Hemomycin, 1 piece, 11.43 g (20 ml), 100 mg/5 ml, powder for oral suspension

Hemomycin

Trade name: Hemomycin International name: Azithromycin

Representative office: HEMOFARM A.D. ATX code: J01FA10 Marketing authorization holder: HEMOFARM, AD manufactured by HEMOFARM, AD azithromycin

Release form, composition and packaging

Hard gelatin capsules, light blue, size No. 0, the contents of the capsules are white powder. 1 caps. azithromycin (in dihydrate form) 250 mg Excipients: anhydrous lactose, corn starch, sodium lauryl sulfate, magnesium stearate. Shell composition: titanium dioxide E171, patented blue dye VE131, gelatin. 6 - blisters (1) - cardboard packs.

Tablets, film-coated, grayish-blue, round, biconvex. 1 tab. azithromycin (in dihydrate form) 500 mg Excipients: microcrystalline cellulose and microcrystalline silicate cellulose, sodium carboxymethyl starch (type A), povidone, magnesium stearate, talc, colloidal silicon dioxide. Shell composition: titanium dioxide, talc, copovidone, ethylcellulose, macrogol 6000, indigo carmine (indigotine) E132, green varnish dye 8%: indigo carmine (indigotine) E132, quinoline yellow E104. 3 - blisters (1) - cardboard packs.

Powder for the preparation of a suspension for oral administration is white or almost white in color, with a fruity odor; the prepared suspension is almost white in color with a fruity odor. 5 ml of ready-made suspension. azithromycin (in the form of dihydrate) 100 mg Excipients: xanthan gum, sodium saccharinate, calcium carbonate, colloidal silicon dioxide, sodium phosphate anhydrous, sorbitol, cherry flavoring, apple and strawberry flavorings. 11.43 g - dark glass bottles (1) complete with a measuring spoon - cardboard packs.

Powder for the preparation of a suspension for oral administration is white or almost white in color, with a fruity odor; the finished suspension is almost white in color with a fruity odor. 5 ml of ready-made suspension. azithromycin (in the form of dihydrate) 200 mg Excipients: xanthan gum, sodium saccharinate, calcium carbonate, colloidal silicon dioxide, sodium phosphate dodecahydrate, sorbitol, cherry flavoring, apple and strawberry flavorings. 10 g - dark glass bottles (1) complete with a measuring spoon - cardboard packs.

Clinical and pharmacological group: Antibiotic of the macrolide group - azalide

Registration No.:

•caps. 250 mg: 6 - P N013856/01, 10/15/07 •powder for preparation. susp. for oral administration 200 mg/5 ml: vial. 1 set with measure spoon - P N013856/02, 07/30/07 •tablets, film-coated, 500 mg: 3 - LSR-001834/07, 08/01/07 •powder for preparation. susp. for oral administration 100 mg/5 ml: vial. 1 set with measure spoon - LSR-002215/07, 08/15/07

——————————————————————————— Description of the drug CHEMOMYCIN is based on the officially approved instructions for use of the drug CHEMOMYCIN for specialists and approved by the manufacturer for the 2011 edition of the year.

Pharmacological action Broad-spectrum antibiotic. Azithromycin is a representative of a subgroup of macrolide antibiotics - azalides. In high concentrations it has a bactericidal effect. Chemomycin is active against aerobic gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus spp. groups C, F and G, Streptococcus viridans, Staphylococcus aureus, aerobic gram-negative bacteria: Haemophilus influenzae, Moraxella catarrhalis, Bordetella pertussis, Bordetella parapertussis, Legionella pneumophila, Haemophilus ducreyi, Helicobacter pylori, Campylobacter jejuni, Neisseria gonorrhoeae and Gardnerella vaginalis, ana erobic bacteria: Bacteroides bivius, Clostridium perfringens, Peptostreptococcus spp. The drug is active against intracellular microorganisms: Chlamydia trachomatis, Mycoplasma pneumoniae, Ureaplasma urealyticum, Borrelia burgdorferi, as well as against Treponema pallidum. Gram-positive bacteria that are resistant to erythromycin are resistant to the drug.

Pharmacokinetics

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

Distribution Azithromycin penetrates well into the respiratory tract, organs and tissues of the urogenital tract, into the prostate gland, into the skin and soft tissues. The high concentration in tissues (10-50 times higher than in blood plasma) and long T1/2 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 Vd (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 at the site of inflammation for 5-7 days after taking the last dose, which made it possible to develop short (3-day and 5-day) courses of treatment.

