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Hemomycin: instructions for use for children. Antibiotic hemomycin in tablets and suspensions - composition, indications for admission, side effects, analogues and price Interaction with other drugs

Hemomycin: instructions for use for children. Antibiotic hemomycin in tablets and suspensions - composition, indications for admission, side effects, analogues and price Interaction with other drugs

02.10.2021

Antibiotics - macrolides and azalides.

Composition of Hemomycin

The active substance is azithromycin.

Manufacturers

Hemofarm A.D. (Serbia)

pharmachologic effect

Pharmacological action - antibacterial.

Suppresses protein biosynthesis, slowing down the growth and reproduction of bacteria, at high concentrations a bactericidal effect is possible. Stable in an acidic environment, lipophilic, rapidly absorbed from the gastrointestinal tract.

The maximum concentration is created in 2-3 hours, the half-life is 68 hours.

A stable plasma level is reached after 5-7 days.

It easily passes histohematic barriers and enters the tissues.

Concentrations in tissues and cells are 10-50 times higher than in plasma, and in the focus of infection - 24-34% higher than in healthy tissues.

A high level (antibacterial) persists in the tissues for 5-7 days after the last injection.

It is excreted in the bile (50%) unchanged and in the urine (6%). The spectrum of action is wide and includes gram-positive (Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, streptococci of groups C, F, G, Streptococcus viridans ), except for those resistant to erythromycin, and gram-negative (Haemophilus influenzae, Moraxella catarrhalis, Bordetella pertussis, Bordetella parapertussis, Campylobacter jejuni, Legionella pneumophila, Neisseria gonorrhoeae, Gardnerella vaginalis) microorganisms, anaerobes (Bacteroides bivius, Peptostreptococcus spp., Clostridium pertusfrens) , chlamydia (Chlamydia trachomatis, Chlamydia pneumoniae), mycobacteria (Mycobacteria avium complex), mycoplasma (Mycoplasma pneumoniae), ureoplasma (Ureaplasma urealyticum), spirochetes (Treponema pallidum, Borrelia burgdorferi).

Side effects of Hemomycin

Nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea, melena, cholestatic jaundice, chest pain, palpitations, weakness, drowsiness, headache, dizziness, nephritis, vaginitis, candidiasis, neutropenia or neutrophilia, pseudomembranous colitis, photosensitivity, rash , angioedema, eosinophilia; in children, in addition, hyperkinesia, agitation, nervousness, insomnia, conjunctivitis.

Indications for use

Infections of the upper and lower respiratory tract (streptococcal pharyngitis and tonsillitis, bacterial exacerbation of chronic obstructive pneumonia, interstitial and alveolar pneumonia, bacterial bronchitis), ENT organs (otitis media, laryngitis and sinusitis), genitourinary system (urethritis and cervicitis), skin and soft tissues (erysipelas, impetigo, secondary infected dermatoses), chronic stage of erythema migrans (Lyme disease).

Contraindications Hemomycin

Hypersensitivity to macrolides, severe liver dysfunction, pregnancy, lactation.

Method of application and dosage

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 decreases.

In case of missing one dose of the drug, it should be taken as soon as possible, and subsequent doses should be taken at intervals of 24 hours.

Overdose

No information.

Interaction

special instructions

Use with caution in severe violations of the liver, kidneys, cardiac arrhythmias.

After discontinuation of treatment, hypersensitivity reactions in some patients may persist, which requires specific therapy under the supervision of a physician.

Storage conditions

List B.

Store in a dry, dark place at room temperature, out of the reach of children.

Hemomycin - a fresh description of the drug, you can read contraindications, side effects, prices in pharmacies for Hemomycin. Reviews about Hemomycin -

Broad spectrum antibiotic.
Drug: CHEMOMYCIN
The active substance of the drug: azithromycin
ATX encoding: J01FA10
CFG: Antibiotic of the macrolide group - azalide
Registration number: P No. 013856/01
Date of registration: 15.10.07
The owner of the reg. credit: HEMOFARM A.D. (Serbia)

Hemomycin release form, drug packaging and composition.

Capsules hard gelatinous, light blue, size No. 0; the contents of the capsules are white powder. Capsules 1 caps. azithromycin (as dihydrate) 250 mg
Excipients: anhydrous lactose, corn starch, sodium lauryl sulfate, magnesium stearate.
Shell composition: titanium dioxide E171, patent blue dye VE131, gelatin.
6 pcs. - blisters (1) - packs of cardboard.
Film-coated tablets, grayish-blue, round, biconvex. Film-coated tablets 1 tab. azithromycin (as dihydrate) 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 lacquer dye 8%: indigo carmine (indigotine) E132, quinoline yellow E104.
3 pcs. - blisters (1) - packs of cardboard.
Powder for suspension for oral administration white or almost white, with a fruity odor; the prepared suspension is almost white in color with a fruity odor. Powder 5 ml prepared susp. azithromycin (as dihydrate) 100 mg
Excipients: xanthan gum, sodium saccharinate, calcium carbonate, colloidal silicon dioxide, anhydrous sodium phosphate, sorbitol, cherry flavor, apple and strawberry flavors.
11.43 g - dark glass bottles (1) complete with a measuring spoon - packs of cardboard.
Powder for suspension for oral administration white or almost white, with a fruity odor; ready suspension of almost white color with a fruity smell. Powder 5 ml prepared susp. azithromycin (as dihydrate) 200 mg
Excipients: xanthan gum, sodium saccharinate, calcium carbonate, colloidal silicon dioxide, sodium phosphate dodecahydrate, sorbitol, cherry flavor, apple and strawberry flavors.
10 g - dark glass bottles (1) complete with a measuring spoon - packs of cardboard.

