Phosphoral Rompharm oral solution granules 3g sachets, 1pc

Composition

1 sachet contains:

Active ingredient:

fosfomycin trometamol 5,631 g in terms of fosfomycin-3,000 g;

Auxiliary substances:

calcium hydroxide-0.300 g,

lemon flavor-0.200 g,

sodium saccharin-0.010 g,

powdered sugar-up to 8,000 g

Pharmacological action

Fosfomycin is a broad-spectrum antibiotic of phosphonic acid. The bactericidal effect of fosfomycin is based on the fact that fosfomycin is a structural analog of phosphoenol pyruvate. It inactivates N-acetyl-glucosamino-3-o-enolpyruvyl transferase, irreversibly blocks the condensation of uridine diphosphate-N-acetyl-glucosamine with phosphoenol pyruvate, and suppresses the synthesis of UDP-N-acetylmuramic acid, thus inhibiting the initial stage of bacterial cell wall peptidoglycan formation. In vitro, fosfomycin reduces the adhesion of a number of bacteria to the urinary tract epithelium.

Gram-positive (Staphylococcus saprophyticus, Enterococcus faecalis) and gram-negative (Escherichia coli, Klebsiella pneumoniae, Citrobacter spp., Enterobacter spp., Proteus mirabilis) microorganisms are susceptible to fosfomycin in vitro.

Inactivation of the enzyme N-acetyl-glucosamino-3-o-enolpyruvyl transferase reduces the likelihood of cross-resistance to antibiotics with a similar mechanism of action and creates conditions for synergy (in vitro experiments revealed a synergistic effect with amoxicillin, cephalexin, and pipemidic acid).

Indications

Treatment of infectious and inflammatory diseases (caused by microorganisms sensitive to the drug) of the lower urinary tract, including acute bacterial cystitis, exacerbation of chronic recurrent bacterial cystitis, acute bacterial vesical syndrome, bacterial nonspecific urethritis, asymptomatic massive bacteriuria (during pregnancy), postoperative urinary tract infection.

Prevention of urinary tract infection during surgical procedures and transurethral diagnostic examinations.

Contraindications

Hypersensitivity to fosfomycin, pregnancy.

Side effects

Rarely:  nausea, vomiting, diarrhea, skin rash that disappears on its own after fosfomycin withdrawal.

Interaction

Concomitant use with metoclopramide, antacids, or drugs containing calcium salts should be avoided, as this may lead to a decrease in the concentration of fosfomycin in the blood serum and urine.

Concomitant use with other medications that enhance gastrointestinal motility may also lead to a decrease in the concentration of fosfomycin in the blood serum and urine.

How to take, course of use and dosage

of Phosphoral ROMPHARM is used once, on an empty stomach,2-3 hours before or after a meal, preferably before bedtime, after emptying the bladder: adults and children over 12 years of age in a daily dose of 3 g. The contents of the package are dissolved in 1/2 cup of water.

For the prevention of urinary tract infections during surgical intervention, diagnostic procedures, the above dose is taken 2 times-3 hours before the intervention and 24 hours after it.

Overdose

Symptoms: diarrhea (with persistent diarrhea, symptomatic treatment is prescribed), vestibular syndrome, hearing loss, ” metallic ” taste and general taste disorders.

In case of overdose, it is recommended to increase the diuresis by taking liquid inside.

There is no specific antidote.

Special instructions

The use of broad-spectrum antibiotics, including fosfomycin trometamol, can lead to the development of antibiotic-associated colitis (including pseudomembranous colitis). Therefore, it is necessary to consider the likelihood of this diagnosis in patients who experience severe diarrhea during or after taking fosfomycin trometamol. If the diagnosis is confirmed, it is necessary to immediately start appropriate treatment, in this case, drugs that inhibit peristalsis are contraindicated.

Simultaneous food intake slows down the absorption of fosfomycin. Therefore, it is advisable to use the drug on an empty stomach or 2-3 hours after a meal.

Phosphoral ROMPHARM contains sucrose.

Patients with diabetes and those who need to follow a diet should take into account that 1 package of Phosphoral ROMPHARM contains up to 1.86 g of sugar. Phosphoral ROMPHARM should not be used in patients with fructose intolerance, glucose-galactose malabsorption syndrome, or sucrose-isomaltase deficiency.

Form of production

Granules for the preparation of a solution for oral use.

Active ingredient

Fosfomycin

Conditions of release from pharmacies

By prescription

Dosage form

solution for oral use

Description

Children over 12 years of age, For adults as prescribed by a doctor

Indications

Urethritis, Urinary Tract Infections