"Hemomycin" is a powder for the preparation of a suspension for oral administration. "Hemomycin" (suspension for children): instruction

Date: 23.06.2020

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

General characteristics. Compound:

Hard gelatin capsules, light blue, size no. 0; the contents of the capsules are white powder. 1 caps. azithromycin (in the form of a dihydrate) 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. Film-coated tablets of grayish-blue color, round, biconvex. 1 tab. azithromycin (in the form of a 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 (indigotin) E132, green varnish dye 8%: indigo carmine (indigotin) E132, quinoline yellow E104. 3 - blisters (1) - cardboard packs. Powder for preparation of suspension for oral administration, white or almost white, with a fruity odor; the prepared suspension is almost white with a fruity odor. 5 ml ready-made suspension. azithromycin (in the form of a dihydrate) 100 mg Excipients: xanthan gum, sodium saccharinate, calcium carbonate, colloidal silicon dioxide, sodium phosphate anhydrous, sorbitol, cherry flavor, apple and strawberry flavor. 11.43 g - dark glass bottles (1) complete with a measuring spoon - cardboard packs. Powder for preparation of suspension for oral administration, white or almost white, with a fruity odor; ready-made suspension of almost white color with a fruity odor. 5 ml ready-made suspension. azithromycin (in the form of a dihydrate) 200 mg Excipients: xanthan gum, sodium saccharinate, calcium carbonate, colloidal silicon dioxide, sodium phosphate dodecahydrate, sorbitol, cherry flavor, apple and strawberry flavor. 10 g - dark glass bottles (1) complete with a measuring spoon - cardboard packs.

Pharmacological properties:

Broad-spectrum antibiotic. Azithromycin is a member of the macrolide antibiotic subgroup - 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 gonorrhoeinalis, and Gardnealis; 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 in a dose of 500 mg, the Cmax of azithromycin in 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. A high concentration in tissues (10-50 times higher than in blood plasma) and a long T1 / 2 are due to the low binding of azithromycin to blood plasma proteins, as well as its ability to penetrate into eukaryotic cells and concentrate in a low pH environment surrounding lysosomes. This, in turn, determines a large apparent Vd (31.1 L / kg) and a 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 its high concentration in phagocytes, azithromycin does not significantly affect their function. Azithromycin remains in bactericidal concentrations in the inflammatory focus for 5-7 days after taking the last dose, which made it possible to develop short (3-day and 5-day) courses of treatment. Excretion. The elimination of azithromycin from blood plasma takes place 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 interval 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! Check out the treatment

Method of administration and dosage:

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

Method of preparation of suspension for oral administration:

water (distilled or boiled and cooled) is gradually added to the bottle to the mark, the contents of the bottle are thoroughly shaken until a homogeneous suspension is obtained. If the level of a homogeneous suspension is below the mark on the bottle 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 child's body weight, the following dosage regimen is recommended:

Patient body weight	Daily dosage (if you bought a suspension of 100 mg / 5 ml)	Daily dosage (if you bought a 200 mg / 5 ml suspension)
	100 mg (5 ml) - 1 spoon per day - 3 days	100 mg (2.5 ml) - ½ spoon per day - 3 days
	200 mg (10 ml) - 2 tablespoons a day - 3 days	200 mg (5 ml) - 1 spoon per day - 3 days
	300 mg (15 ml) - 3 spoons per day - 3 days	300 mg (7.5 ml) - 1 ½ teaspoons per day - 3 days
	400 mg (20 ml) - 4 spoons per day - 3 days	400 mg (10 ml) - 2 spoons per day - 3 days
More than 45 kg		Doses for adults are prescribed: 1 tablet 500mg per day - 3 days

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

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

Adults and children over 12 years old:

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

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

For gastric ulcer and duodenal ulcer associated with Helicobacter pylori - 1 g per day for 3 days as part of a combined anti-Helicobacter pylori therapy.

Application features:

The drug should not be taken with food. It is recommended that an interval of at least 2 hours be observed between taking Hemomycin and antacids. After discontinuation of treatment, hypersensitivity reactions may persist in some patients, which requires specific therapy and medical supervision.

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, Quincke's edema; in children - itching,. Others: increased fatigue, photosensitivity.

Interaction with other medicinal products:

With the simultaneous use of Hemomycin and antacids (aluminum and magnesium-containing), the absorption of azithromycin is slowed down. Ethanol and food slow down and reduce the absorption of azithromycin. With the joint appointment of warfarin and azithromycin (in usual doses), no changes in prothrombin time were detected, however, given that the interaction of macrolides and warfarin may increase the anticoagulant effect, patients need careful control 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). The joint appointment 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 that undergo microsomal oxidation (carbamazepine, terfenadine, cyclosporine, hexobarbital, ergot alkaloids, dissoradic acid, phyporamine agents, theophylline and other xanthine derivatives) - due to the inhibition of microsomal oxidation by azithromycin in hepatocytes. Lincosamines weaken the effectiveness of azithromycin, while tetracycline and chloramphenicol enhance it. Pharmaceutical interactions Pharmaceutical azithromycin is incompatible with heparin.

Contraindications:

-; -; - children under 12 years of age (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 antibiotics of the macrolide group. The drug should be prescribed with caution during pregnancy, if (ventricular arrhythmias and prolongation of the QT interval are possible), in children with severe hepatic or renal dysfunction.

