Producer: JSC VEROPHARM Russia
Code of automatic telephone exchange: J01FA10
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active agent: dihydrate azithromycin ( in terms of 100% azithromycin) — 0,5 g. Excipients: phosphate calcium dihydrate, sodium lauryl sulfate, polyvinylpirrolidone (povidone), полипласдон Ickx El-10 (кросповидон), magnesium stearate; cover: oxypropyl-methyl cellulose, titanium dioxide, polyvinylpirrolidone (povidone), talc, twin-80 (polysorbate), dye acid red.
Antibiotic of a broad spectrum of activity. Is the representative of subgroup of makrolidny antibiotics — azaleads. During creation in the center of an inflammation of high concentration has bactericidal effect. Gram-positive cocci are sensitive to azithromycin: Streptococcus pneumoniae, St. pyogenes, St. agalactiae, streptococci of the groups CF and G, Staphylococcus aureus, St. viridans; gram-negative bacteria: Haemophilus influenzae, Moraxella catarrhalis, Bordetella pertussis, B.parapertussis, Legionella pneumophila, H.ducrei, Campylobacter jejuni, Neisseria gonorrhoeae and Gardnerella vaginalis; some anaerobic microorganisms: Bacteroides bivius, Clostridium perfringens, Peptostreptococcus spp; and also Chlamydia trachomatis, Mycoplasma pneumoniae, Ureaplasma urealyticum, Treponema pallidum, Borrelia burgdoferi. Azithromycin is inactive concerning the gram-positive bacteria steady against erythromycin. Azithromycin is quickly soaked up from a GIT that is caused by its stability in acid medium and lipophilicity. After intake of 500 mg the maximum concentration of azithromycin in a blood plasma is reached in 2,5–2,96 h and makes 0,4 mg/l. Bioavailability makes 37%. Azithromycin well gets into respiratory tracts, bodies and fabrics of an urogenital path (in particular, into a prostate), into skin and soft tissues. High concentration in fabrics ( is 10-50 times higher, than in a blood plasma) and a long elimination half-life are caused by low linkng of azithromycin with proteins of a blood plasma, and also its ability to get into eukaryotic cells and to concentrate in the environment with a low rn, a surrounding lysosome. It , in turn, determines the large seeming distribution volume (31,1 l/kg) and high plasma clearance. Ability of azithromycin to collect preferential in lysosomes is especially important for elimination of intracellular activators. It is proved that phagocytes deliver azithromycin to places of localization of an infection where it is released in the course of phagocytosis. Concentration of azithromycin in the centers of an infection it is reliable above, than in healthy fabrics ( on average for 24–34%) and correlates with degree of inflammatory hypostasis. Despite high concentration in phagocytes, azithromycin has no significant effect on their function. Azithromycin remains in bactericidal concentration in the inflammation center within 5–7 days after reception of the last dose that allowed to develop short (3-day and 5-day) courses of treatment. In a liver it demetilirutsya, the formed metabolites are not active. Removal of azithromycin from a blood plasma takes place in 2 stages: the elimination half-life makes 14–20 h in the range from 8 to 24 h after administration of drug and 41 h — in the range from 24 to 72 h that allows to use drug of 1 times/days.
Indications to use:
The infectious and inflammatory diseases caused by microorganisms, sensitive to drug: Infections of upper parts of respiratory tracts and ENT organs (quinsy, sinusitis, tonsillitis, pharyngitis, average otitis); Scarlet fever; Infections of lower parts of respiratory tracts (bacterial and atypical pneumonia, bronchitis); Infections of skin and soft tissues (the ugly face, impetigo for the second time infected a dermatosis); Infections of an urogenital path (uncomplicated urethritis and/or cervicitis); The Disease Laima (borreliosis), for treatment of an initial stage (erythema migrans); The Disease of a stomach and duodenum, associated with Helicobacter Pylori ( as a part of a combination therapy).
