Fosfomycin Tromethamine (2 brand names, 1 dosage form, 1 route)
Available dosage forms: FOR SOLUTION.
Routes of administration: ORAL.
Brand Names
- FOSFOMYCIN TROMETHAMINE
- MONUROL
Indications and Usage
Fosfomycin tromethamine granules for oral solution 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. Fosfomycin tromethamine granules for oral solution is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with fosfomycin tromethamine granules for oral solution, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.)
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 fosfomycin tromethamine granules for oral solution. Fosfomycin tromethamine granules for oral solution may be taken with or without food. Fosfomycin tromethamine granules for oral solution should not be taken in its dry form. Always mix Fosfomycin tromethamine granules for oral solution with water before ingesting. (See PREPARATION section.)
Contraindications
Fosfomycin tromethamine granules for oral solution is contraindicated in patients with known hypersensitivity to the drug.
Drug Interactions
Metoclopramide:When coadministered with fosfomycin tromethamine, 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 fosfomycin tromethamine.
Overdosage
In acute toxicology studies, oral administration of high doses of fosfomycin tromethamine 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 fosfomycin tromethamine 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.