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