Elimination The removal of azithromycin from blood plasma occurs in 2 stages: T1/2 is 14-20 hours in the interval 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 1 time/

Indications for use of the drug CHEMOMYCIN Infectious and inflammatory diseases caused by microorganisms sensitive to the drug: - infections of the upper respiratory tract and ENT organs (angina, sinusitis, tonsillitis, otitis media), - scarlet fever, - infections of the lower respiratory tract (bacterial and atypical pneumonia, bronchitis), - infections of the urogenital tract (uncomplicated urethritis and/or cervicitis), - infections of the skin and soft tissues (erysipelas, impetigo, secondary infected dermatoses), - 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) (for tablets).

Dosage regimen

The drug is taken orally 1 time / 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 with infections of the upper and lower respiratory tract, Hemomycin is prescribed 500 mg (2 capsules) per day for 3 days, the course dose is 1.5 g. For infections of the skin and soft tissues, 1 g (4 capsules) is prescribed in 1- 1st day, then - 500 mg (2 caps.) daily from 2 to 5 days, course dose - 3 g. For acute uncomplicated urethritis or cervicitis, 1 g (4 caps.) is prescribed once. For Lyme disease (borreliosis), for the treatment of the initial stage (erythema migrans), 1 g (4 capsules) is prescribed on the 1st day and 500 mg (2 capsules) 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 (4 capsules) per day is prescribed for 3 days as part of combined anti-Helicobacter pylori therapy. For children over 12 years of age with infections of the upper and lower respiratory tract, skin and soft tissues, the drug is prescribed at the rate of 10 mg/kg 1 time per day for 3 days (course dose - 30 mg/kg) or on the first day - 10 mg/kg , then 4 days - 5-10 mg/kg/ When treating erythema migrans - 20 mg/kg on the first day and 10 mg/kg from 2 to 5 days.

Tablets For adults and children over 12 years of age, for infections of the upper and lower respiratory tract, prescribed 500 mg/day for 3 days, course dose - 1.5 g. For infections of the skin and soft tissues, prescribed 1 g/day on the first day, then 500 mg daily from 2 to 5 days, course dose - 3 g. For acute uncomplicated urethritis or cervicitis, a single dose of 1 g is prescribed. For Lyme disease (borreliosis), for the treatment of the initial stage (erythema migrans), the drug is prescribed in a dose of 1 g per 1- 1st day and 500 mg daily from 2 to 5 days, course dose - 3 g. For diseases of the stomach and duodenum associated with Helicobacter pylori, 1 g/day is prescribed for 3 days as part of combined anti-Helicobacter pylori 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 - a suspension of 100 mg/5 ml. For children with 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/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.

Body weight Daily dose (suspension 200 mg/5ml) Daily dose (suspension 100 mg/5ml) 10-14 kg 2.5 ml (100 mg) - 1/2 measure. spoons 5 ml (100 mg) - 1 measure. spoon 15-25 kg 5 ml (200 mg) - 1 measure. spoon 10 ml (200 mg) - 2 measures. spoons 26-35 kg 7.5 ml (300 mg) - 1.5 measure. spoons 15 ml (300 mg) - 3 measures. spoons 36-45 kg 10 ml (400 mg) - 2 measures. spoons 20 ml (400 mg) - 4 measures. spoons over 45 kg prescribe doses for adults prescribe doses for adults

Adults are prescribed 500 mg 1 time per day for 3 days, the course dose is 1.5 g.

For infections of the urogenital tract, the drug is prescribed to adults in a dose of 1 g once. For chronic migratory erythema, it is prescribed once a day for 5 days: on the 1st day at a dose of 20 mg/kg body weight, then from the 2nd to the 5th day - 10 mg/kg body weight.

Recommended dosage regimens for Hemomycin in the treatment of erythema migrans in children, depending on body weight and suspension concentration, are presented in the following table.

1st day

Body weight Daily dose (suspension 200 mg/5ml) Daily dose (suspension 100 mg/5ml) 8-14 kg 5 ml (200 mg) - 1 measure. spoons 10 ml (200 mg) - 2 measures. spoons 15-24 kg 10 ml (400 mg) - 2 measures. spoons 20 ml (400 mg) - 4 measures. spoons 25-44 kg 12.5 ml (500 mg) - 2.5 measure. spoons 25 ml (500 mg) - 5 measures. spoons

2-5th day

Body weight Daily dose (suspension 200 mg/5ml) Daily dose (suspension 100 mg/5ml) 8-14 kg 2.5 ml (100 mg) - 1/2 measure. spoons 5 ml (100 mg) - 1 measure. spoons 15-24 kg 5 ml (200 mg) - 1 measure. spoon 10 ml (200 mg) - 2 measures. spoons 25-44 kg 6.5 ml (250 mg) - 1 and 1/4 measure. spoons 12.5 ml (250 mg) - 2.5 measure. spoons

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.