The description of the drug is based on the officially approved instructions for use.

Pharmacological action Hemomycin

Pharmacokinetics of the drug.

Suction
Azithromycin is rapidly absorbed from the gastrointestinal tract, due to its stability in an acidic environment and lipophilicity. After oral administration of Hemomycin at a dose of 500 mg Cmax of azithromycin in plasma is reached after 2.5-2.96 hours and is 0.4 mg / l. Bioavailability is 37%.
Distribution
Azithromycin penetrates well into Airways, organs and tissues of the urogenital tract, into the prostate gland, into the skin and soft tissues. 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 a 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 the sites of infection, where it is released during phagocytosis. The concentration of azithromycin in the foci of infection is significantly higher than in healthy tissues (on average by 24-34%) and correlates with the degree of inflammatory edema. Despite the high concentration in phagocytes, azithromycin does not significantly affect their function.
Azithromycin remains at bactericidal concentrations in the inflammatory focus for 5-7 days after the last dose, which made it possible to develop short (3-day and 5-day) courses of treatment.
breeding
Removal of azithromycin from blood plasma takes place in 2 stages: T1 / 2 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 you to use the drug 1 time / day.

Indications for use:

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
- infections of the upper respiratory tract and ENT organs (tonsillitis, 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, secondarily 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 and method of application of the drug.

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 decreases.
In case of missing 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; course dose - 1.5 g.
For infections of the skin and soft tissues, 1 g (4 capsules) is prescribed on the 1st day, then 500 mg (2 capsules) daily from 2 to 5 days; course dose - 3 g.
In acute uncomplicated urethritis or cervicitis, a single dose of 1 g (4 capsules) is prescribed.
In 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 2 to 5 days (course dose - 3 G).
In diseases of the stomach and duodenum associated with Helicobacter pylori, 1 g (4 caps.) per day for 3 days is prescribed as part of a combined anti-Helicobacter therapy.
For children over 12 years old 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 / day for 3 days (course dose - 30 mg / kg) or on the first day - 10 mg / day kg, then 4 days - 5-10 mg / kg / day.
In the treatment of erythema migrans - 20 mg / kg on day 1 and 10 mg / kg from days 2 to 5.
Pills
Adults and children over 12 years of age with infections of the upper and lower respiratory tract are prescribed 500 mg / day for 3 days; course dose - 1.5 g.
For infections of the skin and soft tissues, 1 g / day is prescribed on the first day, then 500 mg daily from 2 to 5 days; course dose - 3 g.
In acute uncomplicated urethritis or cervicitis, a single dose of 1 g is prescribed.
In Lyme disease (borreliosis) for the treatment of the initial stage (erythema migrans), the drug is prescribed at a dose of 1 g on the 1st day and 500 mg daily from 2 to 5 days; course dose - 3 g.
In diseases of the stomach and duodenum associated with Helicobacter pylori, 1 g / day is prescribed for 3 days as part of a combined anti-Helicobacter therapy.
Suspension 200 mg/5 ml and 100 mg/5 ml
In children older than 12 months, a suspension of 200 mg / 5 ml is used, in children older than 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), Hemomycin in the form of a suspension is prescribed at the rate of 10 mg / kg of body weight for 3 days.
Recommended dosing 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 / 5 ml) Daily dose (suspension 100 mg / 5 ml) 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 measured. spoons 26-35 kg 7.5 ml (300 mg) - 1 and 1/2 measured. spoons 15 ml (300 mg) - 3 scoops. spoons 36-45 kg 10 ml (400 mg) - 2 measured. spoons 20 ml (400 mg) - 4 scoops. spoons over 45 kg prescribe adult doses prescribe adult doses
Adults with infections of the upper and lower respiratory tract are prescribed 500 mg / day for 3 days; course dose - 1.5 g. For infections of the skin and soft tissues, as well as for Lyme disease (borreliosis), for the treatment of the initial stage (erythema migrans), 1 g / day is prescribed on the 1st day, then 500 mg daily from 2 to 5 th day; course dose - 3 g.
In chronic erythema migrans, it is prescribed on the 1st day at a dose of 20 mg / kg of body weight, then from 2 to 5 days - 10 mg / kg of body weight.
For infections of the urogenital tract, the drug is prescribed to children under 8 years of age with a body weight of more than 45 kg at the rate of 10 mg / kg once.
Recommended dosing regimens for Hemomycin in the treatment of erythema migrans in children, depending on body weight and suspension concentration, are presented in the following table.
Day 1 Body weight Daily dose (suspension 200 mg/5 ml) Daily dose (suspension 100 mg/5 ml)< 8 кг - 5 мл (100 мг) — 1 мерн. ложка 8-14 кг 5 мл (200 мг) — 1 мерн. ложки 10 мл (200 мг) — 2 мерн. ложки 15-24 кг 10 мл (400 мг) — 2 мерн. ложки 20 мл (400 мг) — 4 мерн. ложки 25-44 кг 12.5 мл (500 мг) — 2 и1/2 мерн. ложки 25 мл (500 мг) — 5 мерн. ложек
Day 2 to Day 5 Body weight Daily dose (suspension 200 mg/5 ml) Daily dose (suspension 100 mg/5 ml)< 8 кг - 2.5 мл (50 мг) — 1/2 мерн. ложки 8-14 кг 2.5 мл (100 мг) — 1/2 мерн. ложки 5 мл (100 мг) — 1 мерн. ложки 15-24 кг 5 мл (200 мг) — 1 мерн. ложка 10 мл (200 мг) — 2 мерн. ложки 25-44 кг 6.5 мл (250 мг) — 1 и1/4 мерн. ложки 12.5 мл (250 мг) — 2.5 мерн. ложки
Suspension preparation rules
Water (distilled or boiled and cooled) is added to the vial containing the powder up to the mark. The contents of the vial are thoroughly shaken until a homogeneous suspension is obtained. 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 allowed to drink a few sips of liquid (water, tea) in order to wash off and swallow the suspension remaining in the oral cavity.

