Chemomycin 500 mg 3 pcs. film-coated tablets

Chemomycin 500 mg 3 pcs. film-coated tablets

pharmachologic effect

Broad-spectrum antibiotic.
It is a representative of a subgroup of macrolide antibiotics – azalides. In high concentrations it has a bactericidal effect. Gram-positive cocci are sensitive to azithromycin: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, streptococci of groups C, F and G, Staphylococcus aureus, Streptococcus viridans; gram-negative bacteria: Haemophilus influenzae, Moraxella catarrhalis, Bordetella pertussis, Bordetella parapertussis, Legionella pneumophila, Haemophilus ducreyi, Campylobacter jejuni, Neisseria gonorrhoeae and Gardnerella vaginalis; some anaerobic microorganisms: Bacteroides bivius, Clostridium perfringens, Peptostreptococcus spp; as well as Chlamydia trachomatis, Mycoplasma pneumoniae, Ureaplasma urealyticum, Treponema pallidum, Borrelia burgdoferi. Azithromycin is inactive against gram-positive bacteria resistant to erythromycin.

Composition and release form Hemomycin 500 mg 3 pcs. film-coated tablets

1 film-coated tablet contains the active substance azithromycin 500 mg (in the form of azithromycin dihydrate); excipients - microcrystalline cellulose silicate - 69.00 mg, microcrystalline cellulose - 57.00 mg, sodium carboxymethyl starch (type A) - 46.00 mg, povidone - 24.00 mg, magnesium stearate - 10.00 mg, talc - 10.00 mg, colloidal silicon dioxide – 1.00 mg; shell: titanium dioxide – 10.58 mg, talc – 9.57 mg, copovidone – 4.95 mg, ethylcellulose – 4.95 mg, macrogol 6000 – 1.32 mg, indigo carmine (indigotine) E 132 – 1.22 mg , dye varnish green 8% (indigo carmine (indigotine) E 132, quinoline yellow E 104) – 0.41 mg Film-coated tablets 500 mg.

3 tablets per AL/PVC blister. 1 blister with instructions for use in a cardboard box.

Description of the dosage form

Film-coated tablets

Characteristic

Round, biconvex tablets, film-coated, grayish-blue in color.

Directions for use and doses

Orally, 1 hour before or 2 hours after meals, 1 time per day. For adults and children over 12 years of age with infections of the upper and lower respiratory tract - 0.5 g / day per 1 dose for 3 days (course dose - 1.5 g).

For infections of the skin and soft tissues - 1 g / day on the first day for 1 dose, then 0.5 g / day daily from days 2 to 5 (course dose - 3 g).

For acute infections of the genitourinary organs (uncomplicated urethritis or cervicitis) - 1 g once.

For Lyme disease (borreliosis) for the treatment of stage I (erythema migrans) - 1 g on the first day and 0.5 g daily from days 2 to 5 (course dose - 3 g).

For gastric and duodenal ulcers associated with Helicobacter pylori - 1 g/day for 3 days as part of combination anti-Helicobacter pylori therapy.

Pharmacokinetics

Azithromycin is rapidly absorbed from the gastrointestinal tract, due to its stability in an acidic environment and lipophilicity. After oral administration of 500 mg, the maximum concentration of azithromycin in the blood plasma is reached after 2.5 - 2.96 hours and is 0.4 mg/l. Bioavailability is 37%.

Azithromycin penetrates well into the respiratory tract, organs and tissues of the urogenital tract (in particular the prostate gland), skin and soft tissues. The high concentration in tissues (10-50 times higher than in plasma) and the long half-life are due to the low binding of azithromycin to plasma proteins, as well as its ability to penetrate eukaryotic cells and concentrate in the low pH environment surrounding lysosomes. This, in turn, determines the large apparent volume of distribution (31.1 l/kg) and high plasma clearance. The ability of azithromycin to accumulate predominantly in lysosomes is especially important for the elimination of intracellular pathogens. It has been proven that phagocytes deliver azithromycin to sites of infection, where it is released during the process of phagocytosis. The concentration of azithromycin in foci of infection is significantly higher than in healthy tissues (on average by 24-34%) and correlates with the degree of inflammatory edema. Despite its high concentration in phagocytes, azithromycin does not have a significant effect on their function. Azithromycin remains in bactericidal concentrations for 5-7 days after the last dose, which has made it possible to develop short (3-day and 5-day) courses of treatment.

