GNH USA

Europe — EMA

Monuril (Fosfomycin Trometamol)

GNH USA supplies Monuril (Fosfomycin Trometamol), a phosphonic acid antibiotic for acute uncomplicated urinary tract infection.

Fosfomycin Trometamol

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What is Fosfomycin Trometamol?

Fosfomycin trometamol, 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 urinary tract infection in adults caused by susceptible bacteria. GNH USA supplies Monuril as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

What is Fosfomycin Trometamol used for?

Monuril is a phosphonic acid antibiotic indicated for infections of the urinary tract caused by susceptible bacteria. - Acute uncomplicated urinary tract infection (uUTI) in women: single‑dose therapy that eradicates the causative pathogens and relieves dysuria, frequency and urgency. - Acute uncomplicated cystitis caused by Escherichia coli: provides bactericidal activity leading to rapid symptom resolution. - Acute uncomplicated urethritis due to susceptible Gram‑negative organisms: clears infection and reduces bacterial load.

What are the side effects of Fosfomycin Trometamol?

Common Side Effects: - Nausea: mild to moderate stomach upset after ingestion. - Diarrhea: loose stools that are usually self‑limiting. - Abdominal pain or discomfort: cramping in the lower abdomen. - Headache: transient mild headache. - Taste alteration: temporary metallic or altered taste sensation.

Serious or Rare Side Effects: - Allergic reactions: rash, pruritus, or anaphylaxis in hypersensitive individuals. - Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis. - Clostridioides difficile infection: rare but possible colitis. - Hepatic dysfunction: elevated liver enzymes or jaundice. - Renal impairment: acute kidney injury in predisposed patients.

What precautions apply to Fosfomycin Trometamol?

Before prescribing Monuril, consider patient‑specific factors and safety measures. - Renal function assessment: adjust use in severe renal impairment. - Pregnancy: category unknown; use only if potential benefit justifies the risk. - Breastfeeding: caution advised; monitor infant for adverse effects. - Concomitant antacids: avoid within two hours as they may reduce absorption. - Known hypersensitivity: contraindicated in patients with prior fosfomycin allergy. - Store at below 25°C: keep in the original pack, protect from moisture.

What does Fosfomycin Trometamol interact with?

Monuril may interact with other medicines; review patient medication lists. Major Interactions (Avoid): - Antacids containing aluminum or magnesium: significantly decrease fosfomycin absorption. - Probenecid: may increase fosfomycin plasma concentrations, raising toxicity risk. - Live bacterial vaccines: concurrent use can diminish vaccine efficacy.

Moderate Interactions (Monitor Closely): - Warfarin: potential enhancement of anticoagulant effect; monitor INR. - Oral contraceptives: possible reduction in hormonal efficacy; advise backup contraception. - Diuretics: monitor electrolytes as fosfomycin can affect renal handling of sodium and potassium.

Frequently asked questions

What is Monuril used for?+
Monuril is indicated for the treatment of acute uncomplicated urinary tract infection (uUTI) caused by bacteria that are susceptible to fosfomycin. It is commonly prescribed for adult women with cystitis and provides a single‑dose oral therapy to eradicate the infection.
How does fosfomycin trometamol work?+
Fosfomycin trometamol works by blocking 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 peptidoglycan, weakening the bacterial wall and leading to cell death, especially against many Gram‑negative uropathogens.
What is the usual dose of Monuril?+
The prescribed dose of Monuril is determined by the treating clinician based on the patient’s condition, renal function and local guidelines. In most regions a single 3 g dose of fosfomycin trometamol granules is used for uncomplicated urinary infections, but the exact regimen must be confirmed by a healthcare professional.
Is Monuril safe in pregnancy or breastfeeding?+
The pregnancy category for fosfomycin trometamol is not definitively established. It should only be used during pregnancy or lactation when the expected benefit outweighs any potential risk to the fetus or infant, and after careful evaluation by the prescribing physician.
How do I order Monuril from GNH USA?+
To order Monuril, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA 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 assistance with import documentation.
How does Monuril compare with other urinary anti‑infectives?+
Monuril offers a single‑dose oral regimen, which can improve adherence compared with multi‑day courses of trimethoprim‑sulfamethoxazole or fluoroquinolones. It retains activity against many resistant strains of E. coli, but its spectrum is narrower than broad‑spectrum agents, making susceptibility testing important before use.
How should Monuril be stored and handled?+
Monuril granules should be stored at temperatures below 25 °C, in the original container, protected from moisture and direct sunlight. Keep the product out of reach of children and avoid exposure to high humidity, which could affect the stability of the granules.
How is Monuril administered?+
Monuril is supplied as oral granules that are reconstituted with water to form a suspension. The patient should dissolve the entire sachet in the recommended volume of water, stir well, and ingest the suspension in a single dose, preferably on an empty stomach for optimal absorption.
What are the most serious risks to watch for with Monuril?+
Serious risks include severe allergic reactions such as anaphylaxis, rare skin disorders like Stevens‑Johnson syndrome, and Clostridioides difficile‑associated colitis. Patients should seek immediate medical attention if they develop rash, blistering, difficulty breathing, persistent diarrhea or signs of liver dysfunction.
Who should not use Monuril?+
Monuril should be avoided in individuals with a known hypersensitivity to fosfomycin or any component of the formulation. Caution is also advised for patients with severe renal impairment, pregnant or breastfeeding women unless the benefit justifies the risk, and those taking interacting antacids without appropriate timing adjustments.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.
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Product details

Drug
Fosfomycin Trometamol
Route
Oral Use
Manufacturer
Zambon S.P.A.
Origin
EU

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