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Fosfomycin tromethamine

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Overview

What is Monurol?

MONUROL (fosfomycin tromethamine) Granules for Oral Solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single-dose sachet which contains white granules consisting of 5.631 grams of fosfomycin tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: mandarin flavor, orange flavor, saccharin, and sucrose. The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (1,2)-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white granular compound with a molecular weight of 259.2. Its empirical formula is CHOP•CHNO, and its chemical structure is as follows:



What does Monurol look like?



What are the available doses of Monurol?

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What should I talk to my health care provider before I take Monurol?

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How should I use Monurol?

MONUROL is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of . 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 and  sections.)

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 section.)


What interacts with Monurol?

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What are the warnings of Monurol?

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What are the precautions of Monurol?

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What are the side effects of Monurol?

Sorry No records found


What should I look out for while using Monurol?

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

Clostridium difficile

C. difficile

C. difficile

C. difficile

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against   may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.


What might happen if I take too much Monurol?

In acute toxicology studies, oral administration of high doses of MONUROL up to 5 g/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.


How should I store and handle Monurol?

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].MONUROL Granules for Oral Solution is available as a single-dose sachet containing the equivalent of 3 grams of fosfomycin.                         NDCSingle-dose sachet        0456-4300-08One unit carton       0456-4300-01 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.MONUROL Granules for Oral Solution is available as a single-dose sachet containing the equivalent of 3 grams of fosfomycin.                         NDCSingle-dose sachet        0456-4300-08One unit carton       0456-4300-01 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.MONUROL Granules for Oral Solution is available as a single-dose sachet containing the equivalent of 3 grams of fosfomycin.                         NDCSingle-dose sachet        0456-4300-08One unit carton       0456-4300-01 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.MONUROL Granules for Oral Solution is available as a single-dose sachet containing the equivalent of 3 grams of fosfomycin.                         NDCSingle-dose sachet        0456-4300-08One unit carton       0456-4300-01 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.MONUROL Granules for Oral Solution is available as a single-dose sachet containing the equivalent of 3 grams of fosfomycin.                         NDCSingle-dose sachet        0456-4300-08One unit carton       0456-4300-01 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.MONUROL Granules for Oral Solution is available as a single-dose sachet containing the equivalent of 3 grams of fosfomycin.                         NDCSingle-dose sachet        0456-4300-08One unit carton       0456-4300-01 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.MONUROL Granules for Oral Solution is available as a single-dose sachet containing the equivalent of 3 grams of fosfomycin.                         NDCSingle-dose sachet        0456-4300-08One unit carton       0456-4300-01 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.MONUROL Granules for Oral Solution is available as a single-dose sachet containing the equivalent of 3 grams of fosfomycin.                         NDCSingle-dose sachet        0456-4300-08One unit carton       0456-4300-01 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.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Absorption:

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. (See .)

Distribution:

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 mcg per gram of tissue at 3 hours after dosing. Fosfomycin has been shown to cross the placental barrier in animals and man.

Excretion:

A mean urine fosfomycin concentration of 706 (± 466) mcg/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 mcg/mL in samples collected 72-84 hours following a single oral dose of MONUROL.

Following a 3-gram dose of MONUROL administered with a high fat meal, a mean urine fosfomycin concentration of 537 (± 252) mcg/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 greater than 100 mcg/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 (t) is 5.7 (± 2.8) hours.

Special Populations:

Geriatric:

Gender:

Renal Insufficiency:

Microbiology

Fosfomycin (the active component of fosfomycin tromethamine) has activity 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 and in clinical infections as described in the section:

Aerobic gram-positive microorganisms

Enterococcus faecalis

Aerobic gram-negative microorganisms

Escherichia coli

The following data are available, 

Fosfomycin exhibits minimum inhibitory concentrations (MIC’s) of 64 mcg/mL or less against most (≥ 90%) strains of the following microorganisms; however, the safety and effectiveness of fosfomycin in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled clinical trials:

Aerobic gram-positive microorganisms

Enterococcus faecium

Aerobic gram-negative microorganisms

Citrobacter diversus

Citrobacter freundii

Enterobacter aerogenes

Klebsiella oxytoca

Klebsiella pneuomoniae

Proteus mirabilis

Proteus vulgaris

Serratia marcescens

SUSCEPTIBILITY TESTING

Dilution Techniques:

Quantitative methods are used to determine minimum inhibitory concentrations (MIC’s). These MIC’s provide estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure uses a standardized agar dilution method or equivalent with standardized inoculum concentrations and standardized concentrations of fosfomycin tromethamine (in terms of fosfomycin base content) powder supplemented with 25 mcg/mL of glucose-6-phosphate. The MIC values obtained should be interpreted according to the following criteria:

           

      ≤ 64       Susceptible (S)

      128       Intermediate (I)

      ≥ 256       Resistant (R)

A report of “susceptible” indicates that the pathogen is likely to be inhibited by usually achievable concentrations of the antimicrobial compound in the urine. A report of “intermediate” indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “resistant” indicates that usually achievable concentrations of the antimicrobial compound in the urine are unlikely to be inhibitory and that other therapy should be selected.

Standardized susceptibility test procedures require the use of laboratory control microorganisms. Standard fosfomycin tromethamine powder should provide the following MIC values for agar dilution testing in media containing 25 mcg/mL of glucose-6-phosphate.

Microorganism

MIC (

mc

g/mL)

Enterococcus faecalis

Escherichia coli

Pseudomonas aeruginosa

Staphylococcus aureus

Diffusion Techniques:

Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial agents. One such standardized procedure requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 200-mcg fosfomycin and 50-mcg of glucose-6-phosphate to test the susceptibility of microorganisms to fosfomycin.

Reports from the laboratory providing results of the standard single-disk susceptibility tests with disks containing 200-mcg of fosfomycin and 50-mcg of glucose-6-phosphate should be interpreted according to the following criteria:

           

            ≥ 16       Susceptible (S)

            13-15       Intermediate (I)

            ≤ 12       Resistant (R)

Interpretation should be stated as above for results using dilution techniques. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for fosfomycin.

As with standardized dilution techniques, diffusion methods require use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures. For the diffusion technique, the 200-mcg fosfomycin disk with the 50-mcg of glucose-6-phosphate should provide the following zone diameters in these laboratory quality control strains:

Microorganism

Zone Diameter (mm)

Escherichia coli

Staphylococcus aureus

Non-Clinical Toxicology
MONUROL is contraindicated in patients with known hypersensitivity to the drug.

Clostridium difficile

C. difficile

C. difficile

C. difficile

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against   may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.

Metoclopramide:

Cimetidine:

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.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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