Side effect

From the digestive system: diarrhea (5%), nausea (3%), abdominal pain (3%), 1% or less - dyspepsia, vomiting, flatulence, melena, cholestatic jaundice, increased activity of liver enzymes, in children - constipation , anorexia, gastritis, taste change, candidiasis of the oral mucosa. From the cardiovascular system: palpitations, chest pain (1% or less). From the central nervous system: dizziness, headache, vertigo, drowsiness, in children - headache (during treatment of otitis media), hyperkinesia, anxiety, neurosis, sleep disturbance (1% or less). From the reproductive system: vaginal candidiasis. From the urinary system: nephritis (1% or less). Allergic reactions: rash, angioedema, in children - conjunctivitis, itching, urticaria. Other: increased fatigue, photosensitivity.

Contraindications to the use of the drug CHEMOMYCIN - liver failure, - renal failure, - children under 12 years of age (for capsules and tablets), - children under 12 months of age (for a suspension of 200 mg/5 ml), - children under 6 months of age (for suspension 100 mg/5 ml), - increased sensitivity to macrolide antibiotics.

The drug should be prescribed with caution during pregnancy, with arrhythmias (possible ventricular arrhythmias and prolongation of the QT interval), and in children with severe impairment of liver or kidney function.

Use of the drug CHEMOMYCIN during pregnancy and breastfeeding During pregnancy, Hemomycin is prescribed only when the expected benefit of therapy for the mother outweighs the potential risk to the fetus. If it is necessary to use the drug during lactation, the issue of stopping breastfeeding while using the drug should be decided.

Use for liver dysfunction Caution is required when prescribing the drug to patients with severe liver dysfunction (especially children). Contraindicated in liver failure.

Use for impaired renal function Caution is required when prescribing the drug to patients with severe impaired renal function (especially children). Contraindicated in renal failure.

Special instructions Do not take the drug 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: nausea, temporary hearing loss, vomiting, diarrhea. Treatment: gastric lavage, symptomatic therapy.

Drug interactions With the simultaneous use of Hemomycin and antacids (aluminum- and magnesium-containing), the absorption of azithromycin slows down. Ethanol and food slow down and reduce the absorption of azithromycin. 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 anticoagulant effect, patients need careful monitoring of prothrombin time. The combined use of azithromycin and digoxin increases the concentration of the latter. With the simultaneous use of azithromycin with ergotamine and dihydroergotamine, an increase in the toxic effect of the latter (vasospasm, dysesthesia) is observed. Co-administration of triazolam and azithromycin reduces clearance and enhances the pharmacological effect of triazolam. Azithromycin slows down the excretion and increases the concentration of plasma and the toxicity of cycloserin, indirect anticoagulants, methylprednisolone, felodipine, as well as drugs undergoing microsomal oxidation (carbamazepine, terphenin, cyclosporine, hexobarbital, aboloids of knorships, rods, valProtic acid, dysopian acidic acid, dysopian acidic acid, dysopian d, bromocriptine, phenytoin, oral hypoglycemic agents, theophylline and other xanthine derivatives) - due to the inhibition of microsomal oxidation in hepatocytes by azithromycin. Lincosamines weaken the effectiveness of azithromycin, while tetracycline and chloramphenicol enhance them.

Pharmaceutical interactions Azithromycin is pharmaceutically incompatible with heparin.

Conditions for dispensing from pharmacies The drug is dispensed with a prescription.

Conditions and periods of storage List B. The drug should be stored out of the reach of children, protected from light, at a temperature of 15° to 25°C. Shelf life: 2 years.

Chemomycin por.d/prig.susp.d/orally 200mg/5ml fl. 10g

Indications

Capsules, tablets, powder

Infectious and inflammatory diseases caused by microorganisms sensitive to azithromycin:

• infections of the upper respiratory tract and ENT organs (sinusitis, tonsillitis, pharyngitis, otitis media);
• lower respiratory tract infections (acute bronchitis, exacerbation of chronic bronchitis, pneumonia, including those caused by atypical pathogens);
• infections of the skin and soft tissues (moderate acne vulgaris, erysipelas, impetigo, secondary infected dermatoses);
• urinary tract infections (urethritis and/or cervicitis) caused by Chlamydia trachomatis;
• the initial stage of Lyme disease (borreliosis) is erythema migrans.

