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

Single-Dose MONUROL® Versus Multi-Day Regimens of 3 Comparator Antibiotics

  • 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
  • Enrolled patients had:
    • Symptoms and signs of acute cystitis <4 days in duration
    • No evidence of upper tract infection (eg, flank pain, chills, fever)
    • No history of recurrent UTIs, although 20% of patients had a prior episode of acute cystitis within the preceding year2
  • Clinical success (resolution of symptoms) and microbiologic eradication rates are shown below.

Safety and Tolerability

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%).2

 
Antimicrobial Activity of MONUROL® vs Comparators2

Treatment Arm

Treatment Duration (days)

Microbiologic Eradication Rate

Clinical Success Rate

Outcome (based on difference in microbiologic eradication rates 5-11 days post therapy)

5-11 days
post therapy

Study day
12-21

MONUROL® 3 g x 1 dose

1

630/771
(82%)

591/771 (77%)

542/771
(70%)

 

Ciprofloxacin 250 mg BID

7

219/222
(98%)

219/222 (98%)

213/222
(96%)

Fosfomycin inferior to ciprofloxacin

Trimethoprim/sulfamethoxazole
160 mg/800 mg BID

10

194/197
(98%)

194/197 (98%)

186/197
(94%)

Fosfomycin inferior to trimethoprim/
sulfamethoxazole

Nitrofurantoin 100 mg BID

7

180/238
(76%)

180/238 (76%)

183/238
(77%)

Fosfomycin equivalent to nitrofurantoin

 

Antimicrobial Activity of MONUROL® and Active Comparators (by pathogen)2

Pathogen

Fosfomycin
(3-gram
single dose)

 

Ciprofloxacin
(250 mg
BID x
7 days)

Trimethoprim/
sulfamethoxazole
(160 mg/800 mg BID x
10 days)

Nitrofurantoin
(100 mg
BID x
7 days)

E. coli

509/644
(79%)

184/187
(98%)

171/174
(98%)

146/187
(78%)

E. faecalis

10/10
(100%)

0/0

4/4
(100%)

1/2
(50%)

 

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.