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

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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

Learn More About MONUROL

With a well-studied clinical efficacy and safety profile, MONUROL is the only single-dose oral antibiotic for uncomplicated urinary tract infection (UTI) in women. MONUROL has more than 18 years of market experience and is an established treatment option for acute cystitis in women due to susceptible strains of E. coli and E. faecalis.
Product Overview

Review MONUROL®, an IDSA recommended treatment option for acute uncomplicated cystitis in women.

 
Microbiology & MOA

Escherichia coli

Learn more about the antimicrobial spectrum and the mechanism of action of MONUROL.

 
Clinical Efficacy & Tolerability Profile

Single-dose MONUROL was studied against multi-day regimens of 3 comparator antibiotics. Review key clinical study data.

Ellen: A Hypothetical Patient Profile
Ellen, a 28-year-old patient, visits her PCP complaining of burning pain when urinating and increased urinary frequency over the last 24-48 hours. See her patient history, review of systems/exam, diagnosis, and treatment plan.
 

 

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.