Erythromycin (Tablets, Lyophilisate, Ointment) Instructions for Use

Instructions
Dosage forms

ATC Code

J01FA01 (Erythromycin)

Active Substance

Erythromycin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antibiotic of the macrolide group

Pharmacotherapeutic Group

Antibiotic-macrolide

Pharmacological Action

[I] – Instructions for medical use approved by the Pharmacological Committee of the Ministry of Health of the Russian Federation

A bacteriostatic antibiotic from the macrolide group, it reversibly binds to the 50S subunit of the ribosome in its donor part, which disrupts the formation of peptide bonds between amino acid molecules and blocks the synthesis of microbial proteins (does not affect the synthesis of nucleic acids). When used in high doses, it may exhibit a bactericidal effect.

The spectrum of activity includes gram-positive microorganisms (Staphylococcus spp., both penicillinase-producing and non-producing, including Staphylococcus aureus; Streptococcus spp. (including Streptococcus pneumoniae, Streptococcus pyogenes), alpha-hemolytic streptococcus (Viridans group), 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.

Gram-negative rods are resistant: 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 an antibiotic concentration of less than 0.5 mg/L, moderately sensitive at 1-6 mg/L, and moderately resistant and resistant at 6-8 mg/L.

Pharmacokinetics

Absorption is high. Food intake does not affect oral forms of erythromycin as a base, coated with an enteric coating. C_max is reached after oral administration in 2-4 hours. Plasma protein binding is 70-90%.

Bioavailability is 30-65%. It is distributed unevenly in the body. It accumulates in large quantities in the liver, spleen, and kidneys. The concentration in bile and urine is tens of times higher than the concentration in plasma. It penetrates well into lung tissue, lymph nodes, middle ear exudate, prostate secretion, semen, pleural cavity, ascitic and synovial fluids. In the milk of nursing women, it contains 50% of the concentration in plasma. It penetrates poorly through the blood-brain barrier, into the cerebrospinal fluid (its concentration is 10% of the drug content in plasma). During inflammatory processes in the meninges, their permeability to erythromycin increases somewhat. It penetrates the placental barrier and enters the fetal blood, where its content reaches 5-20% of the content in the maternal plasma.

It is metabolized in the liver (more than 90%), partially with the formation of inactive metabolites. T_1/2 is 1.4-2 hours, in anuria – 4-6 hours. Excretion with bile is 20-30% unchanged, by the kidneys (unchanged) after oral administration – 2-5%.

Indications

Bacterial infections caused by susceptible microflora:

Diphtheria (including bacterial carriage);
Whooping cough (including prophylaxis);
Trachoma;
Brucellosis;
Legionnaires’ disease;
Erythrasma;
Listeriosis;
Scarlet fever;
Amebic dysentery;
Gonorrhea;
Neonatal conjunctivitis;
Pneumonia in children;
Urogenital infections in pregnant women caused by Chlamydia trachomatis;
Primary syphilis (in patients allergic to penicillins);
Uncomplicated chlamydia in adults (localized in the lower genitourinary tract and rectum) with intolerance or ineffectiveness of tetracyclines;
Infections of the ENT organs (tonsillitis, otitis, sinusitis);
Infections of the biliary tract (cholecystitis);
Infections of the upper and lower respiratory tract (tracheitis, bronchitis, pneumonia);
Infections of the skin and soft tissues (pustular skin diseases, including juvenile acne, infected wounds, bedsores, II-III degree burns, trophic ulcers);
Infections of the eye mucosa;
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).

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
A06	Amebiasis
A23	Brucellosis
A32	Listeriosis
A36	Diphtheria
A37	Whooping cough
A38	Scarlet fever
A48.1	Legionnaires’ disease
A50	Congenital syphilis
A51	Early syphilis
A54	Gonococcal infection
A56.0	Chlamydial infections of lower genitourinary tract
A56.1	Chlamydial infections of pelvic organs and other genitourinary organs
A71	Trachoma
H10.2	Other acute conjunctivitis
H10.4	Chronic conjunctivitis
H66	Suppurative and unspecified otitis media
J02	Acute pharyngitis
J03	Acute tonsillitis
J04	Acute laryngitis and tracheitis
J15	Bacterial pneumonia, not elsewhere classified
J20	Acute bronchitis
J31.2	Chronic pharyngitis
J32	Chronic sinusitis
J35.0	Chronic tonsillitis
J37	Chronic laryngitis and laryngotracheitis
J42	Unspecified chronic bronchitis
K81.0	Acute cholecystitis
K81.1	Chronic cholecystitis
K83.0	Cholangitis
L01	Impetigo
L08.0	Pyoderma
L08.1	Erythrasma
L70	Acne
L89	Decubitus ulcer and pressure area
L98.4	Chronic skin ulcer, not elsewhere classified
N37.0	Urethritis in diseases classified elsewhere
N77.1	Vaginitis, vulvitis and vulvovaginitis in infectious and parasitic diseases classified elsewhere
P39.1	Neonatal conjunctivitis and dacryocystitis
T30	Burns and corrosions of unspecified body region
T79.3	Posttraumatic wound infection, not elsewhere classified
Z29.2	Other prophylactic chemotherapy (administration of antibiotics for prophylactic purposes)

