Active substanceErythromycinErythromycin
Dosage form: & nbspenteric coated tablets
Composition:1 tablet contains:

active substance: erythromycin (100% substance) 0.1 g and 0.25 g;

Excipients: potato starch, polyvinylpyrrolidone, tween 80, calcium stearate;

sheath: methacrylic acid copolymer, titanium dioxide, 1,2-propylene glycol, talc.

Description:The tablets are biconvex, white or white with a grayish shade of color, round.
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 ribosomes in its donor part, which disrupts the formation of peptide bonds between amino acid molecules and blocks the synthesis of proteins of microorganisms (does not affect the synthesis of nucleic acids). When used in high doses, it may exhibit bactericidal action. The spectrum of action includes gram positive (Staphylococcus spp., producing and not 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. (in t.h. Mycoplasma pneumoniae), Chlamydia spp. (in t.h. Chlamydia trachomatis), Treponema spp., Rickettsia spp., Entamoeba histolytica, Listeria monocytogenes.

Gram-negative rods are stable: Escherichia coli, Pseudomonas aeruginosa, and Shigella spp., Salmonella spp. and etc. Sensitive groups include microorganisms whose growth is delayed at an antibiotic concentration of less than 0.5 mg / l, medium sensitivity - 1-6 mg / l, moderately resistant and stable - 6-8 mg / l.

Pharmacokinetics:

Absorption is high. The ingestion of food does not affect the oral forms of erythromycin in the form of a base, covered with an enteric membrane. The maximum concentration (CmOh) is achieved after oral administration in 2-4 hours. Communication with plasma proteins is 70-90%.

Bioavailability is 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 the tissues of the lungs, lymph nodes, exudate of the middle ear, the secret of the prostate, sperm,pleural cavity, ascites and synovial fluid. The milk of lactating women contains 50% of the concentration in the plasma. Poor penetrates through the blood-brain barrier, into the spinal fluid (its concentration is 10% of the content of the drug in the plasma). In inflammatory processes in the membranes of the brain, their permeability for erythromycin slightly increases. It penetrates the placental barrier and enters the blood of the fetus, where its content reaches 5-20% of the content in the mother's plasma.

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) after oral administration - 2-5%.

Indications:

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

Prevention of exacerbations of streptococcal infection (tonsillitis, pharyngitis) in patients with rheumatism.

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

Contraindications:

Hypersensitivity, hearing loss, simultaneous reception of terfenadine or astemizole, lactation period.

Carefully:

Arrhythmias (in the anamnesis), lengthening of the interval QT, jaundice (history), hepatic and / or renal insufficiency.

Pregnancy and lactation:

In connection with the possibility of penetration into breast milk, it is necessary to refrain from breast-feeding while prescribing erythromycin.

Dosing and Administration:

Inside.

A single dose for adults and adolescents over the age of 14 is 0.25-0.5 g, daily - 1-2 g. The interval between prescribing is 6 hours. In severe infections, the daily dose can be increased to 4 g.

Children from 4 months to 18 years, depending on the age, body weight and severity of infection - 30-50 mg / kg / day in 2-4 admission; children of the first 3 months of life - 20-40 mg / kg / day. In case of more severe infections, the dose can be doubled.

For the treatment of diphtheria carriage - 0.25 g 2 times a day. The course dose for the treatment of primary syphilis is 30-40 g, the duration of treatment is 10-15 days.

With amoebic dysentery adults - 0.25 grams 4 times a day, children - 30-50 mg / kg / day; the duration of the course is 10-14 days.

In legionellosis, 0.5-1 g four times a day for 14 days.

With gonorrhea - 0.5 g every 6 hours for 3 days, then 0.25 g every 6 hours for 7 days.

For preoperative preparation of the intestine in order to prevent infectious complications - inside, 1 g for 19 hours, 18 hours and 9 hours before the start of surgery (only 3 g).

To prevent streptococcal infection (with tonsillitis, pharyngitis), adults - 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 - 0.5 g 4 times a day for at least 7 days or (if the tolerance is poor) - 0.25 g 4 times a day for at least 14 days.

In adults, with uncomplicated clamidiosis and intolerance to tetracyclines - 0.5 g 4 times a day for at least 7 days.

Side effects:

Hypersensitivity reactions: skin allergic reactions (hives, other forms of rash), eosinophilia, rarely anaphylactic shock.

Nausea, vomiting, gastralgia, tenesmus, abdominal pain, diarrhea, dysbacteriosis, rarely oral candidiasis, pseudomembranous enterocolitis (both during and after treatment), liver dysfunction, cholestatic jaundice, increased activity of "liver" transaminases, pancreatitis , hearing loss and / or tinnitus (when using high doses - more than 4 g / day, hearing loss after withdrawal of the drug is usually reversible).

Rarely - tachycardia, lengthening of the interval QT on ECG, ventricular arrhythmias, including ventricular tachycardia (of the "pirouette" type), in patients with an elongated interval QT.

Overdose:

Symptoms: impaired liver function, up to acute liver failure, hearing loss.

Treatment: Activated carbon, careful monitoring of the state of the respiratory system. Gastric lavage is effective when taking a dose five times higher than the average therapeutic dose. Hemodialysis, peritoneal dialysis, forced diuresis are ineffective.

Interaction:

Drugs that block tubular secretion, lengthen T1/2 erythromycin.

Incompatible with lincomycin, clindamycin and chloramphenicol (antagonism).

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

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 the plasma may increase (it is an inhibitor of microsomal liver enzymes).

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.

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

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

With a joint appointment with lovastatinum, rhabdomyolysis is increased.

Increases the bioavailability of digoxin.

Reduces the effectiveness of hormonal contraception.

Special instructions:

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 probability of development of 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 urine and the activity of "liver" transaminases in the blood (colorimetric determination with the help of de-nylhydrazine).

Form release / dosage:Tablets coated with a coat, 100 mg and 250 mg.
Packaging:

10 tablets per contour cell pack.

For 1, 2 contour mesh packages along with the instruction for use are placed in a pack of cardboard.

10, 20 tablets in dark glass jars, polymeric jars, plastic bottles.

Storage conditions:

In a dry place inaccessible to children, at a temperature not exceeding 25 ° C.

In the dark place.

Shelf life:2 years.
Do not use after the expiry date printed on the package.
Terms of leave from pharmacies:On prescription
Registration number:P N002712 / 01-2003
Date of registration:07.10.2008
The owner of the registration certificate:BRYNTSALOV-A, CJSC BRYNTSALOV-A, CJSC Russia
Manufacturer: & nbsp
Representation: & nbspBRYNTSALOV-A, CJSCBRYNTSALOV-A, CJSC
Information update date: & nbsp30.09.2015
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