Product image of Monuril (Fosfomycin Trometamol) supplied by GNH India

Monuril

Active Ingredient:
Fosfomycin Trometamol
Origin:
EU

Monuril (Fosfomycin Trometamol)

Fosfomycin Trometamol, the active ingredient in Monuril, is a phosphonic acid antibiotic presented as an oral powder for solution for oral use. It treats uncomplicated urinary tract infection, primarily in adult women, by delivering a single‑dose antibacterial effect.

GNH India supplies Monuril as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Zambon S.P.A.

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Indications & Clinical Uses

Monuril is a phosphonic acid antibiotic used to manage infections of the urinary tract caused by susceptible bacteria.

  • Uncomplicated cystitis (female): single dose eradicates the causative bacteria and relieves symptoms.
  • Uncomplicated cystitis (male): provides bacterial clearance with a convenient one‑time regimen.
  • Uncomplicated urinary tract infection (adults): resolves symptoms and helps prevent early recurrence.

How It Works

  • Fosfomycin Trometamol inhibits bacterial cell‑wall synthesis by irreversibly inactivating the MurA enzyme, which catalyzes the first step of peptidoglycan formation. This blockade prevents the construction of a functional cell wall, leading to bacterial lysis and eradication of susceptible urinary pathogens.

Side Effects

Adverse reactions may occur with any medication. Common side effects are usually mild and transient.

Common Side Effects

  • Nausea
  • Diarrhoea
  • Headache
  • Abdominal pain
  • Flatulence
  • Dyspepsia

Serious or Rare Side Effects

  • Allergic reactions (rash, pruritus, angio‑edema)
  • Anaphylaxis
  • Severe skin reactions such as Stevens‑Johnson syndrome
  • Clostridioides difficile‑associated colitis
  • Hepatic dysfunction (elevated transaminases)
  • Hematologic abnormalities (eosinophilia, neutropenia)

Precautions & Warnings

Before prescribing Monuril, clinicians should consider patient‑specific factors and safety measures.

  • Assess renal function: adjust use in severe renal impairment.
  • Avoid use in patients with known hypersensitivity to fosfomycin or its excipients.
  • Use with caution in pregnancy: safety not established; weigh benefits against potential risks.
  • Monitor for gastrointestinal disturbances, especially in patients with a history of diarrhoea.
  • Review concomitant medications for possible interactions.
  • Store at ambient temperature: keep in the original pack, protect from moisture.

Avoid Interactions

Fosfomycin may interact with other medicines, requiring attention to avoid reduced efficacy or increased toxicity.

Major Interactions (Avoid)

  • Co‑administration with antacids containing magnesium or aluminum: markedly reduces fosfomycin absorption.
  • Concurrent use with metoclopramide: may decrease fosfomycin bioavailability.

Moderate Interactions (Monitor Closely)

  • Combination with oral contraceptives: may reduce contraceptive effectiveness; advise additional barrier methods.
  • Use with warfarin: monitor INR closely for potential anticoagulant effect alteration.
  • Concomitant use with other antibiotics: assess for additive gastrointestinal side effects.

Frequently Asked Questions

Monuril contains fosfomycin trometamol and is indicated for the treatment of uncomplicated urinary tract infections caused by susceptible bacteria, typically administered as a single oral dose to provide rapid bacterial eradication and symptom relief.

Fosfomycin trometamol blocks the MurA enzyme, which is essential for the first step of bacterial cell‑wall peptidoglycan synthesis. By inactivating this enzyme, the drug prevents the formation of a functional cell wall, leading to bacterial lysis and death.

The prescribed dose of Monuril is determined by the treating clinician based on the patient’s condition, renal function, and local prescribing guidelines. The medication is supplied as a single‑dose oral powder that is reconstituted for ingestion.

The safety of fosfomycin trometamol in pregnancy and lactation has not been fully established. It should be used only if the potential benefit justifies the potential risk to the fetus or infant, and the decision should be made by a qualified healthcare professional.

To request Monuril, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Monuril offers a single‑dose oral regimen, which can improve adherence compared with multi‑day courses of other antibiotics such as trimethoprim‑sulfamethoxazole or nitrofurantoin. Its unique mechanism targeting MurA provides activity against many resistant strains, though susceptibility testing remains essential.

Monuril should be stored at ambient temperature, below 25 °C, in its original packaging to protect it from moisture. Keep the product away from direct sunlight and excessive heat to maintain stability.

Monuril is supplied as a dry oral powder that is reconstituted with a specified amount of water to form a solution. The patient drinks the solution after it has been mixed, typically on an empty stomach to optimise absorption.

Serious risks, although rare, include severe allergic reactions such as anaphylaxis, Stevens‑Johnson syndrome, Clostridioides difficile‑associated colitis, and significant liver enzyme elevations. Patients should seek immediate medical attention if they experience rash, swelling, difficulty breathing, or persistent gastrointestinal symptoms.

Monuril should not be used by individuals with a known hypersensitivity to fosfomycin or any of its excipients. Caution is advised in patients with severe renal impairment, and it is generally avoided in pregnant women unless the benefits outweigh the risks.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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