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 infection in adult women and men who require a single‑dose regimen.
GNH India supplies Monuril as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Zambon - Produtos Farmacêuticos, Lda.

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Indications & Clinical Uses

Monuril is a phosphonic acid antibiotic used to treat infections of the lower urinary tract.

  • Uncomplicated urinary tract infection: provides a single oral dose that eradicates susceptible uropathogens.
  • Acute cystitis: relieves symptoms and clears bacterial growth in the bladder.
  • Recurrent UTI prophylaxis: may be used intermittently to reduce the frequency of future uncomplicated infections.

How It Works

  • Fosfomycin Trometamol inhibits bacterial cell wall synthesis by blocking the formation of N‑acetylmuramic acid, a key precursor in peptidoglycan assembly. This action prevents the construction of a functional cell wall, leading to bacterial lysis and eradication of susceptible Gram‑negative and Gram‑positive organisms that cause urinary tract infections.

Side Effects

Common side effects are generally mild and transient.

Common Side Effects

  • Nausea: mild stomach upset after the dose.
  • Diarrhea: loose stools occurring within 24‑48 hours.
  • Headache: mild to moderate headache.
  • Abdominal pain: cramping or discomfort in the abdomen.
  • Dyspepsia: indigestion or heartburn.
  • Flatulence: increased gas production.

Serious or Rare Side Effects

  • Allergic reaction: rash, itching, or swelling.
  • Severe skin rash: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Clostridioides difficile infection: severe colitis.
  • Liver enzyme elevation: abnormal hepatic function tests.
  • Anaphylaxis: life‑threatening hypersensitivity.
  • Renal impairment: worsening kidney function in susceptible patients.

Precautions & Warnings

Before prescribing Monuril, clinicians should consider patient‑specific factors.

  • Assess renal function: dose adjustment may be required in severe impairment.
  • Review allergy history: avoid in patients with known fosfomycin hypersensitivity.
  • Pregnancy considerations: use only if benefits outweigh potential risks.
  • Monitor gastrointestinal tolerance: advise patients to report persistent diarrhea.
  • Store at below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

Fosfomycin can interact with several medicines that affect absorption or renal handling.

Major Interactions (Avoid)

  • Antacids containing magnesium or aluminum: markedly reduce fosfomycin absorption.
  • Metformin: may increase risk of lactic acidosis in renal impairment.
  • Warfarin: potential alteration of INR, requiring close monitoring.

Moderate Interactions (Monitor Closely)

  • Oral contraceptives: possible reduction in contraceptive efficacy.
  • Other antibiotics (e.g., aminoglycosides): potential antagonistic effect.
  • Diuretics: may modify renal excretion of fosfomycin.

Frequently Asked Questions

Monuril contains fosfomycin trometamol and is indicated for the treatment of uncomplicated urinary tract infections caused by susceptible bacteria. It is administered as a single oral dose, providing convenient therapy for acute cystitis in adult patients.

Fosfomycin trometamol blocks the enzyme MurA, which is essential for the synthesis of N‑acetylmuramic acid, a building block of bacterial cell walls. By preventing cell‑wall formation, the drug leads to bacterial lysis and eradication of the infecting organisms.

The prescribed dose of Monuril is determined by the treating clinician based on the patient’s condition, renal function, and local guidelines. The medication is supplied as a single‑dose oral tablet, and the exact amount should be confirmed by the prescriber.

Safety data for fosfomycin trometamol in pregnancy and lactation are limited. It should only be used when the potential benefit justifies any possible risk to the fetus or infant, and the decision must be made by a qualified 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 oral regimen, which differs from multi‑day courses of trimethoprim‑sulfamethoxazole or nitrofurantoin. Its unique mechanism targeting cell‑wall synthesis can be effective against resistant strains, but susceptibility testing is recommended to ensure optimal therapy.

Monuril tablets should be stored at temperatures below 25 °C, in the original packaging, and protected from moisture and direct sunlight. Keeping the product in a dry, cool environment maintains its stability and potency.

Monuril is taken orally as a single tablet with a full glass of water, preferably on an empty stomach. Patients should avoid food, antacids, or dairy products for at least two hours before and after dosing to ensure optimal absorption.

Serious adverse events, though rare, include severe allergic reactions such as anaphylaxis, Stevens‑Johnson syndrome, and Clostridioides difficile‑associated colitis. Patients should seek immediate medical attention if they develop rash, fever, persistent diarrhea, or signs of an allergic response.

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, pregnant or breastfeeding women unless clearly indicated, and those taking medications that may cause major interactions.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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