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

5 ml of the finished suspension contains: active substance azithromycin (in the form of azithromycin dihydrate 104,809 mg) 100 mg, auxiliary substances - xanthan gum - 20.846 mg, sodium saccharinate - 4.134 mg, calcium carbonate - 162,503 mg, silicon dioxide colloid - 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:

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

Description of the finished suspension: 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 Gardnerella vaginalis', some anaerobic microorganisms: Bacteroides bivius, Clostridium perfringens, Peptostreptococcus spp; and Chlamydia trachomatis, Mycoplasma pneumoniae, Ureaplasma urealyticum, Treponema pallidum, Borrelia burgdoferi. Azithromycin is inactive against gram-positive bacteria resistant to erythromycin.

Pharmacokinetics:

Azithromycin is rapidly absorbed from the digestive tract, which is due to its resistance to 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 toandzinc binding of azithromycin to plasma proteins, as well as its ability to penetrate 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 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. Eating significantly changes the pharmacokinetics (depending on the dosage form): suspension - Cmah increases (by 46%) and AUC (by 14%).

Indications:

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

Infections 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); Infections of the urogenital tract (uncomplicated urethritis and / or cervicitis);

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

Contraindications:

Hypersensitivity (incl. To other macrolides); hepatic and / or renal insufficiency; period of lactation (at the time of treatment is suspended), children's age is up to 6 months.

Carefully:

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

Pregnancy and lactation:

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

If it is necessary to use during the lactation period, the question of stopping breastfeeding should be solved.

Dosing and Administration:

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

In the bottle, gradually add water (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.

With infection of the upper and lower respiratory tract, skin and soft tissues (except Chronic migratory erythema)

For children: at the rate of 10 mg / kg body weight 1 time in day for 3 days (course dose 30 mg / kg). Depending on the body weight of the child, the following dosing regimen is recommended:

Body weight of the patient	The daily dose (suspension of 100 mg / 5 ml)
10-14 kg	5 ml (100 mg) - 1 teaspoon
15-25 kg	10 ml (200 mg) - 2 spoons
26-35 kg	15 ml (300 mg) - 3 spoons
36-45 kg	20 ml (400 mg) - 4 spoons
more than 45 kg	prescribe doses for adults

Adults: 500 mg once a day for 3 days (course dose of 1.5 g)

In infections of the urogenital tract the drug is prescribed to adults: 1 g once.

With chronic migratory erythema - 1 time per day for 5 days: on the 1st day at a dose of 20 mg / kg body weight, and then from the 2nd to the 5th day - 10 mg / kg body weight.

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 100 mg / 5 ml)
<8 kg	5 ml (100 mg) - 1 teaspoon
8-14 kg	10 ml (200 mg) - 2 spoons
15-24 kg	20 ml (400 mg) - 4 spoons
25-44 kg	25 ml (500 mg) - 5. spoon

From the 2nd to the 5th day

Body mass	The daily dose (suspension 100 mg / 5 ml)
<8 kg	2.5 ml (50 mg) - Yg spoons
8-14 kg	5 ml (100 mg) -1 spoon
15-24 kg	10 ml (200 mg) - 2 spoons
25-44 kg	12.5 ml (250 mg) - 2.5 spoons

Before use, the suspension should be shaken.

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 digestive system: 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.

In extremely rare cases: candidiasis of the oral cavity.

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

From the nervous system: dizziness, headache, vertigo, 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: rash, photosensitivity, Quincke's edema.

Other: increased fatigue; children - conjunctivitis, itching, hives.

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 effect (vasospasm, dysesthesia). Triazolam: reduced clearance and increased pharmacological action of 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. Pharmaceutically incompatible with heparin.

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.

If you miss a dose of 1 dose, the missed dose should be taken as soon as possible, and the subsequent dose - with a break of 24 hours.

Form release / dosage:

Powder for the preparation of suspension for ingestion 100 mg / 5 ml.

Packaging:

11.43 g of powder in a vial of dark glass, sealed with a metal lid with the control of the first opening. 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:

List B.

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 expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-002215/07

Date of registration:15.08.2007

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: & nbsp26.10.2015

Illustrated instructions

Instructions

Hemomycin (Hemomycin)