Erythromycin 250 mg 10 enteric-coated tablets

Bacterial infections caused by sensitive microflora: diphtheria (including carrier state), whooping cough (including prevention), trachoma, brucellosis, Legionnaires' disease, erythrasma, listeriosis, scarlet fever, amoebic dysentery, gonorrhea; conjunctivitis in newborns, pneumonia in children, urogenital infections in pregnant women caused by Chlamydia trachomatis.
Primary syphilis (in patients with penicillin allergy), uncomplicated chlamydia in adults (localized in the lower urogenital tract and rectum) in cases of intolerance or ineffectiveness of tetracyclines, etc.
Infections of the ENT organs (tonsillitis, otitis media, sinusitis).
Infections of the biliary tract (cholecystitis);
Infections of the upper and lower respiratory tracts (tracheitis, bronchitis, pneumonia);
Infections of the skin and soft tissues (purulent skin diseases, including acne vulgaris, infected wounds, pressure sores, burns II-III degree, trophic ulcers).
Infections of the mucous membrane of the eyes.
Prevention of exacerbations of streptococcal infection (tonsillitis, pharyngitis) in patients with rheumatism. Prevention of infectious complications during therapeutic and diagnostic procedures (including preoperative bowel preparation, dental interventions, endoscopy, in patients with heart defects).

Orally.
The single dose for adults and adolescents over 14 years is 0.25-0.5 g, with a daily dose of 1-2 g. The interval between doses is 6 hours. In cases of severe infections, the daily dose may be increased to 4 g.
For children aged 3 to 14 years, depending on age, body weight, and severity of the infection - 30-50 mg/kg/day in 2-4 doses. In cases of severe infections, the dose may be doubled.
For the treatment of diphtheria carriers - 0.25 g twice a day. The total dose for treating primary syphilis is 30-40 g, with a treatment duration of 10-15 days.
In cases of amoebic dysentery, adults - 0.25 g four times a day, children - 30-50 mg/kg/day; treatment duration - 10-14 days.
In cases of legionellosis - 0.5-1 g four times a day for 14 days.
In cases of gonorrhea - 0.5 g every 6 hours for 3 days, then 0.25 g every 6 hours for 7 days.
For preoperative bowel preparation to prevent infectious complications - orally, 1 g at 19 hours, 18 hours, and 9 hours before the operation (total 3 g).
For the prevention of streptococcal infection (in tonsillitis, pharyngitis) in adults - 20-50 mg/kg/day, in children - 20-30 mg/kg/day, treatment duration - at least 10 days.
For the prevention of septic endocarditis in patients with heart defects - 1 g for adults and 20 mg/kg for children, 1 hour before a therapeutic or diagnostic procedure, then 0.5 g for adults and 10 mg/kg for children, repeated after 6 hours.
In cases of whooping cough - 40-50 mg/kg/day for 5-14 days.
In cases of pneumonia in children - 50 mg/kg/day in 4 doses, for at least 3 weeks.
In cases of urogenital infections during pregnancy - 0.5 g four times a day for at least 7 days or (if poorly tolerated) - 0.25 g four times a day for at least 14 days.
In adults, for uncomplicated chlamydia and intolerance to tetracyclines - 0.5 g four times a day for at least 7 days.

Composition per tablet.
Active ingredient:
Erythromycin, calculated as 100% substance - 250 mg
Excipients of the core:
gelatin - 7.0 mg
calcium stearate - 4.4 mg
polysorbate 80 (Tween 80) - 1.05 mg
lactose monohydrate (milk sugar) - 45.76 mg
sodium carboxymethyl starch (Primojel), type A - 17.6 mg
potato starch - up to 440 mg
Excipients of the coating:
methacrylic acid and ethyl acrylate copolymer (1:1) (Kollicoat MAE 100R) - 18.41 mg
talc - 5.84 mg
povidone K-30 - 3.52 mg
titanium dioxide - 1.05 mg
polysorbate 80 (Tween 80) - 3.68 mg

Coated tablets, round in shape with biconvex surfaces, white or off-white in color.

