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 a 3 g oral granules for suspension for oral use. It treats acute uncomplicated urinary tract infection in adults caused by susceptible bacteria.
GNH India supplies Monuril 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

Monuril is a phosphonic acid antibiotic indicated for infections of the urinary tract caused by susceptible bacteria.

  • Acute uncomplicated urinary tract infection (uUTI) in women: single‑dose therapy that eradicates the causative pathogens and relieves dysuria, frequency and urgency.
  • Acute uncomplicated cystitis caused by Escherichia coli: provides bactericidal activity leading to rapid symptom resolution.
  • Acute uncomplicated urethritis due to susceptible Gram‑negative organisms: clears infection and reduces bacterial load.

How It Works

  • Fosfomycin trometamol inhibits bacterial cell‑wall synthesis by irreversibly inactivating the enzyme MurA (UDP‑N‑acetylglucosamine enolpyruvyl transferase). This blockade prevents the formation of N‑acetylmuramic acid, a key precursor of peptidoglycan, leading to weakened cell walls and bacterial death, particularly against many Gram‑negative uropathogens.

Side Effects

Common Side Effects

  • Nausea: mild to moderate stomach upset after ingestion.
  • Diarrhea: loose stools that are usually self‑limiting.
  • Abdominal pain or discomfort: cramping in the lower abdomen.
  • Headache: transient mild headache.
  • Taste alteration: temporary metallic or altered taste sensation.

Serious or Rare Side Effects

  • Allergic reactions: rash, pruritus, or anaphylaxis in hypersensitive individuals.
  • Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Clostridioides difficile infection: rare but possible colitis.
  • Hepatic dysfunction: elevated liver enzymes or jaundice.
  • Renal impairment: acute kidney injury in predisposed patients.

Precautions & Warnings

Before prescribing Monuril, consider patient‑specific factors and safety measures.

  • Renal function assessment: adjust use in severe renal impairment.
  • Pregnancy: category unknown; use only if potential benefit justifies the risk.
  • Breastfeeding: caution advised; monitor infant for adverse effects.
  • Concomitant antacids: avoid within two hours as they may reduce absorption.
  • Known hypersensitivity: contraindicated in patients with prior fosfomycin allergy.
  • Store at below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

Monuril may interact with other medicines; review patient medication lists.

Major Interactions (Avoid)

  • Antacids containing aluminum or magnesium: significantly decrease fosfomycin absorption.
  • Probenecid: may increase fosfomycin plasma concentrations, raising toxicity risk.
  • Live bacterial vaccines: concurrent use can diminish vaccine efficacy.

Moderate Interactions (Monitor Closely)

  • Warfarin: potential enhancement of anticoagulant effect; monitor INR.
  • Oral contraceptives: possible reduction in hormonal efficacy; advise backup contraception.
  • Diuretics: monitor electrolytes as fosfomycin can affect renal handling of sodium and potassium.

Frequently Asked Questions

Monuril is indicated for the treatment of acute uncomplicated urinary tract infection (uUTI) caused by bacteria that are susceptible to fosfomycin. It is commonly prescribed for adult women with cystitis and provides a single‑dose oral therapy to eradicate the infection.

Fosfomycin trometamol works by blocking the MurA enzyme, which is essential for the first step of bacterial cell‑wall synthesis. By inhibiting this pathway, the drug prevents the formation of peptidoglycan, weakening the bacterial wall and leading to cell death, especially against many Gram‑negative uropathogens.

The prescribed dose of Monuril is determined by the treating clinician based on the patient’s condition, renal function and local guidelines. In most regions a single 3 g dose of fosfomycin trometamol granules is used for uncomplicated urinary infections, but the exact regimen must be confirmed by a healthcare professional.

The pregnancy category for fosfomycin trometamol is not definitively established. It should only be used during pregnancy or lactation when the expected benefit outweighs any potential risk to the fetus or infant, and after careful evaluation by the prescribing physician.

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 (including any cold‑chain requirements) and assistance with import documentation.

Monuril offers a single‑dose oral regimen, which can improve adherence compared with multi‑day courses of trimethoprim‑sulfamethoxazole or fluoroquinolones. It retains activity against many resistant strains of E. coli, but its spectrum is narrower than broad‑spectrum agents, making susceptibility testing important before use.

Monuril granules should be stored at temperatures below 25 °C, in the original container, protected from moisture and direct sunlight. Keep the product out of reach of children and avoid exposure to high humidity, which could affect the stability of the granules.

Monuril is supplied as oral granules that are reconstituted with water to form a suspension. The patient should dissolve the entire sachet in the recommended volume of water, stir well, and ingest the suspension in a single dose, preferably on an empty stomach for optimal absorption.

Serious risks include severe allergic reactions such as anaphylaxis, rare skin disorders like Stevens‑Johnson syndrome, and Clostridioides difficile‑associated colitis. Patients should seek immediate medical attention if they develop rash, blistering, difficulty breathing, persistent diarrhea or signs of liver dysfunction.

Monuril should be avoided 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 the benefit justifies the risk, and those taking interacting antacids without appropriate timing adjustments.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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