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 bacterial cell wall synthesis. The drug is approved for use in the European Union and is available by prescription.

GNH India supplies Monuril as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, adhering to EU quality standards and providing reliable global distribution.

Manufacturer / TM Owner

Zambon Italia S.R.L.

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Indications & Clinical Uses

  • Monuril (fosfomycin trometamol) is used to treat infections of the urinary tract.
  • Uncomplicated urinary tract infection: provides a single oral dose that eliminates common uropathogenic bacteria and relieves symptoms.

How It Works

  • Fosfomycin trometamol is a phosphonic acid analogue that penetrates bacterial cells through glycerophosphate and glucose‑6‑phosphate transport systems. Inside the cell it covalently binds to the enzyme MurA, blocking the first step of peptidoglycan synthesis—the formation of N‑acetylmuramic acid—thereby preventing bacterial cell‑wall construction and leading to bacterial death.

Side Effects

Fosfomycin trometamol may cause a range of adverse reactions, most of which are mild and transient.

Common Side Effects

  • Nausea: mild stomach upset.
  • Diarrhea: loose stools.
  • Headache: transient head discomfort.

Serious or Rare Side Effects

  • Allergic reaction: rash, itching, swelling, or anaphylaxis.
  • Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Clostridioides difficile infection: persistent diarrhea due to bacterial overgrowth.

Precautions & Warnings

When prescribing Monuril, consider the following precautions.

  • Renal impairment: adjust use or avoid in severe kidney dysfunction.
  • Pregnancy: safety not established; use only if benefits outweigh risks.
  • Hepatic disease: monitor liver function as metabolism may be affected.
  • Known hypersensitivity: avoid if allergic to fosfomycin or related compounds.
  • Concomitant antacids or supplements: may reduce absorption; separate dosing by at least 2 hours.
  • Store below 25°C: keep in original packaging, protect from moisture and heat.

Avoid Interactions

Fosfomycin trometamol has a limited interaction profile.

Major Interactions (Avoid)

  • None identified: no major drug‑drug interactions have been reported for fosfomycin trometamol.

Moderate Interactions (Monitor Closely)

  • Antacids or supplements containing calcium, magnesium, aluminum, or iron: may decrease fosfomycin absorption; separate administration by at least 2 hours.
  • Warfarin: may increase INR; monitor coagulation parameters.
  • Probenecid: can raise fosfomycin plasma levels; adjust dosing if necessary.
  • Oral contraceptives: potential reduction in efficacy; advise additional contraceptive measures.

Frequently Asked Questions

Monuril contains fosfomycin trometamol and is prescribed for the treatment of uncomplicated urinary tract infections (UTIs), primarily in adult women. It works as a single‑dose oral antibiotic that targets common uropathogens such as Escherichia coli, providing symptom relief and bacterial eradication.

Fosfomycin trometamol penetrates bacterial cells via glycerophosphate and glucose‑6‑phosphate transporters. Inside the cell it irreversibly binds to the MurA enzyme, blocking the first step of peptidoglycan synthesis—the formation of N‑acetylmuramic acid—thereby preventing cell‑wall construction and leading to bacterial death.

The prescribed dose of Monuril is determined by the treating physician based on the patient’s clinical condition, renal function, and local prescribing guidelines. In most cases a single oral dose is administered, but the exact amount and timing must be confirmed by a qualified healthcare professional.

The safety of fosfomycin trometamol in pregnancy and lactation has not been definitively established. It should only be used if the potential benefit justifies any possible risk to the fetus or infant, and the decision must be made by a prescriber after evaluating the individual clinical situation.

To place an order, submit an enquiry on the Monuril 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.

Compared with other oral agents such as trimethoprim‑sulfamethoxazole or nitrofurantoin, fosfomycin trometamol offers a single‑dose regimen and retains activity against many multidrug‑resistant uropathogens. However, susceptibility patterns vary by region, and clinicians should consider local resistance data when selecting therapy.

Monuril tablets should be stored at temperatures below 25 °C, in the original blister pack or container, protected from moisture and direct sunlight. Keeping the product in a dry, cool environment helps maintain its potency throughout the shelf life.

Monuril is taken orally, usually as a single tablet taken with a full glass of water on an empty stomach, unless otherwise directed by the prescriber. The tablet should be swallowed whole and not chewed or crushed to ensure proper absorption.

The most serious adverse reactions include severe allergic responses such as anaphylaxis, Stevens‑Johnson syndrome or toxic epidermal necrolysis, and Clostridioides difficile‑associated colitis. Patients should seek immediate medical attention if they develop rash, swelling, difficulty breathing, or persistent severe diarrhea.

Monuril is contraindicated in individuals with a known hypersensitivity to fosfomycin, its salts, or any component of the formulation. Caution is also advised for patients with severe renal impairment, and it should be avoided during pregnancy or breastfeeding unless the prescriber determines that the benefits outweigh the risks.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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