ICD-11 code	Indication
1A36.Z	Amoebiasis, unspecified
1A60.Z	Congenital syphilis, unspecified
1A61.Z	Early syphilis, unspecified
1A7Z	Gonococcal infection, unspecified
1A81.0	Chlamydial infection of lower genitourinary tract
1A81.1	Chlamydial infection of internal reproductive organs
1B50	Scarlet fever
1B72.0	Bullous impetigo
1B72.1	Nonbullous impetigo
1B72.Z	Impetigo, unspecified
1B95	Brucellosis
1C12.Z	Whooping cough, unspecified
1C17.Z	Diphtheria, unspecified
1C19.Z	Legionellosis, unspecified
1C1A.Z	Listeriosis, unspecified
1C23.Z	Trachoma, unspecified
1C44	Non-pyogenic bacterial infections of skin
1F23.10	Candidiasis of vulva and vagina
1F65	Enterobiasis
1H0Z	Unspecified infection
9A60.Z	Conjunctivitis, unspecified
AA9Z	Unspecified suppurative otitis media
CA02.Z	Acute pharyngitis, unspecified
CA03.Z	Acute tonsillitis, unspecified
CA05	Acute laryngitis or tracheitis
CA09.2	Chronic pharyngitis
CA0A.Z	Chronic rhinosinusitis, unspecified
CA0F.Y	Other specified chronic diseases of the palatine tonsils and adenoids
CA0G	Chronic laryngitis or laryngotracheitis
CA20.1Z	Chronic bronchitis, unspecified
CA40.0Z	Bacterial pneumonia, unspecified
CA42.Z	Acute bronchitis, unspecified
DC12.0Z	Acute cholecystitis, unspecified
DC12.1	Chronic cholecystitis
DC13	Cholangitis
EA40	Tropical phagedenic ulcer
EB21	Pyoderma gangrenosum
ED80.Z	Acne, unspecified
EF60	Ischemic ulceration of the skin
EH90.Z	Pressure ulcer of unspecified degree
EM0Z	Unspecified skin disorder
GC02.1	Nonspecific urethritis
KA65.0	Conjunctivitis or dacryocystitis of newborn
ME60.2	Ulcerative skin lesion of unspecified nature
NE11	Burn of unspecified body region
NF0A.3	Posttraumatic wound infection, not elsewhere classified
QC05.Y	Other specified prophylactic measures
1A94.0	Genital or urogenital tract infection caused by Herpes simplex virus
GA41	Ulcerative or erosive diseases of vulva

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets

Orally.

A single dose for adults and adolescents over 14 years is 250-500 mg, the daily dose is 1-2 g. The interval between doses is 6 hours. For severe infections, the daily dose can be increased to 4 g.

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

For treatment of diphtheria carriage – 250 mg twice a day. The course dose for treatment of primary syphilis is 30-40 g, the duration of treatment is 10-15 days.

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

For legionellosis – 500 mg-1 g 4 times a day for 14 days.

For gonorrhea – 500 mg every 6 hours for 3 days, then – 250 mg 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 start of surgery (total 3 g).

For prevention of streptococcal infection (in tonsillitis, pharyngitis), adults – 20-50 mg/kg/day, children – 20-30 mg/kg/day, the duration of the course is 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 500 mg for adults and 10 mg/kg for children, repeated after 6 hours.

For whooping cough – 40-50 mg/kg/day for 5-14 days. For pneumonia in children – 50 mg/kg/day in 4 divided doses, for at least 3 weeks. For urogenital infections during pregnancy – 500 mg 4 times a day for at least 7 days or (if such a dose is poorly tolerated) – 250 mg 4 times a day for at least 14 days.

