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

Manufacturer / TM Owner

Zambon Nv

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Indications & Clinical Uses

  • 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.

How It Works

  • Fosfomycin trometamol inhibits bacterial cell wall synthesis by irreversibly blocking the enzyme MurA (enolpyruvyl transferase). This prevents the formation of N‑acetylmuramic acid, a key precursor in peptidoglycan construction, leading to bacterial lysis. The drug reaches high concentrations in urine, allowing rapid bactericidal activity against a broad range of Gram‑negative and some Gram‑positive organisms.

Side Effects

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.

Precautions & Warnings

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.

Avoid Interactions

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.

Frequently Asked Questions

Monuril contains fosfomycin trometamol and is indicated for the treatment of acute uncomplicated urinary tract infection (cystitis). It is administered as a single oral dose that delivers high urinary concentrations to eradicate susceptible bacteria.

Fosfomycin trometamol blocks the bacterial enzyme MurA, which is essential for synthesising the peptidoglycan layer of the cell wall. By inhibiting this step, the drug prevents bacterial growth and leads to rapid cell lysis, especially in the urinary tract where drug concentrations are high.

The prescribed dose of Monuril is determined by the treating clinician based on the patient’s condition and local guidelines. Typically, a single 3 g sachet is reconstituted and taken orally, but exact dosing must follow the prescriber’s instructions.

The pregnancy category for fosfomycin trometamol is listed as unknown. It should only be used during pregnancy or lactation when the potential benefit justifies any possible risk, and after a careful assessment by the 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 regimen, which can improve adherence compared with multi‑day courses of trimethoprim‑sulfamethoxazole or nitrofurantoin. Its broad spectrum includes many resistant strains, but susceptibility testing is recommended to ensure effectiveness against the causative pathogen.

Monuril should be stored below 25 °C in its original packaging, protected from moisture and direct sunlight. Maintaining these conditions preserves the stability of the powder until it is reconstituted for oral administration.

The product is supplied as an oral powder that is dissolved in water to create a solution. After mixing, the patient drinks the solution in a single dose, usually on an empty stomach, unless otherwise directed by the prescriber.

Serious adverse events, though rare, include severe allergic reactions such as anaphylaxis, Stevens‑Johnson syndrome, Clostridioides difficile‑associated colitis, and significant hepatic or renal dysfunction. Patients should seek immediate medical attention if they experience rash, fever, jaundice, or persistent diarrhoea.

Monuril is contraindicated in individuals with a known hypersensitivity to fosfomycin or any of its excipients. Caution is also advised for patients with severe renal impairment, known hepatic disease, or those taking interacting medications listed under major interactions.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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