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

Monurol

Active Ingredient:
Fosfomycin Trometamol
Origin:
EU

Monurol (Fosfomycin Trometamol)

Fosfomycin Trometamol, the active ingredient in Monurol, is a phosphonic acid antibiotic presented as a 3 g granules for oral solution for oral use. It treats uncomplicated urinary tract infections caused by susceptible bacteria in adult patients.

GNH India supplies Monurol 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

  • Monurol is indicated for bacterial infections of the urinary tract, specifically targeting uncomplicated infections.
  • Uncomplicated urinary tract infections (UTIs): provides a single‑dose eradication of susceptible uropathogens, relieving symptoms and reducing bacterial load.
  • Acute uncomplicated cystitis: achieves microbiological cure in most female patients with a single oral dose.
  • Prophylaxis of recurrent urinary tract infections: may be used intermittently to prevent recurrence in patients with a history of repeated UTIs.

How It Works

  • Fosfomycin Trometamol inhibits bacterial cell wall synthesis by irreversibly blocking the enzyme MurA (enolpyruvyl transferase), which catalyzes the first step in peptidoglycan formation. This action prevents the construction of a functional cell wall, leading to bacterial lysis and death, particularly against Gram‑negative uropathogens.

Side Effects

Adverse reactions may occur with any antibiotic therapy. Most are mild and self‑limiting.

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Diarrhea: loose stools, usually transient.
  • Headache: mild cranial discomfort.
  • Abdominal pain: cramping or discomfort in the abdomen.
  • 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 associated with antibiotic use.
  • Hepatic dysfunction: elevated liver enzymes or jaundice.
  • Renal impairment: worsening kidney function in susceptible individuals.
  • Hematologic abnormalities: neutropenia or thrombocytopenia.

Precautions & Warnings

  • Before prescribing Monurol, consider patient‑specific factors and safety measures.
  • Renal function: assess severity of impairment and adjust use if necessary.
  • Pregnancy: safety category unknown; avoid unless benefits outweigh potential risks.
  • Breastfeeding: unknown excretion in milk; consider risk to infant.
  • Allergy to fosfomycin: contraindicated in patients with known hypersensitivity.
  • Drug interactions: review concomitant medications for potential effects on absorption or efficacy.
  • Store at below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

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

Major Interactions (Avoid)

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

Moderate Interactions (Monitor Closely)

  • Warfarin: potential potentiation of anticoagulant effect; monitor INR.
  • Oral contraceptives: possible reduction in hormonal efficacy; advise additional contraceptive measures.
  • Diabetes medications: monitor blood glucose as fosfomycin may affect glycemic control.

Frequently Asked Questions

Monurol contains fosfomycin trometamol and is used to treat uncomplicated urinary tract infections caused by susceptible bacteria. It is typically prescribed as a single oral dose for adult patients with acute cystitis.

Fosfomycin trometamol blocks the bacterial enzyme MurA, which is essential for the first step of peptidoglycan synthesis in the cell wall. By inhibiting this pathway, the drug prevents bacterial cell wall formation, leading to bacterial death.

The prescribed dose of Monurol is determined by the treating clinician based on the patient’s condition, age, renal function and local guidelines. It is commonly supplied as a single 3 g granule dose for oral solution.

The safety of fosfomycin trometamol in pregnancy and lactation has not been established. It should only be used if the potential benefit justifies any possible risk to the fetus or infant, and after consultation with a healthcare professional.

To place an order, 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.

Monurol offers a single‑dose oral regimen, which can improve adherence compared with multi‑day courses of trimethoprim‑sulfamethoxazole or nitrofurantoin. Its spectrum includes many resistant Gram‑negative organisms, though susceptibility testing remains essential.

Monurol granules should be stored at temperatures below 25 °C, in the original packaging, and protected from moisture. Do not expose the product to excessive heat or humidity to maintain its stability.

The granules are dissolved in a specified amount of water to create an oral solution, which is then taken as a single dose. Patients should follow the preparation instructions provided with the product and drink the solution promptly after mixing.

Serious risks include severe allergic reactions such as anaphylaxis, rare skin disorders like Stevens‑Johnson syndrome, Clostridioides difficile‑associated colitis, and potential hepatic or renal dysfunction. Patients should seek immediate medical attention if they experience signs of a serious reaction.

Monurol is contraindicated in individuals with a known hypersensitivity to fosfomycin or any component of the formulation. Caution is advised for patients with severe renal impairment, pregnant or breastfeeding women, and those taking interacting medications without proper monitoring.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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