Lyophilisate for the preparation of solution for infusion

• severe community-acquired pneumonia caused by Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus or Streptococcus pneumoniae;
• infectious and inflammatory diseases of the pelvic organs of severe course (endometritis and salpingitis) caused by Chlamydia trachomatis, Neisseria gonorrhoeae or Mycoplasma hominis.

pharmachologic effect

Azithromycin is a broad-spectrum bacteriostatic antibiotic from the macrolide-azalide group. Has a wide spectrum of antimicrobial action. The mechanism of action of azithromycin is associated with the suppression of protein synthesis in microbial cells. By binding to the 50S ribosomal subunit, it inhibits peptide translocase at the translation stage and suppresses protein synthesis, slowing down the growth and reproduction of bacteria. In high concentrations it has a bactericidal effect.

It is active against a number of gram-positive, gram-negative, anaerobic, intracellular and other microorganisms.

Microorganisms may initially be resistant to the action of the antibiotic or may acquire resistance to it.

Scale of sensitivity of microorganisms to azithromycin:

* Minimum inhibitory concentration.

In most cases, the following are sensitive to azithromycin:

• aerobic gram-positive microorganisms: Staphylococcus aureus (methicillin-sensitive), Streptococcus pneumoniae (penicillin-sensitive), Streptococcus pyogenes;
• aerobic gram-negative microorganisms: Haemophilus influenzae, Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Pasteurella multocida, Neisseria gonorrhoeae;
• anaerobic microorganisms: Clostridium perfringens, Fusobacterium spp., Prevotella spp., Porphyromonas spp.;
• other microorganisms: Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi.

Microorganisms with acquired resistance to azithromycin:

• aerobic gram-positive microorganisms: Streptococcus pneumoniae (penicillin-resistant).

Microorganisms that are initially resistant:

• aerobic gram-positive microorganisms: Enterococcus faecalis, Staphylococcus spp. (methicillin-resistant staphylococci with a very high frequency have acquired resistance to macrolides);
• gram-positive bacteria resistant to erythromycin;
• anaerobic microorganisms: Bacteroides fragilis.

Cases of cross-resistance between Streptococcus pneumoniae, Streptococcus pyogenes (group A β-hemolytic streptococcus), Enterococcus faecalis and Staphylococcus aureus, including Staphylococcus aureus (methicillin-resistant strains) to erythromycin, azithromycin, other macrolides and lincosamides have been described.

Drug interactions

Antacids

Antacids do not affect the bioavailability of azithromycin, but reduce Cmax in the blood by 30%, so the drug should be taken at least 1 hour before or 2 hours after taking these drugs and food.

Cetirizine

Concomitant use of azithromycin with cetirizine (20 mg) for 5 days in healthy volunteers did not lead to pharmacokinetic interaction or a significant change in the QT interval.

Didanosine (dideoxyinosine)

The simultaneous use of azithromycin (1200 mg/day) and didanosine (400 mg/day) in 6 HIV-infected patients did not reveal changes in the pharmacokinetic parameters of didanosine compared to the placebo group.

Digoxin and colchicine (P-glycoprotein substrates)

Simultaneous use of macrolide antibiotics, incl. azithromycin, with P-glycoprotein substrates such as digoxin and colchicine, leads to increased serum concentrations of P-glycoprotein substrate. Thus, with the simultaneous use of azithromycin and digoxin, it is necessary to take into account the possibility of increasing the concentration of digoxin in the blood serum.

Zidovudine

The simultaneous use of azithromycin (single dose of 1000 mg and multiple doses of 1200 mg or 600 mg) has a minor effect on pharmacokinetics, incl. renal excretion of zidovudine or its glucuronide metabolite. However, the use of azithromycin caused an increase in the concentration of phosphorylated zidovudine, a clinically active metabolite in peripheral blood mononuclear cells. The clinical significance of this fact is unclear.

Azithromycin interacts weakly with isoenzymes of the cytochrome P450 system. Azithromycin has not been found to be involved in pharmacokinetic interactions similar to erythromycin and other macrolides. Azithromycin is not an inhibitor or inducer of cytochrome P450 isoenzymes.

Ergot alkaloids

Given the theoretical possibility of ergotism, the simultaneous use of azithromycin with ergot alkaloid derivatives is not recommended.

Pharmacokinetic studies were conducted on the simultaneous use of azithromycin and drugs whose metabolism occurs with the participation of isoenzymes of the cytochrome P450 system.

Atorvastatin

Concomitant use of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not cause changes in atorvastatin plasma concentrations (based on an HMC-CoA reductase inhibition assay). However, in the post-marketing period, isolated case reports of rhabdomyolysis have been received in patients receiving concomitant azithromycin and statins.

Carbamazepine

Pharmacokinetic studies involving healthy volunteers did not reveal a significant effect on the plasma concentrations of carbamazepine and its active metabolite in patients receiving concomitant azithromycin.

