3.9%), dizziness (1.3%), asthenia (1.1%), and dyspepsia (1.1%).
 
Please click here to read full Prescribing Information for MONUROL.