fosfomycin trometamol: clinical use

Prescribing considerations

• Confirm that cystitis is acute and uncomplicated and that the patient is within the licensed population.
• Persistent infection requires review for a complicated UTI or resistant pathogen.
• Male UTIs are generally considered complicated and are not a licensed treatment indication for this product.
• Safety and efficacy have not been established in children younger than 12 years.
• Do not use in hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency; consider the sulphite hypersensitivity warning.

Contraindications and cautions

• Hypersensitivity to fosfomycin trometamol or any excipient.

Monitoring

• Check renal function when severe impairment is possible; use is not recommended when creatinine clearance is below 10 mL/min.
• Reassess persistent or recurrent symptoms and review microbiology where appropriate.
• Assess significant diarrhoea during or after treatment for antibiotic-associated colitis.
• Consider INR monitoring for patients taking oral anticoagulants according to clinical circumstances.

Clinical pharmacology

Fosfomycin inhibits the first intracellular stage of peptidoglycan synthesis. It is not appreciably metabolised and is excreted mainly unchanged by glomerular filtration; renal impairment prolongs elimination.

Formulation and product differences

• The selected product is granules for oral solution in sachets and requires reconstitution in water.
• It contains sucrose, saccharin, mandarin and orange flavourings and is essentially sodium-free.
• Sulphites may rarely cause severe hypersensitivity or bronchospasm.

Oral solution

Route: Oral

Strengths: 3 g