It is demethylated in the liver, the resulting metabolites are not active.

The elimination of azithromycin from blood plasma occurs in 2 stages: the half-life is 14-20 hours in the range from 8 to 24 hours after taking the drug and 41 hours in the range from 24 to 72 hours, which allows the drug to be used once a day. Food intake significantly changes pharmacokinetics (depending on the dosage form): tablets - the maximum concentration (Cmax) increases (by 31%), the area under the curve (AUC) does not change.

Indications for use Chemomycin 500 mg 3 pcs. film-coated tablets

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

Infections of the upper respiratory tract and ENT organs (sore throat, sinusitis,

tonsillitis, pharyngitis, otitis media);

Scarlet fever;

Infections of the lower respiratory tract (bacterial and atypical pneumonia, bronchitis);

Infections of the skin and soft tissues (erysipelas, impetigo, secondary infected dermatoses);

Infections of the urogenital tract (uncomplicated urethritis and/or cervicitis);

Lyme disease (borreliosis), for the treatment of the initial stage (erythema migrans);

Diseases of the stomach and duodenum associated with Helicobacter Pylori (as part of combination therapy).

Contraindications

Hypersensitivity (including to other macrolides); liver and/or kidney failure; children under 12 years of age (for this dosage form), lactation period.

With caution - pregnancy, arrhythmia (possible ventricular arrhythmias and prolongation of the QT interval), children with severe impairment of liver or kidney function.

Application Hemomycin 500 mg 3 pcs. film-coated tablets during pregnancy and breastfeeding

Use during pregnancy is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to use it during lactation, the issue of stopping breastfeeding should be decided.

special instructions

The drug should not be taken during meals.

It is recommended to maintain an interval of at least 2 hours between taking Hemomycin and antacid medications.

After discontinuation of treatment, hypersensitivity reactions may persist in some patients, which requires specific therapy and medical monitoring.

Overdose

Symptoms: severe nausea, temporary hearing loss, vomiting, diarrhea.

Treatment: symptomatic; gastric lavage.

Side effects Hemomycin 500 mg 3 pcs. film-coated tablets

From the digestive system: diarrhea (5%), nausea (3%), abdominal pain (3%); 1% or less - dyspepsia, flatulence, vomiting, melena, cholestatic jaundice, increased activity of “liver” transaminases; in children - constipation, anorexia, gastritis.

From the cardiovascular system: palpitations, chest pain (1% or less).

From the nervous system: dizziness, headache, vertigo, drowsiness; in children - headache (during treatment of otitis media), hyperkinesia, anxiety, neurosis, sleep disturbance (1% or less).

From the genitourinary system: vaginal candidiasis, nephritis (1% or less).

Allergic reactions: rash, photosensitivity, Quincke's edema.

Other: increased fatigue; in children - conjunctivitis, itching, urticaria.

Drug interactions

Antacids (aluminum and magnesium), ethanol and food slow down and reduce absorption.

When warfarin and azithromycin were co-administered (in usual doses), no changes in prothrombin time were detected, however, given that the interaction of macrolides and warfarin may enhance the anticoagulation effect, patients need careful monitoring of prothrombin time.

Digoxin: increased digoxin concentrations.

Ergotamine and dihydroergotamine: increased toxic effects (vasospasm, dysesthesia).

Triazolam: decreased clearance and increased pharmacological action of triazolam. Slows down the elimination and increases the plasma concentration and toxicity of cycloserine, indirect anticoagulants, methylprednisolone, felodipine, as well as drugs subject to microsomal oxidation (carbamazepine, terfenadine, cyclosporine, hexobarbital, ergot alkaloids, valproic acid, disopyramide, bromocriptine, phenytoin, oral hypoglycemic agents, theophylline and other xanthine derivatives) - due to inhibition of microsomal oxidation in hepatocytes by azithromycin.

Lincosamines weaken the effectiveness, tetracycline and chloramphenicol enhance it.

Pharmaceutically incompatible with heparin.

Chemomycin, 1 piece, 500 mg, lyophilisate for solution for infusion

Capsules, film-coated tablets

Orally, 1 hour before or 2 hours after meals, 1 time per day.

For infections of the upper and lower respiratory tract, 500 mg/day is prescribed for 3 days (course dose: 1.5 g).

