Product image of Monuril (Fosfomycin) supplied by GNH India

Monuril

Active Ingredient:
Fosfomycin
Origin:
EU

Monuril (Fosfomycin)

Fosfomycin, 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 cystitis in women and other urinary tract infections.

GNH India supplies Monuril as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with established quality‑assurance processes and regulatory compliance across EU and other markets, the company provides batch‑tested product, documentation and logistics support to meet the needs of healthcare providers globally.

Manufacturer / TM Owner

Zambon S.P.A.

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Indications & Clinical Uses

Fosfomycin, a phosphonic acid antibiotic, is used to treat infections of the urinary tract.

  • Acute uncomplicated cystitis in women: single‑dose therapy that clears infection and relieves symptoms.
  • Uncomplicated urinary tract infection: provides bacterial eradication in a single oral administration.
  • Susceptible uropathogen infection: effective against strains of Escherichia coli, Enterococcus faecalis and other bacteria that cause urinary infections.

How It Works

  • Fosfomycin inhibits bacterial cell‑wall synthesis by covalently binding to the MurA enzyme (enolpyruvyl transferase), preventing the formation of N‑acetylmuramic acid, an essential precursor of peptidoglycan. This blockade halts peptidoglycan polymerisation, leading to bactericidal activity against a broad range of Gram‑positive and Gram‑negative organisms, including many uropathogens. The drug penetrates urinary tract tissues and achieves high concentrations in urine, sustaining its antibacterial effect throughout the dosing interval.

Side Effects

Fosfomycin may be associated with several adverse reactions, which are generally categorized by frequency and severity.

Common Side Effects

  • Diarrhea: loose stools occurring during or after treatment.
  • Nausea: feeling of sickness or urge to vomit.
  • Abdominal discomfort: mild pain or cramping in the stomach area.
  • Vomiting: expulsion of stomach contents.
  • Headache: mild to moderate head pain.
  • Flatulence: excess gas causing abdominal distension.

Serious or Rare Side Effects

  • Allergic reactions: rash, itching, swelling, or anaphylaxis in susceptible individuals.
  • Clostridioides difficile‑associated colitis: severe diarrhea due to intestinal flora disruption.
  • Hepatic dysfunction: elevated liver enzymes or jaundice indicating liver involvement.

Precautions & Warnings

When prescribing Fosfomycin, clinicians should consider several safety aspects.

  • Renal impairment: dose adjustment may be required in patients with reduced kidney function.
  • Pregnancy: safety not established; use only if clearly needed after risk assessment.
  • Breastfeeding: unknown safety; weigh potential benefits against risks.
  • Drug interactions: avoid concomitant use with agents that may diminish absorption or increase toxicity.
  • Allergy: discontinue immediately if hypersensitivity signs appear.
  • Store at ambient temperature: keep below 25 °C, protect from moisture and light.

Avoid Interactions

Fosfomycin can interact with other medicines, requiring attention to avoid reduced efficacy or increased toxicity.

Major Interactions (Avoid)

  • Antacids containing aluminum or magnesium: may reduce fosfomycin absorption.
  • Probenecid: can increase serum fosfomycin levels, raising risk of adverse effects.

Moderate Interactions (Monitor Closely)

  • Warfarin: fosfomycin may potentiate anticoagulant effect; monitor INR.
  • Oral contraceptives: possible reduction in hormonal efficacy; consider backup contraception.
  • Other antibiotics (e.g., aminoglycosides): may have additive nephrotoxic potential.

Frequently Asked Questions

Monuril contains fosfomycin, an antibiotic indicated for the treatment of acute uncomplicated cystitis in women and other uncomplicated urinary tract infections caused by susceptible bacteria.

Fosfomycin blocks the MurA enzyme, preventing the formation of N‑acetylmuramic acid, a key building block of bacterial cell‑wall peptidoglycan. This inhibition stops cell‑wall synthesis, leading to bacterial death.

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 3 g granule packet for oral suspension.

Safety data for fosfomycin 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 under medical supervision.

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.

Compared with many oral UTI agents, fosfomycin offers a single‑dose regimen and retains activity against several multidrug‑resistant strains. However, susceptibility testing is essential, as resistance patterns vary among regions and bacterial species.

Monuril granules should be stored at ambient temperature, below 25 °C, in the original packaging to protect from moisture and light. Keep the product out of reach of children.

The granules are reconstituted with a measured amount of water to create a suspension, which is then taken orally as a single dose. Patients should follow the preparation instructions provided with the product.

Serious risks include severe allergic reactions such as anaphylaxis, Clostridioides difficile‑associated colitis, and hepatic dysfunction. Prompt medical attention is required if signs of these conditions appear.

Monuril should be avoided in patients with known hypersensitivity to fosfomycin or any component of the formulation, and it should be used with caution in individuals with severe renal impairment or those taking interacting medications.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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