Overdose:

Symptoms: nausea, temporary hearing loss, vomiting, diarrhea. Treatment: carrying out 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 is 2 years.

Vacation 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 preparation of oral suspension 100 mg / 5 ml *. In a dark glass bottle. The package contains a measuring spoon for 5 ml, with a line for 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 bottle, 20 ml (4 tablespoons) of the 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 preparation of oral suspension 200 mg / 5 ml *. In a dark glass bottle. The package contains a measuring spoon for 5 ml, with a line for 2.5 ml. * What does a 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 bottle, 20 ml (4 tablespoons) of the 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.

Registration number: LSR-002215 / 07-271015
Tradename: Hemomycin
International non-proprietary name: azithromycin
Dosage form: powder for preparation of suspension for oral administration.

Compound:
5 ml of the finished suspension contains: active substance azithromycin (in the form of azithromycin dihydrate 104.809 mg) 100 mg, excipients - xanthan gum - 20.846 mg, sodium saccharinate - 4.134 mg, calcium carbonate - 162.503 mg, colloidal silicon dioxide - 26.008 mg, sodium phosphate anhydrous - 17.259 mg, sorbitol - 2145.682 mg, apple flavor - 3.303 mg, strawberry flavor - 8.159 mg, cherry flavor - 12.096 mg.

Description
White or almost white powder with a fruity odor.
Description of the finished suspension: almost white suspension with a fruity odor.

Pharmacotherapeutic group: antibiotic, azalide
ATX code:

Pharmacological properties

Pharmacodynamics
Azithromycin is a broad-spectrum bacteriostatic antibiotic from the group of macrolides-azalides. Possesses a wide spectrum of antimicrobial action. The mechanism of action of azithromycin is associated with the suppression of microbial cell protein synthesis. By binding to the 50S-subunit of the ribosome, it inhibits peptide translocase at the stage of translation and suppresses protein synthesis, slowing down the growth and reproduction of bacteria. In high concentrations, it has a bactericidal effect.
Has activity against a number of gram-positive, gram-negative, anaerobic, intracellular and other microorganisms.
Microorganisms may initially be resistant to antibiotic action or may acquire resistance to it.
The scale of susceptible 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, 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., Peptostreprococcus spp .;
- other microorganisms: Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdoferi.
Microorganisms with acquired resistance to azithromycin:
- 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;
- anaerobes: Bacteroides fragilis.
Pharmacokinetics
Azithromycin is rapidly absorbed from the gastrointestinal tract, which is due to its stability in an acidic environment and lipophilicity. After oral administration of 500 mg, the maximum concentration of azithromycin in the blood plasma is reached after 2.5 - 2.96 hours and is 0.4 mg / l. Bioavailability is 37%.
Azithromycin penetrates well into the respiratory tract, organs and tissues of the urogenital tract (in particular, the prostate gland), into the skin and soft tissues. The high concentration in tissues (10-50 times higher than in blood plasma) and a long half-life are due to the low binding of azithromycin to blood plasma proteins, as well as its ability to penetrate into eukaryotic cells and concentrate in a low pH environment surrounding lysosomes. This, in turn, determines a large apparent volume of distribution (31.1 L / kg) and a 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 its high concentration in phagocytes, azithromycin does not significantly affect their function. Azithromycin remains in bactericidal concentrations for 5-7 days after the last dose, which made it possible to develop short (3-day and 5-day) courses of treatment.
It is demethylated in the liver, the resulting metabolites are inactive.
Azithromycin has a very long half-life - 35-50 hours. The half-life from tissues is much longer. Azithromycin is excreted mainly unchanged - 50% by the intestines, 6% by the kidneys.

Indications for use

Infectious and inflammatory diseases caused by microorganisms sensitive to azithromycin:
- infections of the upper respiratory tract and ENT organs (sinusitis, tonsillitis, pharyngitis, otitis media);
- infections of the lower respiratory tract (bacterial and atypical pneumonia, acute bronchitis, exacerbation of chronic bronchitis);
- infections of the skin and soft tissues (acne vulgaris of moderate severity, erysipelas, impetigo, secondarily infected dermatoses);
- infections of the urogenital tract (urethritis and / or cervicitis) caused by Chlamydia trachomatis;
- Lyme disease (borreliosis), for the treatment of the initial stage (erythema migrans).

Contraindications

Hypersensitivity to azithromycin or other components of the drug;
- hypersensitivity to erythromycin, other macrolides, ketolides;
- simultaneous reception with ergotamine, dihydroergotamine;
- severe liver dysfunctions;
- severe renal dysfunction (creatinine clearance less than 40 ml / min);
- the period of breastfeeding (suspended for the duration of treatment);
- children's age up to 6 months.

Carefully

Myasthenia gravis, mild to moderate liver dysfunction, mild to moderate renal dysfunction (creatinine clearance more than 40 ml / min), in patients with proarrhythmogenic factors (especially in elderly patients): with congenital or acquired lengthening of the QT interval, in patients receiving therapy with class IA antiarrhythmic drugs (quinidine, procainamide) and III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotics (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with imbalances in water-electrolyte in case of hypokalemia or hypomagnesemia, with clinically significant bradycardia, cardiac arrhythmias or severe heart failure; simultaneous use of digoxin, warfarin, cyclosporin; pregnancy.

