Europe — EMA
Monuril (Fosfomycin Trometamol)
GNH USA supplies Monuril (Fosfomycin Trometamol), a fosfomycin antibacterial for acute uncomplicated urinary tract infection.
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What is Fosfomycin Trometamol?
Fosfomycin trometamol, the active ingredient in Monuril, is a fosfomycin presented as a 3 g oral powder for solution for oral use. It treats acute uncomplicated urinary tract infection (cystitis) in adult women. GNH USA supplies Monuril as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Fosfomycin Trometamol used for?
Fosfomycin trometamol is an antibacterial agent used primarily for urinary tract infections.
Acute uncomplicated urinary tract infection (cystitis): provides a single‑dose eradication of susceptible uropathogens. Recurrent urinary tract infection prophylaxis: reduces recurrence when administered intermittently. Infections caused by susceptible Enterobacteriaceae: effective against uncomplicated lower urinary tract infections when the pathogen is known to be sensitive.
What are the side effects of Fosfomycin Trometamol?
Common Side Effects: - Nausea: mild to moderate stomach upset. - Diarrhoea: watery stools, usually transient. - Abdominal pain or discomfort. - Headache: dull or throbbing. - Taste disturbance: metallic or altered taste perception. - Flatulence: increased gas production.
Serious or Rare Side Effects: - Allergic reactions: rash, urticaria, or anaphylaxis. - Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis. - Clostridioides difficile infection: colitis presenting with severe diarrhoea. - Hepatic dysfunction: elevated liver enzymes or jaundice. - Renal impairment: worsening kidney function in susceptible patients. - Severe hypersensitivity: eosinophilia or systemic inflammatory response.
What precautions apply to Fosfomycin Trometamol?
Before prescribing Monuril, consider the following precautions: - Renal function assessment: adjust use in patients with severe renal impairment. - Pregnancy safety: category unknown; avoid unless benefits outweigh risks. - Hepatic impairment: use with caution in patients with liver disease. - Known hypersensitivity: do not use in individuals with documented allergy to fosfomycin or its excipients. - Concomitant antacids: may reduce absorption; separate administration by at least 2 hours. - Store below 25°C: keep in the original pack, protect from moisture.
What does Fosfomycin Trometamol interact with?
Fosfomycin trometamol can interact with several medicines.
Major Interactions (Avoid): - Probenecid: reduces renal excretion, increasing systemic exposure. - Cimetidine: decreases intestinal absorption, lowering efficacy. - Antacids containing magnesium or aluminium: markedly reduce fosfomycin absorption.
Moderate Interactions (Monitor Closely): - Warfarin: possible alteration of INR; monitor coagulation parameters. - Oral contraceptives: may reduce hormonal effectiveness; advise additional contraception. - Diuretics: altered renal clearance may affect drug levels; observe renal function.