Side effects of Hemomycin:

From the side 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, change in taste, candidiasis of the oral mucosa.
From the side of the cardiovascular system: palpitations, chest pain (1% or less).
From the side of the central nervous system: dizziness, headache, vertigo, drowsiness; in children - headache (in the 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 drug:

Liver failure;
- renal failure;
- children's age up to 12 years (for capsules and tablets);
- children's age up to 12 months (for a suspension of 200 mg / 5 ml);
- children's age up to 6 months (for a suspension of 100 mg / 5 ml);
- Hypersensitivity to macrolide antibiotics.
With caution, the drug should be prescribed during pregnancy, with arrhythmias (possible ventricular arrhythmias and prolongation of the QT interval), children with severe hepatic or renal impairment.

Use during pregnancy and lactation.

During pregnancy, Hemomycin is prescribed only when the expected benefit of therapy for the mother outweighs the potential risk to the fetus.
If necessary, the use of the drug during lactation should decide on the termination of breastfeeding for the duration of the drug.

Special instructions for the use of Hemomycin.

Do not take the drug during meals.
It is recommended to observe an interval of at least 2 hours between taking Hemomycin and antacids.
After discontinuation of treatment in some patients, hypersensitivity reactions may persist, which requires specific therapy and medical monitoring.

Drug overdose:

Symptoms: nausea, temporary hearing loss, vomiting, diarrhea.
Treatment: gastric lavage, symptomatic therapy.

Interaction of Hemomycin with other drugs.

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.
With the joint appointment of warfarin and azithromycin (at usual doses), no change in prothrombin time was detected, however, given that the interaction of macrolides and warfarin may increase 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, there is an increase in the toxic effect of the latter (vasospasm, dysesthesia).
Co-administration of triazolam and azithromycin reduces clearance and increases pharmachologic effect triazolam.
Azithromycin slows down the excretion and increases the plasma concentration and toxicity of cycloserine, indirect anticoagulants, methylprednisolone, felodipine, as well as drugs undergoing microsomal oxidation (carbamazepine, terfenadine, cyclosporine, hexobarbital, ergot alkaloids, valproic acid, disopyramide, bromocriptine, phenytoin, oral hypoglycemic drugs, 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 increase it.
Pharmaceutical interaction
Azithromycin is pharmaceutically incompatible with heparin.

Conditions of sale in pharmacies.

The drug is dispensed by prescription.

Terms of storage conditions of the drug Hemomycin.

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.

Hemomycin is a drug from the group of azalide antibiotics, which has a pronounced bacteriostatic effect.

The active substance of the drug is azithromycin. Its effect on microorganisms leads to a stop of protein synthesis in the microbial cell. If the protein is not synthesized, the microbe cannot grow and reproduce. In high doses, Hemomycin can be bactericidal (killing bacteria).

In this article, we will look at why doctors prescribe Hemomycin, including instructions for use, analogues and prices for this drug in pharmacies. Real REVIEWS of people who have already used Hemomycin can be read in the comments.

Composition and form of release

Clinical and pharmacological group: macrolide antibiotic - azalide.

The antibiotic in the form of tablets (500 mg) has a round shape, the color is blue. One tablet is taken daily. This form of release is for adults only. One package contains 3 tablets.
Capsules 250 mg. They have a pleasant blue color, with a white powder inside. There are 6 pieces in a pack. Drink orally (by mouth) before meals once a day.
Powder for breeding. The 100 mg baby suspension is suitable for the smallest (from 6 months to one year). The diluted powder should be drunk once a day, the calculation of the children's dosage is 10 mg per kg of weight. Suspension after preparation has white color with a pleasant smell. The powder is available in darkened bottles. Sealed in a cardboard box.

What is Hemomycin used for?

Hemomycin is used in diseases caused by pathogens sensitive to azithromycin:

Scarlet fever;
Infections of the respiratory tract and ENT organs (tonsillitis, otitis media, acute bronchitis, pneumonia, sinusitis, exacerbation of chronic bronchitis);
Soft tissue/skin infections (impetigo, secondarily infected dermatoses, erysipelas);
Infections of the genitourinary system (uncomplicated urethritis, uncomplicated cervicitis, including those caused by mycoplasma, chlamydial, gonococcal, ureaplasma infection).