Application during pregnancy and lactation

Use during pregnancy is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus.
If necessary, use during lactation should decide on the termination of breastfeeding.

Method of administration and dosage

The drug is taken orally 1 time / day. 1 hour before meals or 2 hours after meals.
Water (distilled or boiled and cooled) is gradually added to the bottle 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 bottle 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 erythema migrans)
Children: at the rate of 10 mg / kg body weight 1 time per day for 3 days (course dose 30 mg / kg). Depending on the child's body weight, the following dosage regimen is recommended:

Adults: 500 mg (25 ml of a suspension of 100 mg / 5 ml) once a day for 3 days (course dose of 1.5 g).
For moderate acne vulgaris (adults):
On the 1st, 2nd and 3rd day of treatment, take 500 mg (25 ml of a suspension of 100 mg / 5 ml) once a day, then take a break from the fourth to the seventh day of treatment, from the eighth day of treatment, take 500 mg (25 ml) 1 once a week (at intervals of 7 days) for 9 weeks. Heading dose - 6 g.
For uncomplicated urethritis and / or cervicitis caused by Chlamydia trachomatis - the drug is prescribed for adults: 1 g (50 ml) once.
With Lyme disease (borreliosis) for the treatment of the initial stage (erythema migrans) - 1 time per day for 5 days: on the 1st day at a dose of 20 mg / kg of body weight, and then from the 2nd to the 5th day - 10 mg / kg of body weight body.
The following dosage regimen of the suspension of the drug CHEMOMYCIN is recommended in children with erythema migrans:
1st day

2nd to 5th day

The suspension should be shaken before use.
Immediately after taking the suspension, the child should be given a few sips of liquid (water, tea) to drink in order to wash off and swallow the suspension remaining in the oral cavity.
In the event that a dose of the drug has been missed, it must, if possible, be taken immediately, and then subsequent doses should be taken at intervals of 24 hours.
Patients with impaired renal function
When used in patients with mild to moderate renal impairment (creatinine clearance> 40 ml / min), dose adjustment is not required.
Patients with impaired liver function
When used in patients with impaired liver function of mild and moderate severity, dose adjustment is not required.
Elderly patients
No dose adjustment is required in elderly patients.

Side effect

The frequency of side effects is classified in accordance with the recommendations of the World Health Organization: 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 - 0.1%, very rarely - less than 0.01%; unknown frequency - cannot be estimated from the available data.
Infectious diseases: infrequently - candidiasis, including the mucous membrane of the oral cavity and genitals, pneumonia, pharyngitis, gastroenteritis, respiratory diseases, rhinitis; unknown frequency - pseudomembranous colitis.
On the part of the blood and lymphatic system: infrequently - leukopenia, neutropenia, eosinophilia; very rarely - thrombocytopenia, hemolytic anemia.
From the side of metabolism and nutrition: infrequently - anorexia.
Allergic reactions: infrequently - angioedema, hypersensitivity reaction; unknown frequency - anaphylactic reaction.
From the nervous system: often - headache; infrequently - dizziness, impaired taste, paresthesia, drowsiness, insomnia, nervousness; rarely - agitation; unknown frequency - hypesthesia, anxiety, aggression, fainting, convulsions, psychomotor hyperactivity, loss of smell, perverted sense of smell, loss of taste, myasthenia gravis, delirium, hallucinations.
On the part of the organ of vision: infrequently - visual impairment.
From the side of the organ of hearing and labyrinth disorders: infrequently - hearing impairment, vertigo; unknown frequency - hearing impairment, including deafness and / or tinnitus.
On the part of the cardiovascular system: infrequently - a feeling of palpitations, "hot flushes" of blood to the face; unknown frequency - a decrease in blood pressure, an increase in the QT interval on the electrocardiogram, arrhythmia of the "pirouette" type, ventricular tachycardia.
From the respiratory system: infrequently - shortness of breath, nosebleeds.
From the gastrointestinal tract: very often - diarrhea; often - nausea, vomiting, abdominal pain; infrequently - flatulence, dyspepsia, constipation, gastritis, dysphagia, bloating, dryness of the oral mucosa, increased secretion of the salivary glands; very rarely - discoloration of the tongue, pancreatitis.
From the liver and biliary tract: infrequently - hepatitis; rarely - impaired liver function, cholestatic jaundice, unknown frequency - liver failure (in rare cases with a fatal outcome, mainly against the background of severe liver dysfunction); liver necrosis, fulminant hepatitis.
On the part of the skin and subcutaneous tissues: infrequently - skin rash, itching, urticaria, dermatitis, dry skin, sweating; rarely - photosensitivity reaction; unknown frequency - Steven-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.
From the side of the musculoskeletal system: infrequently - osteoarthritis, myalgia, back pain, neck pain; unknown frequency - arthralgia.
From the kidneys and urinary tract: infrequently - dysuria, pain in the kidney area; unknown frequency - interstitial nephritis, acute renal failure.
On the part of the genitals and mammary gland: infrequently - metrorrhagia, dysfunction of the testicles.
Others: infrequently - asthenia, malaise, fatigue, facial edema, chest pain, fever, peripheral edema.
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 - an increase in the activity of aspartate aminotransferase, alanine aminotransferase, an increase in the concentration of bilirubin in the blood plasma, an increase in the concentration of urea in the blood plasma, an increase in the concentration of creatinine in the blood plasma, a change in the content of potassium in the blood plasma, an increase in the activity of alkaline phosphatase in the blood plasma, an increase in the content of chlorine in the blood plasma , an increase in blood glucose, an increase in the number of platelets, an increase in hematocrit, an increase in the concentration of bicarbonates in the blood plasma, a change in the sodium content in the blood plasma.

