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

Hypothetical Patient Case

For illustrative purposes only.

 
Reason for Visit
Patient presents to her PCP office complaining of burning pain when urinating and increased urinary frequency over the last 24-48 hours.
 
Patient History
  • 28-year-old female; accountant
  • She has had 1 prior UTI within the last year and reports that this episode is “the same as the other one”
    • Prior UTI was treated with trimethoprim-sulfamethoxazole
    • Patient asks whether there is another option with a shorter duration of therapy available
  • Sexually active with 1 partner, takes oral contraceptive pills
 
Patient Review of Systems/Exam
  • Reports acute onset of burning pain with urination, increased frequency and urgency x 1-2 days, prior to appointment
  • Reports lower abdominal discomfort
    • Denies back pain, vaginal discharge, fever, nausea, and vomiting
  • She is not pregnant, has no known voiding abnormalities, and no comorbid conditions
Physical Exam
  • Vital signs stable and WNL; afebrile
  • Patient is in mild discomfort, abdomen NT/ND; no tenderness in her costovertebral areas
  • Pelvic examination demonstrates no vaginal lesions or rashes, minimal white vaginal discharge and no cervicitis
  • Rest of exam is unremarkable
Laboratory
  • Dipstick urinalysis positive for leukocyte esterase, nitrate, and blood
  • Pregnancy test negative
 
Patient Assessment/Diagnosis
Patient is a 28-year-old female with symptoms consistent with an uncomplicated UTI (acute cystitis)
  • Suspected pathogen = E. coli
 
Treatment Plan
  • Begin empiric therapy for UTI
    • Patient expressed interest in a shorter regimen than prior treatments
  • PCP recommends MONUROL® granules for oral solution one 3-g sachet, orally, mixed with 1/2 cup of water, x 1 dose2
  • PCP also recommends increasing fluid intake and OTC pain reliever for discomfort
 
 
OTC=over the counter; NT/ND=nontender/nondistended; PCP=primary care physician; WNL=within normal limits.
 

 

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.