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 fosfomycin (phosphonic acid derivative antibacterial) presented as an oral tablet for oral use. It treats acute uncomplicated urinary tract infection, primarily in adult women, by eradicating susceptible uropathogens and providing symptomatic relief with a single-dose regimen.

GNH India supplies Monuril as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with reliable quality assurance and regulatory compliance, ensuring consistent product availability across markets and competitive pricing.

Manufacturer / TM Owner

Zambon France S.A.

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Indications & Clinical Uses

  • Monuril, a fosfomycin antibacterial, is indicated for infections of the urinary tract.
  • Acute uncomplicated urinary tract infection (female): provides bacterial eradication and rapid symptom relief.
  • Acute uncomplicated urinary tract infection (male): offers effective treatment when indicated, targeting common uropathogens.
  • Recurrent uncomplicated urinary tract infection (prophylaxis): may be used as a single-dose therapy under medical supervision to reduce recurrence.

How It Works

  • Fosfomycin Trometamol penetrates bacterial cells through glycerophosphate transport systems and binds irreversibly to the MurA enzyme (enolpyruvyl‑transferase). This blocks the first step of peptidoglycan synthesis, preventing formation of the bacterial cell wall and leading to bactericidal activity against a broad range of Gram‑positive and Gram‑negative uropathogens. The drug achieves high urinary concentrations after a single oral dose, maintaining levels above the minimum inhibitory concentration for the typical causative organisms for up to 48 hours.

Side Effects

Fosfomycin Trometamol may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Nausea
  • Diarrhea
  • Headache

Serious or Rare Side Effects

  • Anaphylactic reaction
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis
  • Clostridioides difficile‑associated colitis

Precautions & Warnings

  • When prescribing Monuril, clinicians should consider several precautionary measures to ensure safe use.
  • Assess renal function: adjust use in patients with severe renal impairment.
  • Verify hypersensitivity: avoid in individuals with known allergy to fosfomycin or its excipients.
  • Evaluate pregnancy status: use only if potential benefit justifies potential risk.
  • Monitor gastrointestinal tolerance: counsel patients on possible nausea or diarrhea.
  • Review concomitant medications: consider possible interactions that may affect efficacy.
  • Store at ambient temperature: keep in original packaging, protect from moisture and heat.

Avoid Interactions

Fosfomycin Trometamol can interact with other medicines; some combinations should be avoided while others require monitoring.

Major Interactions (Avoid)

  • Antacids containing aluminum or magnesium: may markedly reduce fosfomycin absorption.
  • Probenecid: can increase systemic exposure and risk of toxicity.
  • Warfarin: may potentiate anticoagulant effect and raise INR.

Moderate Interactions (Monitor Closely)

  • Oral contraceptives: possible reduction in hormonal efficacy; advise backup method.
  • Diabetes medications: monitor blood glucose as fosfomycin may affect glycemic control.
  • Other renally excreted drugs: adjust dosing if renal function is compromised.

Frequently Asked Questions

Monuril contains fosfomycin trometamol and is used primarily to treat acute uncomplicated urinary tract infections (UTIs). It is indicated for single‑dose oral therapy in adults, especially women, to eradicate susceptible uropathogens and relieve symptoms such as dysuria, frequency, and urgency. The medication is prescribed by a healthcare professional after confirming the infection.

Fosfomycin trometamol penetrates bacterial cells via glycerophosphate transporters and binds irreversibly to the MurA enzyme, which catalyzes the first step of peptidoglycan synthesis. By blocking this step, the drug prevents formation of the bacterial cell wall, leading to bactericidal activity against a broad spectrum of Gram‑positive and Gram‑negative organisms commonly responsible for urinary tract infections.

The dosing regimen for Monuril is determined by the prescribing clinician based on the patient’s age, renal function, and the specific infection being treated. Typically, a single oral dose is administered for uncomplicated urinary tract infection, but the exact amount and any adjustments must be specified by the healthcare provider. Patients should follow the prescriber’s instructions precisely.

Safety data for fosfomycin trometamol in pregnancy are limited, and the drug is generally classified as use‑only when the potential benefit outweighs any possible risk to the fetus. It is excreted in breast milk, so caution is advised for nursing mothers. Physicians should evaluate the clinical situation and discuss potential risks and alternatives with the patient before prescribing.

To request Monuril, visit the product page on gnhindia.com, enter the desired quantity, and submit the inquiry form. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifying trade or institutional credentials before providing a formal quotation. The sales team will respond with pricing, availability, shipping details—including any required temperature controls—and assistance with import documentation.

Compared with other oral agents such as nitrofurantoin or trimethoprim‑sulfamethoxazole, fosfomycin offers the convenience of a single‑dose regimen and retains activity against many multidrug‑resistant uropathogens. However, its spectrum is narrower for certain organisms, and resistance can develop with repeated use. Clinicians consider local susceptibility patterns, patient tolerance, and dosing convenience when selecting the most appropriate urinary antiseptic.

Monuril should be stored at ambient temperature, preferably below 25 °C, in its original blister pack or container. The product must be kept away from moisture, direct sunlight, and excessive heat to maintain stability. Do not store in bathrooms or near kitchen appliances, and keep out of reach of children.

Monuril is taken orally as a single dose, usually with a full glass of water. The tablet should be swallowed whole and not chewed or crushed. Patients are advised to take the medication on an empty stomach, at least 30 minutes before or after meals, to optimize absorption. Specific instructions may vary, so patients should follow the prescribing clinician’s guidance.

The most serious adverse reactions to fosfomycin trometamol include severe allergic responses such as anaphylaxis, life‑threatening skin conditions like Stevens‑Johnson syndrome or toxic epidermal necrolysis, and Clostridioides difficile‑associated colitis. Renal or hepatic impairment may also occur, particularly in patients with pre‑existing organ dysfunction. Prompt medical attention is required if any signs of these reactions develop.

Monuril is contraindicated in individuals with a known hypersensitivity to fosfomycin, its salts, or any of the tablet excipients. Patients with severe renal impairment (e.g., creatinine clearance below 10 mL/min) should avoid the drug unless dose adjustment is explicitly directed by a physician. It should also be used with caution in pregnant or breastfeeding women, and in patients taking medications that may interact significantly, such as certain anticoagulants or antacids.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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