Overdose

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

Interaction with other medicinal products

Antacids (aluminum and magnesium-containing) do not affect the bioavailability of azithromycin, but reduce its maximum concentration in the blood by about 25%, so the drug should be taken at least one hour before or two hours after taking these drugs.
Food slows down and reduces absorption.
When used together with indirect anticoagulants of the coumarin series (warfarin), an increase in the anticoagulant effect is possible; patients need careful monitoring of prothrombin time.
Digoxin: an increase in the concentration of digoxin is possible; it is necessary to control the concentration of digoxin in the blood.
Ergotamine and dihydroergotamine: increased toxic effects (vasospasm, dysesthesia); combined use is not recommended.
The simultaneous use of terfenadine and antibiotics of the macrolide class causes arrhythmias and prolongation of the QT interval. It is necessary to take these data into account with the simultaneous use of terfenadine and azithromycin.
With the simultaneous use of fluconazole reduces the maximum concentration of azithromycin in the blood by 18%, which has no clinical significance.
There have been isolated reports of cases of rhabdomyolysis in patients concomitantly taking azithromycin and statins.
With the simultaneous use of azithromycin and rifabutin, neutropenia was sometimes observed. Despite the fact that neutropenia was associated with the use of rifabutin, a causal relationship between the use of a combination of azithromycin and rifabutin and neutropenia has not been established.
With the simultaneous use of azithromycin and cyclosporine, it is necessary to control the concentration of cyclosporine in the blood plasma and adjust the dose accordingly.
When used simultaneously with zidovudine, azithromycin has a slight effect on pharmacokinetics, including excretion by the kidneys, of zidovudine and its glucuronide metabolite, however, the concentration of the active metabolite, phosphorylated zidovudine, increases in peripheral blood mononuclear cells (the clinical significance of this fact has not been determined).
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. No clinically significant side effects were observed, and no dose adjustment of azithromycin is required when used simultaneously with nelfinavir.
Azithromycin weakly interacts with cytochrome P450 isoenzymes. It was not 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.
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, provided that cimetidine was used 2 hours before azithromycin.
Azithromycin does not affect the plasma concentration of carbamazepine, efavirenz, didanosine, fluconazole, indinavir, cetirizine, midazolam, theophylline, triazolam, nelfinavir, trimethoprim / sulfamethoxazole, simultaneous use of sildenafil, atorvadnizolin, methylphenol.

special instructions

In case of missing one dose of the drug, the missed dose should be taken as early as possible, and the subsequent ones should be taken at intervals of 24 hours.
Azithromycin should be taken at least one hour before or two hours after taking antacids.
Azithromycin should be taken with caution in patients with mild to moderate hepatic impairment due to the possibility of developing fulminant hepatitis and severe renal failure.
In the presence of symptoms of liver dysfunction, 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.
In case of impaired renal function of mild and moderate severity (creatinine clearance more than 40 ml / min), azithromycin therapy should be carried out with caution under the control of the state of renal function.
As with the use of other antibacterial drugs, during therapy with azithromycin, patients should be regularly examined for the presence of refractory microorganisms and signs of the development of superinfections, including fungal infections.
The drug should not be used for longer courses than indicated in the instructions, since the pharmacokinetic properties of azithromycin make it possible to recommend a short and simple dosing 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 prolonged use of azithromycin, the development of pseudomembranous colitis caused by Clostridium difficile is possible, as in the form of mild diarrhea against the background of priming the drug, and also 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded.
When treated with macrolides, including azithromycin, lengthening of cardiac repolarization and QT interval was observed, increasing the risk of developing cardiac arrhythmias, including arrhythmias of the "pirouette" type, 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), including those with congenital or acquired prolonged QT interval; in patients receiving therapy with drugs of classes IA (quinidine, procainamide), III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotic drugs (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with disturbances in the water-electrolyte balance, especially in the case of water-electrolyte balance hypokalemia or hypomagnesemia, with clinically significant bradycardia, cardiac arrhythmias, or severe heart failure.
The use of azithromycin can provoke the development of myasthenic syndrome or exacerbate myasthenia gravis.

Influence on the ability to drive vehicles and mechanisms
In connection with the possible development of undesirable reactions from the central nervous system against the background of treatment, care must be taken when driving vehicles and performing other activities that require increased concentration of attention and speed of psychomotor reactions.

The key to quickly getting rid of infectious diseases is the correct selection of antibacterial drugs and the scheme for their use. One of the most effective and safe medicines is Hemomycin for children. What is this remedy, how to take it, what contraindications should you remember and are there any analogues?

Hemomycin powder 100 mg / 5 ml

Composition of the drug and release form

The main active substance of Hemomycin is azithromycin. It has a detrimental effect on pathogenic microorganisms, among which there are gonococci, meningococci, streptococci, listeria, mycoplasma, chlamydia. The composition of the drug includes excipients:

calcium carbonate;
xanthan gum;
phosphates;
sodium saccharinate;
silica.