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

Ointment

Apply topically – the drug is placed behind the lower eyelid. The dose, frequency and duration of use are determined individually.

Lyophilisate

The dosage regimen is set individually, depending on the indications for use, the severity of the disease, the patient’s age, and the tolerability of therapy.

Administer intravenously as a slow bolus (over 3-5 minutes) or by drip.

Adverse Reactions

Hypersensitivity reactions skin allergic reactions (urticaria, 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), impaired liver function, 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 drug withdrawal is usually reversible).

Rarely – tachycardia, prolongation of the QT interval on ECG, ventricular arrhythmias, including ventricular tachycardia (of the “torsades de pointes” type) in patients with prolonged QT interval.

Contraindications

Hypersensitivity;
Hearing loss;
Concomitant use of terfenadine or astemizole;
Lactation period.

With caution arrhythmias (in history); QT interval prolongation; jaundice (in history); hepatic insufficiency; renal insufficiency.

Use in Pregnancy and Lactation

Due to the possibility of penetration into breast milk, breastfeeding should be avoided while taking erythromycin.

Use in Hepatic Impairment

Contraindicated in hepatic insufficiency.

Use in Renal Impairment

Contraindicated in renal insufficiency.

Pediatric Use

Geriatric Use

The likelihood of developing an ototoxic effect is higher in elderly patients.

Special Precautions

During long-term therapy, it is necessary to monitor laboratory parameters of liver function.

Symptoms of cholestatic jaundice may develop several days after the start of therapy, but the risk of development 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 of Haemophilus influenzae are sensitive to the simultaneous administration of erythromycin and sulfonamides.

May interfere with the determination of urinary catecholamines and the activity of liver transaminases in the blood (colorimetric determination using diphenylhydrazine).

Overdose

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

Treatment activated charcoal, careful monitoring of the respiratory system. Gastric lavage is effective when taking a dose five times the average therapeutic dose. Hemodialysis, peritoneal dialysis, forced diuresis are ineffective.

Drug Interactions

Drugs that block tubular secretion prolong the T_1/2 of erythromycin.

Incompatible with lincomycin, clindamycin and chloramphenicol (antagonism).

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

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

Increases the nephrotoxicity of cyclosporine (especially in patients with concomitant renal insufficiency). Reduces the clearance of triazolam and midazolam, which may enhance the pharmacological effects of benzodiazepines.

With simultaneous use with terfenadine or astemizole – possibility of developing arrhythmias, with dihydroergotamine or non-hydrogenated ergot alkaloids – vasoconstriction to spasm, dysesthesia.

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

When taken together with lovastatin, rhabdomyolysis is enhanced.

Increases the bioavailability of digoxin.

Reduces the effectiveness of hormonal contraception.

Storage Conditions

List B. Store in a dry, light-protected place, out of reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years. Do not use after the expiration date.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Erythromycin [Avva Rus, JSC (Russia)]
Enteric-coated tablets, 250 mg: 10 or 20 pcs.

Marketing Authorization Holder

Avva Rus, JSC (Russia)

Dosage Form

Erythromycin

Enteric-coated tablets, 250 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated tablets	1 tab.
Erythromycin	250 mg

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (1) – aluminum foil bags (1) – cardboard packs.
10 pcs. – contour cell packs (1) – aluminum foil bags (2) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
10 pcs. – plastic bottles (1) – cardboard packs.
20 pcs. – plastic bottles (1) – cardboard packs.

Erythromycin [Avva Rus, JSC (Russia)]
Tablets, coated with an enteric-soluble coating, 100 mg: 10 or 20 pcs.

Marketing Authorization Holder

Avva Rus, JSC (Russia)

Dosage Form

Erythromycin

Tablets, coated with an enteric-soluble coating, 100 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated tablets	1 tab.
Erythromycin	100 mg

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (1) – aluminum bags (1) – cardboard packs.
10 pcs. – contour cell packs (1) – aluminum bags (2) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
10 pcs. – plastic bottles (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – plastic bottles (1) – cardboard packs.

Erythromycin [Atoll LLC (Russia)]
Enteric film-coated tablets, 250 mg: 5, 10, 20, 40 or 80 pcs.
Enteric film-coated tablets, 500 mg: 5, 10, 20, 40 or 80 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Forms

	Erythromycin	Enteric film-coated tablets, 250 mg: 5, 10, 20, 40 or 80 pcs.
		Enteric film-coated tablets, 500 mg: 5, 10, 20, 40 or 80 pcs.