Hemomycin is also indicated for the initial stage of Lyme disease. As part of complex therapy used in diseases of the stomach / duodenum associated with Helicobacter pylori.

Pharma action

Hemomycin is a broad-spectrum antibiotic. Azithromycin is a representative of a subgroup of macrolide antibiotics - azalides. In high concentrations, it has a bactericidal effect.

The drug is active against intracellular microorganisms: Chlamydia trachomatis, Mycoplasma pneumoniae, Ureaplasma urealyticum, Borrelia burgdorferi, as well as against Treponema pallidum.
Hemomycin 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; anaerobic bacteria: Bacteroides bivius, Clostridium perfringens, Peptostreptococcus spp.

Gram-positive bacteria resistant to erythromycin are resistant to the drug.

Instructions for use

The instruction for Hemomycin recommends taking an antibiotic orally (tablets, suspension, capsules) once a day 1 hour before or 2 hours after a meal, since taking Hemomycin together with food reduces the bioavailability of the drug.

In infectious and inflammatory diseases of the respiratory tract, soft tissues and skin for children from 12 years of age, the drug is prescribed at the rate of 10 mg / kg 1 time per day for 3 days, in the treatment of the initial stage of Lyme disease - 20 mg / kg on the first day and 10 mg/kg from the second to the fifth day.
In infectious and inflammatory diseases of the respiratory system for adults, Hemomycin is prescribed at a dosage of 500 mg per day for three days.
In infectious and inflammatory diseases of soft tissues and skin, as well as at the initial stage of Lyme disease, 1 gram is prescribed on the first day, then 500 mg once a day from the second to the fifth day.
In diseases of the duodenum and stomach associated with Helicobacter pylori, take 1 gram per day for 3 days as part of multicomponent anti-Helicobacter therapy.
In acute urethritis or cervicitis, a single dose of 1 gram of azithromycin is recommended.

Suspension 200 mg/5 ml and 100 mg/5 ml. In children older than 12 months, a suspension of 200 mg / 5 ml is used, in children older than 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), Hemomycin in the form of a suspension is prescribed at the rate of 10 mg / kg of body weight 1 time / day for 3 days (course dose - 30 mg / kg).

Suspension preparation rules:

Water (distilled or boiled and cooled) is gradually added to the vial containing the powder to the mark.
The contents of the vial are thoroughly shaken until a homogeneous suspension is obtained.
If the level of the prepared suspension is below the mark on the vial label, re-add water 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 allowed to drink a few sips of liquid (water, tea) in order to wash off and swallow the suspension remaining in the oral cavity.

Contraindications

The drug or analogues of Hemomycin are contraindicated:

with liver and kidney failure;
with hypersensitivity to antibiotics of the macrolide group;
in childhood up to six months (for a suspension of 100 mg);
in childhood up to a year (for a suspension of 200 mg);
in children under twelve years of age (for tablets and capsules).

According to reviews, Hemomycin should be administered with caution when:

arrhythmias;
pregnancy.

Caution should also be exercised when using Hemomycin or its analogue in children with severe renal or hepatic impairment.

Side effects

According to reviews, Hemomycin sometimes causes such side effects: palpitations, chest pain, nausea, diarrhea, vomiting, dyspepsia, abdominal pain, cholestatic jaundice, melena, increased activity of liver enzymes.

In addition to this, the drug can cause: hyperkinesia, headache, vertigo, neurosis, dizziness, insomnia or drowsiness, anxiety, vaginal candidiasis, Quincke's edema, skin rash, nephritis, photosensitivity, increased fatigue.

According to reviews of Hemomycin, children may experience: gastritis, candidiasis of the oral mucosa, constipation, changes in taste, pruritus, urticaria, conjunctivitis.

Pregnancy and lactation

During pregnancy, Hemomycin is prescribed only when the expected benefit of therapy for the mother outweighs the potential risk to the fetus. If necessary, the use of the drug during lactation should decide on the termination of breastfeeding for the duration of the drug.

Analogues

There are analogues of Hemomycin, among them: Azivok, Azithromycin Azitral, AzitRus, Azitrox, Azimycin, Azitsid, Retard, Zetamax ZI-Factor, Zitrolid, Zitrocin, Zitnob, Sumaklid, Sumazid, Sumamed, Sumamox, Sumametsin, Sumatrolid solutab, Ecolab, Tremak- Sanovel.

Attention: the use of analogues must be agreed with the attending physician.

Release form: Solid dosage forms. Powder for oral administration.