Cimetidine

In pharmacokinetic studies of the effect of a single dose of cimetidine on the pharmacokinetics of azithromycin, no changes in the pharmacokinetics of azithromycin were detected when cimetidine was administered 2 hours before azithromycin.

Indirect anticoagulants (coumarin derivatives)

In pharmacokinetic studies, azithromycin did not affect the anticoagulant effect of a single 15 mg dose of warfarin administered to healthy volunteers. Potentiation of the anticoagulant effect has been reported after simultaneous use of azithromycin and indirect anticoagulants (coumarin derivatives). Although a causal relationship has not been established, the need for frequent monitoring of prothrombin time should be considered when using azithromycin in patients receiving indirect oral anticoagulants (coumarin derivatives).

Cyclosporine

In a pharmacokinetic study involving healthy volunteers who took azithromycin (500 mg/day once) orally for 3 days, followed by cyclosporine (10 mg/kg/day once), a significant increase in plasma Cmax and AUC0-5 of cyclosporine was detected. . Caution is advised when using these drugs together. If simultaneous use of these drugs is necessary, it is necessary to monitor the concentration of cyclosporine in the blood plasma and adjust the dose accordingly.

Efavirenz

Concomitant use of azithromycin (600 mg/day once) and efavirenz (400 mg/day) daily for 7 days did not cause any clinically significant pharmacokinetic interaction.

Fluconazole

Concomitant use of azithromycin (1200 mg once) did not change the pharmacokinetics of fluconazole (800 mg once). The total exposure and T1/2 of azithromycin did not change with simultaneous use of fluconazole, however, a decrease in Cmax of azithromycin was observed (by 18%), which had no clinical significance.

Indinavir

The simultaneous use of azithromycin (1200 mg once) did not cause a statistically significant effect on the pharmacokinetics of indinavir (800 mg 3 times a day for 5 days).

Methylprednisolone

Azithromycin does not have a significant effect on the pharmacokinetics of methylprednisolone.

Nelfinavir

The simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times / day) causes an increase in the Css of azithromycin in the blood serum. No clinically significant side effects were observed and no dose adjustment of azithromycin was required when used concomitantly with nelfinavir.

Rifabutin

The simultaneous use of azithromycin and rifabutin does not affect the concentration of each drug in the blood serum. Neutropenia has sometimes been observed with simultaneous use of azithromycin and rifabutin. Although neutropenia has been associated with the use of rifabutin, a causal relationship between the use of the combination of azithromycin and rifabutin and neutropenia has not been established.

Sildenafil

When used in healthy volunteers, there was no evidence of the effect of azithromycin (500 mg/day daily for 3 days) on the AUC and Cmax of sildenafil or its main circulating metabolite.

Terfenadine

In pharmacokinetic studies, there was no evidence of interaction between azithromycin and terfenadine. There have been isolated cases reported where the possibility of such an interaction could not be completely excluded, but there was no concrete evidence that such an interaction occurred.

It has been found that the simultaneous use of terfenadine and macrolides can cause arrhythmia and prolongation of the QT interval.

Theophylline

No interaction has been detected between azithromycin and theophylline.

Triazolam/midazolam

No significant changes in pharmacokinetic parameters were detected with simultaneous use of azithromycin with triazolam or midazolam in therapeutic doses.

Trimethoprim/sulfamethoxazole

Concomitant use of trimethoprim/sulfamethoxazole with azithromycin did not show a significant effect on Cmax, total exposure or renal excretion of trimethoprim or sulfamethoxazole. Azithromycin serum concentrations were consistent with those found in other studies.

Dosage regimen

The drug in the form of capsules, tablets and suspensions is taken orally, 1 time/day, 1 hour before meals or 2 hours after meals. Capsules and tablets are swallowed whole without chewing.

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.

Capsules and tablets

Adults and children over 12 years of age weighing more than 45 kg

For infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues

— 500 mg (2 capsules or 1 tablet) 1 time/day for 3 days (course dose 1.5 g).

For acne vulgaris of moderate severity

— 500 mg (2 capsules or 1 tablet) 1 time/day for 3 days, then 500 mg (2 capsules or 1 tablet) 1 time/week. (with an interval of 7 days) for 9 weeks (course dose 6 g).

For urinary tract infections (uncomplicated urethritis and/or cervicitis) caused by Chlamydia trachomatis

- once 1 g (4 capsules or 2 tablets).

For Lyme disease (the initial stage of borreliosis) - erythema migrans

-1 time/day for 5 days: 1st day - 1 g (4 caps. or 2 tablets), then from 2nd to 5th day - 500 mg (2 caps. or 1 tablet) (course dose 3 g).

