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Pharmacological properties

fosfomycin trometamol - a broad-spectrum antibiotic, a derivative of phosphonic acid. the mechanism of action is associated with blocking the first stage of the synthesis of the bacterial cell wall. a specific mechanism for the inhibition of enolpiruvyl transferase prevents the development of cross-resistance with other antibiotics.

Effective against gram-positive and gram-negative strains of microorganisms, including penicillin-forming, and the main strains - causative agents of urinary tract infections: E. coli, Proteus, Klebsiella, Enterobacter, Staphylococcus, Streptococcus and other resistant strains.

Pharmacokinetics Espa-focin is well absorbed in the digestive tract. Cmax in blood plasma (20-30 μg / ml) is achieved 2–2.5 hours after administration. In urine, the therapeutic concentration persists for 48 hours.

Indications

Treatment of acute uncomplicated urinary tract infections caused by microorganisms sensitive to fosfomycin in adult patients and in girls over the age of 12 years. prevention of infectious diseases during diagnostic procedures and surgical interventions in adult patients.

Application

Apply inside on an empty stomach. the contents of the bag are dissolved in 125 ml (½ cup) of cold water, stirred until completely dissolved and drunk. the dose is set individually.

Typically, a single dose for adults (including elderly patients) and girls over the age of 12 years in the acute phase of the disease is 3 g of phosphomycin (1 packet) once.

In order to prevent urinary tract infection during surgery, transurethral diagnostic tests take 3 g of phosphomycin (1 packet) 3 hours before the intervention and 3 g of phosphomycin (1 packet) 24 hours after the intervention.

Contraindications

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

Side effects

The most common adverse reactions with a single dose of trometamol fosfomycin include dysfunction of the gastrointestinal tract, mainly diarrhea. these phenomena are most often short-lived and disappear on their own.

The frequency of side effects is determined as follows: very often (1/10); often (1 / 100–1 / 10); infrequently (1 / 1000–1 / 100); rarely (1/10 000–1 / 1000); very rarely (1/100 000); unknown (cannot be determined from the available data).

In each group, the frequency of adverse reactions is presented in order of decreasing severity.

System Classes

organs

Adverse reactions and their frequency of development
Often Infrequently Rarely Unknown
Infections and infestations Vulvovaginitis      
From the immune system       Anaphylactic shock, allergic reactions
From the nervous

the system

Headache, dizziness Paresthesia    
From the cardiovascular system     Tachycardia Arterial

hypotension

From the respiratory system, chest and mediastinal organs       BA
From the digestive system Diarrhea, nausea, digestive disorders Abdominal pain, vomiting   Pseudomembranous colitis
On the part of the skin and subcutaneous tissue   Urticaria, rash, itching   Angioedema
Systemic disorders   Fatigue    

special instructions

The use of broad-spectrum antibiotics, including fosfomycin trometamol, can lead to 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 taking tromethamol fosfomycin. if the diagnosis is confirmed, appropriate treatment should be started immediately. in this case, drugs that inhibit peristalsis are contraindicated.

Simultaneous eating slows down the absorption of fosfomycin. It is recommended to use on an empty stomach (1 hour before or 2 hours after eating).

For patients with diabetes mellitus and those who need to follow a diet, it should be borne in mind that 1 packet of Espafocin contains 2.213 g of sucrose. Also, the drug should not be used in patients with fructose intolerance, glucose-galactose malabsorption and sucrose-isomaltase deficiency.

Perhaps a transient increase in the activity of hepatic transaminases.

Clinical manifestations generally disappear on the 2nd or 3rd day of treatment. Sometimes certain symptoms may appear that do not indicate the absence of a therapeutic effect, but are a consequence of inflammatory processes.

Use during pregnancy and lactation. 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.

According to reports, fosfomycin trometamol does not have teratogenic and fetotoxic effects. Animal studies also did not reveal reproductive toxicity.

During breastfeeding, the drug is not used. Studies on the use during breastfeeding have not been conducted.

Children. Perhaps the use for the treatment of acute uncomplicated infections of the lower urinary tract in girls over the age of 12 years. There is insufficient data regarding the use of the drug for therapeutic purposes in boys over the age of 12 years, as well as regarding the use of the drug for prophylactic purposes in both boys and girls.

The ability to influence the reaction rate when driving vehicles or other mechanisms. There is no data.

Interactions

Concomitant use with metoclopramide reduces the absorption of fosfomycin, which leads to a decrease in the concentration of fosfomycin in blood plasma and urine.

Overdose

The package contains 1 package of the drug, so the risk of overdose is minimal. in case of an overdose, it is recommended to drink plenty of fluids (to increase diuresis). symptomatic treatment.

Storage conditions

At a temperature not exceeding 25 ° C.

Tags: Fosfomycin