General characteristics. Compound:

Capsules hard gelatinous, light blue, size No. 0; the contents of the capsules are white powder. 1 caps. azithromycin (in the form of dihydrate) 250 mg Excipients: anhydrous lactose, corn starch, sodium lauryl sulfate, magnesium stearate. Shell composition: titanium dioxide E171, patent blue dye VE131, gelatin. 6 - blisters (1) - packs of cardboard. Film-coated tablets, grayish-blue, round, biconvex. 1 tab. azithromycin (in the form of dihydrate) 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 lacquer dye 8%: indigo carmine (indigotine) E132, quinoline yellow E104. 3 - blisters (1) - packs of cardboard. Powder for suspension for oral administration white or almost white, with a fruity odor; the prepared suspension is almost white in color with a fruity odor. 5 ml of finished susp. azithromycin (in the form of dihydrate) 100 mg Excipients: xanthan gum, sodium saccharinate, calcium carbonate, colloidal silicon dioxide, anhydrous sodium phosphate, sorbitol, cherry flavor, apple and strawberry flavors. 11.43 g - dark glass bottles (1) complete with a measuring spoon - packs of cardboard. Powder for suspension for oral administration white or almost white, with a fruity odor; ready suspension of almost white color with a fruity smell. 5 ml of finished susp. azithromycin (in the form of dihydrate) 200 mg Excipients: xanthan gum, sodium saccharinate, calcium carbonate, colloidal silicon dioxide, sodium phosphate dodecahydrate, sorbitol, cherry flavor, apple and strawberry flavors. 10 g - dark glass bottles (1) complete with a measuring spoon - packs of cardboard.

Pharmacological properties:

Broad spectrum antibiotic. Azithromycin is a representative of a subgroup of macrolide antibiotics - azalides. In high concentrations, it has a bactericidal effect. Hemomycin 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; anaerobic 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 resistant to erythromycin are resistant to the drug. Suction. Azithromycin is rapidly absorbed from the gastrointestinal tract, due to its stability in an acidic environment and lipophilicity. After oral administration of Hemomycin at a dose of 500 mg Cmax of azithromycin in 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. 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 a 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 the sites of infection, where it is released during phagocytosis. The concentration of azithromycin in the foci of infection is significantly higher than in healthy tissues (on average by 24-34%) and correlates with the degree of inflammatory edema. Despite the high concentration in phagocytes, azithromycin does not significantly affect their function. Azithromycin remains at bactericidal concentrations in the inflammatory focus for 5-7 days after the last dose, which made it possible to develop short (3-day and 5-day) courses of treatment. Withdrawal. Removal of azithromycin from blood plasma takes place in 2 stages: T1 / 2 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 1 time / day.

Indications for use:

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug: - infections of the upper respiratory tract and ENT organs (tonsillitis, middle); - ; - infections of the lower respiratory tract (bacterial and atypical,); - infections of the urogenital tract (uncomplicated and / or); - infections of the skin and soft tissues (erysipelas, secondarily infected dermatoses); - Lyme disease (borreliosis) for the treatment of the initial stage (erythema migrans); - associated with Helicobacter pylori (as part of combination therapy) (for tablets).

Important! Get to know the treatment

Dosage and administration:

Children (the drug is approved for use starting from 6 months, depending on the dosage. See instructions):

How to prepare a suspension for oral administration:

water (distilled or boiled and cooled) is gradually added to the vial to the mark, the contents of the vial are thoroughly shaken until a homogeneous suspension is obtained. If the level of a homogeneous suspension is below the mark on the vial label, re-add water 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 (with the exception of chronic migratory erythema), the amount of the drug is taken at the rate of 10 mg per 1 kg of the child's weight, 1 time per day, for 3 days (course dose 30 mg / kg). Depending on the body weight of the child, the following dosing regimen is recommended:

The patient's body weight	Daily dosage (if you bought a suspension of 100 mg / 5 ml)	Daily dosage (if you bought a suspension of 200 mg / 5 ml)
	100 mg (5 ml) - 1 scoop per day - 3 days	100 mg (2.5 ml) - ½ teaspoon per day - 3 days
	200 mg (10 ml) - 2 scoops per day - 3 days	200 mg (5 ml) - 1 scoop per day - 3 days
	300 mg (15 ml) - 3 scoops per day - 3 days	300 mg (7.5 ml) - 1 ½ scoops per day - 3 days
	400 mg (20 ml) - 4 scoops per day - 3 days	400 mg (10 ml) - 2 scoops per day - 3 days
Over 45 kg		Assign doses for adults: 1 tablet 500 mg per day - 3 days

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

In the event that a dose of the drug has been missed, it should, if possible, be taken immediately, and then subsequent doses should be taken at intervals of 24 hours.

Adults and children over 12 years of age:

The drug is taken orally 1 time / day. 1 hour before or 2 hours after a meal.

In acute infections of the urogenital tract and urogenital organs (uncomplicated urethritis or cervicitis) - once 1 g.

With peptic ulcer of the stomach and duodenum associated with Helicobacter pylori - 1 g per day for 3 days as part of a combined anti-Helicobacter therapy.

Application Features:

Do not take the drug during meals. It is recommended to observe an interval of at least 2 hours between taking Hemomycin and antacids. After discontinuation of treatment in some patients, hypersensitivity reactions may persist, which requires specific therapy and medical monitoring.

Side effects:

From the digestive system: (5%), (3%), abdominal pain (3%); 1% or less - melena, cholestatic jaundice, increased activity of liver enzymes, in children - constipation, change in taste, candidiasis of the oral mucosa. From the side of the cardiovascular system: palpitations, chest pain (1% or less). From the side of the central nervous system: vertigo, drowsiness; in children - headache (during therapy), hyperkinesia, anxiety, sleep disturbance (1% or less). From the reproductive system: vaginal candidiasis. From the urinary system: (1% or less). Allergic reactions: rash, angioedema; in children -, itching,. Other: increased fatigue, photosensitivity.

