Ecofomurals - instructions for use, doses, side effects, contraindications

active substance: phosphomycin trometamol (in terms of 100% substance) - 3.752 g (5.629 grams in terms of phosphomycin - 2.0 g / 3.0 g; Excipients: lactulose - 1,000 g / 1,500 g, sodium saccharinate - 0.010 g / 0.016 g, strawberry flavoring - 0.070 g / 0.070 g, maltitol - up to a weight of 6.0 g / weight of 8.0 g.

Description:

A mixture of powder and granules from white to light yellow with a strawberry odor.

Pharmacotherapeutic group:Antibiotic

ATX: & nbsp

J.01.X.X.01 Phosphomycin

Pharmacodynamics:

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

Ecofomural®, being a structural analogue of pyruvate phosphoenol, inactivates the enzyme N-acetyl-glucosamino-3-o-enolpyruvyl transferase, irreversibly blocks the condensation of uridine diphosphate-N-acetyl-glucosamine with phosphoenol pyruvate, inhibits the synthesis of UDF-N-acetylmuramic acid, as a result of which 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-glucosamino-3-o-enolpyruvyl transferase reduces the likelihood of cross-resistance to antibiotics with a similar mechanism of action and creates the conditions for synergism (in experiments in vitro the synergistic effect with amoxicillin, cephalexin, pipemidinic acid was revealed).

In vitro to phosphomycin are sensitive Gram-positive (Staphylococcus saprophyticus, Enterococcus faecalis) and Gram-negative (Escherichia coli, Klebsiella pneumonia, Citrobacler spp., Enterobacter spp., Proteus mirabilis) microorganisms.

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 gastrointestinal 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%. The maximum concentration in plasma (Cmax) is observed after 2-2.5 hours (Tmah.) after oral administration and is 22-32 mg / l (CmOh.). The half-life of plasma is 4 hours.

Distribution:

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, to 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:

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 intestine unchanged. In patients with moderately reduced renal function (creatinine clearance <80 ml / min),including age-related physiological decline in kidney function (elderly persons), the half-life of phosphomycin 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 susceptible to phosphomycin: acute uncomplicated urinary tract infections; asymptomatic bacteriuria; prevention of urinary tract infections after surgery and transurethral diagnostic studies.

Contraindications:

Hypersensitivity to fosfomycin or other components of the drug, severe renal failure (creatinine clearance <10 ml / min), children under 5 years of age, sugar / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

Pregnancy and lactation:When pregnancy is used only if the intended benefit for 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.

Dosing and Administration:

Ecofomural® is applied once, on an empty stomach, 2-3 hours before or after meals, preferably before going to bed, previously emptying the bladder: adults and children over 12 years of age in a daily dose of 3.0 g, children from 5 to 12 lay in a daily dose of 2.0 g. The contents of the package are dissolved in ½ a glass of water

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 effects:

Disorders from the gastrointestinal tract (nausea, heartburn, diarrhea), skin rashes, allergic reactions, headache, dizziness, asthenia, paresthesia (sensation of numbness of the skin, "crawling crawling"), optic neuritis, tachycardia, lowering of blood pressure , itchy skin, bronchial asthma, angioedema, urticaria, anaphylactic shock, vomiting, dyspepsia, pseudomembranous colitis, abdominal pain, increased activity of "liver" transaminases, vulvovaginitis, thrombocytosis, and leukopenia.

Overdose:

Symptoms of overdose are diarrhea, vestibular syndrome, hearing impairment,"metallic" taste and general taste disorders. With persistent diarrhea, symptomatic treatment is prescribed.

In case of an overdose, it is recommended to increase the diuresis by taking the liquid inside.

Interaction:

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

Special instructions:

Admission Ekofomurala® during meals leads to a slowing of its absorption, in connection with which, 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, because of its slow and poor absorption from the gastrointestinal tract, maltitol 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.

Effect on the ability to drive transp. cf. and fur:Patients should be warned about the possibility of developing dizziness, and when dizziness occurs, one should refrain from performing these activities.

Form release / dosage:

Granules for solution for oral administration, 2.0 g and 3.0 g.

Packaging:

By 6.0 g (for a dosage of 2.0 g) and 8.0 g (for a dosage of 3.0 g) into single-use packages from a multi-layer packaging material (polyethylene terephthalate-polypropylene-aluminum-polyethylene). For 1 package, together with instructions for use, put in a pack of cardboard.

Storage conditions:

In a place protected from moisture and light, at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-003302

Date of registration:10.11.2015

Expiration Date:10.11.2020

The owner of the registration certificate:ABVA Pharmaceuticals AGABVA Pharmaceuticals AG Switzerland

Manufacturer: & nbsp

AVVA RUS, OJSC Russia

Representation: & nbspAVVA ENG JSC AVVA ENG JSC Russia

Information update date: & nbsp15.03.2017

Illustrated instructions

Instructions

Ecofomural® (Ecofomural®)