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MONUROL is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains ofEscherichia 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. (SeePRECAUTIONSandCLINICAL STUDIESsection)
Dosing Information
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.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Fosfomycin in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Fosfomycin in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Safety and effectiveness in children age 12 years and under have not been established in adequate and well-controlled studies..
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Fosfomycin in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Fosfomycin in pediatric patients.
Contraindications
MONUROL is contraindicated in patients with known hypersensitivity to the drug.
Warnings
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Fosfomycin in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Fosfomycin in the drug label.
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Fosfomycin in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Fosfomycin during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Fosfomycin with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Fosfomycin with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Fosfomycin with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Fosfomycin with respect to specific gender populations.
Race
There is no FDA guidance on the use of Fosfomycin with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Fosfomycin in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Fosfomycin in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Fosfomycin in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Fosfomycin in patients who are immunocompromised.
Administration and Monitoring
Administration
Oral
Intravenous
Monitoring
There is limited information regarding Monitoring of Fosfomycin in the drug label.
Description
IV Compatibility
There is limited information regarding IV Compatibility of Fosfomycin in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
Description
Management
Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Fosfomycin in the drug label.
Pharmacology
There is limited information regarding Fosfomycin Pharmacology in the drug label.
Mechanism of Action
Fosfomycin (the active component of fosfomycin tromethamine) hasin vitroactivity against a broad range of gram-positive and gram-negative aerobic microorganisms which are associated with uncomplicated urinary tract infections. Fosfomycin is bactericidal in urine at therapeutic doses. The bactericidal action of fosfomycin is due to its inactivation of the enzyme enolpyruvyl transferase, thereby irreversibly blocking the condensation of uridine diphosphate-N-acetylglucosamine with p-enolpyruvate, one of the first steps in bacterial cell wall synthesis. It also reduces adherence of bacteria to uroepithelial cells.
There is generally no cross-resistance between fosfomycin and other classes of antibacterial agents such as beta-lactams and aminoglycosides.
Fosfomycin has been shown to be active against most strains of the following microorganisms, both in vitroand in clinical infections
There is limited information regarding Pharmacodynamics of Fosfomycin in the drug label.
Pharmacokinetics
Absorption
Fosfomycin tromethamine is rapidly absorbed following oral administration and converted to the free acid, fosfomycin. Absolute oral bioavailability under fasting conditions is 37%. After a single 3-gm dose of MONUROL, the mean (± 1 SD) maximum serum concentration (Cmax) achieved was 26.1 (± 9.1) μg/mL within 2 hours. The oral bioavailability of fosfomycin is reduced to 30% under fed conditions. Following a single 3-gm oral dose of MONUROL with a high-fat meal, the mean Cmaxachieved was 17.6 (± 4.4) μg/mL within 4 hours.
Cimetidine does not affect the pharmacokinetics of fosfomycin when coadministered with MONUROL. Metoclopramide lowers the serum concentrations and urinary excretion of fosfomycin when coadministered with MONUROL. (SeePRECAUTIONS, DRUG INTERACTIONS)
Distribution
The mean apparent steady-state volume of distribution (Vss) is 136.1 (±44.1) L following oral administration of MONUROL. Fosfomycin is not bound to plasma proteins.
Fosfomycin is distributed to the kidneys, bladder wall, prostate, and seminal vesicles. Following a 50 mg/Kg dose of fosfomycin to patients undergoing urological surgery for bladder carcinoma, the mean concentration of fosfomycin in the bladder, taken at a distance from the neoplastic site, was 18.0 μg per gram of tissue at 3 hours after dosing. Fosfomycin has been shown to cross the placental barrier in animals and man.
Excretion
Fosfomycin is excreted unchanged in both urine and feces. Following oral administration of MONUROL, the mean total body clearance (CLTB) and mean renal clearance (CLR) of fosfomycin were 16.9 (± 3.5) L/hr and 6.3 (± 1.7) L/hr, respectively. Approximately 38% of a 3-gm dose of MONUROL is recovered from urine, and 18% is recovered from feces. Following intravenous administration, the mean CLTBand mean CLRof fosfomycin were 6.1 (± 1.0) L/hr and 5.5 (±1.2) L/hr, respectively.
A mean urine fosfomycin concentration of 706 (± 466) μg/mL was attained within 2-4 hours after a single oral 3-gm dose of MONUROL under fasting conditions. The mean urinary concentration of fosfomycin was 10 μg/mL in samples collected 72-84 hours following a single oral dose of MONUROL.
Following a 3-gm dose of MONUROL administered with a high fat meal, a mean urine fosfomycin concentration of 537 (± 252) μg/mL was attained within 6-8 hours. Although the rate of urinary excretion of fosfomycin was reduced under fed conditions, the cumulative amount of fosfomycin excreted in the urine was the same, 1118 (± 201) mg (fed) vs. 1140 mg (± 238) (fasting). Further, urinary concentrations equal to or greaterthan 100 μg/mL were maintained for the same duration, 26 hours, indicating that MONUROL can be taken without regard to food.
Following oral administration of MONUROL, the mean half-life for elimination (t1/2) is 5.7 (± 2.8) hours.
Nonclinical Toxicology
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 thein vitroAmes' bacterial reversion test, in cultured human lymphocytes, in Chinese hamster V79 cells, and thein vivomouse micronucleus assay. MONUROL did not affect fertility or reproductive performance in male and female rats.
Clinical Studies
In controlled, double-blind studies of acute cystitis performed in the United States, a single-dose of MONUROL was compared to three other oral antibiotics (See table below). The study population consisted of patients with symptoms and signs of acute cystitis of less than 4 days duration, no manifestations of upper tract infection (e.g., flank pain, chills, fever), no history of recurrent urinary tract infections (20% of patients in the clinical studies had a prior episode of acute cystitis within the preceding year), no known structural abnormalities, no clinical or laboratory evidence of hepatic dysfunction, and no known or suspected CNS disorders, such as epilepsy, or other factors which would predispose to seizures. In these studies, the following clinical success (resolution of symptoms) and microbiologic eradication rates were obtained.
T1
T2
How Supplied
MONUROL is available as a single-dose sachet containing the equivalent of 3 grams of fosfomycin.
NDC # 0456-4300-08
Storage
Store at 25 C (77 F); excursions permitted to 15-30 C (59-86 F).
Images
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That their symptoms should improve in two to three days after taking MONUROL; if not improved, the patient should contact her health care provider.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
Precautions with Alcohol
Alcohol-Fosfomycin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
