Fosfostal Special Precautions

The use of Fosfomycin is not recommended in patients with renal impairment (creatinine clearance <10 mL/min).
Since there is insufficient data for children under 12 years of age, Fosfomycin should not be given to them. Hypersensitivity reactions, including anaphylaxis and anaphylactic shock, may occur during Fosfomycin treatment and may be life-threatening.
If such reactions occur, Fosfomycin should never be readministered to these patients. An adequate medical treatment is required.
Antibiotic-associated diarrhea has been reported with the use of nearly all antibacterial agents, including Fosfomycin trometamol and may range in severity from mild diarrhea to fatal colitis. Diarrhea, particularly if severe and persistent, during or after treatment, may be symptomatic of Clostridium difficile-associated diarrhea (CDAD). It is therefore important to consider the diagnosis of CDAD in patients who develop serious diarrhea during or after treatment with Fosfomycin. If CDAD is suspected or confirmed, appropriate treatment should be initiated without delay. Anti peristaltic medicinal products are contraindicated in this situation.
In case of persistent infections, a thorough examination and a re-evaluation of the diagnosis is recommended as this is often due to complicated urinary tract infections or the prevalence of resistant pathogens (e.g., Staphylococcus saprophyticus). In general, urinary tract infections in male patients have to be considered as complicated urinary tract infections, for which this medicinal product is not indicated.
Fosfomycin contains sucrose. Its use is not recommended in patients with hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency.
Effects on Ability to Drive and Use Machines: No corresponding studies have been performed.
Since Fosfomycin can cause dizziness, this could affect the ability to drive vehicles or use machines.