Instructions for Urofoscin (Fosfomycin)
Release form Urofoscin:
Granules for preparation of oral solution.
Composition Urofoscin:
1 package contains:
Active ingredient: fosfomycin trometamol 3.754 g or 5.631 g (corresponds to fosfomycin 2.000 g or 3.000 g).
Excipients: sucrose 1.475 g or 2.213 g, sodium saccharinate 0.011 g or 0.016 g, tangerine flavor 0.047 g or 0.070 g, orange flavor 0.047 g or 0.070 g. Urofoscin (Fosfomycin)
Pharmaco-therapeutic group Urofoscin:
Antibiotic.
Pharmacological properties Urofoscin:
Granular powder of white or almost white color, with a weak citrus odor, not containing large agglomerates of sticky particles.
Indications for use Urofoscin:
Bacterial urinary tract infections of various localization caused by microorganisms sensitive to fosfomycin: acute uncomplicated urinary tract infections; asymptomatic bacteriuria; prevention of urinary tract infections after surgery and transurethral diagnostic tests.
Mode of application Urofoscin:
Urofoscin @ is used once, on an empty stomach, 2-3 hours before or after a meal, preferably before bedtime, having previously emptied the bladder: adults and children over 12 years old in a daily dose of 3 g, children from 5 to 12 years old in a daily dose of 2 g Dissolve the contents of the bag in 1/2 glass of water.
For the prevention of urinary tract infections, the diagnostic procedures are indicated 3 hours before the intervention and 24 hours after it.
The course of treatment is 1 day. Urofoscin (Fosfomycin)
Contraindications Urofoscin:
Hypersensitivity to fosfomycin or other components of the drug; severe renal failure (creatinine clearance <10 ml / min); children under 5 years old; deficiency of sucrase / isomaltase, fructose intolerance, glucose-galactose malabsorption.
Application during pregnancy and during breastfeeding
During pregnancy, the drug is prescribed only when the potential benefit to the mother outweighs the potential risk to the fetus. If necessary, the appointment of the drug during lactation should stop breastfeeding for the duration of treatment.
Side effects Urofoscin:
Possible disorders of the gastrointestinal tract (nausea, heartburn, diarrhea), skin rash, allergic reactions, headache, dizziness, asthenia, paresthesia (feeling of numbness of the skin, "creeping"), optic neuritis, tachycardia, lowering blood pressure , pruritus, bronchial asthma, angioedema, urticaria, anaphylactic shock, vomiting, dyspepsia, pseudomembranous colitis, abdominal pain, increased activity of hepatic transaminases, vulvovaginitis, thrombocytosis, leukopenia. Overdose Overdose
symptoms: diarrhea (if persistent diarrhea occurs, symptomatic treatment is recommended), vestibular syndrome, hearing impairment, "metallic" taste and general taste disturbances.
In case of an overdose, it is recommended to take liquid by mouth to increase urine output.
special instructions Urofoscin:
The occurrence of acute and persistent diarrhea during or after antibiotic treatment may be a symptom of antibiotic-induced colitis. The most serious form is pseudomembranous colitis.
In case of pseudomembranous colitis, appropriate measures must be taken immediately. In this case, the use of drugs that slow down peristalsis is contraindicated.
Simultaneous food intake slows down the absorption of Urofoscin, it is necessary to use the drug 2-3 hours before or after a meal.
Patients with diabetes mellitus should take into account that 1 package of Urofoscin @ with a dosage of 2 g or 3 g of fosfomycin contains 1.475 g or 2.213 g of sucrose, respectively.
Influence on the ability to control vehicles and mechanisms Patients should be warned about the possibility of dizziness development and, if dizziness occurs, they should refrain from performing these activities.
Drug interactions Urofoscin:
Simultaneous administration with metoclopramide, antacids or preparations containing calcium salts should be avoided, as this can lead to a decrease in the concentration of fosfomycin in serum and urine. Simultaneous administration with other drugs that increase the motility of the gastrointestinal tract can also lead to a decrease in the concentration of fosfomycin in serum and urine.
Terms of dispensing from pharmacies and shelf life
Store at a temperature not exceeding 25 ° C.
Keep out of the reach of children. Shelf life 3 years.
Do not use after the expiration date.
On prescription.
Description of the pharmacological action Urofoscin:
The active substance of Urofoscin @ - fosfomycin trometamol is a broad spectrum antibiotic, a derivative of phosphonic acid.
Urofoscin @ has a bactericidal effect. The mechanism of action is associated with the suppression of the first stage of the synthesis of the bacterial cell wall. Being a structural analogue of phosphoenol pyruvate, it enters into a competitive interaction with the enzyme PM-acetyl-glucosamine-3-o-enolpyruvyl transferase, as a result of which specific, selective and irreversible inhibition of this enzyme occurs, which ensures the absence of cross-resistance with other classes of antibiotics and the possibility synergism with other antibiotics (synergism with amoxicillin, cephalexin, pipemidic acid is noted in vitro). The antibacterial spectrum of action of fosfomycin trometamol in vitro includes most of the usual gram-positive (Enterococcus spp., Enterococcus faecalis, Staphylococcus aureus, Staphylococcus saprophyt., Staphylococcus spp. ) and gram-negative (E. coli, Citrobacter spp., Enterobacter spp., klebsiella spp., klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Pseudomonas spp., Serratia spp.) pathogens. In vitro fosfomycin trometamol reduces the adhesion of a number of bacteria to the epithelium of the urinary tract.
Description of pharmacokinetics Urofoscin:
Absorption: fosfomycin is rapidly absorbed from the gastrointestinal T6Ak4d when taken orally. In the body, it dissociates into [fosfomyCyћЈ \ dGmfoKGgtamol. The latter does not have antibacterial properties. Bioavailability with a single oral dose of 3 g ranges from 34 to 65 94. The maximum plasma concentration is observed 2-2.5 hours after oral administration and is 22-32 mg / l. The plasma half-life is 4 hours.
Distribution: fosfomycin does not bind to plasma proteins, is not metabolized, mainly accumulates in the urine. When a single dose of 3 g is taken orally, a high concentration is achieved in urine (from 1053 to 4415 mg / l), 99% bactericidal for most common causative agents of urinary tract infections. The minimum inhibitory concentration of fosfomycin for these pathogens is 128 mg / l. It is maintained in the urine for 24 to 48 hours, suggesting a single dose course of treatment. The concentration of fosfomycin in urine above the minimum inhibitory concentration for E. coli persists for at least 80 hours.
Excretion: 90% of fosfomycin is excreted by the kidneys unchanged with the creation of high concentrations in the urine. About 10% of the dose taken is excreted through the intestine unchanged.In patients with a moderate decrease in renal function (creatinine clearance <80 ml / min), including its physiological decrease in the elderly, the half-life of fosfomycin is slightly lengthened, but the concentration in urine remains at a therapeutic level.
Indications for use
Bacterial urinary tract infections of various localization caused by microorganisms sensitive to fosfomycin: acute uncomplicated urinary tract infections; asymptomatic bacteriuria; prevention of urinary tract infections after surgery and transurethral diagnostic tests.