Increased sensitivity to erythromycin, other components of the drug,
hearing loss,
simultaneous use of terfenadine, ergotamine, dihydroergotamine, astemizole, cisapride, pimozide,
children under 3 years of age,
breastfeeding period,
lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

With caution
Erythromycin may cause QT interval prolongation, arrhythmia (including history), jaundice (including history), liver and/or kidney failure, simultaneous use of hepatotoxic drugs, myasthenia gravis.
Caution should be exercised when co-administering erythromycin and colchicine (see "Special Instructions" section).

Use during pregnancy and breastfeeding.
The use of the drug during pregnancy is possible only when the expected benefit to the mother outweighs the potential risk to the fetus.
During the treatment with erythromycin, breastfeeding should be suspended.

During prolonged therapy, it is necessary to monitor laboratory indicators of liver function.
Symptoms of cholestatic jaundice may develop within a few days after the start of therapy; however, the risk increases after 7-14 days of continuous therapy. The likelihood of developing ototoxic effects is higher in patients with renal and hepatic insufficiency, as well as in elderly patients.
It may interfere with the determination of catecholamines in urine and the activity of "liver" transaminases in the blood (colorimetric determination using dinitrophenylhydrazine).
When co-administering colchicine and erythromycin, a dose adjustment of colchicine is necessary, along with careful monitoring of the patient's condition to detect signs of toxicity.
Concurrent use with statins may lead to the development of rhabdomyolysis and pseudomembranous colitis.
There are reports of the development of interstitial nephritis during treatment with erythromycin.
If symptoms of this condition manifest, appropriate measures should be taken.

Effects on the ability to drive vehicles and operate machinery
During treatment, caution should be exercised when driving motor vehicles and engaging in potentially hazardous activities that require increased attention and rapid psychomotor responses.

Hypersensitivity reactions: skin allergic reactions (urticaria, other forms of rash), eosinophilia, rarely - anaphylactic shock.
Nausea, vomiting, gastralgia, tenesmus, abdominal pain, diarrhea, dysbiosis, 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 (with high doses - over 4 g/day, hearing loss after discontinuation of the drug is usually reversible).
Rarely - tachycardia, QT interval prolongation on ECG, ventricular arrhythmias, including ventricular tachycardia (type "Torsades de Pointes"), in patients with prolonged QT interval.

Symptoms: liver function impairment, up to acute liver failure, hearing loss.
Treatment: activated charcoal, careful monitoring of respiratory system status. Gastric lavage is effective when a dose is five times higher than the average therapeutic dose. Hemodialysis, peritoneal dialysis, forced diuresis are ineffective.

Drugs that block tubular secretion prolong the half-life of erythromycin.
Reduces the bactericidal action (antagonism) of beta-lactam antibiotics (penicillins, cephalosporins, carbapenems), lincomycin, clindamycin, chloramphenicol, streptomycin, tetracyclines, colistin.
When taken simultaneously with drugs whose metabolism occurs 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 liver microsomal enzymes).
In interaction with theophylline, a reduction in the dose of theophylline may be required; simultaneously, the concentration of erythromycin may decrease, which can lead to subtherapeutic concentrations of erythromycin and a reduction in its effect.
Increases the nephrotoxicity of cyclosporine (especially in patients with concomitant renal failure). Reduces the clearance of triazolam and midazolam, which may enhance the pharmacological effects of benzodiazepines.
When taken simultaneously with terfenadine or astemizole - the possibility of developing arrhythmia; with dihydroergotamine or non-hydrated ergot alkaloids - vasoconstriction up to spasm, dysesthesias.
Slows elimination (enhances effect) of methylprednisolone, felodipine, and anticoagulants of the coumarin group.
When co-administered with lovastatin and other HMG-CoA reductase inhibitors, the risk of developing rhabdomyolysis increases.
Increases the bioavailability of digoxin.
Reduces the effectiveness of hormonal contraception.
When taken simultaneously with drugs whose metabolism occurs in the liver (acenocoumarol, astemizole, cilostazol, cyclosporine, dihydroergotamine, ergotamine, omeprazole, quinidine, rifabutin, tacrolimus, terfenadine, vinblastine, and antifungal drugs such as fluconazole, ketoconazole, and itraconazole), the concentration of these drugs in plasma increases.
The simultaneous use of erythromycin with ergotamine is associated with the risk of developing acute toxicity, manifested by vasospasm, ischemia of the limbs and other organs, including the central nervous system. Therefore, erythromycin is contraindicated in patients taking ergotamine.
When taken simultaneously with erythromycin, an increase in the level of cisapride is possible, which may lead to a prolongation of the QTc interval and the development of arrhythmia (ventricular fibrillation and flutter), and type "Torsades de Pointes" ventricular tachycardia.
When co-administered with verapamil and other slow calcium channel blockers, hypotension, bradyarrhythmia, and lactic acidosis are observed.
Drugs that are inducers of CYP3A4 isoenzymes (such as rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's wort) may induce the metabolism of erythromycin, which may lead to subtherapeutic concentrations of erythromycin and a reduction in its effect. The interaction persists for 2 weeks after discontinuation of treatment with CYP3A4 inducers.
The interaction of erythromycin with colchicine may increase toxicity and lead to a significant increase in the concentration of the latter in plasma due to erythromycin's ability to inhibit CYP3A4.
Erythromycin alters the metabolism of mizolastine.
When taken simultaneously with pimozide, the development of arrhythmia (ventricular fibrillation and flutter), type "Torsades de Pointes" ventricular tachycardia, cardiac arrest, up to fatal outcome is possible.
Protease inhibitors: inhibit the metabolism of erythromycin; monitoring of erythromycin concentration in plasma is necessary.
Cimetidine inhibits the metabolism of erythromycin, which may lead to increased plasma concentration of erythromycin.
Erythromycin reduces the clearance of zopiclone and may thus increase the pharmacodynamic effects of this drug.

