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 tablet for systemic use. It treats uncomplicated urinary tract infections caused by susceptible bacteria, typically in adult women. The single‑dose regimen provides convenient therapy for acute infections.

GNH India supplies Monuril as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies, clinics and procurement teams worldwide. The company adheres to stringent quality standards and provides regulatory documentation to support import and distribution across multiple regions.

Manufacturer / TM Owner

Zambon S.P.A.

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Indications & Clinical Uses

  • Monuril, a phosphonic acid antibiotic, is indicated for infections of the urinary tract.
  • Uncomplicated urinary tract infection (cystitis): achieves bacterial eradication and rapid symptom relief.
  • Acute uncomplicated cystitis: provides a single‑dose treatment that clears infection in most patients.
  • Suspected infection by fosfomycin‑susceptible uropathogens: offers broad‑spectrum coverage for first‑line therapy.

How It Works

  • Fosfomycin Trometamol exerts its antibacterial effect by inhibiting the early stage of peptidoglycan synthesis. It blocks the enzyme MurA (UDP‑N‑acetylglucosamine enolpyruvyl transferase), preventing formation of N‑acetylmuramic acid, an essential precursor of the bacterial cell wall. This action is bactericidal and effective against a range of Gram‑positive and Gram‑negative uropathogens, including strains resistant to other classes.

Side Effects

Fosfomycin Trometamol may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Nausea
  • Diarrhea
  • Headache

Serious or Rare Side Effects

  • Anaphylactic reaction: severe allergy requiring immediate medical attention.
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis: rare severe skin reactions.
  • Clostridioides difficile‑associated colitis: may occur after antibiotic therapy.

Precautions & Warnings

Before prescribing Monuril, clinicians should consider several safety aspects.

  • Renal function assessment: evaluate kidney function before initiating therapy.
  • Pregnancy safety: avoid use unless benefits outweigh potential risks, as data are limited.
  • Breastfeeding: consider potential exposure to infant; use only if clearly needed.
  • Known hypersensitivity: do not administer to patients with documented fosfomycin allergy.
  • Concomitant medications: review for possible interactions that may affect efficacy.
  • Store at ambient temperature: keep below 25 °C in original packaging, protect from moisture.

Avoid Interactions

Fosfomycin Trometamol can interact with other medicines, requiring attention to the level of risk.

Major Interactions (Avoid)

  • Antacids containing magnesium or aluminum: significantly reduce fosfomycin absorption.
  • Metoclopramide: may decrease oral bioavailability of fosfomycin.
  • Probenecid: can increase serum fosfomycin concentrations, raising toxicity risk.

Moderate Interactions (Monitor Closely)

  • Warfarin: monitor INR as fosfomycin may potentiate anticoagulant effect.
  • Oral contraceptives: possible reduction in efficacy; advise additional contraceptive measures.
  • Diuretics: monitor electrolyte balance and renal function during combined use.

Frequently Asked Questions

Monuril contains fosfomycin trometamol and is used to treat uncomplicated urinary tract infections, particularly acute cystitis caused by susceptible bacteria. It provides a convenient single‑dose oral therapy that targets the infection at its source.

Fosfomycin trometamol inhibits the bacterial enzyme MurA, blocking the first step of peptidoglycan synthesis. By preventing formation of N‑acetylmuramic acid, it disrupts cell‑wall construction, leading to bacterial death and eradication of the infecting uropathogens.

The exact dose of Monuril is determined by the prescribing clinician based on the patient’s condition, age, renal function and local guidelines. In most cases a single oral dose is prescribed, but the specific amount must be confirmed by the healthcare professional.

Safety data for fosfomycin trometamol in pregnancy and lactation are limited. It is generally avoided during pregnancy unless the potential benefit justifies the risk, and breastfeeding mothers should discuss possible infant exposure with their physician before use.

To order 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 required import documentation.

Compared with nitrofurantoin or trimethoprim‑sulfamethoxazole, fosfomycin offers a single‑dose regimen and retains activity against many resistant strains. However, its spectrum is narrower, and local resistance patterns should guide selection. Clinicians often choose the agent with the best susceptibility profile for the patient’s pathogen.

Monuril tablets should be stored at ambient temperature, preferably below 25 °C. Keep them in the original blister pack, protect from moisture and direct sunlight, and ensure the container is tightly closed to maintain product stability.

Monuril is taken orally as a single tablet with a full glass of water. It is usually administered on an empty stomach, at least 30 minutes before or after meals, to maximise absorption. No additional dosing is required unless directed by a physician.

The most serious adverse reactions include severe allergic responses such as anaphylaxis, rare skin disorders like Stevens‑Johnson syndrome, and Clostridioides difficile‑associated colitis. Patients should seek immediate medical attention if they experience rash, difficulty breathing, persistent diarrhea or any signs of a severe reaction.

Monuril should be avoided in individuals with a known hypersensitivity to fosfomycin or any component of the formulation. It is also contraindicated in patients with severe renal impairment where dosing cannot be adjusted safely, and in those where the infection is not caused by a susceptible organism.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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