Route of administration and doses:
Inside, for 1 h to or in 2 h after food of 1 times a day. The adult at infections of upper and lower parts of respiratory tracts — 500 mg/days for 1 reception within 3 days (a course dose — 1,5 g). At infections of skin and soft tissues — 1000 mg/days in the first day for 1 reception, further on 500 mg/days daily from 2 to 5 day (a course dose — 3 g). At acute infections of urinogenital bodies (an uncomplicated urethritis or a cervicitis) — once 1 g. At a disease Laima (borreliosis) for treatment of the I stage (erythema migrans) — 1 g in the first day and 500 mg daily from 2 to 5 day (a course dose — 3 g). At a peptic ulcer of a stomach and the duodenum associated with Helicobacter pylori — 1 g/days within 3 days as a part of the combined antikhelikobakterny therapy. To children appoint at the rate of 10 mg/kg of 1 times a day within 3 days or in the first day — 10 mg/kg, then 4 days — on 5–10 mg/kg/days within 3 days (a course dose — 30 mg/kg). At treatment of erythema migrans at children a dose — 20 mg/kg in the first day and on 10 mg/kg from 2 to 5 day.
Features of use:
It is necessary to observe a break in 2 h at simultaneous use of antacids. After cancellation of treatment of reaction of hypersensitivity at some patients can remain that demands specific therapy under observation of the doctor.
From the alimentary system: diarrhea (5%), nausea (3%), abdominal pains (3%); 1% and less — dyspepsia, a meteorism, vomiting, a melena, cholestatic jaundice, increase in activity of "hepatic" transaminases; children have locks, anorexia, gastritis. From cardiovascular system: heartbeat, thorax pain (1% and less). From a nervous system: dizziness, headache, drowsiness; children have a headache (at therapy of average otitis), a hyperkinesia, uneasiness, neurosis, a sleep disorder (1% and less). From urinogenital system: vaginal candidiasis, nephrite (1% and less). Allergic reactions: rash, photosensitization, Quincke's edema. Other: increased fatigue; children have a conjunctivitis, an itch, urticaria.
Interaction with other medicines:
Antacids (aluminum and magniysoderzhashchy), ethanol and food slow down and reduce absorption. At joint purpose of warfarin and azithromycin (in usual doses) changes of a prothrombin time it is not revealed, however, considering that at interaction of macroleads and warfarin strengthening of anti-coagulative effect is possible, careful control of a prothrombin time is necessary for patients. Digoxin: increase in concentration of digoxin. Ergotamine and dihydroergotamine: strengthening of toxic action (vasospasm, dizesteziya). To triazoles: decrease in clearance and increase in pharmacological action of a triazolam. Slows down removal and increases concentration in plasma and toxicity of Cycloserinum, indirect anticoagulants, Methylprednisolonum, felodipin, and also HP which are exposed to a microsomal oxidation (carbamazepine, терфенадин, cyclosporine, hexobarbital, ergot alkaloids, valproic acid, Disopyramidum, Bromocriptinum, Phenytoinum, peroral hypoglycemic means, theophylline , etc. ksantinovy derivatives) — at the expense of inhibition of a microsomal oxidation in hepatocytes azithromycin. Linkozamina weaken efficiency, tetracycline and chloramphenicol — strengthen. Pharmaceutical it is incompatible with heparin.
Hypersensitivity (in t. h to other macroleads); liver and/or renal failure; the lactation period ( for the period of treatment stop); children's age up to 12 months.
With care — pregnancy (it can be applied when the advantage of its use considerably exceeds the risk existing always when using any drug during pregnancy), arrhythmia (ventricular arrhythmias and lengthening of an interval of QT are possible), to children with the expressed abnormal liver functions or kidneys.
List B. In the dry, protected from light place, at a temperature not above 25 °C. To store in the place, unavailable to children. A period of validity - 2 years. Not to use after expiry date.
According to the recipe
Tablets, coated, on 500 mg. On 3 tablets in a blister strip packaging; on 3 tablets in bank of light-protective glass. Each can or a blister strip packaging together with the application instruction are placed in a pack from a cardboard.