Dosage Form, Packaging, and Composition

Enteric film-coated tablets are almost white in color, round, biconvex; on the cross-section of tablets of any dosage, two layers are visible: a core ranging from almost white to light yellow and a coating.

	1 tab.
Erythromycin	250 mg

Excipients: microcrystalline cellulose (MCC-101) – 146 mg, croscarmellose sodium – 27 mg, povidone K25 – 13.5 mg, polysorbate 80 – 9 mg, magnesium stearate – 4.5 mg.

Coating composition Acryl-EZE White 93A – 32.4 mg, including: methacrylic acid and ethyl acrylate copolymer [1:1] – 21.384 mg, talc – 5.346 mg, titanium dioxide – 4.86 mg, colloidal silicon dioxide – 0.324 mg, sodium bicarbonate – 0.324 mg, sodium lauryl sulfate – 0.162 mg; triethyl citrate – 3.6 mg, polyvinyl alcohol – 3 mg, macrogol-4000 – 1 mg.

5 pcs. – contour cell packs – cardboard packs.
5 pcs. – contour cell packs (2) – cardboard packs.
5 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
20 pcs. – contour cell packs – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (4) – cardboard packs.

Enteric film-coated tablets are almost white in color with a score line, capsule-shaped, biconvex; on the cross-section of tablets of any dosage, two layers are visible: a core ranging from almost white to light yellow and a coating.

	1 tab.
Erythromycin	500 mg

Excipients: microcrystalline cellulose (MCC-101) – 292 mg, croscarmellose sodium – 54 mg, povidone K25 – 27 mg, polysorbate 80 – 18 mg, magnesium stearate – 9 mg.

Coating composition Acryl-EZE White 93A – 64.8 mg, including: methacrylic acid and ethyl acrylate copolymer [1:1] – 42.768 mg, talc – 10.692 mg, titanium dioxide – 9.72 mg, colloidal silicon dioxide – 0.648 mg, sodium bicarbonate – 0.648 mg, sodium lauryl sulfate – 0.324 mg; triethyl citrate – 7.2 mg, polyvinyl alcohol – 6 mg, macrogol-4000 – 2 mg.

Erythromycin [Biosintez, PJSC (Russia)]
Ointment for external use 10 thousand IU/1 g: tube 15 g

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Erythromycin

Ointment for external use 10 thousand IU/1 g: tube 15 g

Dosage Form, Packaging, and Composition

Ointment for external use	1 g
Erythromycin	10 thousand IU

15 g – aluminum tubes (1) – cardboard packs.

Erythromycin [Biosintez, PJSC (Russia)]
Tablets, coated with an enteric-soluble coating, 100 mg: 10 or 20 pcs.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Erythromycin

Tablets, coated with an enteric-soluble coating, 100 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated tablets	1 tab.
Erythromycin	100 mg

10 pcs. – dark glass jars (1) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – dark glass jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.

Erythromycin [Biosintez, PJSC (Russia)]
Enteric-coated tablets, 250 mg: 10 or 20 pcs.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Erythromycin

Enteric-coated tablets, 250 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated tablets	1 tab.
Erythromycin	250 mg

Erythromycin [Bryntsalov-A, JSC (Russia)]
Tablets, coated with an enteric-soluble coating, 100 mg: 10 or 20 pcs.

Marketing Authorization Holder

Bryntsalov-A, JSC (Russia)

Dosage Form

Erythromycin

Tablets, coated with an enteric-soluble coating, 100 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated tablets	1 tab.
Erythromycin	100 mg

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – dark glass jars (1) – cardboard packs.
20 pcs. – dark glass jars (1) – cardboard packs.
10 pcs. – plastic bottles (1) – cardboard packs.
20 pcs. – plastic bottles (1) – cardboard packs.

Erythromycin [Bryntsalov-A, JSC (Russia)]
Enteric-coated tablets, 250 mg: 10 or 20 pcs.

Marketing Authorization Holder

Bryntsalov-A, JSC (Russia)

Dosage Form

Erythromycin

Enteric-coated tablets, 250 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated tablets	1 tab.
Erythromycin	250 mg

Erythromycin [Irbit Chemical Pharmaceutical Plant, JSC (Russia)]
Enteric-coated tablets, 100 mg: 20 or 2000 pcs.

Marketing Authorization Holder

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Manufactured By

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Dosage Form

Erythromycin

Enteric-coated tablets, 100 mg: 20 or 2000 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated tablets	1 tab.
Erythromycin	100 mg

10 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – polymer jars (100) – cardboard boxes.