Bacteriostatic antibiotic from the macrolide group, reversibly binds to the 50S subunit of the ribosome at its donor site, disrupting the formation of peptide bonds between amino acid molecules and blocking protein synthesis in microorganisms (does not affect nucleic acid synthesis). When used in high doses, it may exhibit bactericidal action. The spectrum of activity includes gram-positive (Staphylococcus spp., both penicillinase-producing and non-producing, including Staphylococcus aureus; Streptococcus spp. (including Streptococcus pneumoniae, Streptococcus pyogenes), alpha-hemolytic streptococci (group Viridans), Bacillus anthracis, Corynebacterium diphtheriae, Corynebacterium minutissimum) and gram-negative microorganisms (Neisseria gonorrhoeae, Haemophilus influenzae, Bordetella pertussis, Brucella spp., Legionella spp., including Legionella pneumophila) and other microorganisms: Mycoplasma spp. (including Mycoplasma pneumoniae), Chlamydia spp. (including Chlamydia trachomatis), Treponema spp., Rickettsia spp., Entamoeba histolytica, Listeria monocytogenes.
Resistant gram-negative rods include: Escherichia coli, Pseudomonas aeruginosa, as well as Shigella spp., Salmonella spp., and others. The group of sensitive microorganisms includes those whose growth is inhibited at antibiotic concentrations of less than 0.5 mg/L, moderately sensitive at 1-6 mg/L, and moderately resistant and resistant at 6-8 mg/L.

Absorption - high. Food intake does not affect the oral forms of erythromycin in the form of the base, coated with enteric-soluble film. Maximum concentration (Cmax) is reached after oral administration within 2-4 hours. Plasma protein binding - 70-90%.
Bioavailability - 30-65%. It is distributed unevenly in the body. It accumulates in large amounts in the liver, spleen, and kidneys. In bile and urine, the concentration exceeds that in plasma by tens of times. It penetrates well into the tissues of the lungs, lymph nodes, middle ear exudate, prostatic secretions, sperm, pleural cavity, ascitic and synovial fluids. In the milk of nursing women, it is present at 50% of the concentration in plasma. It poorly crosses the blood-brain barrier, with a concentration in cerebrospinal fluid being 10% of the drug content in plasma. In inflammatory processes in the membranes of the brain, their permeability to erythromycin slightly increases. It crosses the placental barrier and enters the fetal bloodstream, where its concentration reaches 5-20% of that in maternal plasma.
It is metabolized in the liver (over 90%), partially forming inactive metabolites. The half-life (T1/2) is 1.4-2 hours; in anuria - 4-6 hours. Excretion via bile - 20-30% in unchanged form, via kidneys (in unchanged form) after oral administration - 2-5%.