Interaction with other drugs:

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. With the joint appointment of warfarin and azithromycin (at usual doses), no change in prothrombin time was detected, however, given that the interaction of macrolides and warfarin may increase 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, there is an increase in the toxic effect of the latter (vasospasm, dysesthesia). Co-administration of triazolam and azithromycin reduces clearance and enhances the pharmacological action of triazolam. Azithromycin slows down the excretion and increases the plasma concentration and toxicity of cycloserine, indirect anticoagulants, methylprednisolone, felodipine, as well as drugs undergoing microsomal oxidation (carbamazepine, terfenadine, cyclosporine, hexobarbital, ergot alkaloids, valproic acid, disopyramide, 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 increase it. Pharmaceutical interactions Azithromycin is pharmaceutically incompatible with heparin.

Contraindications:

- ; - ; - children's age up to 12 years (for capsules and tablets); - children's age up to 12 months (for a suspension of 200 mg / 5 ml); - children's age up to 6 months (for a suspension of 100 mg / 5 ml); - Hypersensitivity to macrolide antibiotics. With caution, the drug should be prescribed during pregnancy, with (possible ventricular arrhythmias and prolongation of the QT interval), children with severe impaired liver or kidney function.

Overdose:

Symptoms: nausea, temporary hearing loss, vomiting, diarrhea. Treatment: conducting symptomatic therapy.

Storage conditions:

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.

Leave conditions:

On prescription

Package:

Film-coated tablets 500 mg. There are 3 tablets in a blister, 1 blister in a cardboard box; Capsules 250 mg. There are 6 capsules in a blister, 1 blister in a cardboard box; Powder for suspension for oral administration 100 mg/5 ml*. In a dark glass bottle. The package contains a measuring spoon of 5 ml, with a mark of 2.5 ml. * What does the dosage of 100 mg / 5 ml mean: this means that every 5 ml (1 whole spoon) of the finished suspension contains 100 mg of the active ingredient of the antibiotic. When preparing the medicine for use in a vial, 20 ml (4 spoons) of suspension is obtained. Thus, if your child weighs from 10 to 14 kg, then one bottle of Hemomycin, 100 mg / 5 ml, will be enough for you for the course of treatment. Powder for oral suspension 200 mg/5 ml*. In a dark glass bottle. The package contains a measuring spoon of 5 ml, with a mark of 2.5 ml. * What does the dosage of 200 mg / 5 ml mean: this means that every 5 ml (1 whole spoon) of the finished suspension contains 200 mg of the active ingredient of the antibiotic. When preparing the medicine for use in a vial, 20 ml (4 spoons) of suspension is obtained. Thus, if your child weighs from 15 to 25 kg, then one bottle of Hemomycin, 200 mg / 5 ml, will be enough for you for the course of treatment.

Catad_pgroup Antimicrobial ( different groups)

Hemomycin lyophilizate - instructions for use

Registration number

ATX code

International non-proprietary name

azithromycin

Dosage form

lyophilisate for solution for infusion.

Compound

1 vial contains
active substance- azithromycin (in the form of azithromycin dihydrate 524.00 mg) 500 mg;
Excipients: citric acid monohydrate - 110 mg, mannitol - 146 mg, sodium hydroxide - up to pH 6.0 - 7.0.

Description

Freeze-dried powder or compacted into a tablet mass of white or almost white color.

Pharmacotherapeutic group

Antibiotic - azalide

Pharmacological properties

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

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

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

Microorganism sensitivity scale to azithromycin:

Microorganisms	MIC*, mg/l
Microorganisms	sensitive	sustainable
Staphylococcus
Streptococcus A, B, C, G
Streptococcus pneumoniae
haemophilus influenzae
Moraxella catarrhalis
Neisseria gonorrhoeae

*Minimum inhibitory concentration

In most cases, azithromycin sensitive:

Staphylococcus aureus(methicillin-sensitive), Streptococcus pneumoniae(penicillin-sensitive), Streptococcus pyogenes, Streptococcus agalactiae, streptococci of groups C, G ;
aerobic Gram-negative microorganisms: Haemophilus influenzae, Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Pasteurella multocida, Neisseria gonorrhoeae;
anaerobic microorganisms: Clostridium perfringens, Fusobacterium spp., Prevotella spp., Porphyriomonas spp.,Peptostreptococcus spp.;
other microorganisms: Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi.

Microorganisms with acquired resistance to azithromycin:

Streptococcus pneumoniae(penicillin-resistant).

Microorganisms inherently resistant:

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

Pharmacokinetics
Azithromycin quickly penetrates from blood plasma into tissues. Concentrating in phagocytes and without violating their function, azithromycin migrates to the focus of inflammation, accumulating directly in infected tissues. The pharmacokinetic profile of azithromycin is characterized by low plasma concentration and high tissue concentration.

In healthy volunteers, with intravenous infusion of azithromycin at a dose of 500 mg (solution concentration 1 mg / ml) for 3 hours, the maximum concentration of the drug C max in blood plasma was 1.1 μg / ml, with a baseline concentration of 0.18 μg / ml. Similar values were found in patients with community-acquired pneumonia who received the same therapy for 2 to 5 days (C max 3.6 μg / ml, at a baseline concentration of 0.2 μg / ml).

