Universal reference book for medicines
Name of the preparation: ECOFOMURAL ® (ECOFOMURAL)

Active substance: fosfomycin

Type: Antibiotic group of phosphonic acid derivatives

Manufacturer: AVVA PHARMACEUTICALS (Switzerland) produced by АВВА РУС (Russia)
Composition, form of production and packaging
Granules for the preparation of a solution for ingestion of
white or almost white, with a strawberry odor.

1 pack.

phosphomycin trometamol 3.752 g,

which corresponds to the content of phosphomycin 2 g

Excipients: lactulose - 1 g, sodium saccharinate - 0.01 g, strawberry flavor - 0.07 g, maltitol - up to weight 6 g.

6 g - single-use packages from the packaging multilayer (1) - cardboard package.

Granules for the preparation of a solution for ingestion of white or almost white, with a strawberry odor.

1 pack.

phosphomycin trometamol 5.629 g,

which corresponds to the content of phosphomycin 3 g

Excipients: lactulose - 1.5 g, sodium saccharinate - 0.016 g, strawberry flavor - 0.07 g, maltitol - up to 8 g.

8 g - single-use packages from the packaging multilayer (1) - cardboard package.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2016.

PHARMACHOLOGIC EFFECT

Ecofomural® (active substance: phosphomycin) is a broad-spectrum antibiotic, a phosphonic acid derivative.

Phosphomycin, as a structural analogue of phosphoenol pyruvate, inactivates the enzyme N-acetyl-glucosamine-3-o-enolpyruvyl transferase, irreversibly blocks the condensation of uridine-diphosphate-N-acetyl-glucosamine with phosphoenol pyruvate, inhibits the synthesis of UDP-N-acetylmuric acid, the initial stage of peptidoglycan formation of the bacterial cell wall is suppressed, and as a result, the microbial cell death (bactericidal action) occurs.
Inactivation of the enzyme N-acetyl-glucosamine-3-o-enolpyruvl transferase reduces the likelihood of cross-resistance to antibiotics with a similar mechanism of action and creates conditions for synergism (in vitro experiments a synergistic effect with amoxicillin, cephalexin, pipemidic acid) was revealed. In vitro, Gram-positive (Staphylococcus saprophyticus, Enterococcus faecalis) and Gram-negative (Escherichia coli, Klebsiella pneumonia, Citrobacter spp., Enterobacter spp., Proteus mirabilis) microorganisms are sensitive to phosphomycin.
In vitro phosphomycin reduces the adhesion of a number of bacteria to the epithelium of the urinary tract.

PHARMACOKINETICS

Suction

Fosfomycin is rapidly absorbed from the digestive tract by oral ingestion.
In the body dissociates into phosphomycin and trometamol. The latter does not have antibacterial properties. Bioavailability of a single oral dose of 3.0 g is from 34% to 65%. C max in plasma is observed after 2-2.5 h (T max ) after oral administration and is 22-32 mg / l.
Distribution and Metabolism

Phosphomycin does not bind to plasma proteins, is not metabolized in the body, accumulates in the urine.
With oral intake of a single dose of 3.0 g in urine, a high concentration of antibiotic (from 1053 to 4415 mg / l) is achieved, 99% bactericidal for most common pathogens of urinary tract infections. The minimum inhibitory concentration of phosphomycin for these pathogens is 128 mg / l and is maintained in the urine for 24-48 hours, which implies a one-day course of treatment with a single administration of the drug.
Excretion

T 1/2 from the blood plasma is 4 hours. 90% of phosphomycin is excreted by the kidneys in an unchanged form with the creation of high concentrations in the urine.About 10% of the accepted dose of the drug is excreted through the intestine in an unchanged form.

Pharmacokinetics in special clinical cases

In patients with moderately reduced renal function (CC <80 ml / min), including age-related physiological decline in renal function (elderly persons), T 1/2phosphomycin is prolonged, but the concentration in the urine remains at the therapeutic level.

INDICATIONS

Bacterial infections of the urinary tract of various locations, caused by microorganisms sensitive to phosphomycin:

- Acute uncomplicated urinary tract infections;

- asymptomatic bacteriuria;

- prevention of urinary tract infections after surgery and transurethral diagnostic tests.

DOSING MODE

Ecofomural ® is applied once, on an empty stomach, 2-3 hours before or after a meal, preferably before going to bed, pre-emptying the bladder.

The contents of the package are dissolved in 1/4 cup of water.

Adults and children over 12 years of age the drug is prescribed in a daily dose of 3.0 g, children aged 5 to 12 years - in a daily dose of 2.0 g.

The course of treatment is 1 day.

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.

SIDE EFFECT

Possible disorders

On the part of the digestive system: nausea, heartburn, diarrhea, vomiting, dyspepsia, pseudomembranous colitis, abdominal pain, increased activity of hepatic transaminases.

From the cardiovascular system: tachycardia, lowering blood pressure.

On the part of the nervous system: headache, dizziness, asthenia, paresthesia (sensation of numbness of the skin, "crawling crawling"), optic neuritis.

Allergic reactions: skin rash, allergic reactions, itching, bronchial asthma, angioedema, hives, anaphylactic shock.

Other: vulvovaginitis, thrombocytosis, leukopenia.

CONTRAINDICATIONS

- hypersensitivity to phosphomycin or other components of the drug;

- severe renal failure (CC <10 ml / min);

- Children's age till 5 years;

- deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption.

PREGNANCY AND LACTATION

In pregnancy, the drug is used only if the intended benefit to the mother exceeds the potential risk to the fetus.

When prescribing the drug during lactation it is necessary to stop breastfeeding for the duration of therapy.

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated use of the drug in severe renal failure (CC <10 ml / min).

APPLICATION FOR CHILDREN

Contraindicated use of the drug in childhood to 5 years.

SPECIAL INSTRUCTIONS

Taking Ekofomural® with food leads to a slowing of its absorption, and therefore, it is recommended to take the drug 2-3 hours before or after eating.

During or after treatment with phosphomycin, diarrhea may occur, in this case, the diagnosis of pseudomembranous colitis should be excluded, which requires the appointment of appropriate treatment.
Contraindicated in the use of drugs that suppress the intestinal peristalsis.
Patients with diabetes should take into account that the drug includes maltitol.
For the metabolism of maltitol, insulin is needed, but, due to its slow and poor absorption from the gastrointestinal tract, maltholit slightly affects the concentration of glucose in the plasma, so correction of the dose of hypoglycemic drugs is not required.
Due to the content of maltitol, Ecofomural® is not recommended for patients with hereditary intolerance to fructose.

Impact on the ability to drive vehicles and manage mechanisms

Patients should be warned about the possibility of developing dizziness.
When dizziness occurs, you should refrain from performing these activities.
OVERDOSE

Symptoms: diarrhea, vestibular syndrome, hearing loss, "metallic" taste and general taste disorders.

Treatment: with persistent diarrhea, symptomatic treatment is prescribed.
In case of an overdose, it is recommended to increase the diuresis by taking the liquid inside.
DRUG INTERACTION

You should avoid simultaneous reception with metoclopramide, antacids, or preparations containing calcium salts, because
this can lead to a decrease in the concentration of phosphomycin in serum and urine.
Simultaneous reception with other drugs that increase motility of the gastrointestinal tract, can also lead to a decrease in the concentration of phosphomycin in serum and urine.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored in a place protected from moisture and light, inaccessible to children at a temperature of no higher than 25 ° C.
Shelf life - 2 years. Do not use after the expiration date.
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