For infections of the skin and soft tissues - 1 g / day on the first day for 1 dose, then - 0.5 g / day daily, from the 2nd to the 5th day (course dose - 3 g).

For uncomplicated urethritis and/or cervicitis, 1 g is prescribed once.

For Lyme disease (borreliosis), for the treatment of the initial stage (erythema migrans), 1 g is prescribed on the 1st day and 500 mg daily from the 2nd to the 5th day (course dose - 3 g).

For diseases of the stomach and duodenum associated with Helicobacter pylori, 1 g per day is prescribed for 3 days as part of combination therapy.

If you miss 1 dose of the drug, the missed dose should be taken as soon as possible, and subsequent doses should be taken 24 hours apart.

Powder for suspension for oral administration

Orally, 1 hour before or 2 hours after meals, 1 time per day.

Water (distilled or boiled and cooled) is gradually added to the bottle to the mark. The contents of the bottle are thoroughly shaken until a homogeneous suspension is obtained. If the level of the prepared suspension is below the mark on the bottle label, add water again to the mark and shake.

The prepared suspension is stable at room temperature for 5 days.

For infections of the upper and lower respiratory tract, skin and soft tissues (except for chronic migratory erythema): children - at the rate of 10 mg/kg once a day for 3 days (course dose - 30 mg/kg). A suspension of 100 mg/5 ml is recommended for use in children over 6 months, 200 mg/5 ml - over 12 months. Recommended dosage regimens depending on the child’s body weight are presented in Table 1.

Table 1

Adults with upper and lower respiratory tract infections - 500 mg once a day for 3 days (course dose - 1.5 g); for infections of the skin, soft tissues, as well as Lyme disease (borreliosis) for the treatment of the initial stage (erythema migrans) - 1 g per day on the 1st day for 1 dose, then 0.5 g per day daily from the 2nd to Day 5 (course dose - 3 g).

For chronic migratory erythema - once a day for 5 days: on the 1st day at a dose of 20 mg/kg, and then from the 2nd to the 5th day - 10 mg/kg.

Recommendations for taking Hemomycin suspension 100 mg/5 ml in children with erythema migrans are presented in Table 2.

table 2

The suspension should be shaken before use.

Immediately after taking the suspension, the child should be given a few sips of liquid (water, tea) to drink in order to wash off and swallow the suspension remaining in the mouth.

If you miss 1 dose of the drug, the missed dose should be taken as soon as possible, and subsequent doses should be taken 24 hours apart.

Lyophilisate for the preparation of solution for infusion

The drug should be used only in a hospital setting.

IV. Recommended doses for intravenous administration in the treatment of adults and children over 16 years of age with the following diseases

Community-acquired pneumonia. 500 mg/day, once for at least 2 days. IV administration should be followed by oral azithromycin at a dose of 500 mg/day once until the 7-10-day total course of treatment is completed.

Infectious and inflammatory diseases of the pelvic organs. 500 mg/day, once for at least 2 days. IV administration should be followed by oral azithromycin at a dose of 250 mg/day once until the 7-day total course of treatment is completed. The timing of transition to oral treatment is determined in accordance with clinical examination data.

Patients with liver and kidney failure. For patients with moderate impairment of liver and kidney function (Cl creatinine >40 ml/min), no dose adjustment is necessary.

The solution for infusion is prepared in 2 stages

Stage 1 - preparation of the reconstituted solution. Add 4.8 ml of sterile water for injection to a bottle with 500 mg of the drug and shake thoroughly until the powder is completely dissolved. 1 ml of the resulting solution contains 100 mg of azithromycin. The prepared solution remains stable for 24 hours at room temperature.

Stage 2 - dilution of the reconstituted solution (100 mg/ml). It is carried out immediately before administration in accordance with the data presented below:

To obtain a concentration of azithromycin in an infusion solution of 1 mg/ml, 500 ml of solvent is required; to obtain a concentration of azithromycin in an infusion solution of 2 mg/ml - 250 ml.

The reconstituted solution is added to a vial with a solvent (0.9% sodium chloride solution; 5% dextrose solution; Ringer's solution) to obtain a final concentration of azithromycin of 1-2 mg per 1 ml of infusion solution.

Hemomycin solution cannot be administered intravenously or intramuscularly. It is recommended to administer the prepared solution dropwise for at least 1 hour.

Before administration, the solution is subjected to visual inspection. If the prepared solution contains particles of the substance, it should not be used.

