Product image of Monuril (Fosfomycin) supplied by GNH India

Monuril

Active Ingredient:
Fosfomycin
Origin:
EU

Monuril (Fosfomycin)

Fosfomycin, the active ingredient in Monuril, is a fosfomycin‑type antibacterial presented as an oral powder for suspension for oral administration. It is indicated for the treatment of uncomplicated urinary tract infection (cystitis), primarily in adult female patients and can be used as a single‑dose therapy.

GNH India supplies Monuril as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing reliable sourcing with consistent quality, batch traceability and compliance with EU pharmacopeial standards.

Manufacturer / TM Owner

Zambon S.P.A.

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Indications & Clinical Uses

  • Monuril (fosfomycin) is used to treat infections of the urinary tract.
  • Uncomplicated urinary tract infection (cystitis): eradicates susceptible uropathogens and relieves symptoms.
  • Acute uncomplicated cystitis in women: provides a single‑dose oral therapy that achieves high cure rates.
  • Lower urinary tract infection caused by susceptible organisms: reduces bacterial load and prevents progression.

How It Works

  • Fosfomycin inhibits bacterial cell‑wall synthesis by irreversibly blocking the MurA (enolpyruvyl transferase) enzyme, preventing the formation of N‑acetylmuramic acid, a key precursor in peptidoglycan construction. This disruption leads to bactericidal activity against a broad spectrum of Gram‑positive and Gram‑negative organisms that are susceptible to the drug.

Side Effects

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Diarrhea: loose stools occurring shortly after dosing.
  • Abdominal pain: cramping or discomfort in the abdomen.
  • Headache: transient mild headache.
  • Dizziness: occasional light‑headed sensation.
  • Flatulence: increased gas production.

Serious or Rare Side Effects

  • Allergic reactions: rash, itching, or anaphylaxis.
  • Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Clostridioides difficile infection: severe colitis in rare cases.
  • Hepatic dysfunction: elevated liver enzymes or jaundice.
  • Renal impairment: worsening kidney function in susceptible patients.
  • Hematologic abnormalities: neutropenia or thrombocytopenia.

Precautions & Warnings

  • Before prescribing Monuril, consider the following precautions.
  • Renal function: adjust use in patients with severe renal impairment.
  • Pregnancy: safety not established; avoid unless clearly needed.
  • Breastfeeding: unknown; consider risk vs benefit.
  • Drug interactions: review concomitant medications for potential interactions.
  • Store at ambient temperature: keep in the original pack, protect from moisture and heat.

Avoid Interactions

Monuril may interact with other medicines; monitor patients accordingly.

Major Interactions (Avoid)

  • Probenecid: may reduce urinary excretion of fosfomycin.
  • Antacids containing magnesium or aluminum: may decrease absorption.

Moderate Interactions (Monitor Closely)

  • Warfarin: possible alteration of INR.
  • Oral contraceptives: may reduce efficacy.
  • Ceftriaxone: potential additive nephrotoxicity.

Frequently Asked Questions

Monuril contains fosfomycin and is used to treat uncomplicated urinary tract infections, specifically cystitis, in adult patients. It works as a single‑dose oral therapy that targets the bacteria causing the infection.

Fosfomycin blocks the MurA enzyme, which is essential for building the bacterial cell wall. By preventing the formation of peptidoglycan, the drug weakens the wall and leads to bacterial death, effectively clearing the infection.

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

Safety data for fosfomycin in pregnancy and lactation are limited. It should only be used if the potential benefit justifies the potential risk to the fetus or infant, and the decision should be made by a healthcare professional.

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 required import documentation.

Compared with other oral agents such as trimethoprim‑sulfamethoxazole or nitrofurantoin, fosfomycin offers a single‑dose regimen and a distinct mechanism of action, which can be useful for resistant strains. Choice of therapy depends on local resistance patterns and patient-specific factors.

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

The oral powder is reconstituted with a specified amount of water to create a suspension, which is then taken as a single dose. Patients should follow the preparation instructions provided with the product and drink the full dose.

Serious risks include severe allergic reactions such as anaphylaxis, rare skin conditions like Stevens‑Johnson syndrome, Clostridioides difficile‑associated colitis, and potential liver or kidney injury in susceptible individuals. Any signs of these reactions require immediate medical attention.

Monuril is contraindicated in patients with known hypersensitivity to fosfomycin or any of the formulation excipients. Caution is also advised for individuals with severe renal impairment, pregnant or breastfeeding women unless clearly indicated by a physician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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