Hemomycin - instructions for use, dose, side effects, contraindications

Composition:5 ml of the finished suspension contains: azithromycin (in the form of azithromycin dihydrate 209.6 mg) - 200 mg.
Auxiliary substances-xanthan gum 20 mg, sodium saccharinate 4 mg, calcium carbonate -150 mg, silicon colloidal dioxide 25 mg, sodium phosphate anhydrous 17.26 mg, sorbitol-2054.74 mg, apple flavor 4 mg, flavored strawberry - 10 mg, flavored cherry - 15 mg.

Description:

The powder is white or almost white with a fruity smell.

Description of the finished slurry: a suspension of almost white color with a fruity smell.

Pharmacotherapeutic group:Antibiotic - azalide

ATX: & nbsp

J.01.F.A.10 Azithromycin

Pharmacodynamics:

Antibiotic of a wide spectrum of action. Is a representative of a subgroup of macrolide antibiotics - azalides. In high concentrations has a bactericidal effect.

Gram-positive cocci is sensitive to azithromycin: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, streptococcus groups C, F and G, Staphylococcus aureus, Streptococcus viridans; Gram-negative bacteria: Haemophilus influenzae, Moraxella catarrhalis, Bordetella pertussis, Bordetella parapertussis, Legionella pneumophila, Haemophilus ducreyi, Campylobacter jejuni, Neisseria gonorrhoeae and Gardnereila vaginalis; some anaerobic microorganisms: Bacteroides bivius, Clostridium perfringens, Peptostreptococcus spp; and Chlamydia trachomatis, Mycoplasma pneumoniae, Ureaplasma urealyticum, Treponema pallidum, Barrelia burgdorferi. Azithromycin is inactive against gram-positive bacteria resistant to erythromycin.

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 achieved after 2.5 - 2.96 hours and is 0.4 mg / l. Bioavailability is 37%.

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

In the liver demethylated, the metabolites formed are not active.

Excretion of azithromycin from the blood plasma takes place in 2 stages: the half-life period is 14-20 hours in the interval from 8 to 24 hours after the drug administration and 41 hours in the interval from 24 to 72 hours, which allows using the drug once a day.

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:

infection of the upper respiratory tract and ENT organs (sore throat, sinusitis, tonsillitis, pharyngitis, otitis media);

scarlet fever;

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

infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses);

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

Contraindications:

Hypersensitivity (including to other macrolides); hepatic and / or renal insufficiency; lactation period; children up to 12 months.

Carefully:

Carefully - pregnancy, arrhythmia (possible ventricular arrhythmias and lengthening of the interval QT), Children with severe impairment of liver or kidney function.

Pregnancy and lactation:

In pregnancy, it can be used when the benefits of using it significantly exceed the risk that exists always when using any drug during pregnancy. If you need to use the drug during lactation, breastfeeding is suspended.

Dosing and Administration:

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

Water is added to the vial (distilled or boiled and cooled) to the label.

The contents of the vial are shaken carefully until a uniform suspension is obtained.

If the level of the prepared suspension is below the label on the vial label, re-add water to the label and shake.

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

In infections of the upper and lower respiratory tract, skin and soft tissues (with the exception of chronic migratory erythema), the drug is prescribed for children at a dose of 10 mg / kg body weight once a day for 3 days.

Suspension of this dosage is recommended for use in children older than 12 months.

Depending on the body weight of the child, the following dosing regimen is recommended:

Body weight of the patient	The daily dose (suspension 200 mg / 5 ml)
10-14 kg	2.5 ml (100 mg) - ½ spoons
15-25 kg	5 ml (200 mg) -1 spoon
26-35 kg	7.5 ml (300 mg) -1, ½ spoons
36-45 kg	10 ml (400 mg) - 2 spoons
more than 45 kg	prescribe doses for adults

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

With chronic migratory erythema - 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. It is recommended that the following dosage regimen for suspension of the drug CHEMOMYCIN in children with Erythema migrans:

1st day
Body mass	The daily dose (suspension 200 mg / 5 ml)
8-14 kg	5 ml (200 mg) -1 spoon
15-24 kg	10 ml (400 mg) - 2 spoons
25-44 kg	12.5 ml (500 mg) - 2, ½ spoons
From 2 to 5 days
Body mass	The daily dose (suspension 200 mg / 5 ml)
8-14 kg	2.5 ml (100 mg) - ½ spoons
15-24 kg	5 ml (200 mg) -1 spoon
25-44 kg	6.25 ml (250 mg) -1, ½ spoons

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

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

Side effects:

On the part of the gastrointestinal tract: diarrhea (5%), nausea (3%), abdominal pain (3%); 1% or less - dyspepsia (flatulence, vomiting), melena, cholestatic jaundice, increased activity of "liver" transaminases; in children - constipation, anorexia, gastritis.

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

From the nervous system: dizziness, headache, drowsiness; children - headache (with medication otitis media), hyperkinesia, anxiety, neurosis, sleep disturbance (1% or less).

From the genitourinary system: vaginal candidiasis, nephritis (1% or less). Allergic reactions: a rash, Quincke's edema, in children - conjunctivitis, itching, hives. Other: increased fatigue; photosensitization.

Overdose:

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

Treatment: symptomatic; gastric lavage.

Interaction:

Antacids (aluminum and magnesium-containing), ethanol and food slows down and reduces absorption.

When co-administration of warfarin and azithromycin (in normal doses) changes in prothrombin time were found, however, given that the interaction of macrolides and warfarin may be increased anticoagulant effect, patients requires careful monitoring of the prothrombin time.

Digoxin: increased digoxin concentration.

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

Triazolam: reduced clearance and increased pharmacological action triazolam.

Slows down the excretion and increases plasma concentrations and toxicity of cycloserine, indirect anticoagulants, methylprednisolone, felodipine, as well as drugs exposed to microsomal oxidation (carbamazepine, terfenadine, ciclosporin, hexobarbital, ergot alkaloids, valproic acid, disopyramide, bromocriptine, phenytoin, oral hypoglycemic agents, theophylline and others xanthine derivatives) - due to the inhibition of microsomal oxidation in hepatocytes with azithromycin.

Lincosamines weaken the effectiveness, tetracycline and chloramphenicol - strengthen.

Special instructions:

It is necessary to observe a break of 2 hours with the simultaneous use of antacids. After the withdrawal of the treatment, hypersensitivity reactions in some patients may persist, which requires specific therapy under the supervision of a physician.

Form release / dosage:Powder for the preparation of a suspension for oral administration of 200 mg / 5 ml.

Packaging:10 g of powder in a bottle of dark glass, ukuporenny screwed, with the control of the first opening a plastic or metal lid. On the top side of the plastic cover is a scheme for opening the bottle.Vial with a measuring spoon (volume 5 ml, with a risk for volume of 2.5 ml) and instructions for use in a pack of cardboard.

Storage conditions:

Store in a dry, protected from light place at a temperature of 15 to 25 ° C.

Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiration date indicated on 1 package.

Terms of leave from pharmacies:On prescription

Registration number:П N013856 / 02

Date of registration:30.07.2007

The owner of the registration certificate:Hemofarm ADHemofarm AD Serbia

Manufacturer: & nbsp

HEMOFARM, A.D. Serbia

Representation: & nbspHEMOFARM A.D. HEMOFARM A.D. Serbia

Information update date: & nbsp14.08.2015

Illustrated instructions

Instructions

Hemomycin (Hemomycin)