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

For children

for
infections of the upper and lower respiratory tract, ENT organs, infections of the skin and soft tissues
(with the exception of chronic migratory erythema), the drug 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 depending on the child’s body weight and suspension concentration:

For pharyngitis/tonsillitis caused by Streptococcus pyogenes

, azithromycin is used at a dose of 20 mg/kg/day for 3 days (course dose 60 mg/kg). The maximum daily dose is 500 mg.

Children weighing up to 10 kg

You should take azithromycin preparations in powder form to prepare an oral suspension with a concentration of 100 mg/5 ml.

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

– 1 time/day for 5 days: on the 1st day at a dose of 20 mg/kg body weight, and then from the 2nd to the 5th day – 10 mg/kg body weight (course dose 60 mg/kg ).

The following dosage regimen for the suspension of the drug Hemomycin in children

with erythema migrans:

1st day

From 2nd to 5th day

Adults and children over 12 years of age weighing over 45 kg

For infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues

prescribed 500 mg (12.5 ml of 200 mg/5 ml suspension) 1 time/day for 3 days (course dose – 1.5 g).

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

– 1 g (25 ml of 200 mg/5 ml suspension)/day on the first day for 1 dose, then 0.5 g (12.5 ml of 200 mg/5 ml suspension) per day daily from days 2 to 5 (course dose – 3 g ).

Rules for preparing the suspension

Add water (distilled or boiled and cooled) 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.

Lyophilisate for the preparation of solution for infusion

The drug should be used only in inpatient medical institutions.

For community-acquired pneumonia

Prescribe 500 mg 1 time/day intravenously for at least 2 days (if necessary, according to the decision of the attending physician, the intravenous course of treatment can be extended, but should not last more than 5 days). IV administration should be followed by subsequent oral administration of azithromycin in the form of a single daily dose of 500 mg until the 7-10-day total course of treatment is completed.

For infectious and inflammatory diseases of the pelvic organs

Prescribe 500 mg 1 time/day IV for at least 2 days (IV course of treatment is no more than 5 days). IV administration should be followed by oral administration of azithromycin in the form of a single daily dose of 250 mg 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.

Rules for preparing the solution

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) - is carried out immediately before administration in accordance with the table below.

The reconstituted solution is injected into a vial with a solvent (0.9% sodium chloride solution, 5% dextrose solution, Ringer's solution) to obtain a final concentration of azithromycin of 1.0-2.0 mg/ml in the infusion solution.

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 solution cannot be administered intravenously or intramuscularly.

It is recommended to administer the prepared solution intravenously over 3 hours - a solution for infusion at a concentration of 1 mg/ml, over 1 hour - at a concentration of 2 mg/ml. It is necessary to avoid administration of higher concentrations due to the risk of reactions at the injection site.

Special patient groups

In patients with impaired renal function with GFR 10-80 ml/min

no dose adjustment is required.

When used in patients with mild to moderate liver dysfunction

no dose adjustment is required.

In elderly patients

no dose adjustment is required. Since elderly people may already have ongoing proarrhythmogenic conditions, caution should be exercised when using azithromycin due to the high risk of developing cardiac arrhythmias, incl. ari.

Overdose

Symptoms:

nausea, temporary hearing loss, vomiting, diarrhea, abdominal pain, liver dysfunction.

Treatment:

carrying out symptomatic therapy.

Contraindications for use

• severe liver dysfunction;
• simultaneous use with ergotamine, dihydroergotamine;
• age up to 18 years (for lyophilisate);
• children under 12 years of age with body weight up to 45 kg (for tablets and capsules);
• children up to 6 months (for suspension);
• lactase deficiency, lactose intolerance, glucose-galactose malabsorption (for capsules);
• fructose intolerance (for suspension);
• hypersensitivity to azithromycin or other components of the drug;
• hypersensitivity to erythromycin, other macrolides, ketolides.

Carefully:

myasthenia gravis, mild to moderate liver dysfunction, end-stage renal failure with GFR less than 10 ml/min, in patients with the presence of proarrhythmogenic factors (especially in elderly patients): with congenital or acquired prolongation of the QT interval, in patients receiving therapy with antiarrhythmic drugs classes IA (quinidine, procainamide) and III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotics (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with disturbances of water-electrolyte balance, especially in the case of hypokalemia or hypomagnesemia, with clinically significant bradycardia, cardiac arrhythmia or severe heart failure; simultaneous use of digoxin, warfarin, cyclosporine.

Use in children

Contraindication: children under 12 years of age with body weight up to 45 kg (for capsules and tablets); children up to 6 months (for suspension); age up to 18 years (lyophilisate).