Flavors are added to the composition of the suspension: strawberry, cherry, apple. Without them, the taste of the drug is very unpleasant, so it is difficult to treat children with it. Fragrances do not lose their odor on contact with water and other solvents.

Chemomycin is available in the form of tablets, capsules, powder for suspension and injection. The principle of operation is the same for all varieties, but there is a difference in the regimen for taking the medication:

Capsules (250 mg) and tablets (500 mg) are prescribed for children over 12 years of age. The most effective in the fight against diseases of the upper and middle respiratory tract, scarlet fever, soft tissues and skin.

Suspension Hemomycin 100 is intended for the treatment of babies from six months, Hemomycin 200 - from 1 year.
Injection solution. It is forbidden to use at home, it is allowed to use it only in a hospital under the supervision of a doctor. However, it is not recommended to use it for the treatment of patients under 16 years of age.

Principle of action and indications for admission

The active substance of the drug penetrates into the skin, respiratory organs, genitourinary system and soft tissues. Having reached the maximum concentration there, it destroys the pathogenic microflora. Absorption of the drug into the bloodstream occurs through the intestines or stomach. The maximum concentration in the blood is reached three hours after taking the medicine.

The drug is indicated for infectious diseases of various organs and systems caused by bacteria sensitive to azithromycin:

infections of the upper and lower respiratory tract (sinusitis, tonsillitis, pharyngitis, otitis media, pneumonia, bronchitis);
urological diseases (urethritis, cervicitis);
skin infections (bacterial dermatoses, erysipelas, impetigo);
borreliosis.

Active substances remain in the affected cells for up to 7 days, gradually losing their density. This feature of the drug made it possible to develop courses of treatment for up to five days. The release of the drug from the body is carried out through the blood plasma.

Instructions for using the suspension for children

The suspension is taken 1 time per day one hour before meals or 2 hours after. Shake the bottle before use.

Hemomycin 100

For respiratory tract infections, the suspension is prescribed at a dosage of 10 mg per 1 kg of body weight (within 3 days):

Hemomycin 200

For infections of the respiratory tract, skin and soft tissues, the suspension is prescribed at a dosage of 10 mg per 1 kg of body weight (within 3 days):

In what cases should the drug not be used?

The antibiotic is safe, but there are limitations. They are associated with the age of the patient. Capsules and tablets are contraindicated in children under 12 years of age. The suspension is given to a child over 6 months old, but if the concentration of active substances is 200 mg per 5 ml, then replace it with a weak form - 100 mg / 5 ml. Leave the increased concentration for the treatment of one-year-old babies. The tool is prohibited to use when:

kidney disease;
liver failure;
hypersensitivity to antibacterial macrolides;
arrhythmias.

The negative effects of an antibiotic

The use of Hemomycin can cause diarrhea and vomiting

Side effects occur when the conditions for using the drug are violated or the patient's body is too sensitive to various substances. On the part of the digestive system, patients often experience vomiting and diarrhea. An exacerbation of gastritis, accompanied by flatulence, is not excluded. On the part of other organs and systems, the following side effects have been identified:

nephritis;
vaginal candidiasis;
heartache;
dizziness;
drowsiness;
neurosis;
anxiety;
insomnia (rare).

Children may experience allergic reactions. They appear in a rash, itching and Quincke's edema. The condition is eliminated by taking classic antihistamines (for example, Zodak).

Interaction with other medications

The combination with other drugs reduces the effectiveness of Hemomycin

In combination with a number of agents, azithromycin decreases in effectiveness. This does not cause any serious consequences:

the combination with antacids slows down the absorption of Hemomycin;
its use with ergotamines causes intoxication - azithromycin increases the toxicity of these drugs;
the combination with Triosalam increases the activity of the latter, but the strength of the action of Hemomycin weakens, the antibiotic loses its effectiveness.

Overdose

As is the case with other medicines, Hemomycin can cause negative effects in case of an overdose. Their intensity depends on the age of the patient and his individual characteristics. So, in one-year-old babies, intoxication is much stronger than in 10-12 year-old children. An overdose manifests itself in:

diarrhea;
vomiting;
nausea;
temporary vision problems.

The first thing to do in case of an overdose is to flush the baby's stomach. If after 20-30 minutes there is no improvement, go to the hospital. An overdose of this drug leads to the development of severe allergies, which does not always end well for babies.

How and for how long can the medicine be stored?

Violation of storage conditions reduces the effectiveness of the drug. The use of "delay" is prohibited - there is a risk of poisoning. Store the drug out of the reach of children. The optimum temperature is 15-25 degrees Celsius. The shelf life of tablets and powder is 2 years. In capsules, it is more - up to three years. The storage location should be protected from direct sunlight and high temperatures.

Rehabilitation course after antibiotic

Like any other antibacterial drug, Hemomycin-100 affects the functionality of organs and systems. The main blow is applied to the gastrointestinal tract. The microflora of the stomach and intestines is disrupted, which sometimes leads to disorders of the digestive system. To eliminate this negative effect, Linex is used (for more details in the article:). Before use, you must consult a specialist. It is also recommended to take:

Linex powder for children allows you to normalize the microflora of the stomach after taking an antibiotic (more in the article :)

hepatoprotectors;
vitamin complexes.

The last point is due to the fact that antibiotics have a detrimental effect on the immune system. Vitamins restore its functionality and strengthen the body's defenses.

