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 oral use. It treats uncomplicated urinary tract infections, primarily in adult women, by targeting common uropathogens such as Escherichia coli and Klebsiella pneumoniae.

GNH India supplies Monuril as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing reliable sourcing, regulatory support and timely delivery across multiple regions. The company adheres to stringent quality standards and offers customized logistics solutions to meet the needs of healthcare providers.

Manufacturer / TM Owner

Zambon Nederland B.V.

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Indications & Clinical Uses

Monuril (fosfomycin trometamol) is indicated for bacterial infections of the urinary tract, specifically uncomplicated lower urinary tract infections.

  • Uncomplicated urinary tract infection: provides a single‑dose oral therapy that eradicates common uropathogens.
  • Acute uncomplicated cystitis: resolves symptoms and clears bacterial growth in adult women.
  • Single‑dose treatment of E. coli urinary infection: achieves microbiological cure with one administration.

How It Works

  • Fosfomycin trometamol is a phosphonic acid derivative that penetrates bacterial cells through glycerophosphate transporters. Inside the cell it inactivates the enzyme MurA (UDP‑N‑acetylglucosamine enolpyruvyl transferase), blocking the first step of peptidoglycan synthesis. By preventing formation of N‑acetylmuramic acid, the drug halts bacterial cell‑wall construction, leading to bactericidal activity against a broad range of Gram‑negative and some Gram‑positive organisms.

Side Effects

Fosfomycin trometamol may cause adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Nausea: mild stomach upset often reported.
  • Diarrhea: loose stools occurring during treatment.
  • Headache: transient cranial discomfort.
  • Abdominal pain: cramping or discomfort in the abdomen.
  • Dyspepsia: indigestion or feeling of fullness.

Serious or Rare Side Effects

  • Allergic reaction: rash, itching, swelling that may indicate hypersensitivity.
  • Severe skin eruption: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Clostridioides difficile infection: colitis associated with antibiotic use.
  • Hepatic dysfunction: elevated liver enzymes or jaundice.
  • Anaphylaxis: life‑threatening systemic allergic response.
  • Renal impairment: acute kidney injury in susceptible patients.

Precautions & Warnings

Before prescribing Monuril, consider the following precautions to ensure safe use.

  • Renal function: assess creatinine clearance, dose may need adjustment in severe impairment.
  • Pregnancy: use only if clearly needed after risk‑benefit evaluation.
  • Breastfeeding: evaluate infant exposure; consider alternative therapy.
  • Known hypersensitivity: avoid in patients with previous fosfomycin allergy.
  • Concomitant nephrotoxic drugs: monitor renal parameters closely.
  • Store at below 25°C: keep in the original packaging, protect from moisture and heat.

Avoid Interactions

Fosfomycin trometamol can interact with other medicines; awareness of major and moderate interactions helps prevent adverse outcomes.

Major Interactions (Avoid)

  • Antacids containing aluminum or magnesium: may markedly reduce fosfomycin absorption.
  • Probenecid: can increase fosfomycin plasma concentrations, raising toxicity risk.
  • Warfarin: may potentiate anticoagulant effect, requiring INR monitoring.

Moderate Interactions (Monitor Closely)

  • Oral contraceptives: fosfomycin may reduce hormonal efficacy, advise backup contraception.
  • Diuretics: monitor electrolytes and renal function during combined use.
  • Ciprofloxacin or other fluoroquinolones: additive nephrotoxic potential, observe kidney function.

Frequently Asked Questions

Monuril contains fosfomycin trometamol and is used to treat uncomplicated urinary tract infections, especially acute cystitis in adult women. It provides a single oral dose that targets common uropathogens such as Escherichia coli.

Fosfomycin trometamol enters bacterial cells via glycerophosphate transporters and blocks the enzyme MurA, which is essential for the first step of peptidoglycan synthesis. This inhibition prevents cell‑wall formation, leading to bacterial death.

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

Safety of fosfomycin trometamol in pregnancy and lactation has not been fully established. It should be used only if the potential benefit justifies any possible risk to the fetus or infant, and the decision must be made by a qualified prescriber.

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 necessary import documentation.

Monuril offers a single‑dose oral regimen, which can improve adherence compared with multi‑day courses of trimethoprim‑sulfamethoxazole or fluoroquinolones. Its unique mechanism provides activity against some resistant strains, though susceptibility testing remains important to guide therapy.

Monuril should be stored at below 25 °C in its original packaging, protected from moisture and heat. Keep the product out of reach of children and avoid exposure to direct sunlight.

Monuril is taken orally as a single tablet, usually with a full glass of water. It may be taken with or without food, but patients should follow the specific instructions provided by their prescriber.

Serious adverse events include severe allergic reactions such as anaphylaxis, Stevens‑Johnson syndrome, Clostridioides difficile‑associated colitis, hepatic dysfunction and acute renal impairment. Patients should seek immediate medical attention if they experience rash, swelling, difficulty breathing, persistent diarrhea or jaundice.

Monuril is contraindicated in individuals with a known hypersensitivity to fosfomycin or any component of the formulation. Caution is also advised for patients 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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