MONUROL Granules for oral solution (2019)

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Allergan, Inc.

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1. Description

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 ...

2. Clinical Pharmacology

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. Indications and Usage

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 ...

4. Contraindications

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

5. 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. ...

6.1. 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 ...

6.2. Information for Patients

Patients should be informed: That MONUROL can be taken with or without food. That their symptoms should improve in two to three days after taking MONUROL; if not improved, the patient should contact her ...

6.4. 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 ...

6.6. 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' ...

6.7. Pregnancy

Teratogenic Effects. When administered intramuscularly as the sodium salt at a dose of 1 gram to pregnant women, fosfomycin crosses the placental barrier. MONUROL crosses the placental barrier of rats; ...

6.9. 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 ...

6.10. Pediatric Use

Safety and effectiveness in children age 12 years and under have not been established in adequate and well-controlled studies.

6.11. 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 ...

7. Adverse Reactions

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 ...

9. Overdosage

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 ...

10. Dosage and Administration

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 ...

11. How Supplied

MONUROL Granules for Oral Solution is available as a single-dose sachet containing the equivalent of 3 grams of fosfomycin. NDC: Single-dose sachet 0456-4300-08 One unit carton 0456-4300-01 Manufactured ...

12. Storage and Handling

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.

13. 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 ...

14. References

1. National Committee for Clinical Laboratory Standards, Methods for Dilution. Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically – Third Edition; Approved Standard NCCLS Document M7-A3, ...