Phosphoral granules for oral solution 3 g, package 8 g No. 1

Instructions Phosphoral granules for oral solution 3 g package 8 g No. 1

Composition

active ingredient: fosfomycin;

1 packet contains 5.631 g of fosfomycin trometamol, which is equivalent to 3 g of fosfomycin;

excipients: tangerine flavoring, orange flavoring, saccharin, sucrose.

Dosage form

Granules for oral solution.

Main physicochemical properties: white granular powder with a characteristic fruity odor (orange-mandarin).

Pharmacotherapeutic group

Antimicrobial agents for systemic use.

Other antimicrobial agents. ATX code J01X X01.

Pharmacological properties

Pharmacodynamics

Phosphoral has a broad spectrum of antibacterial activity. It is effective against the most commonly isolated strains of urinary tract infections: Escherichia coli, Citrobacter spp., Klebsiella spp., Proteus spp., Serratia spp., Pseudomonas aeruginosa and Enterococcus faecalis – even if they are resistant to other antibacterial drugs. The drug also acts on penicillinase-producing strains. Phosphoral has an anti-adhesive effect on bacteria that have the property of adhesion to the epithelium lining the urinary tract.

Pharmacokinetics

Phosphoral is easily absorbed from the gastrointestinal tract, the maximum concentration in the blood plasma is observed after 2 hours and is 30-35 μg/ml, the half-life from plasma is 2 hours. Phosphoral is not metabolized in the body, it is excreted by glomerular filtration in a biologically active form. Phosphoral accumulates mainly in the kidneys at a concentration of 2500-3500 μg/ml, and its minimum inhibitory concentration for Escherichia coli is 128 μg/ml. Enterohepatic circulation of Phosphoral allows you to maintain the therapeutic level of the drug for 48 hours, this time is sufficient for urine sterilization and recovery.

Indication

Treatment of acute uncomplicated lower urinary tract infections caused by organisms susceptible to fosfomycin in males and females aged 12 years and older and adult women. Prophylaxis during diagnostic procedures and surgical interventions in adult patients.

Contraindication

Hypersensitivity to the components of the drug, severe renal failure (creatinine clearance < 10 ml/min), children under 12 years of age, undergoing hemodialysis.

Interaction with other medicinal products and other types of interactions

Concomitant administration with metoclopramide reduces the absorption of Phosphoral, which leads to a decrease in the concentration of Phosphoral in blood serum and urine.

Application features

The use of broad-spectrum antibiotics, including fosfomycin trometamol, can lead to the development of antibiotic-associated colitis (including pseudomembranous colitis). Therefore, the possibility of this diagnosis should be considered in patients who develop severe diarrhea during or after taking fosfomycin trometamol. If the diagnosis is confirmed, appropriate treatment should be initiated immediately. 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 contains sucrose. Diabetics and those who need to follow a diet should take into account that 1 packet of Phosphoral contains 2.213 g of sucrose. Phosphoral should not be used in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrose-isomaltase deficiency.

Ability to influence reaction speed when driving vehicles or other mechanisms

There is no data confirming the effect on reaction rate.

Use during pregnancy or breastfeeding

During pregnancy, the use of the drug is possible if necessary, when the expected effect of therapy for the mother outweighs the potential risk to the fetus.

Fosfomycin trometamol is not known to be teratogenic or fetotoxic. Animal studies have also shown no reproductive toxicity.

During breastfeeding, the use of the drug should be discontinued. Studies on use during breastfeeding have not been conducted.

Method of administration and doses

Phosphoral should be taken orally on an empty stomach, preferably before bedtime after emptying the bladder. Dissolve the contents of the sachet in ½ glass of water. The dosage regimen is determined by the doctor.

Usually, a single dose for adults, including elderly patients (up to 75 years of age), in the acute phase of the disease is 3 g (1 packet) once.

To prevent urinary tract infections during surgery and transurethral diagnostic studies, take the contents of 1 packet 3 hours before the intervention and the second packet 24 hours after the intervention.

Children

Possible use for the treatment of acute uncomplicated lower urinary tract infections in girls aged 12 years and older.

There is insufficient data on the therapeutic use of the drug in boys aged 12 years and older, nor is there sufficient data on the prophylactic use of the drug in both boys and girls.

Overdose

Symptoms: vestibular disorders, hearing loss, metallic taste in the mouth, and a general decrease in taste perception.

Treatment: symptomatic and supportive therapy. It is recommended to drink plenty of fluids to increase diuresis.

Adverse reactions

The most common adverse reactions with a single dose of fosfomycin trometamol include gastrointestinal disturbances, mainly diarrhea. These phenomena are most often short-lived and resolve spontaneously.

The frequency of side effects is determined as follows:

very common (> 1/10); common (> 1/100 - <1/10); uncommon (> 1/1000 - <1/100); rare (> 1/10000 - <1/1000); very rare (<1/100000); unknown (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Adverse reactions and their frequency of development

Expiration date

3 years.

Storage conditions

Store in the original packaging at a temperature not exceeding 30 °C.

Packaging

3 g per bag, 1 bag per cardboard pack.

Vacation category

According to the recipe.

Producer

Labiana Pharmaceuticals, S.L.U.

Location of the manufacturer and its business address

C/Casanova, 27-31, Curbera da Llubragat, 08757, Barcelona, Spain.