Trade name of the drug: ARZICIN 500 Active substance (INN): Azithromycin Dosage form: film-coated tablets Composition: 1 film-coated tablet contains: active substance: azithromycin dihydrate, equivalent to acithromycin -500 mg; excipients: starch, calcium phosphate dibasic, microcrystalline cellulose, aerosil, povidone, starch sodium glycolate, talc, magnesium stearate, sodium croscarmellose, isopropyl alcohol, Wincoat F/C* dye, purified water. Description: white or whitish oblong biconvex tablets covered with a film shell with a risk on one side. Pharmacotherapeutic group: Antibacterial drug of the macrolide group. ATX Code: J01FA10
Pharmacological properties A broad-spectrum antibiotic. It is the first representative of a new subgroup of macrolide antibiotics – azalides. The main mechanism acts bacteriostatically. Binding to the 50S subunit of ribosomes, it inhibits peptidtranslase at the translation stage, suppresses protein synthesis, slows down the growth and reproduction of bacteria, and has a bactericidal effect in high concentrations. It acts on extracellular and intracellular pathogens. It is active against gram-positive microorganisms: Streptococcusspp. (groups C, F and G, except erythromycin resistant), Streptococcuspneumonie, Streptococuspyogenes, Streptococcusagalactiae, Streptococusviridans, Staphylococcusepidermidis, Staphyloccocusaureus; Gram-negative bacteria: Haemophilusinfluenzae, Moraxellacatarrhalis, Bordetellaparapertusis, Legionellapnemophila, Haemophilusducreyi, Campylobacterjajuni, Neisseriagonorroeaeba and Gardnerellavaginalis; some anaerobic microorganisms: Bacteroidesbivius, Clostridiumperfringens, Peptostreptococcusspp; and also Chlamydiatrachomatis, Chlamydiapneumoniae, Mycoplasmapneumoniae, Mycobaccteriaaviumcomplex, Ureaplasmaurealyticum, Terponemapallidum, Borreliaburgdoferi. It is not active against gram-positive bacteria resistant to erythromycin. When high concentrations are created in the focus of inflammation, it has a bactericidal effect. Pharmacokinetics Absorption: azithromycin is rapidly absorbed from the gastrointestinal tract, due to its stability in an acidic environment and lipophilicity. After ingestion of 500mg of azithromycin, the maximum concentration 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 (in particular, the prostate gland), skin and soft tissues. The high concentration in tissues (10-50 times higher than in blood plasma) and the long half–life are due to the low binding of azithromycin to plasma proteins, as well as its ability to penetrate eukaryotic cells and concentrate in a low pH environment surrounding lysosomes. This, in turn, determines a large apparent volume of distribution (31.1 l/kg) and a high plasma clearance. The ability of azithromycin to accumulate mainly in lysosomes is especially important for the elimination of intracellular pathogens. It has been proven that phagocytes deliver azithromycin to the sites 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 (on average by 24-34%) and correlates with the degree of inflammatory edema. Despite the high concentration in phagocytes, azithromycin does not significantly affect their function. Azithromycin remains in bactericidal concentrations in the focus of inflammation for 5-7 days after taking the last dose, which made it possible to develop short (3-day and 5-day) courses of treatment. Excretion: the excretion of azithromycin from the blood plasma takes place in 2 stages: the half-life is 14-20 hours in the range from 8 to 24 seconds 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.
Indications for use Infectious diseases caused by microorganisms sensitive to the drug: - infections of ENT organs (angina, sinusitis, tonsillitis, otitis media); - scarlet fever; - respiratory tract infections (bacterial and atypical pneumonia, tracheitis, bronchitis); - skin and soft tissue infections (erysipelas, impetigo, secondarily infected dermatoses); - infections of the urogenital tract (uncomplicated urethritis and/or cervicitis); - Lyme disease (borrelysis), for the treatment of the initial stage (erythemamigrans); - stomach and duodenal disease associated with Helicobacter Pylori.
Method of administration and dosage Inside. Azithromycin should be taken 1 hour before meals or 2 hours after meals. The drug is taken 1 time a day. In case of upper and lower respiratory tract infections, skin and soft tissue infections, 500 mg / day is prescribed for 3 days (the course dose is 1.5 g). With uncomplicated urethritis and / or cervicitis, 1 g is prescribed once (2 tablets of 500 mg each). In Lyme disease (borreliosis), for the treatment of the initial stage (erythemamigrans), 1 g (2 tablets of 500 mg) is prescribed on 1 day and 500 mg daily from 2 to 5 days (the course dose is 3 g). For diseases of the stomach and duodenum associated with Helicobacter Pyloti, 1 g (2 tablets of 500 mg) per day is prescribed for 3 days as part of combination therapy. If you miss taking 1 dose of the drug, the missed dose should be taken as early as possible, and the subsequent ones should be taken with a break of 24 hours.
