Hemomycin powder d / prig.susp. for oral administration 100mg / 5ml, 11.43g

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, including those caused by atypical pathogens, 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 and capsules).

The reception mode is individual.

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

If one dose of the drug is missed, it should be taken as early as possible, and subsequent doses - with an interval of 24 hours.

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

In children over 12 months old, a suspension of 200 mg / 5 ml is used, in children over 6 months of age - a suspension of 100 mg / 5 ml.

Children with infections of the upper and lower respiratory tract, infections of the skin and soft tissues (except for 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 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.

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.

5 ml ready-made suspension.

azithromycin dihydrate 104.809 mg,

which corresponds to the content of azithromycin 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.

• liver failure;

• 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, with arrhythmias (ventricular arrhythmias and prolongation of the QT interval are possible), children with severe impaired liver or kidney function.

pharmachologic effect

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

Pharmacokinetics

Suction

Azithromycin is rapidly absorbed from the gastrointestinal tract, which is due to its stability in an acidic environment and lipophilicity. After oral administration of Hemomycin in a dose of 500 mg, 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. Metabolism Azithromycin is demethylated in the liver, the resulting metabolites are inactive. Withdrawal 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.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. Metabolism Azithromycin is demethylated in the liver, the resulting metabolites are inactive. Withdrawal 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.Azithromycin remains in bactericidal concentrations in the inflammation focus for 5-7 days after the last dose, which made it possible to develop short (3-day and 5-day) courses of treatment. Metabolism Azithromycin is demethylated in the liver, the resulting metabolites are inactive. Withdrawal 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.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.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.

Side effect

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

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

Application during pregnancy and lactation

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, it is necessary to decide on the termination of breastfeeding during the use of the drug.

Application for violations of liver function

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

Application for impaired renal function

Caution is needed when prescribing the drug to patients with severe renal impairment (especially children). Contraindicated in renal failure.

special instructions

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.

Overdose

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

Drug interactions

With the simultaneous use of Hemomycin and antacids (aluminum and magnesium-containing), the absorption of azithromycin 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, valproeramine agents, theophylline and other xanthine derivatives) - due to 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.exposed to microsomal oxidation (carbamazepine, terfenadine, cyclosporine, hexobarbital, ergot alkaloids, valproic acid, disopyramide, bromocriptine, phenytoin, oral hypoglycemic agents, theophylline and other xanthine oxidative derivatives by hepatic azanthine derivatives) - due to inhibition of azanthine derivatives by hepatic azanthromycin by microcytachromycin micrositomatom in microcytachomatom, microcytachomatomatachomate, microcytachytachytachytachytachytachytachytach. Lincosamines weaken the effectiveness of azithromycin, while tetracycline and chloramphenicol enhance it. Pharmaceutical interactions Pharmaceutical azithromycin is incompatible with heparin.exposed to microsomal oxidation (carbamazepine, terfenadine, cyclosporine, hexobarbital, ergot alkaloids, valproic acid, disopyramide, bromocriptine, phenytoin, oral hypoglycemic agents, theophylline and other xanthine oxidative derivatives by hepatic azanthine derivatives) - due to inhibition of azanthine derivatives by hepatic azanthromycin by microcytachromycin micrositomatom in microcytachomatom, microcytachomatomatachomate, microcytachytachytachytachytachytachytachytach. Lincosamines weaken the effectiveness of azithromycin, while tetracycline and chloramphenicol enhance it. Pharmaceutical interactions Pharmaceutical azithromycin is incompatible with heparin.Lincosamines weaken the effectiveness of azithromycin, while tetracycline and chloramphenicol enhance it. Pharmaceutical interactions Pharmaceutical azithromycin is incompatible with heparin.Lincosamines weaken the effectiveness of azithromycin, while tetracycline and chloramphenicol enhance it. Pharmaceutical interactions Pharmaceutical azithromycin is incompatible with heparin.