If the treatment was carried out for a baby, it is necessary to give up complementary foods for a while and feed the baby only by breastfeeding. The baby's digestive system will return to normal, and the immune system will be strengthened thanks to the antibodies contained in breast milk.

Analogs of the remedy

If for some reason the use of Hemomycin is impossible due to active contraindications or striking side effects, doctors prescribe analogs. They act on the same principle - they destroy the infection, but they affect the body more gently. These drugs include Azicid, Azivok, AzitRus, Vero Azithromycin, Zitrolide and Zitrolide Forte, Zitnob, Sumazid, Sumamed, Sumamox, Ecomed.

Consult a qualified healthcare professional before using any of these drugs. They have their own contraindications and side effects, they are combined in different ways with other medicines. The decision to replace Hemomycin-100 with analogs can be made independently, but after a thorough study of the instructions.

Composition and form of release

5 ml of the finished suspension contains:

active substance azithromycin (in the form of azithromycin dihydrate 104.809 mg) 100 mg, excipients - xanthan gum - 20.846 mg, sodium saccharinate - 4.134 mg, calcium carbonate - 162.503 mg, colloidal silicon dioxide - 26.008 mg, sodium phosphate anhydrous - 17.259 mg, sorbitol - 2145.682 mg, apple flavor - 3.303 mg, strawberry flavor - 8.159 mg, cherry flavor - 12.096 mg. Powder for preparation of oral suspension 100 mg / 5 ml.

11.43 g of powder in a dark glass bottle with a capacity of 60 ml, sealed with a screw cap with a plastic or metal cap with a first opening control. On the upper side of the plastic cap, there is a diagram of the bottle opening.

The bottle, together with a measuring spoon (5 ml volume, scored for a volume of 2.5 ml) and instructions for use are placed in a cardboard box.

Description of the dosage form

powder for preparation of suspension for oral administration

Characteristic

White or almost white powder with a fruity odor.

Description of the finished suspension: almost white suspension with a fruity odor.

Pharmacokinetics

Azithromycin is rapidly absorbed from the gastrointestinal tract, which is due to its stability in an acidic environment and lipophilicity. After oral administration of 500 mg, the maximum concentration of azithromycin in the blood plasma is reached after 2.5 - 2.96 hours and is 0.4 mg / l. Bioavailability is 37%. Azithromycin penetrates well into the respiratory tract, organs and tissues of the urogenital tract (in particular, the prostate gland), into the skin and soft tissues. The high concentration in tissues (10-50 times higher than in blood plasma) and a long half-life are due to the low binding of azithromycin to blood plasma proteins, as well as its ability to penetrate into eukaryotic cells and concentrate in a low pH environment surrounding lysosomes. This, in turn, determines a large apparent volume of distribution (31.1 L / kg) and a 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 its high concentration in phagocytes, azithromycin does not significantly affect their function. Azithromycin remains in bactericidal concentrations for 5-7 days after the last dose, which made it possible to develop short (3-day and 5-day) courses of treatment.

It is demethylated in the liver, the resulting metabolites are inactive.

Azithromycin has a very long half-life - 35-50 hours. The half-life from tissues is much longer. Azithromycin is excreted mainly unchanged - 50% by the intestines, 6% by the kidneys.

Pharmacodynamics

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

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

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

The scale of the sensitivity of microorganisms to azithromycin:

Microorganisms | MIC *, mg / l

| Sensitive | Sustainable

Staphylococcus | ≤1 | more than 2

Streptococcus A, B, C, G | ≤0.25 | more than 0.5

Streptococcus pneumoniae | ≤0.25 | more than 0.5

Haemophilus influenzae | ≤0.12 | more than 4

Moraxella catarrhalis | ≤0.5 | more than 0.5

Neisseria gonorrhoeae | ≤0.25 | more than 0.5

* Minimum inhibitory concentration

in most cases, sensitive to azithromycin:

aerobic gram-positive microorganisms: Staphylococcus aureus (methicillin-sensitive), Streptococcus pneumoniae (penicillin-sensitive), Streptococcus pyogenes, Streptococcus agalactiae, group C, G streptococci;
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 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;
anaerobes: Bacteroides fragilis.

Clinical pharmacology

Antibiotic - azalide

Indications for use

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 (bacterial and atypical pneumonia, acute bronchitis, exacerbation of chronic bronchitis);

Infections of the skin and soft tissues (acne vulgaris of moderate severity, erysipelas, impetigo, secondarily infected dermatoses);

Urogenital tract infections (urethritis and / or cervicitis) caused by Chlamydia trachomatis;

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

Contraindications for use

Hypersensitivity to azithromycin or other components of the drug;

Hypersensitivity to erythromycin, other macrolides, ketolides;

Simultaneous reception with ergotamine, dihydroergotamine;

Severe liver dysfunctions;

Severe renal dysfunction (creatinine clearance less than 40 ml / min);

Breastfeeding period (suspended for the duration of treatment);

Children up to age 6 months.

Use during pregnancy and children

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

If necessary, use during lactation should decide on the termination of breastfeeding.

Side effects

Infectious diseases: infrequently - candidiasis, including the mucous membrane of the oral cavity and genitals, pneumonia, pharyngitis, gastroenteritis, respiratory diseases, rhinitis; unknown frequency - pseudomembranous colitis.