The prepared solution is stable at room temperature for 24 hours.

Hemomycin

The drug is taken orally 1 time/day 1 hour before meals or 2 hours after meals, because When taken simultaneously with food, the absorption of azithromycin is reduced.

If you miss one dose of the drug, it should be taken as soon as possible, and subsequent doses should be taken at intervals of 24 hours.

Capsules

For adults

for
infections of the upper and lower respiratory tract,
Hemomycin is prescribed 500 mg (2 caps.) per day for 3 days; course dose - 1.5 g.

For skin and soft tissue infections

Prescribe 1 g (4 caps.) on the 1st day, then 500 mg (2 caps.) daily from 2 to 5 days; course dose - 3 g.

For acute uncomplicated urethritis or cervicitis

Prescribe 1 g (4 caps.) once.

For Lyme disease

(borreliosis) for the treatment of the initial stage (erythema migrans) is prescribed 1 g (4 caps.) on the 1st day and 500 mg (2 caps.) daily from 2 to 5 days (course dose - 3 g).

For diseases of the stomach and duodenum associated with Helicobacter pylori

, prescribed 1 g (4 caps.) per day for 3 days as part of combined anti-Helicobacter therapy.

Children over 12 years old

for
infections of the upper and lower respiratory tract, skin and soft tissues,
the drug is prescribed at a rate of 10 mg/kg 1 time/day for 3 days (course dose - 30 mg/kg) or on the first day - 10 mg/kg, then 4 day - 5-10 mg/kg/day.

In the treatment of erythema migrans

- 20 mg/kg on the first day and 10 mg/kg from days 2 to 5.

Pills

Adults and children over 12 years old

for
infections of the upper and lower respiratory tract,
500 mg/day is prescribed for 3 days; course dose - 1.5 g.

For skin and soft tissue infections

Prescribe 1 g/day on the first day, then 500 mg daily from days 2 to 5; course dose - 3 g.

For acute uncomplicated urethritis or cervicitis

prescribed once in a dose of 1 g.

For Lyme disease

(borreliosis) for the treatment of the initial stage (erythema migrans) the drug is prescribed in a dose of 1 g on the 1st day and 500 mg daily from the 2nd to the 5th day; course dose - 3 g.

For diseases of the stomach and duodenum associated with Helicobacter pylori

, prescribed 1 g/day for 3 days as part of combined anti-Helicobacter therapy.

Suspension 200 mg/5 ml and 100 mg/5 ml

In children over 12 months

a suspension of 200 mg/5 ml is used, in
children over 6 months of age
- a suspension of 100 mg/5 ml.

For children

for
infections of the upper and lower respiratory tract, infections of the skin and soft tissues
(with the exception of chronic migratory erythema) Chemomycin in the form of a suspension is prescribed at the rate of 10 mg/kg body weight 1 time/day for 3 days (course dose - 30 mg/kg ).

Recommended dosage regimens for Hemomycin depending on the child’s body weight and suspension concentration are presented in the following table.

For adults

for
infections of the upper and lower respiratory tract,
500 mg is prescribed 1 time / day for 3 days; course dose - 1.5 g.

For infections of the urogenital tract

the drug is prescribed
to adults
in a dose of 1 g once;
children under 8 years of age with a body weight of more than 45 kg
- 10 mg/kg once.

For chronic migratory erythema

prescribed 1 time/day for 5 days:
adults
— 1 g/day on the 1st day for 1 dose, then 500 mg/day daily from days 2 to 5, course dose — 3 g;
children
- on day 1 at a dose of 20 mg/kg body weight, then from days 2 to 5 - 10 mg/kg body weight.

Recommended dosage regimens for Chemomycin in the treatment of erythema migrans

in
children
, depending on body weight and concentration of the suspension, are presented in the following table.

1st day

2-5th day

Rules for preparing the suspension

Water (distilled or boiled and cooled) is gradually added to the bottle containing the powder to the mark. The contents of the bottle are thoroughly shaken until a homogeneous suspension is obtained.

If the level of the prepared suspension is below the mark on the bottle label, add water again to the mark and shake.

The prepared suspension is stable at room temperature for 5 days.

The suspension should be shaken before use.

Immediately after taking the suspension, the child should be given a few sips of liquid (water, tea) to wash off and swallow the suspension remaining in the mouth.