Phosphoral granules for solution 3g №1

Active substance

Fosfomycin

Composition

1 bag contains:

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

Excipients: Calcium hydroxide - 0.300 g, lemon flavor - 0.200 g, saccharin sodium - 0.010 g, icing sugar - up to 8,000 g.

Mechanism of action

Fosfomycin - a broad-spectrum antibiotic of phosphonic acid. The bactericidal effect of fosfomycin is based on the fact that fosfomycin is a structural analogue of phosphoenol pyruvate. Inactivates N- acetyl-glucosamine-3-o-enolpyruvyl transferase, the condensation irreversibly blocked uridine diphosphate-N-acetyl-glucosamine with fosfoenola pyruvate suppresses the synthesis of UDP-N-acetylmuramic acid, thus inhibiting the initial step of forming the cell wall peptidoglycan of bacteria. In vitro fosfomycin reduces the adhesion of a number of bacteria on the epithelium of the urinary tract.

In vitro, phosphomitsin-sensitive gram-positive (Staphylococcus saprophyticus, Enterococcus faecalis) and gram-negative (Escherichia coli, Klebsiella pneumoniae, Citrobacter spp., Enterobacter spr., Proteus mirabilis) microorganisms.

Inactivation of the enzyme N-acetyl-glucosamino-3-o-enolpiruvil-transferase reduces the likelihood of cross-resistance to antibiotics with a similar mechanism of action and creates conditions for synergism (in vitro experiments revealed a synergistic effect with Amoxicillin, cephalexin, pimemidinic 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 lesion syndrome, bacterial nonspecific urethritis, asymptomatic massive bacteriuria (during pregnancy), postoperative urinary tract infection. Prevention of urinary tract infection during surgery and transurethral diagnostic examinations.

Contraindications

Hypersensitivity to fosfomycin, pregnancy.

Side effects

Rarely: nausea, vomiting, diarrhea, skin rash, disappearing on their own after the withdrawal of fosfomycin.

Interaction

Concurrent use with Metoclopramide, antacids or drugs containing calcium salts should be avoided, as this may lead to a decrease in serum and fosfomycin concentrations in urine. Simultaneous use with other drugs that enhance the motility of the gastrointestinal tract, can also lead to a decrease in the concentration of fosfomycin in the serum and urine.

How to take, the course of administration and dosage

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 old at a daily dose of 3 g. The contents of the bag are dissolved in 1/2 cup of water.

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

Overdosage

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 diuresis by ingestion of liquid. The specific antidote is absent.

Special notes

The use of broad-spectrum antibiotics, including fosfomycin trometamol, can lead to the occurrence of antibiotic-associated colitis (including pseudomembranous colitis). Therefore, it is necessary to take into account the likelihood of this diagnosis in patients with severe diarrhea during or after administration of fosfomycin trometamol. In case of confirmation of the diagnosis, it is necessary to immediately begin the appropriate treatment, in this case, drugs that inhibit peristalsis are contraindicated.

Simultaneous food intake slows down the absorption of fosfomycin. Therefore, it is desirable 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 sucrase-isomaltase deficiency.

Release form

Granules for the preparation of oral solution.