MONURIL ® Fosfomycin trometamol salt

MONURIL ® is a drug based on Fosfomycin trometamol salt

THERAPEUTIC GROUP: Antibacterial for systemic use

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Directions MONURIL ® Fosfomycin trometamol salt

MONURIL ® is indicated for the treatment of low aspecific and acute urinary tract infections.

This medicine has also been shown to be effective in preventing cystitis and post-surgical or post-diagnostic urethritis.

Mechanism of action MONURIL ® Fosfomycin trometamol salt

MONURIL ® is a drug of Fosfomycin, an active ingredient with marked bactericidal activity both against Gram positive and Gram negative bacteria.

Taken orally, this molecule is rapidly absorbed from the gastro-enteric tract, reaching the various tissues in therapeutic concentrations in particularly short times, being eliminated unchanged through the urine in just 2-4 hours.

The persistence of unchanged phosphomycin in the lower urinary tract allows the drug to carry out its therapeutic action against the pathogenic microorganisms present in this district, replacing the phosphoenolpyruvate and thus seriously compromising the structure and the protective capacity of the bacterial wall.

The absence of cross-resistance mechanisms to other drugs active on the bacterial wall, allow Fosfomicina to carry out its therapeutic action effectively and safely, thus reducing the onset of pharmacologically multi-resistant strains.

Studies carried out and clinical efficacy

PHOSPHOMYCIN AND AMOXYCILLIN IN THE PREVENTION OF URINARY TRACT INFECTIONS

Antimicrob Agents Chemother. 2013 Mar; 57 (3): 1518-20.

Study demonstrating how the combination of Fosfomycin and Amoxicillin can be effective in preventing urinary tract infections in kidney transplant patients.

LOW RESISTANCE TO PHOSPHOMYCIN

J Vet Med Sci. 2012 Dec 19.

PHOSPHOMYCIN IN THE PREVENTION OF POST-SURGICAL INFECTIONS OF THE PROSTATE

Urol Int. 2012; 89 (4): 439-44.

Work that shows how the great clinical efficacy of fosfomycin can guarantee excellent results in terms of post-surgical prevention, reducing the use of other antibiotics, therefore also the associated associated resistance mechanisms.

Method of use and dosage

MONURIL ®

Granules for oral solution of 2 - 3 grams of Fosfomycin per bag.

The MONURIL ® based dosing schedule useful in the treatment and prevention of cystitis or other lower urinary tract infections should be defined by the physician based on the patient's physiopathological and clinical characteristics.

In order to optimize the therapeutic efficacy of fosfomycin it would be advisable to take the drug before going to bed and after having emptied the bladder, so that the active ingredient exerts its therapeutic action longer over time.

Warnings MONURIL ® Fosfomycin trometamol salt

Before starting treatment with MONURIL ® it would be advisable to undergo a careful medical examination to assess the patient's clinical conditions, the possible presence of contraindications, and therefore the appropriateness of the therapy.

The effectiveness of the drug could be compromised by taking active drugs on kidney function rather than by active ingredients on peristalsis.

MONURIL ® contains sucrose, therefore its intake is contraindicated in patients suffering from fructose intolerance, glucose-galactose malabsorption syndrome, sucrase-isomaltase insufficiency and possibly in diabetic patients.

PREGNANCY AND BREASTFEEDING

The use of MONURIL ® during pregnancy should only take place in cases of real need and under the strict specialized medical supervision.

The data currently present in the literature fail to completely clarify the safety profile of the drug for fetal health and of the infant.

Interactions

In order to preserve the pharmacokinetic properties of Fosfomycin, it would be advisable to avoid the simultaneous intake of drugs active on diuresis, peristalsis, antacids or food.

It is recommended that you consult your doctor if it becomes necessary to take other medicines together with MONURIL ®.

Contraindications MONURIL ® Fosfomycin trometamol salt

The use of MONURIL ® is contraindicated in patients hypersensitive to the active substance or to any of its excipients, in patients suffering from severe renal insufficiency and in all patients undergoing hemodialysis.

Undesirable effects - Side effects

Therapy with MONURIL ® could cause onset, with a certain frequency of diarrhea, nausea, dyspepsia, headache and dizziness

Fortunately, clinically more relevant manifestations such as asthma, pseudomembranous colitis, adverse hypersensitivity reactions and hypotension are rare.