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 tablet for oral administration. It targets bacterial cell wall synthesis and is used to treat uncomplicated urinary tract infections in adult patients, providing a single‑dose therapy option that is effective against common uropathogens.

GNH India supplies Monural as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality‑assured products that meet European Union regulatory standards and reliable supply chains for global healthcare providers.

Manufacturer / TM Owner

Zambon S.P.A.

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Indications & Clinical Uses

  • Monural (fosfomycin trometamol) belongs to the phosphonic acid antibiotic class and is employed in the management of infections affecting the urinary tract.
  • Uncomplicated urinary tract infection: provides a single oral dose that eradicates common uropathogens, relieving symptoms such as dysuria, frequency, and urgency.
  • Acute uncomplicated cystitis: single‑dose therapy that clears infection caused by susceptible Escherichia coli and other typical bacteria.
  • Uncomplicated urinary tract infection (female): single‑dose treatment that alleviates typical symptoms in adult women.

How It Works

  • Fosfomycin trometamol inhibits the bacterial enzyme MurA (phosphoenolpyruvate transferase), which catalyzes the first step of peptidoglycan synthesis in the cell wall. By blocking this enzymatic reaction, the drug prevents formation of a functional cell wall, leading to bacterial lysis and eradication of susceptible organisms.

Side Effects

Adverse reactions to Monural may range from mild, transient events to rare but serious conditions.

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Diarrhea: loose stools that are usually self‑limiting.
  • Abdominal pain: cramping or discomfort in the stomach area.
  • Headache: mild tension‑type headache.
  • Dizziness: transient feeling of light‑headedness.
  • Vomiting: occasional emesis after dosing.

Serious or Rare Side Effects

  • Allergic reactions: rash, pruritus, or anaphylaxis in hypersensitive individuals.
  • Clostridioides difficile infection: severe colitis presenting with watery diarrhea.
  • Severe skin disorders: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Hepatic enzyme elevation: abnormal liver function tests requiring monitoring.
  • Hematologic abnormalities: rare cases of neutropenia or thrombocytopenia.

Precautions & Warnings

  • When prescribing Monural, clinicians should consider several precautionary measures to ensure safe use.
  • Assess renal function: adjust use in patients with severe renal impairment.
  • Avoid in known hypersensitivity: do not prescribe to individuals allergic to fosfomycin or excipients.
  • Use with caution in pregnancy: safety not established; weigh benefits against potential risks.
  • Monitor gastrointestinal events: advise patients to report persistent diarrhea or abdominal pain.
  • Review concomitant medications: consider potential drug‑drug interactions before initiating therapy.
  • Store at ambient temperature below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

Fosfomycin trometamol can affect, or be affected by, other medicines. Interactions are grouped by clinical significance.

Major Interactions (Avoid)

  • Metoclopramide: reduces fosfomycin absorption, diminishing efficacy.
  • Cimetidine: may lower systemic exposure to fosfomycin.
  • Antacids containing magnesium or aluminum: significantly decrease oral bioavailability.

Moderate Interactions (Monitor Closely)

  • Warfarin: potential alteration of INR; monitor coagulation parameters.
  • Oral contraceptives: possible reduction in contraceptive effectiveness; advise additional protection.
  • Other antibiotics with overlapping resistance mechanisms: assess for additive resistance risk.
  • Diuretics: monitor electrolyte balance if concurrent renal stress is anticipated.

Frequently Asked Questions

Monural contains fosfomycin trometamol, an oral antibacterial indicated for the treatment of uncomplicated urinary tract infections caused by susceptible bacteria in adult patients. It is usually prescribed as a single dose to relieve symptoms such as dysuria, frequency and urgency.

It inhibits the bacterial enzyme MurA (phosphoenolpyruvate transferase), which is essential for the first step of peptidoglycan synthesis in the cell wall. By blocking this pathway, fosfomycin prevents cell‑wall formation, leading to bacterial lysis and eradication of the infecting organisms.

The prescribed dose of Monural is determined by the treating clinician based on the patient’s condition, renal function and local prescribing guidelines. In most regions a single oral dose of 3 g of fosfomycin trometamol is recommended for uncomplicated urinary tract infection, but the exact regimen must be confirmed by a healthcare professional.

Safety data for fosfomycin trometamol in pregnancy are limited, and the product is classified as pregnancy category unknown. It should only be used during pregnancy or lactation if the potential benefit outweighs the possible risk, and the decision should be made by a qualified prescriber after evaluating the individual situation.

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 temperature requirements) and the necessary import documentation.

Compared with trimethoprim‑sulfamethoxazole or nitrofurantoin, fosfomycin offers a single‑dose regimen and retains activity against many multidrug‑resistant strains, including some ESBL‑producing Enterobacteriaceae. However, susceptibility testing is essential, as resistance patterns vary regionally, and alternative agents may be preferred when fosfomycin‑resistant organisms are prevalent.

Monural tablets should be stored at ambient temperature below 25 °C, in the original blister pack or container to protect from moisture and light. Keep the product out of reach of children and do not use it after the expiry date printed on the packaging.

Monural is taken orally, preferably on an empty stomach with a full glass of water. The tablet should be swallowed whole and not chewed or crushed. Food may delay absorption, so patients are advised to wait at least two hours after a meal before taking the dose.

Although generally well tolerated, Monural can cause serious adverse reactions such as severe allergic responses (including anaphylaxis), Clostridioides difficile‑associated colitis, and rare skin disorders like Stevens‑Johnson syndrome. Patients should seek immediate medical attention if they develop rash, fever, persistent diarrhea, or signs of an allergic reaction.

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

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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