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 dosage form for oral use. It treats acute uncomplicated urinary tract infections and is used to prevent recurrent infections in adults.

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 indicated for urinary tract infection management and prevention.

  • Acute uncomplicated urinary tract infection (uUTI): provides single‑dose eradication of susceptible uropathogens.
  • Prophylaxis of recurrent urinary tract infections: reduces the frequency of recurrence in patients with a history of UTIs.
  • Urinary tract infection caused by susceptible Gram‑negative bacteria: effective against common pathogens such as Escherichia coli.

How It Works

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

Side Effects

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

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Diarrhea: loose stools occurring shortly after dosing.
  • Abdominal pain: cramping or discomfort in the lower abdomen.
  • Headache: transient mild headache.
  • Dyspepsia: indigestion or heartburn.
  • Vomiting: occasional emesis.

Serious or Rare Side Effects

  • Allergic reactions: rash, pruritus, or anaphylaxis.
  • Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Clostridioides difficile infection: colitis due to bacterial overgrowth.
  • Hepatic dysfunction: elevated liver enzymes or hepatitis.
  • Renal impairment: worsening kidney function in susceptible individuals.
  • Hematologic abnormalities: neutropenia or thrombocytopenia.

Precautions & Warnings

Before prescribing Monural, clinicians should consider several safety aspects.

  • Assess renal function: dose adjustment may be required in renal impairment.
  • Evaluate hypersensitivity: avoid in patients with known fosfomycin allergy.
  • Use with caution in pregnancy: classified as Category B, benefits should outweigh risks.
  • Monitor liver enzymes: prolonged therapy may affect hepatic function.
  • Review concomitant medications: potential interactions may necessitate monitoring.
  • Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Fosfomycin trometamol can interact with other medicines, influencing its absorption or effect.

Major Interactions (Avoid)

  • Metoclopramide: reduces fosfomycin absorption; avoid co‑administration.
  • Antacids containing aluminum or magnesium: may significantly decrease bioavailability.
  • Warfarin: may potentiate anticoagulant effect, increasing INR.

Moderate Interactions (Monitor Closely)

  • Diuretics: may increase risk of electrolyte disturbances.
  • Probenecid: can raise plasma concentrations of fosfomycin.
  • Oral contraceptives: potential reduction in contraceptive efficacy; advise additional contraceptive measures.

Frequently Asked Questions

Monural contains fosfomycin trometamol and is used to treat acute uncomplicated urinary tract infections and to prevent recurrent urinary tract infections in adults. It provides a single‑dose oral therapy that targets common uropathogens.

Fosfomycin trometamol blocks 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 a functional peptidoglycan layer, leading to bacterial cell death, especially in Gram‑negative organisms.

The prescribed dose of Monural is determined by the treating physician based on the patient’s clinical condition, renal function, and local guidelines. Dosage regimens are not standardized in public information and should follow the prescriber’s instructions.

Monural is classified as Pregnancy Category B, indicating that animal studies have not shown risk to the fetus and there are no adequate human studies. It may be used during pregnancy if the potential benefit justifies the risk. Limited data are available for breastfeeding, so clinicians should weigh benefits against possible exposure.

To request Monural, 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.

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 to guide therapy.

Monural should be stored at temperatures below 25 °C, in its original packaging, protected from moisture and direct sunlight. No refrigeration is required for this oral formulation.

Monural is taken orally, usually as a single dose with a full glass of water. It can be taken with or without food, but patients should follow any specific instructions provided by their healthcare professional.

Serious risks include severe allergic reactions such as anaphylaxis, rare skin disorders like Stevens‑Johnson syndrome, Clostridioides difficile‑associated colitis, and potential hepatic or renal impairment with prolonged use. Patients should seek immediate medical attention if they experience signs of a serious reaction.

Monural should not be used by individuals with a known hypersensitivity to fosfomycin or any component of the formulation. Caution is advised in patients with severe renal impairment, active liver disease, or those taking medications that may interact significantly, such as metoclopramide or certain antacids.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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