The half-life of the drug is 65-72 hours.

Plasma protein binding decreases with an increase in the concentration of azithromycin in the blood. Azithromycin has a protein binding percentage of 51 at 0.02 µg/mL and 7% at 2 µg/mL.

After intravenous administration, azithromycin is distributed into most tissues and body fluids. The high level of observed volume of distribution (average 32 l/kg) and plasma clearance (10.8 ml/min/kg) suggests that the long half-life of the drug is a consequence of the accumulation of the antibiotic in tissues, followed by its slow release.

Easily passes through histohematic barriers. It penetrates well into the respiratory tract, urinary organs and tissues, incl. the prostate gland, into the skin and soft tissues; accumulates in an environment with low pH, in lysosomes (which is especially important for the eradication of intracellularly located pathogens). It is also transported by phagocytes: polymorphonuclear leukocytes and macrophages. Penetrates through cell membranes and creates high concentrations in them.

The concentration in the foci of infection is significantly higher (by 24-34%) than in healthy tissues, and correlates with the severity of inflammatory edema. It remains in the body in effective concentrations for 5-7 days after the last dose.

The main pathway of biotransformation is N-demethylation in the liver.

It is excreted by the intestines, mainly unchanged. A small amount of the drug is excreted by the kidneys. On the first day, 11% is excreted by the kidneys, and after 5 days 14% of the intravenously administered dose.

Indications for use

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

Contraindications

hypersensitivity to azithromycin or other components of the drug;
hypersensitivity to erythromycin, other macrolides, ketolides;
severe liver dysfunction;
severe renal dysfunction (creatinine clearance less than 40 ml / min);
Children's age up to 16 years;
Simultaneous administration with ergotamine and dihydroergotamine.

Carefully

Myasthenia gravis, mild to moderate liver dysfunction, mild to moderate renal dysfunction (creatinine clearance more than 40 ml / min), in patients with proarrhythmic 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) and III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotics (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with impaired fluid 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 during pregnancy and during breastfeeding

The use of the drug during pregnancy is possible only in cases where the benefit of its use for the mother outweighs the possible risk to the fetus. During lactation breast-feeding suspend.

Dosage and administration

The drug should be used only in stationary medical institutions!
Recommended doses for intravenous administration of azithromycin in the treatment of adults and patients over 18 years of age with the following diseases:

Community acquired pneumonia (CAP)
500 mg once a day intravenously (in / in) for at least 2 days (if necessary, according to the decision of the attending physician, the IV course can be extended, but should not be more than 5 days). Intravenous 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.

Infectious and inflammatory diseases of the pelvic organs
500 mg once a day intravenously for at least 2 days (in / in the course of treatment is not more than 5 days). Intravenous administration should be followed by subsequent 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 the transition to oral treatment is determined in accordance with the data of the clinical examination.

Patients with impaired renal function
When used in patients with impaired renal function of mild to moderate severity (creatinine clearance> 40 ml / min), dose adjustment is not required.

Patients with impaired liver function
When used in patients with mild to moderate hepatic impairment, dose adjustment is not required.

Elderly patients
Dose adjustment is not required in elderly patients.

The solution for infusion is prepared in 2 stages:
Stage 1 - preparation of the reconstituted solution:
4.8 ml of sterile water for injection is added to a vial with 500 mg of the drug and shaken 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 - breeding reconstituted solution (100 mg/ml) carried out immediately before the introduction in accordance with the table below.

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

Hemomycin solution must not be administered intravenously by stream or intramuscularly!

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

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

Side effect

From the side nervous system : dizziness/vertigo, headache, drowsiness convulsions; hypoesthesia, peresthesia, asthenia, insomnia, syncope, aggressiveness, nervousness, agitation, delirium, hallucinations, anxiety, hyperactivity, myasthenia gravis.

From the sense organs: tinnitus, reversible hearing loss up to deafness (when taking high doses for a long time), visual impairment, impaired perception of taste and smell, perversion of smell, loss of smell, loss of taste sensations.

From the side of the cardiovascular system: palpitations, arrhythmia, including ventricular tachycardia, an increase in the QT interval, bidirectional ventricular tachycardia, lowering blood pressure.

From the digestive system: nausea, vomiting, diarrhea, abdominal pain and spasms, loose stools, flatulence, dysphagia, dryness of the oral mucosa, belching, ulcers of the oral mucosa, increased secretion of salivary glands, indigestion, cholestatic jaundice, hepatitis, gastritis, changes in laboratory liver function tests, constipation, discoloration of the tongue, pseudomembranous colitis, pancreatitis, fulminant hepatitis, liver necrosis, liver failure (possibly fatal).

From the respiratory system: pneumonia, respiratory diseases, rhinitis, shortness of breath.

From the circulatory and lymphatic systems: eosinophilia, hemolytic anemia, decreased number of lymphocytes, thrombocytopenia, neutropenia, leukopenia, neutrophilia, increased number of basophils, monocytes, platelets.

Allergic reactions: hypersensitivity reaction, pruritus, skin rashes, angioedema, urticaria, photosensitivity, anaphylactic reaction, including edema (in rare cases fatal), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

From the side of the musculoskeletal system: arthralgia, osteoarthritis, myalgia.

