Product image of Monuril (Fosfomycin) supplied by GNH India

Monuril

Active Ingredient:
Fosfomycin
Origin:
EU

Monuril (Fosfomycin)

Fosfomycin, the active ingredient in Monuril, is an antibacterial presented as a 3 g oral powder for suspension for oral use. It is indicated for the treatment of uncomplicated urinary tract infections, primarily in adult female patients, and works by inhibiting bacterial cell‑wall synthesis. The product is approved in the European Union and is available only by prescription.

GNH India supplies Monuril as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing reliable sourcing, regulatory support and consistent product quality across multiple markets.

Manufacturer / TM Owner

Zambon S.P.A.

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Indications & Clinical Uses

Monuril (fosfomycin) is an antibacterial used to treat infections of the urinary tract.

  • Uncomplicated urinary tract infection: provides a single‑dose eradication of susceptible uropathogens, relieving symptoms and reducing bacterial load.

How It Works

  • Fosfomycin inhibits bacterial cell‑wall synthesis by blocking the formation of N‑acetylmuramic acid, a key precursor in peptidoglycan construction. This action prevents the assembly of a functional cell wall, leading to bacterial lysis and death, particularly against Gram‑negative uropathogens.

Side Effects

Adverse reactions may occur with any medication. Common side effects are usually mild and self‑limiting.

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Diarrhoea: loose stools occurring within a few hours of dosing.
  • Abdominal pain: cramping or discomfort in the lower abdomen.
  • Headache: transient mild headache.
  • Vomiting: occasional emesis after ingestion.
  • Flatulence: increased gas production.

Serious or Rare Side Effects

  • Allergic reactions: rash, pruritus, or anaphylaxis requiring immediate medical attention.
  • Clostridioides difficile infection: severe colitis presenting with watery diarrhoea.
  • Severe liver injury: jaundice, elevated transaminases, or hepatitis.
  • Renal impairment: worsening kidney function in susceptible individuals.
  • Hematologic abnormalities: rare cases of neutropenia or thrombocytopenia.

Precautions & Warnings

Before prescribing Monuril, clinicians should consider several safety aspects.

  • Renal function assessment: adjust use in patients with severe renal impairment.
  • Pregnancy caution: safety category unknown; weigh benefits against potential risks.
  • Breastfeeding advice: consider potential excretion in milk and infant exposure.
  • Hypersensitivity screening: avoid in individuals with known fosfomycin allergy.
  • Concomitant medications: monitor for interactions that may affect efficacy or safety.
  • Store below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

Fosfomycin may interact with other medicines, altering its absorption or effect.

Major Interactions (Avoid)

  • Antacids containing magnesium or aluminum: reduce fosfomycin absorption.
  • Metoclopramide: delays gastric emptying, decreasing bioavailability.
  • Other antibacterial agents: may interfere with synergistic activity.

Moderate Interactions (Monitor Closely)

  • Warfarin: possible increase in INR, requiring coagulation monitoring.
  • Oral contraceptives: potential reduction in contraceptive efficacy; advise additional protection.
  • Diabetes medications: may affect glycaemic control, necessitating closer monitoring.

Frequently Asked Questions

Monuril contains fosfomycin and is indicated for the treatment of uncomplicated urinary tract infections (UTIs) in adult patients, particularly women. It provides a single‑dose therapy that eradicates susceptible uropathogens and relieves typical UTI symptoms such as dysuria and frequency.

Fosfomycin blocks the enzyme MurA, preventing the formation of N‑acetylmuramic acid, an essential building block of bacterial peptidoglycan. Without this precursor, the bacterial cell wall cannot be assembled, leading to cell lysis and death, especially against common Gram‑negative urinary pathogens.

The prescribed dose of Monuril is determined by the treating clinician. In most adult cases, a single 3 g oral dose of the reconstituted suspension is used, but the exact regimen, including any adjustments for renal function, must be set by a qualified healthcare professional.

The pregnancy safety category for fosfomycin is not definitively established. Use during pregnancy or lactation should only occur when the potential benefit justifies any possible risk to the fetus or infant, and it must be decided by the prescribing physician after a careful assessment.

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

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

Monuril should be stored below 25 °C in its original packaging. Protect the powder from moisture and direct sunlight. Once reconstituted, the suspension should be used promptly according to the prescribing information and any remaining product discarded if not used within the recommended time frame.

The oral powder is mixed with a specified volume of clean water to create a suspension, as indicated in the package insert. The resulting solution is taken orally as a single dose, preferably on an empty stomach, unless otherwise directed by the prescriber.

Serious adverse events include severe allergic reactions such as rash, angioedema or anaphylaxis, and Clostridioides difficile‑associated colitis. Patients with significant renal impairment may experience worsening kidney function, and rare cases of liver injury or hematologic abnormalities have been reported.

Monuril is contraindicated in individuals with a known hypersensitivity to fosfomycin or any of its excipients. It should be used with caution, or avoided, in patients with severe renal impairment, and it is not recommended for children unless specifically prescribed by a pediatric specialist.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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