Restrictions for children

Use with caution

Use in elderly patients

In elderly patients, no dose adjustment is required. Since elderly people may already have ongoing proarrhythmogenic conditions, caution should be exercised when using azithromycin due to the high risk of developing cardiac arrhythmias, incl. ari.

Restrictions for elderly patients

Use with caution

Use for liver dysfunction

The use of the drug is contraindicated in severe liver dysfunction.

The drug should be prescribed with caution for mild to moderate liver dysfunction.

Restrictions for liver dysfunction

Use with caution

Use during pregnancy and breastfeeding

During pregnancy and breastfeeding, the drug is used only if the expected benefit to the mother outweighs the potential risk to the fetus and child.

If it is necessary to use azithromycin during breastfeeding, it is recommended to stop breastfeeding.

Restrictions when breastfeeding

Contraindicated

Restrictions during pregnancy

Use with caution

Use for renal impairment

The drug should be prescribed with caution in cases of end-stage renal failure (GFR less than 10 ml/min).

Restrictions for impaired renal function

Use with caution

Storage conditions

The drug should be stored in its original packaging, out of the reach of children, at a temperature not exceeding 25°C (lyophilisate - at a temperature from 10°C to 25°C).

Terms of sale

The drug is available with a prescription.

special instructions

The drug should not be administered in longer courses than indicated in the instructions, because The pharmacokinetic properties of azithromycin allow the use of a short dosage regimen.

It is possible that superinfection (including fungal) may occur during treatment with Hemomycin (as with any antibiotic therapy).

As with the use of erythromycin and other macrolides, rare cases of serious allergic reactions, including angioedema and anaphylaxis (in rare cases fatal), skin reactions, including acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis (in in rare cases with a fatal outcome), drug rash with eosinophilia and systemic manifestations (DRESS syndrome). Some of these reactions that developed during the use of azithromycin acquired a recurrent course and required long-term treatment and observation.

If an allergic reaction develops, the drug should be discontinued and appropriate treatment prescribed. It should be borne in mind that after discontinuation of symptomatic therapy, the symptoms of an allergic reaction may resume, which requires specific therapy under the supervision of a physician.

Azithromycin in oral dosage forms should be taken at least 1 hour before or 2 hours after taking antacids. If you miss taking one dose of the drug, the missed dose should be taken as soon as possible, and subsequent doses should be taken at intervals of 24 hours.

Azithromycin should be used with caution in patients with mild to moderate hepatic impairment due to the possibility of developing fulminant hepatitis and severe liver failure.

If there are symptoms of liver dysfunction, such as rapidly increasing asthenia, jaundice, darkening of urine, tendency to bleeding, hepatic encephalopathy, drug therapy should be stopped and a study of the functional state of the liver should be performed.

For impaired renal function: in patients with GFR 10-80 ml/min, no dose adjustment is required; Therapy with Chemomycin should be carried out with caution and monitoring of renal function in patients with GFR less than 10 ml/min.

As with the use of other antibacterial drugs, during therapy with azithromycin, patients should be regularly examined for the presence of non-susceptible microorganisms and signs of the development of superinfections, incl. fungal.

The drug should not be used for longer courses than indicated in the instructions, because The pharmacokinetic properties of azithromycin allow us to recommend a short and simple dosage regimen.

There is no data on a possible interaction between azithromycin and ergotamine and dihydroergotamine derivatives, but due to the development of ergotism with the simultaneous use of macrolides with ergotamine and dihydroergotamine derivatives, this combination is not recommended.

With long-term use of azithromycin, the development of pseudomembranous colitis caused by Clostridium difficile, both in the form of mild diarrhea and severe colitis, is possible. Therefore, patients with diarrhea should be closely monitored. If antibiotic-associated diarrhea develops while taking the drug, as well as 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded. The use of drugs that inhibit intestinal motility is contraindicated in the development of pseudomembranous colitis.

When treated with macrolides, incl. azithromycin, prolongation of cardiac repolarization and QT interval was observed, increasing the risk of developing cardiac arrhythmias, incl. ari, which can lead to cardiac arrest.

Caution should be exercised when using the drug in patients with the presence of proarrhythmogenic factors (especially in elderly patients): with congenital or acquired prolongation of the QT interval, in patients receiving therapy with antiarrhythmic drugs of classes IA (quinidine, procainamide), III (dofetilide, amiodarone and sotalol) , cisapride, terfenadine, antipsychotics (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with water-electrolyte imbalance, especially in the case of hypokalemia or hypomagnesemia, with clinically significant bradycardia, cardiac arrhythmia or severe heart failure.

The use of azithromycin may provoke the development of myasthenic syndrome or cause an exacerbation of myasthenia gravis.

