BERNY ® Fosfomycin trometamol salt

BERNY ® 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

Indications BERNY ® Fosfomycin trometamol salt

BERNY ® is indicated for the treatment and prevention of acute and recurrent lower urinary tract infections.

Phosphomycin has also proved particularly useful in the prevention of cystitis and post-surgical and post-diagnostic urethritis.

Mechanism of action BERNY ® Fosfomycin trometamol salt

Fosfomicina, active ingredient of BERNY ®, is a molecule with antibiotic activity, particularly effective against both Gram positive and Gram negative bacteria.

Its biological activity, concentrated above all at the level of the lower urinary tract, is possible thanks to its characteristic pharmacokinetic properties which allow its accumulation in unchanged form in the urine and persistence in the lower urinary tract for different hours.

Here, Fosfomicina, presenting a structure similar to that of phosphoenolpyruvate, can bind and inhibit enzymes involved in the synthesis of the bacterial wall, thus exerting a bacteriostatic and bactericidal action that results in the impairment of the normal structural and protective properties of the wall, thus resulting in death of the pathogenic microorganism.

Once the activity is over, obviously the unchanged Fosfomycin is eliminated through the urine.

In addition to the typical pharmacokinetic characteristics, Fosfomicina owes its high use in the clinical setting, even to the low degree of resistance that manifests itself in the various microorganisms, and which therefore makes the therapy generally well tolerated and effective.

Studies carried out and clinical efficacy

PHOSPHOMYCIN IN THE TREATMENT OF URINARY TRACT INFECTIONS FROM MULTIPURPOSE MICRORGANISMS

Antimicrob Agents Chemother. 2012 Nov; 56 (11): 5744-8.

Yet another study that demonstrates how Fosfomycin can be effective in treating urinary tract infections sustained by microorganisms that are generally multi-resistant to conventional antibiotic drug therapy with beta lactams.

PHOSPHOMYCIN AND CYSTIC FIBROSIS

J Cyst Fibros. 2012 May; 11 (3): 163-72.

Very interesting work that evaluates the effectiveness of Fosfomycin in the treatment of infections sustained by microorganisms such as P.Aeuriginosa in characteristic conditions such as cystic fibrosis.

These experimental studies are of particular clinical interest for potential applications in very delicate clinical settings.

PHOSPHOMYCIN AND STAPHILOCOCCUS BACTERIEMIA MULTIRESIST AUREUS

J Med Assoc Thai. 2012 Jul; 95 (7): 960-3.

Case report demonstrating how the addition of Fosfomycin to Vancomycin has ensured effective therapeutic resolution against multi-resistant Staphylococcus aures responsible for bacteremia.

Method of use and dosage

BERNY ®

Granules for oral solution 3 gr of Fosfomycin per bag.

Treatment with Fosfomycin should be defined in doses and times by your doctor based on the patient's physiopathological and clinical characteristics.

Usually taking a sachet a day for a few days is sufficient to guarantee complete remission of symptoms in 2-3 days.

However, it is important to take the drug in the evening before going to bed, after having emptied the bladder, so that Fosfomycin can concentrate in the urinary area and carry out its therapeutic action effectively.

Warnings BERNY ® Fosfomycin trometamol salt

Although BERNY ® therapy is generally well tolerated and easy to use, it is necessary to consult your doctor before taking this drug, so that you can carefully consider the potential contraindications or the presence of conditions that require a dosage adjustment.

Particular caution should in fact be reserved for patients suffering from renal pathologies or subjected simultaneously to different pharmacological therapies, such as to alter the pharmacokinetic characteristics of Fosfomycin.

BERNY ® 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

Although studies on the safety of Fosfomycin for the fetus are generally encouraging, especially at the doses normally used, the use of BERNY ® in pregnancy and during breastfeeding should only take place in cases of inevitable necessity and clearly under the supervision of a specialized doctor.

Interactions

The patient on Fosfomycin therapy should pay particular attention to the simultaneous intake of diuretics, active peristalsis drugs, antacids and food.

These precautions would be necessary in order to preserve the pharmacokinetic characteristics of Fosfomycin, thus avoiding the unpleasant appearance of side effects.

Contraindications BERNY ® Fosfomycin trometamol salt

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

Undesirable effects - Side effects

The use of BERNY ®, especially when prolonged for a long time, could determine the appearance of adverse reactions, fortunately transitory such as diarrhea, nausea, abdominal pain and allergic reactions.

The most clinically relevant adverse reactions characterized by pseudomembranous colitis, asthma and possibly hypersensitivity reactions such as skin rasch, hypotension and anaphylactic shock are decidedly more rare.