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Medically reviewed by Oliinyk Elizabeth Ivanovna, PharmD. Last updated on 31.03.2022
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MONUROL is available as a single-dose sachet containing the equivalent of 3 grams of fosfomycin.
NDC # 0456-4300-08
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
Keep this and all drugs out of the reach of children
Manufactured by: Zambon Switzerland Ltd. Division of Zambon Group, SpA Via Industria 13 6814 Cadempino, Switzerland. Distributed by: Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, Inc. St. Louis, MO 63045. Rev. 02/2011
MONUROL 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. (See PRECAUTIONS and Clinical Studies section)
The recommended dosage for women 18 years of age and older for uncomplicated urinary tract infection (acute cystitis) is one sachet of MONUROL.
MONUROL may be taken with or without food. MONUROL should not be taken in its dry form. Always mix MONUROL with water before ingesting. (See PREPARATION section.)
Preparation
MONUROL should be taken orally. Pour the entire contents of a single-dose sachet of MONUROL into 3 to 4 ounces of water (½ cup) and stir to dissolve. Do not use hot water. MONUROL should be taken immediately after dissolving in water.
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. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. 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. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
PRECAUTIONS
General
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. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long term carcinogenicity studies in rodents have not been conducted because MONUROL is intended for single dose treatment in humans. MONUROL was not mutagenic or genotoxic in the in vitro Ames' bacterial reversion test, in cultured human lymphocytes, in Chinese hamster V79 cells, and the in vivo mouse micronucleus assay. MONUROL did not affect fertility or reproductive performance in male and female rats.
Pregnancy
Teratogenic Effects - Pregnancy Category B
When administered intramuscularly as the sodium salt at a dose of 1 gm to pregnant women, fosfomycin crosses the placental barrier. MONUROL crosses the placental barrier of rats; it does not produce teratogenic effects in pregnant rats at dosages as high as 1000 mg/kg/day (approximately 9 and 1.4 times the human dose based on body weight and mg/m², respectively). When administered to pregnant female rabbits at dosages as high as 1000 mg/kg/day (approximately 9 and 2.7 times the human dose based on body weight and mg/m², respectively), fetotoxicities were observed. However, these toxicities were seen at maternally toxic doses and were considered to be due to the sensitivity of the rabbit to changes in the intestinal microflora resulting from the antibiotic administration. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers
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.
Pediatric Use
Safety and effectiveness in children age 12 years and under have not been established in adequate and well-controlled studies.
Geriatric Use
Clinical studies of Monurol did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
SIDE EFFECTS
Clinical Trials: In clinical studies, drug related adverse events which were reported in greater than 1% of the fosfomycin-treated study population are listed below:
Drug-Related Adverse Events (%) in Fosfomycin and Comparator
Populations
Adverse Events | Fosfo-mycin N=1233 |
Nitro-furantoin N=374 |
Trimeth-oprim/ sulfameth-oxazole N=428 |
Cipro-floxacin N=455 |
Diarrhea | 9.0 | 6.4 | 2.3 | 3.1 |
Vaginitis | 5.5 | 5.3 | 4.7 | 6.3 |
Nausea | 4.1 | 7.2 | 8.6 | 3.4 |
Headache | 3.9 | 5.9 | 5.4 | 3.4 |
Dizziness | 1.3 | 1.9 | 2.3 | 2.2 |
Asthenia | 1.1 | 0.3 | 0.5 | 0.0 |
Dyspepsia | 1.1 | 2.1 | 0.7 | 1.1 |
In clinical trials, the most frequently reported adverse events occurring in > 1% of the study population regardless of drug relationship were: diarrhea 10.4%, headache 10.3%, vaginitis 7.6%, nausea 5.2%, rhinitis 4.5%, back pain 3.0%, dysmenorrheal 2.6%, pharyngitis 2.5%, dizziness 2.3%, abdominal pain 2.2%, pain 2.2%, dyspepsia 1.8%, asthenia 1.7%, and rash 1.4%.
The following adverse events occurred in clinical trials at a rate of less than 1%, regardless of drug relationship: abnormal stools, anorexia, constipation, dry mouth, dysuria, ear disorder, fever, flatulence, flu syndrome, hematuria, infection, insomnia, lymphadenopathy, menstrual disorder, migraine, myalgia, nervousness, paresthesia, pruritus, SGPT increased, skin disorder, somnolence, and vomiting.
One patient developed unilateral optic neuritis, an event considered possibly related to MONUROL therapy.
Post-marketing Experience
Serious adverse events from the marketing experience with MONUROL outside of the United States have been rarely reported and include: angioedema, aplastic anemia, asthma (exacerbation), cholestatic jaundice, hepatic necrosis, and toxic megacolon.