Blood and lymphatic system disorders: infrequently - leukopenia, neutropenia, eosinophilia; very rarely - thrombocytopenia, hemolytic anemia.

From the side of metabolism and nutrition: infrequently - anorexia.

Allergic reactions: infrequently - angoneurotic edema, hypersensitivity reaction; unknown frequency - anaphylactic reaction.

From the side of the nervous system: often - headache; infrequently - dizziness, impaired taste, paresthesia, drowsiness, insomnia, nervousness; rarely - agitation; unknown frequency - hypesthesia, anxiety, aggression, fainting, convulsions, psychomotor hyperactivity, loss of smell, perverted sense of smell, loss of taste, delusional hallucinations.

From the side of the organ of hearing and labyrinth disorders: infrequently - hearing disorder, vertigo; unknown frequency - hearing impairment, including deafness and / or tinnitus.

From the side of the cardiovascular system: infrequently - a feeling of palpitations, "hot flushes" of blood to the face; unknown frequency - a decrease in blood pressure, an increase in the QT interval on the electrocardiogram, arrhythmia of the "pirouette" type, ventricular tachycardia.

From the respiratory system: infrequently - shortness of breath, epistaxis.

From the gastrointestinal tract: very often - diarrhea; often - nausea, vomiting, abdominal pain; infrequently - flatulence, dyspepsia, constipation, gastritis, dysphagia, bloating, dryness of the oral mucosa, increased secretion of the salivary glands; very rarely - discoloration of the tongue, pancreatitis.

From the liver and biliary tract: infrequently - hepatitis; rarely - impaired liver function, cholestatic jaundice, unknown frequency - liver failure (in rare cases with a fatal outcome, mainly against the background of severe liver dysfunction); liver necrosis, fulminant hepatitis.

Skin and subcutaneous tissue disorders: infrequently - skin rash, itching, urticaria, dermatitis, dry skin, sweating; rarely - photosensitivity reaction; unknown frequency - Steven-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme. From the musculoskeletal system: infrequently - osteortritis, myalgia, back pain, neck pain; unknown frequency - arthralgia.

From the side of the kidneys and urinary tract: infrequently - dysuria, pain in the kidney area; unknown frequency - interstitial nephritis, acute renal failure.

From the genitals and mammary gland: infrequently - metrorrhagia, dysfunction of the testicles.

Others: infrequently - asthenia, malaise, fatigue, facial edema, chest pain, fever, peripheral edema.

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 - an increase in the activity of aspartate aminotransferase, alanine aminotransferase, an increase in the concentration of bilirubin in the blood plasma, an increase in the concentration of urea in the blood plasma, an increase in the concentration of creatinine in the blood plasma, a change in the content of potassium in the blood plasma, an increase in the activity of alkaline phosphatase in the blood plasma, an increase in the content of chlorine in the blood plasma , an increase in blood glucose, an increase in the number of platelets, an increase in hematocrit, an increase in the concentration of bicarbonates in the blood plasma, a change in the sodium content in the blood plasma.

Drug interactions

Food slows down and reduces absorption.

When used together with indirect anticoagulants of the coumarin series (warfarin), an increase in the anticoagulant effect is possible; patients need careful monitoring of prothrombin time.

Digoxin: an increase in the concentration of digoxin is possible; it is necessary to control the concentration of digoxin in the blood.

Ergotamine and dihydroergotamine: increased toxic effects (vasospasm, dysesthesia); combined use is not recommended.

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

With the simultaneous use of fluconazole reduces the maximum concentration of azithromycin in the blood by 18%, which has no clinical significance.

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

With the simultaneous use of azithromycin and rifabutin, neutropenia was sometimes observed. Despite the fact that neutropenia was associated with the use of rifabutin, a causal relationship between the use of a combination of azithromycin and rifabutin and neutropenia has not been established.

With the simultaneous use of azithromycin and cyclosporine, it is necessary to control the concentration of cyclosporine in the blood plasma and adjust the dose accordingly.

With simultaneous use with zidovudine, azithromycin has a slight effect on pharmacokinetics, including excretion by the kidneys, of zadovudine and its glucuronide metabolite, however, the concentration of the active metabolite, phosphorylated zidovudine, in peripheral blood mononuclear cells increases (the clinical significance of this fact has not been determined).

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. No clinically significant side effects were observed, and no dose adjustment of azithromycin is required when used simultaneously with nelfinavir.

Azithromycin weakly interacts with cytochrome P450 isoenzymes. It was not 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.

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, provided that cimetidine was used 2 hours before azithromycin.

Azithromycin does not affect the plasma concentration of carbamazepine, efavirenz, didanosine, fluconazole, indinavir, cetirizine, midazols, theophylline, triazolam, nelfinavir, trimethoprim / sulfamethoxazole, simultaneous use of sildenafil, atorvirenzolone, methylphenol.

Dosage

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

Water (distilled or boiled and cooled) is gradually added to the bottle 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 bottle 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 erythema migrans)

Children: at the rate of 10 mg / kg of body weight 1 time per day for 3 days (course dose of 30 mg / kg). Depending on the child's body weight, the following dosage regimen is recommended:

Patient body weight | Daily dose (suspension 100 mg / 5 ml)

more than 8 kg | 2.5 ml (50 mg) - ½ spoon

25-34 kg | 12.5 ml (250 mg) - 2.5 spoons

more than 45 kg | administer doses for adults

Adults: 500 mg (25 ml of a suspension of 100 mg / 5 ml) once a day for 3 days (course dose of 1.5 g).