Side effects From the digestive system: when ingested – diarrhea (5%), nausea (3%), abdominal pain (3%); 1% or less – dyspepsia, flatulence, vomiting, melena, cholestatic jaundice, increased activity of "liver" transaminases; in addition, in children – constipation, decreased appetite, gastritis; candidiasis of the oral mucosa. From the cardiovascular system: palpitations, chest pain (1% or less). From the nervous system: dizziness, headache, vertigo, drowsiness; in children – headache (in the treatment of otitis media), hyperkinesia, anxiety, neurosis, sleep disorders (1% or less). From the urinary system: vaginal candidiasis, nephritis (1% or less). Allergic reactions: rash, urticaria, itching, Quincke's edema; with intravenous administration – bronchospasm (1% or less). Other: increased fatigue, photosensitization; conjunctivitis in children; taste change (1% or less).
Contraindications - hypersensitivity to macrolide group antibiotics; - severe liver and kidney dysfunction; - pregnancy; - the period of breastfeeding; - children under 12 years of age.
Drug interactions Antacids (aluminum and magnesium containing), etalon and food slow down and reduce the absorption of azithromycin. With the joint administration of warfarin and azithromiuine (in normal doses), no changes in prothrombin time were detected, however, given that the interaction of macrolides and warfarin may increase the anti-coagulant effect, patients need careful monitoring of prothrombin time. Increases the concentration of digoxin, due to the weakening of its inactivation by the intestinal flora. Ergotamine and dihydroergotamine: increased toxic effects (vasospasm, dysesthesia). Triazolam: decreased clearance and increased pharmacological effect of triazolam. Slows down the excretion and increases the plasma concentration and toxicity of cycloserine, indirect anticoagulants,methylprednisolone, felodipine, AG LS, subsurface microsomal oxidation (carbamazepine, terfenadine, ciclosporin, hexobarbital, alkaloid, hexobarbital, valproic acid, disopyradim, bromocriptine, phenytoin, peropename, hypoglycemic agents, theophillin, etc.xanthin-derivative (xanthin-derived (xanthin-derived)) for the reported ingibirated microsomal oxidations in hepatocytach azithromycinoma. Lincosamine infinitesimal, and tetracycline and tetracycline and chloramphenicol enhance the dysfunctionality of azithromycin.
Specificservice instructions In the case of missed reception dose. missed dose follow-up as possible, and follow-up with an interval of 24 hours. It is necessary to go to the Perr Urga at 2 o'clock in the case of antacids. Definitively not established safety of azithromycin prescribed in detei and subrostkov junior 16 L. Then canceled the treatments reactions hyperensities in the noncot. the patient's mogut was kept, which was used for specific therapies under the supervision of the doctor. Change in bremenization and lactation period In the event of a change in circumstances so much in the case, it is assumed that there is a potential risk to the fetus. During the period of treatment preparation in lactation, tuberous incarmulation after discontinue. Influence of the ability to drive a car and complex Urga mechanism When the preparation is changed, it will be used by the chief motor vehicle and will work with a potentially unsafe number of mechanical devices.
Shape in aposematic Each of 3 tablets, cover the whole blister blister. 1 blister with medical instructions in cardboard corobu.
Feeding conditions Eat in suhom, protected from the World place at a temperature not in Urgench 25 C. Eat in an uncomplicated place.
Shelf life 3 years. Do not follow the giant then and there the length of the year.
Terms of leave from pharmacy Recipe.
Manufacturer Ion Healthcare Pvt. Ltd (A WHO GMP Certified Company) Baddi-Barotiwala Road, Baddi Distt. Solan (H.P.) - 173205, INDIA
Owner registration certificates HARASHA PHARMA PVT. LTD., India
Name and address organizations making claims (proposals) for quality medicinal products of territories Republic of Uzbekistan «FUTURE-WORLD GROUP» Republic of Uzbekistan, Tashkent, Chilanzarsky r-n, str.Sanyat 13A. Tel.:+99891 134 94 14 E-mail: info.fwg@yandex.com