Although causality has not been established, during post marketing surveillance, the following events have occurred in patients prescribed Monurol: anaphylaxis and hearing loss.
Laboratory Changes
Significant laboratory changes reported in U.S. clinical trials of MONUROL without regard to drug relationship include: increased eosinophil count, increased or decreased WBC count, increased bilirubin, increased SGPT, increased SGOT, increased alkaline phosphatase, decreased hematocrit, decreased hemoglobin, increased and decreased platelet count. The changes were generally transient and were not clinically significant.
DRUG INTERACTIONS
Metoclopramide
When coadministered with MONUROL, metoclopramide, a drug which increases gastrointestinal motility, lowers the serum concentration and urinary excretion of fosfomycin. Other drugs that increase gastrointestinal motility may produce similar effects.
Cimetidine
Cimetidine does not affect the pharmacokinetics of fosfomycin when coadministered with MONUROL.
Teratogenic Effects - Pregnancy Category B
When administered intramuscularly as the sodium salt at a dose of 1 gm to pregnant women, fosfomycin crosses the placental barrier. MONUROL crosses the placental barrier of rats; it does not produce teratogenic effects in pregnant rats at dosages as high as 1000 mg/kg/day (approximately 9 and 1.4 times the human dose based on body weight and mg/m², respectively). When administered to pregnant female rabbits at dosages as high as 1000 mg/kg/day (approximately 9 and 2.7 times the human dose based on body weight and mg/m², respectively), fetotoxicities were observed. However, these toxicities were seen at maternally toxic doses and were considered to be due to the sensitivity of the rabbit to changes in the intestinal microflora resulting from the antibiotic administration. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Clinical Trials: In clinical studies, drug related adverse events which were reported in greater than 1% of the fosfomycin-treated study population are listed below:
Drug-Related Adverse Events (%) in Fosfomycin and Comparator
Populations
Adverse Events | Fosfo-mycin N=1233 |
Nitro-furantoin N=374 |
Trimeth-oprim/ sulfameth-oxazole N=428 |
Cipro-floxacin N=455 |
Diarrhea | 9.0 | 6.4 | 2.3 | 3.1 |
Vaginitis | 5.5 | 5.3 | 4.7 | 6.3 |
Nausea | 4.1 | 7.2 | 8.6 | 3.4 |
Headache | 3.9 | 5.9 | 5.4 | 3.4 |
Dizziness | 1.3 | 1.9 | 2.3 | 2.2 |
Asthenia | 1.1 | 0.3 | 0.5 | 0.0 |
Dyspepsia | 1.1 | 2.1 | 0.7 | 1.1 |
In clinical trials, the most frequently reported adverse events occurring in > 1% of the study population regardless of drug relationship were: diarrhea 10.4%, headache 10.3%, vaginitis 7.6%, nausea 5.2%, rhinitis 4.5%, back pain 3.0%, dysmenorrheal 2.6%, pharyngitis 2.5%, dizziness 2.3%, abdominal pain 2.2%, pain 2.2%, dyspepsia 1.8%, asthenia 1.7%, and rash 1.4%.
The following adverse events occurred in clinical trials at a rate of less than 1%, regardless of drug relationship: abnormal stools, anorexia, constipation, dry mouth, dysuria, ear disorder, fever, flatulence, flu syndrome, hematuria, infection, insomnia, lymphadenopathy, menstrual disorder, migraine, myalgia, nervousness, paresthesia, pruritus, SGPT increased, skin disorder, somnolence, and vomiting.
One patient developed unilateral optic neuritis, an event considered possibly related to MONUROL therapy.
Post-marketing Experience
Serious adverse events from the marketing experience with MONUROL outside of the United States have been rarely reported and include: angioedema, aplastic anemia, asthma (exacerbation), cholestatic jaundice, hepatic necrosis, and toxic megacolon.
Although causality has not been established, during post marketing surveillance, the following events have occurred in patients prescribed Monurol: anaphylaxis and hearing loss.
Laboratory Changes
Significant laboratory changes reported in U.S. clinical trials of MONUROL without regard to drug relationship include: increased eosinophil count, increased or decreased WBC count, increased bilirubin, increased SGPT, increased SGOT, increased alkaline phosphatase, decreased hematocrit, decreased hemoglobin, increased and decreased platelet count. The changes were generally transient and were not clinically significant.
In acute toxicology studies, oral administration of high doses of MONUROL up to 5 gm/kg were well-tolerated in mice and rats, produced transient and minor incidences of watery stools in rabbits, and produced diarrhea with anorexia in dogs occurring 2-3 days after single dose administration. These doses represent 50-125 times the human therapeutic dose.
The following events have been observed in patients who have taken Monurol in overdose: vestibular loss, impaired hearing, metallic taste, and general decline in taste perception. In the event of overdosage, treatment should be symptomatic and supportive.