From the genitourinary system: nephritis, acute renal failure, dysuria, pain in the kidney area, metrorrhagia, testicular dysfunction.

From the side of the skin: dermatitis, dry skin, sweating.

Laboratory indicators: in blood plasma: a decrease or increase in the concentration of bicarbonates, an increase in the activity of alkaline phosphatase, an increase in the content of chlorine, a change in the content of potassium, an increase in the concentration of glucose, a change in the sodium content, an increase in hematocrit, an increase in the activity of alanine aminotransferase, an increase in the concentration of bilirubin, urea, creatinine.

Local reactions: pain and inflammation at the injection site.

Other: candidiasis, incl. mouth and genitals, fatigue, malaise, anorexia, vaginitis, pharyngitis, facial flushing, epistaxis, back pain, neck pain, chest pain, peripheral edema, facial swelling, fever.

Overdose

Symptoms: severe nausea, temporary hearing loss, vomiting, diarrhea, abdominal pain, abnormal liver function.
Treatment: symptomatic.

Interaction with other drugs

Azithromycin does not affect the concentration of carbamazepine, cimetidine, didanosine, efavirenz, fluconazole, indinavir, midazolam, theophylline, triazolam, trimethoprim / sulfamethoxazole, rifabutin, cetirizine, nelfinavir, sidenafil, atorvastatin and methylprednisolone in the blood when used together.

In pharmacokinetic studies of the effect of a single dose of cimetidine on the pharmacokinetics of azithromycin, there were no changes in the pharmacokinetics of azithromycin, provided that cimetidine was used 2 hours before azithromycin.

If necessary, joint use with cyclosporine, it is recommended to control the content of cyclosporine in the blood and adjust the dose accordingly.

With the combined use of digoxin and azithromycin, it is necessary to control the concentration of digoxin in the blood, because. many macrolides increase the absorption of digoxin in the intestine, thereby increasing its concentration in blood plasma.

When combined with indirect anticoagulants (warfarin, other coumarin anticoagulants), it is recommended that patients carefully monitor prothrombin time.

The simultaneous use of terfenadine and antibiotics of the macrolide class causes arrhythmia and prolongation of the QT interval. It is necessary to take into account these data when using terfenadine and azithromycin together.

The simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times a day) causes an increase in the equilibrium concentration of azithromycin in the blood plasma; clinically significant side effects was not observed and dose adjustment of azithromycin with its simultaneous use with nelfinavir is not required.

When used simultaneously with zidovudine, azithromycin has little effect on the pharmacokinetics, including renal excretion, of zidovudine and its glucuronide metabolite. However, the concentration of the active metabolite, phosphorylated zidovudine, increases in mononuclear cells of peripheral vessels. The clinical significance of this fact has not yet been determined.

With the combined use of azithromycin with ergotamine and dihydroergotamine, their toxic effects (vasospasm, dysesthesia) may occur.

There have been separate reports of cases of rhabdomyolysis in patients taking azithromycin and statins concomitantly.

With the simultaneous use of azithromycin and rifabutin, neutropenia was sometimes observed. 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.

Azithromycin weakly interacts with cytochrome P450 isoenzymes, it has not been revealed that azithromycin is involved in pharmacokinetic interactions similar to erythromycin and other macrolides, azithromycin is not an inducer and inhibitor of cytochrome P450 isoenzymes.

Pharmaceutically incompatible with heparin.

special instructions

The safety of use and efficacy of the injectable form of the drug Hemomycin in children under 18 years of age have not been established.

Do not administer the drug for longer courses than indicated in the instructions, since the pharmacokinetic properties of azithromycin allow the use of a short dosing regimen.

It is possible to add superinfection (including fungal infection) during treatment with Hemomycin (as with any antibiotic therapy).

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

If there are symptoms of impaired liver function, such as rapidly increasing asthenia, jaundice, dark urine, a tendency to bleeding, hepatic encephalopathy, drug therapy should be discontinued and a study of the functional state of the liver should be carried out.

Azithromycin should be used with caution in patients with mild to moderate renal impairment.

The use of azithromycin can provoke the development of myasthenic syndrome or exacerbate myasthenia gravis.

When using the drug Hemomycin, diarrhea / pseudomembranous colitis caused by Clostridium difficile. In this regard, patients with diarrhea should be carefully observed. The use of drugs that inhibit intestinal motility in the development of pseudomembranous colitis is contraindicated.

After discontinuation of treatment, hypersensitivity reactions in some patients may persist, which requires specific therapy under the supervision of a physician.

Patients on a sodium-restricted diet should take into account that one vial contains 6.2 mg of sodium (sodium hydroxide is an excipient) during treatment with Hemomycin.

Influence on the ability to drive vehicles and mechanisms
Given the likelihood of side effects from the central nervous system, care should be taken when driving vehicles and mechanisms.

Release form

Lyophilisate for solution for infusion 500 mg.
500 mg of the active substance are placed in a colorless glass vial of hydrolytic class 1, sealed with a rubber stopper and sealed with an aluminum cap with an insert in the form of a plastic disk (first opening control). 1 bottle with instructions for use in a cardboard box.