Erythromycin [Irbit Chemical Pharmaceutical Plant, JSC (Russia)]
Enteric-coated tablets, 250 mg: 20 or 2000 pcs.

Marketing Authorization Holder

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Manufactured By

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Dosage Form

Erythromycin

Enteric-coated tablets, 250 mg: 20 or 2000 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated tablets	1 tab.
Erythromycin	250 mg

10 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – polymer jars (100) – cardboard boxes.

Erythromycin [Sintez PJSC (Russia)]
Ointment for external use 10 thousand IU/1 g: tubes 5 g, 10 g or 15 g

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Form

Erythromycin

Ointment for external use 10 thousand IU/1 g: tubes 5 g, 10 g or 15 g

Dosage Form, Packaging, and Composition

Ointment for external use is light yellow to brownish-yellow in color.

	1 g
Erythromycin	10 thousand IU

Excipients: lanolin (anhydrous lanolin), sodium disulfite (sodium metabisulfite, sodium pyrosulfite), petrolatum.

5 g – aluminum tubes (1) – cardboard packs.
10 g – aluminum tubes (1) – cardboard packs.
15 g – aluminum tubes (1) – cardboard packs.

Erythromycin [Sintez PJSC (Russia)]
Enteric film-coated tablets, 100 mg: 10 or 20 pcs.
Enteric film-coated tablets, 250 mg: 10 or 20 pcs.

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Forms

	Erythromycin	Enteric film-coated tablets, 100 mg: 10 or 20 pcs.
		Enteric film-coated tablets, 250 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Enteric film-coated tablets are white or almost white in color, round, biconvex; on the cross-section, one white layer is visible.

	1 tab.
Erythromycin	100 mg

Excipients: povidone (low molecular weight polyvinylpyrrolidone 12600±2700, povidone K17), crospovidone, calcium stearate, talc, potato starch.

Coating composition: cellacephate (cellulose acetate phthalate), titanium dioxide, castor oil.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.

Enteric film-coated tablets are white or almost white in color, round, biconvex; on the cross-section, one white layer is visible.

	1 tab.
Erythromycin	250 mg

Excipients: povidone (low molecular weight polyvinylpyrrolidone 12600±2700, povidone K17), crospovidone, calcium stearate, talc, potato starch.

Coating composition: cellacephate (cellulose acetate phthalate), titanium dioxide, castor oil.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.

Erythromycin [Sintez PJSC (Russia)]
Film-coated enteric-soluble tablets, 500 mg: 5, 10, 15, 20, 25, or 30 pcs.

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Form

Erythromycin

Film-coated enteric-soluble tablets, 500 mg: 5, 10, 15, 20, 25, or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated enteric-soluble tablets are white or almost white in color, oval, biconvex; on the cross-section, one white layer is visible.

	1 tab.
Erythromycin	500 mg

Excipients: povidone 12.6 thousand (low molecular weight medical polyvinylpyrrolidone 12600±2700) – 18.9 mg, crospovidone (Kollidon CL, Kollidon CL-M) – 27 mg, calcium stearate – 8.28 mg, polysorbate 80 (Tween-80) – 0.18 mg, talc – 20.7 mg, potato starch – 324.94 mg.

Coating composition cellacephate (cellulose acetate phthalate) – 32.4 mg, titanium dioxide – 1.6 mg, castor oil – 6 mg.

5 pcs. – contour cell packs (1) – cardboard packs.
5 pcs. – contour cell packs (2) – cardboard packs.
5 pcs. – contour cell packs (3) – cardboard packs.
5 pcs. – contour cell packs (4) – cardboard packs.
5 pcs. – contour cell packs (5) – cardboard packs.
5 pcs. – contour cell packs (6) – cardboard packs.

Erythromycin [Sintez PJSC (Russia)]
Film-coated enteric-soluble tablets, 500 mg: 5, 10, 15, 20, 25, or 30 pcs.

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Form

Erythromycin

Film-coated enteric-soluble tablets, 500 mg: 5, 10, 15, 20, 25, or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated enteric-soluble tablets are white or almost white in color, oval, biconvex; on the cross-section, one white layer is visible.

	1 tab.
Erythromycin	500 mg

Excipients: povidone -12.6 thousand (low molecular weight medical polyvinylpyrrolidone 12600±2700) – 18.9 mg, crospovidone (Kollidon CL, Kollidon CL-M) – 27 mg, calcium stearate – 8.28 mg, polysorbate 80 (Tween 80) – 0.18 mg, talc – 20.7 mg, potato starch – 324.94 mg.