For moderate acne vulgaris (adults):

On the 1st, 2nd and 3rd day of treatment, take 500 mg (25 ml of a suspension of 100 mg / 5 ml) once a day, then take a break from the fourth to the seventh day of treatment, from the eighth day of treatment, take 500 mg (25 ml) 1 once a week (at intervals of 7 days) for 9 weeks. Heading dose - 6 g.

For uncomplicated urethritis and / or cervicitis caused by Chlamydia trachomatis - the drug is prescribed for adults: 1 g (50 ml) once.

In Lyme disease (borreliosis) for the treatment of the initial stage (erythema migrans) - 1 time per day for 5 days: on the 1st day at a dose of 20 mg / kg of body weight, and then from the 2nd to the 5th day - 10 mg / kg body weight.

8 kg | 5 ml (100 mg) - 1 spoon

8-14 kg | 10 ml (200 mg) - 2 spoons

15-24 kg | 20 ml (400 mg) - 4 spoons

25-34 kg | 25 ml (500 mg) - 5 spoons

35-45 kg | 35 ml (700 mg) - 7 spoons

2nd to 5th day

Body weight | Daily dose (suspension 100 mg / 5 ml)

8 kg | 2.5 ml (50 mg) - ½ spoon

8-14 kg | 5 ml (100 mg) - 1 spoon

15-24 kg | 10 ml (200 mg) - 2 spoons

25-34 kg | 12.5 ml (250 mg) - 2.5 spoons

35-45 kg | 17.5 ml (350 mg) - 3 ½ tablespoons

The suspension should be shaken before use.

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

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

Patients with impaired renal function

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

Patients with impaired liver function

When used in patients with impaired liver function of mild and moderate severity, dose adjustment is not required.

Elderly patients

No dose adjustment is required in elderly patients.

Overdose

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

Treatment: symptomatic; gastric lavage.

Precautionary measures

Azithromycin.

Excipients: xanthan gum - 20.846 mg, sodium saccharinate - 4.134 mg, calcium carbonate - 162.503 mg, colloidal silicon dioxide - 26.008 mg, sodium phosphate anhydrous - 17.259 mg, sorbitol - 2145.682 mg, apple flavor - 3.303 mg, strawberry flavor - 8.159 mg, cherry flavor - 12.096 mg.

11.43 g - dark glass bottles (1) complete with a measuring spoon (5 ml, with a line for 2.5 ml) - cardboard packs.

Powder for preparation of suspension for oral administration, white or almost white, with a fruity odor; the prepared suspension is almost white in color, with a fruity odor.

With the simultaneous use of Hemomycin and antacids (aluminum and magnesium-containing), the absorption of azithromycin is slowed down.

Ethanol and food slow down and reduce the absorption of azithromycin.

With the joint appointment of warfarin and azithromycin (in usual doses), no changes in prothrombin time were detected, however, given that the interaction of macrolides and warfarin may increase the anticoagulant effect, patients need careful control 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).

The joint appointment 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 that undergo microsomal oxidation (carbamazepine, terfenadine, cyclosporine, hexobarbital, ergot alkaloids, dissoradic acid, phyporamine agents, theophylline and other xanthine derivatives) - due to the inhibition of microsomal oxidation by azithromycin in hepatocytes.

Lincosamines weaken the effectiveness of azithromycin, while tetracycline and chloramphenicol enhance it.

Pharmaceutical interactions

Azithromycin is pharmaceutically incompatible with heparin.

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;

Lower respiratory tract infections (bacterial, including those caused by atypical pathogens, pneumonia, bronchitis);

Urogenital tract infections (uncomplicated urethritis and / or cervicitis);

Skin and soft tissue infections (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 (in combination therapy) (for tablets and capsules).

Liver failure;

Renal failure;

Children under 12 years of age (for capsules and tablets);

Children's age up to 12 months (for a suspension of 200 mg / 5 ml);

Children up to 6 months of age (for a suspension of 100 mg / 5 ml);

Hypersensitivity to macrolide antibiotics.

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

During pregnancy, Hemomycin is prescribed only when the expected benefit of therapy to 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 resolved.

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

Have children over 12 months a suspension of 200 mg / 5 ml is used, children over 6 months- suspension 100 mg / 5 ml.

For children at upper and lower respiratory tract infections, skin and soft tissue infections(except for chronic erythema migrans) Hemomycin 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).

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

At infections of the urogenital tract the drug is prescribed for adults at a dose of 1 g once; children under 8 years with a body weight of more than 45 kg- 10 mg / kg as a single dose.

At chronic erythema migrans appoint 1 time / day for 5 days: adults- 1 g / day on the 1st day for 1 dose, then 500 mg / day every day from 2 to 5 days, course dose - 3 g; children- 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.

1st day

2-5th day

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 bottle 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 given a few sips of liquid (water, tea) to drink in order to wash off and swallow the suspension remaining in the oral cavity.

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.

On the part 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).

The drug should be stored out of the reach of children, protected from light, at a temperature of 15 ° to 25 ° C. Shelf life for tablets and powder is 2 years; for capsules - 3 years.