Product image of Monural (Fosfomycin Trometamol) supplied by GNH India

Monural

Active Ingredient:
Fosfomycin Trometamol
Origin:
EU

Monural (Fosfomycin Trometamol)

Fosfomycin Trometamol, the active ingredient in Monural, is a phosphonic acid antibiotic presented as an oral powder for solution for oral use. It is indicated for the treatment of uncomplicated urinary tract infections in adult patients.
GNH India supplies Monural 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

  • Monural is a phosphonic acid antibiotic used to treat infections of the urinary tract caused by susceptible bacteria.
  • Uncomplicated urinary tract infection: provides a single‑dose oral therapy that clears acute cystitis caused by common uropathogens.
  • Acute uncomplicated cystitis: achieves rapid symptom relief and bacterial eradication in women with first‑time infections.

How It Works

  • Fosfomycin Trometamol inhibits bacterial cell wall synthesis by irreversibly blocking the enzyme MurA (enolpyruvyl transferase), which catalyzes the first step in peptidoglycan formation. This blockade prevents the construction of a functional cell wall, leading to bacterial lysis and death, particularly against Gram‑negative uropathogens.

Side Effects

Common Side Effects

  • Nausea: mild to moderate upset stomach.
  • Diarrhea: loose stools occurring within 24‑48 hours.
  • Headache: transient tension‑type headache.
  • Abdominal discomfort: cramping or mild pain.
  • Vomiting: occasional emesis.
  • Dizziness: brief episodes of light‑headedness.

Serious or Rare Side Effects

  • Allergic reactions: rash, itching, or anaphylaxis.
  • Clostridioides difficile infection: severe colitis risk.
  • Hepatic dysfunction: elevated liver enzymes.
  • Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Hemolytic anemia: reduced red blood cell count.

Precautions & Warnings

Before prescribing Monural, consider the following precautions:

  • Renal impairment: assess kidney function and adjust use if necessary.
  • Pregnancy and lactation: safety not established; use only if benefits outweigh risks.
  • Known allergy to fosfomycin: avoid administration.
  • Concomitant medications: review for potential interactions.
  • Storage: Store at room temperature: keep in the original pack, protect from moisture and direct sunlight.

Avoid Interactions

Monural may interact with several medicines.

Major Interactions (Avoid)

  • Probenecid: reduces urinary excretion of fosfomycin, lowering efficacy.
  • Ceftriaxone: potential antagonistic effect when used together.

Moderate Interactions (Monitor Closely)

  • Antacids containing magnesium or aluminum: may decrease fosfomycin absorption.
  • Metformin: monitor renal function as both are renally cleared.
  • Warfarin: may increase INR; monitor coagulation parameters.

Frequently Asked Questions

Monural contains fosfomycin trometamol and is used as a single‑dose oral therapy to treat uncomplicated urinary tract infections caused by susceptible bacteria, primarily in adult patients.

Fosfomycin trometamol blocks the bacterial enzyme MurA, which is essential for the first step of peptidoglycan synthesis. By inhibiting cell‑wall formation, it leads to bacterial lysis and eradication of the infection.

The prescribed dose of Monural is determined by the treating clinician based on the patient’s condition, renal function, and local guidelines. No fixed regimen is provided here.

Safety data for fosfomycin trometamol in pregnancy and lactation are limited. It should only be used if the potential benefit justifies the potential risk to the fetus or infant, after a professional risk‑benefit assessment.

To request Monural, submit an enquiry on the product page at gnhindia.com with 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.

Monural offers a single‑dose oral regimen, which can improve adherence compared with multi‑day courses of trimethoprim‑sulfamethoxazole or fluoroquinolones. Its unique mechanism targeting MurA provides activity against some resistant strains, though susceptibility testing remains essential.

Monural should be stored at room temperature, below 25 °C, in its original packaging to protect it from moisture and light. Keep the powder in a dry place and avoid exposure to extreme temperatures.

The oral powder is reconstituted with a specified amount of water to create a solution, which is then taken 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, hepatic dysfunction, and rare skin disorders like Stevens‑Johnson syndrome. Immediate medical attention is required if any of these occur.

Monural should not be used by individuals with a known hypersensitivity to fosfomycin or any component of the formulation, and it should be avoided in patients with severe renal impairment unless specifically advised by a healthcare professional.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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