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

auxiliary substances - silicate cellulose microcrystalline - 69.00 mg, microcrystalline cellulose - 57,00 mg, sodium carboxymethyl starch (type A) 46.00 mg, povidone - 24,00 mg, magnesium stearate - 10.00 mg, talc - 10.00 mg, silicon dioxide colloid - 1.00 mg; shell: titanium dioxide - 10.58 mg, talc - 9.57 mg, copovidone 4.95 mg, ethyl cellulose 4.95 mg, macrogol 6000 1.32 mg, indigocarmine (indigotine) E 132-1.22 mg, dye lacquer green 8% (indigocarmine (indigotine) E 132, quinoline yellow E 104) 0.41 mg.

Description:

Round, biconvex tablets, covered with a film coat of grayish-blue color.

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 to low binding of azithromycin to 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.Eating significantly changes the pharmacokinetics (depending on the dosage form): tablets - the maximum concentration (Cmax) increases (by 31%), the area under the curve (AUC) does not change.

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);

Disease of the stomach and duodenum associated with Helicobacter Pylori (as part of combination therapy).

Contraindications:

Hypersensitivity (including to other macrolides); hepatic and / or renal insufficiency; children's age till 12 years (for a given dosage form), lactation period.

Carefully:

FROM caution - 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:

Inside, 1 hour before or 2 hours after meals 1 time per day. Adults and children older than 12 years with infections of the upper and lower respiratory tract - 0.5 g / day for 1 reception for 3 days (exchange dose -1.5 g).

For infections of the skin and soft tissues -1 g / day on the first day for 1 dose, then 0.5 g / day daily from 2 to 5 days (course dose - 3 g).

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

With Lyme disease (borreliosis) for treatment of stage I (erythema migrans) -1 g on the first day and 0.5 g daily from 2 to 5 days (course dose - 3 g).

With gastric ulcer and 12 duodenal ulcer associated with Helicobacter pylori -1 g / day for 3 days as a combination of anti-Helicobacter therapy.

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.

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:

In case of missed intake of 1 dose, the missed dose should be taken as soon as possible, and the subsequent dose should be taken at an interval of 24 hours.

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:

Tablets, film-coated 500 mg.

Packaging:

3 tablets per blister AL/ PVC. 1 blister with instructions for use in a pack of cardboard.

Storage conditions:In a dry, dark 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 printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-001834/07

Date of registration:01.08.2007

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: & nbsp20.08.2015

Illustrated instructions

Instructions

Hemomycin (Hemomycin)