Active substanceErythromycinErythromycin
Dosage form: & nbspenteric coated tablets
Composition:

1 tablet contains:

Active substance:

Erythromycin (in terms of the active substance)

250 mg

Excipients:

Tween-80 (polysorbate)

5.8 mg

Calcium stearate

4.5 mg

Polyvinylpyrrolidone (povidone)

29.6 mg

Croscarmellose sodium

9.0 mg

Potato starch

Before receiving the tablet

without shell by mass

450.0 mg

Shell accessories:

Titanium dioxide

0.5 mg

1,2-Propyleneglycol

2.3 mg

Kollikut MAE 100P

15.1 mg

Talc

4.1 mg

Description:

Biconvex tablets covered with white or white coating with a grayish shade of color.

Pharmacotherapeutic group:antibiotic-macrolide
ATX: & nbsp

S.01.A.A.17   Erythromycin

J.01.F.A.01   Erythromycin

Pharmacodynamics:

Bacteriostatic antibiotic from the group of macrolides, reversibly binds to 50S subunit of bacterial ribosomes, blocks protein synthesis, prevents the growth and multiplication of bacteria (does not affect the synthesis of nucleic acids).In high doses can exhibit bactericidal action. The activity spectrum includes gram positive (Staphylococcus spp., producing and non-producing penicillinase, incl. Staphylococcus aureus; Streptococcus spp. (incl. Streptococcus pneumoniae, Streptococcus pyogenes), alpha-hemolytic streptococcus (groups Viridans), Bacillus anthracis, Corynebacterium diphtheriae, Corynebacterium minutissimum) and gram-negative microorganisms (Neisseria gonorrhoeae, Haemophilus influenzae, Bordetella pertussis, Brucella spp., Legionella spp., incl. Legionella pneumophila) and other microorganisms: Mycoplasma spp. (incl. Mycoplasma pneumoniae), Chlamydia spp. (incl. Chlamydia trachomatis), Treponema spp., Rickettsia spp., Protozoa: Entamoeba histolytica, Listeria monocytogenes.

To erythromycin, gram-negative are stable: Escherichia coli, Pseudomonas aeruginosa, a also Shigella spp., Salmonella spp. and others. Sensitive groups include microorganisms whose growth is delayed at an antibiotic concentration of less than 0.5 mg / L, moderate sensitivity -1-6 mg / L, moderately resistant and resistant-6-8 mg / L.

Pharmacokinetics:

Absorption is high. The intake of food has no effect on the absorption of erythromycin in tablets coated with an enteric coating. The maximum concentration (CmOh) is achieved in 2-4 hours. The connection with plasma proteins is 70-90%. Bioavailability - 30-65%. In the body it is distributed unevenly. In large quantities, it accumulates in the liver, spleen, kidneys. In bile and urine, the concentration is tens of times higher than the concentration in the plasma.It penetrates well into lung tissue, lymph nodes, middle ear, secretion of the prostate, sperm, pleural cavity, ascites and synovial fluid. In the milk of lactating women, the erythromycin concentration is 50% of the serum. Poorly penetrates the blood-brain barrier.

In inflammatory processes in the membranes of the brain, their permeability for erythromycin slightly increases. Penetrates through the placental barrier.

Metabolised in the liver (more than 90%), partially with the formation of inactive metabolites. The half-life (T1/2) - 1,4-2 hours, with anuria 4-6 hours. Excretion with bile - 20-30% unchanged, kidneys (unchanged) - 2-5%.

Indications:

Infectious-inflammatory diseases caused by sensitive microflora: diphtheria (including bacteriocarrier), whooping cough (including prophylaxis), trachoma, brucellosis, legionnaires, erythrasma, listeriosis, scarlet fever, amoebic dysentery, gonorrhea; genitourinary infections in pregnant women caused by Chlamydia trachomatis; uncomplicated chlamydia in adults (with localization in the lower sections of the urogenital tract and rectum), with intolerance or inefficiency of tetracyclines, etc .; infection of ENT organs(tonsillitis, otitis, sinusitis); bile duct infection (cholecystitis); infections of the upper and lower respiratory tract (tracheitis, bronchitis, pneumonia); infections of the skin and soft tissues (juvenile acne, infected wounds, pressure sores, burns II-III st, trophic ulcers), infections of the conjunctiva.

Infections caused by streptococci (tonsillitis, pharyngitis).

Prevention of infectious complications in medical and diagnostic procedures (including dental interventions, endoscopy, in patients with heart defects).

Treatment of infectious-inflammatory diseases caused by pathogens (in particular Staphylococcus spp.), resistant to penicillin, tetracycline, chloramphenicol, streptomycin.

Contraindications:

Hypersensitivity, significant hearing loss, simultaneous reception of terfenadine or astemizole, lactation period, children under 3 years (for this dosage form).

Carefully:

Arrhythmias (in the anamnesis), lengthening of the interval Q-T, renal failure, pregnancy, lactation.

Dosing and Administration:

Inside.

Single dose for adults and adolescents, over 14 years, is 250-500 mg, daily -1.2 g. The interval between prescription is 6 hours.In severe infections, the daily dose can be increased to 4 g.

