Europe — EMA
Monural (Fosfomycin Trometamol)
GNH USA supplies Monural (Fosfomycin Trometamol), a phosphonic acid antibiotic for acute uncomplicated urinary tract infections and prophylaxis of recurrent
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What is Fosfomycin Trometamol?
Fosfomycin trometamol, the active ingredient in Monural, is a phosphonic acid antibiotic presented as an oral dosage form for oral use. It treats acute uncomplicated urinary tract infections and is used to prevent recurrent infections in adults.
GNH USA supplies Monural as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Fosfomycin Trometamol used for?
Monural is a phosphonic acid antibiotic indicated for urinary tract infection management and prevention. - Acute uncomplicated urinary tract infection (uUTI): provides single‑dose eradication of susceptible uropathogens. - Prophylaxis of recurrent urinary tract infections: reduces the frequency of recurrence in patients with a history of UTIs. - Urinary tract infection caused by susceptible Gram‑negative bacteria: effective against common pathogens such as Escherichia coli.
What are the side effects of Fosfomycin Trometamol?
Fosfomycin trometamol may cause a range of adverse reactions, most of which are mild and transient.
Common Side Effects: - Nausea: mild to moderate stomach upset. - Diarrhea: loose stools occurring shortly after dosing. - Abdominal pain: cramping or discomfort in the lower abdomen. - Headache: transient mild headache. - Dyspepsia: indigestion or heartburn. - Vomiting: occasional emesis.
Serious or Rare Side Effects: - Allergic reactions: rash, pruritus, or anaphylaxis. - Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis. - Clostridioides difficile infection: colitis due to bacterial overgrowth. - Hepatic dysfunction: elevated liver enzymes or hepatitis. - Renal impairment: worsening kidney function in susceptible individuals. - Hematologic abnormalities: neutropenia or thrombocytopenia.
What precautions apply to Fosfomycin Trometamol?
Before prescribing Monural, clinicians should consider several safety aspects. - Assess renal function: dose adjustment may be required in renal impairment. - Evaluate hypersensitivity: avoid in patients with known fosfomycin allergy. - Use with caution in pregnancy: classified as Category B, benefits should outweigh risks. - Monitor liver enzymes: prolonged therapy may affect hepatic function. - Review concomitant medications: potential interactions may necessitate monitoring. - Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.
What does Fosfomycin Trometamol interact with?
Fosfomycin trometamol can interact with other medicines, influencing its absorption or effect.
Major Interactions (Avoid): - Metoclopramide: reduces fosfomycin absorption; avoid co‑administration. - Antacids containing aluminum or magnesium: may significantly decrease bioavailability. - Warfarin: may potentiate anticoagulant effect, increasing INR.
Moderate Interactions (Monitor Closely): - Diuretics: may increase risk of electrolyte disturbances. - Probenecid: can raise plasma concentrations of fosfomycin. - Oral contraceptives: potential reduction in contraceptive efficacy; advise additional contraceptive measures.