For patients on a diet with limited sodium intake, when treating with Chemomycin lyophilisate for preparing a solution for infusion, it is necessary to take into account that one bottle contains 6.2 mg of sodium (sodium hydroxide is an excipient).

Use in pediatrics

The safety and effectiveness of the injection form of the drug Hemomycin in children and adolescents under the age of 18 have not been established.

Impact on the ability to drive vehicles and machinery

Due to the possible development of undesirable reactions from the central nervous system and the organ of vision during treatment, care must be taken when driving vehicles and performing other activities that require increased concentration and speed of psychomotor reactions.

Side effect

The frequency of side effects is classified in accordance with WHO recommendations: very often - at least 10%, often - at least 1%, but less than 10%, infrequently - at least 0.1%, but less than 1%, rarely - at least 0.01%, but less than 0.1%, very rarely - less than 0.01%; unknown frequency - cannot be estimated based on available data.

Infectious diseases:

uncommon – candidiasis, incl. oral mucosa, vaginal infection, pneumonia, pharyngitis, gastroenteritis, respiratory diseases, rhinitis, fungal infection, bacterial infection; unknown frequency - pseudomembranous colitis.

From the blood and lymphatic system:

uncommon - leukopenia, neutropenia, eosinophilia; very rarely - thrombocytopenia, hemolytic anemia.

Allergic reactions:

uncommon - angioedema, hypersensitivity reaction; unknown frequency - anaphylactic reaction.

From the nervous system:

often - headache; infrequently - dizziness, disturbance of taste, paresthesia, drowsiness, insomnia, nervousness; rarely - agitation; unknown frequency - hypoesthesia, anxiety, aggression, fainting, convulsions, psychomotor hyperactivity, loss of smell, perversion of smell, loss of taste, myasthenia gravis, delirium, hallucinations.

From the side of the organ of vision:

infrequently - visual impairment.

Hearing and labyrinth disorders:

uncommon - hearing loss, vertigo; unknown frequency - hearing loss, incl. deafness and/or tinnitus.

From the cardiovascular system:

infrequently - a feeling of palpitations, “flushes” of blood to the face; unknown frequency - decreased blood pressure, increased QT interval on ECG, ari, ventricular tachycardia.

From the respiratory system:

infrequently - shortness of breath, nosebleeds.

From the gastrointestinal tract:

very often - diarrhea; often - nausea, vomiting, abdominal pain; uncommon - flatulence, dyspepsia, constipation, gastritis, dysphagia, bloating, dry oral mucosa, belching, ulcers of the oral mucosa, increased secretion of the salivary glands; very rarely - change in tongue color, pancreatitis.

From the liver and biliary tract:

uncommon - hepatitis; rarely - impaired liver function, cholestatic jaundice; unknown frequency - liver failure (in rare cases with death, mainly due to severe liver dysfunction); liver necrosis, fulminant hepatitis.

For the skin and subcutaneous tissues:

uncommon - skin rash, itching, urticaria, dermatitis, dry skin, sweating; rarely - photosensitivity reaction, acute generalized exanthematous pustulosis; unknown frequency - Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug rash with eosinophilia and systemic manifestations (DRESS syndrome).

From the musculoskeletal system:

uncommon - osteoarthritis, myalgia, back pain, neck pain; unknown frequency - arthralgia.

From the urinary system:

uncommon - dysuria, pain in the kidney area; unknown frequency - interstitial nephritis, acute renal failure.

From the genital organs and breast:

infrequently - metrorrhagia, testicular dysfunction.

Other:

uncommon – anorexia, edema, asthenia, malaise, feeling tired, facial swelling, chest pain, neck pain, back pain, fever, peripheral edema.

Local reactions

(with intravenous drip): pain and inflammation at the injection site.

Laboratory data:

often - a decrease in the number of lymphocytes, an increase in the number of eosinophils, an increase in the number of basophils, an increase in the number of monocytes, an increase in the number of neutrophils, a decrease in the concentration of bicarbonates in the blood plasma; infrequently - increased activity of AST, ALT, increased concentration of bilirubin in the blood plasma, increased concentration of urea in the blood plasma, increased concentration of creatinine in the blood plasma, change in the potassium content in the blood plasma, increased activity of alkaline phosphatase in the blood plasma, increased chlorine content in the blood plasma, increased blood glucose concentration, increased platelet count, decreased hematocrit, increased plasma bicarbonate concentration, change in plasma sodium content.

Possible product names

• Chemomycin por. d/prig. susp. for oral administration 200 mg/5 ml vial. 10g
• CHEMOMYCIN 200 MG/5 ML POR. D/SUSPENSIONS
• (Hemomycin) Hemomycin por. d/prig. susp. for oral administration 200 mg/5 ml vial. 10g