Children from 3 to 18 years, depending on the age, body weight and severity of infection - 30-50 mg / kg / day in 3-4 hours. In case of more severe infections, the dose can be doubled.

For the treatment of diphtheria carriage - 250 mg twice a day.

With amoebic dysentery adults - 250 mg 4 times a day, children - 30-50 mg / kg / day; the duration of the course is 10-14 days.

When legionellosis - 500-1000 mg 4 times a day for 14 days.

With gonorrhea - 500 mg every 6 hours for 3 days, then 250 mg every 6 hours for 7 days.

In tonsillitis, adults with pharyngitis - 20-50 mg / kg / day, children - 20-30 mg / kg / day, the course duration - at least 10 days.

For prevention of septic endocarditis in patients with heart defects, 1 g for adults and 20 mg / kg for children, 1 hour before the therapeutic or diagnostic procedure, then 0.5 g for adults and 10 mg / kg for children, again in 6 hours.

In whooping cough - 40-50 mg / kg / day for 5-14 days.

When pneumonia in children - 50 mg / kg / day in 4 divided doses, for at least 3 weeks.

When urogenital infections during pregnancy - 500 mg 4 times a day for 7 days or (with tolerability) - 250 mg 4 times a day for 14 days.

In adults, with uncomplicated chlamydia and intolerance to tetracyclines - 500 mg 4 times a day for at least 7 days.

Side effects:

From the digestive system: nausea, vomiting, gastralgia, abdominal pain, tenesmus, diarrhea, dysbacteriosis, rarely - candidiasis of the oral cavity, pseudomembranous enterocolitis, impaired liver function, cholestatic jaundice, increased activity of "liver" transaminases, pancreatitis.

From the organs of hearing: ototoxicity - hearing loss and / or tinnitus (when applied at high doses - more than 4 g / day, usually reversible).

From the side of the cardiovascular system: lengthening the interval QT on ECG, flicker and / or atrial flutter (in patients with an elongated interval QT on the ECG).

Allergic reactions: urticaria, other forms of skin rash, eosinophilia, rarely anaphylactic shock.

Overdose:

Symptoms: a violation of the liver, up to acute liver failure, rarely - hearing impairment.

Treatment: Activated carbon, careful monitoring of the state of the respiratory system (if necessary - ventilation), CBS and electrolyte exchange, ECG. Gastric lavage is effective when taking a dose five times higher than the average therapeutic dose. Hemodialysis, peritoneal dialysis and forced diuresis are ineffective.

Interaction:

Reduces the bactericidal action of beta-lactam antibiotics (penicillins, cephalosporins, carbapenems).

Increases the nephrotoxicity of cyclosporine (especially in patients with concomitant renal failure).

Reduces the clearance of triazolam and midazolam, and therefore can enhance the pharmacological effects of benzodiazepines.

Slows down the elimination (increases the effect) of methylprednisolone, felodipine and anticoagulants of the coumarin series.

Increases the bioavailability of digoxin.

Reduces the effectiveness of hormonal contraception.

Drugs that block tubular secretion, prolong the half-life of erythromycin.

With simultaneous administration with drugs metabolized in the liver (theophylline, carbamazepine, valproic acid, hexobarbital, phenytoin, alfentanil, disopyramide, lovastatin, bromocriptine), the concentration of these drugs in plasma may increase (it is an inhibitor of microsomal liver enzymes).

With simultaneous reception with terfenadine or astemizole - the possibility of arrhythmia development, with dihydroergotamine or dehydrated ergot alkaloids - vasoconstriction before spasm, dysesthesia.

Incompatible with chloramphenicol (antagonism).

With a joint appointment with lovastatinum, rhabdomyolysis is increased.

Special instructions:

In connection with the possibility of penetration into breast milk, breastfeeding should be stopped with the administration of erythromycin.

With prolonged therapy, it is necessary to monitor the laboratory parameters of liver function.

Symptoms of cholestatic jaundice can develop a few days after the start of therapy, but the risk of developing increases after 7-14 days of continuous therapy. The likelihood of developing an ototoxic effect is higher in patients with renal and hepatic insufficiency, as well as in elderly patients.

Some resistant strains Haemophilus influenzae are sensitive to the simultaneous administration of erythromycin and sulfonamides.

May interfere with the determination of catecholamines in the urine and the activity of "hepatic" transaminases in the blood (colorimetric determination with the help of de-nylhydrazine).

Form release / dosage:

Intestine-soluble film coated tablets, 250 mg.

Packaging:

For 10 tablets in a contour mesh box made of polyvinyl chloride film and aluminum foil foil lacquered.

For 10 tablets in a contour mesh box made of polyvinyl chloride film and aluminum foil foil lacquered and flexible packaging in rolls on the basis of aluminum foil for medicines.

For 10 or 20 tablets in cans of polymer or in polymeric bottles.

Each jar, bottle, 1, 2 contour mesh packages together with the instruction for use is placed in a pack of cardboard.

Storage conditions:

Store 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:LSR-009315/08
Date of registration:25.11.2008
The owner of the registration certificate:AVVA RUS, OJSC AVVA RUS, OJSC Russia
Manufacturer: & nbsp
Representation: & nbspAVVA ENG JSC AVVA ENG JSC Russia
Information update date: & nbsp30.09.2015
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