Coating composition cellacephate (cellulose acetate phthalate) – 32.4 mg, titanium dioxide – 1.6 mg, castor oil – 6 mg.

Erythromycin [Sintez PJSC (Russia)]
Lyophilisate for preparation of solution for intravenous administration 100 mg: vial. 10 or 50 pcs.

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Form

Erythromycin

Lyophilisate for preparation of solution for intravenous administration 100 mg: vial. 10 or 50 pcs.

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for intravenous administration in the form of a white porous mass.

	1 vial
Erythromycin (as phosphate)	100 mg

100 mg – Vials with a capacity of 10 ml (1) – cardboard packs.
100 mg – Vials with a capacity of 10 ml (10) – cardboard packs.
100 mg – Vials with a capacity of 10 ml (5) – cardboard packs.
100 mg – Vials with a capacity of 10 ml (50) – cardboard packs.

Erythromycin [Sintez PJSC (Russia)]
Lyophilisate for preparation of solution for intravenous administration 200 mg: vial. 10 or 50 pcs.

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Form

Erythromycin

Lyophilisate for preparation of solution for intravenous administration 200 mg: vial. 10 or 50 pcs.

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for intravenous administration in the form of a white porous mass.

	1 vial
Erythromycin (as phosphate)	200 mg

200 mg – Vials with a capacity of 20 ml (1) – cardboard packs.
200 mg – Vials with a capacity of 20 ml (5) – cardboard packs.
200 mg – Vials with a capacity of 20 ml (10) – cardboard packs.
200 mg – Vials with a capacity of 20 ml (50) – cardboard packs.

Erythromycin [Sintez PJSC (Russia)]
Eye ointment 10 thousand IU/1 g: tubes 3 g, 5 g or 10 g

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Form

Erythromycin

Eye ointment 10 thousand IU/1 g: tubes 3 g, 5 g or 10 g

Dosage Form, Packaging, and Composition

Eye ointment from light yellow to brownish-yellow in color.

	1 g
Erythromycin	10 thousand IU

Excipients: lanolin (anhydrous lanolin), sodium disulfite (sodium metabisulfite, sodium pyrosulfite), white soft paraffin (petrolatum).

3 g – aluminum tubes (1) – cardboard packs.
5 g – aluminum tubes (1) – cardboard packs.
10 g – aluminum tubes (1) – cardboard packs.

Erythromycin [Tatkhimpharmpreparaty, JSC (Russia)]
Tablets, coated with an enteric-soluble coating, 100 mg: 10 or 20 pcs.

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

Dosage Form

Erythromycin

Tablets, coated with an enteric-soluble coating, 100 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets, coated with an enteric-soluble coating	1 tab.
Erythromycin	100 mg

20 pcs. – dark glass jars (1) – cardboard packs.
10 pcs. – dark glass jars (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.

Erythromycin [Tatkhimpharmpreparaty, JSC (Russia)]
Enteric-coated tablets, 200 mg: 20 pcs.

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

Dosage Form

Erythromycin

Enteric-coated tablets, 200 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets, coated with an enteric-soluble coating	1 tab.
Erythromycin	200 mg

20 pcs. – dark glass jars (1) – cardboard packs.

Erythromycin [Tatkhimpharmpreparaty, JSC (Russia)]
Enteric-coated tablets, 250 mg: 10 or 20 pcs.

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

Dosage Form

Erythromycin

Enteric-coated tablets, 250 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets, coated with an enteric-soluble coating	1 tab.
Erythromycin	250 mg

20 pcs. – dark glass jars (1) – cardboard packs.
10 pcs. – dark glass jars (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.

Erythromycin [Tatkhimpharmpreparaty, JSC (Russia)]
Eye ointment 10 thousand IU/1 g: tubes 3 or 10 g

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

Dosage Form

Erythromycin

Eye ointment 10 thousand IU/1 g: tubes 3 or 10 g

Dosage Form, Packaging, and Composition

Eye ointment from yellowish to brownish-yellow in color.

	1 g
Erythromycin*	10 thousand IU

* calculated as the anhydrous substance and an activity of 1000 mcg/mg

Excipients: anhydrous lanolin, sodium metabisulfite, petrolatum.

10 g – aluminum tubes (1) – cardboard packs.
3 g – aluminum tubes (1) – cardboard packs.
7 g – aluminum tubes (1) – cardboard packs.

Medixlife (Author)

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