Azitsin, the tab. п / about on 0,5g No. 3

General characteristics. Structure:

excipients: lactose, monohydrate; cellulose microcrystallic; povidone; sodium of a kroskarmelloz; sodium lauryl sulfate; talc; magnesium stearate; сепифилм     752 white; macrogoal 4000.

Pharmacological properties:

Pharmacodynamics. Azithromycin – the representative of new subgroup of makrolidny antibiotics – azaleads. Communicates from subunit 50S of a ribosome 70S of sensitive microorganisms, oppressing RNA-dependent synthesis of protein, slows down growth and reproduction of bacteria, at high concentration the bactericidal effect is possible.

Has a wide range of antimicrobic action. It is active concerning a number of gram-positive bacteria: Streptococcus pneumoniae, S. pyogenes, S. agalacticae, streptococci of the C, F groups, and G, Staphylococcus aureus and S. epidermidis. Does not influence the gram-positive bacteria resistant to effect of erythromycin. It is effective rather gram-negative microorganisms: Haemophilus influenzae,   H. parainfluenzae and H. ducrei, Moraxella catarrhalis, Bordetella pertussis and B. parapertussis, Neisseria gonorrhoeae and also N. meningitidis, Brucella melitensis, Helicobacter pylori, Gardnerella vaginalis. Affects sensitive anaerobic microbes: Clostridium spp., Peptostreptococcus spp. and Peptococcus spp. Besides, effective rather intracellular and other microorganisms, including Legionella pneumophila, Chlamydia trachomatis and C. pneumoniae, Mycoplasma pneumoniae, Ureaplasma urealyticum, Listeria monocitogenes, Treponema pallidum, Borrelia burgdorferi.

Pharmacokinetics. After intake of azithromycin it is quickly soaked up from the digestive channel. Bioavailability makes about 37% (effect of "the first passing"). The maximum concentration in blood serum is reached in 2,5 - 3 h and makes 0,4 mg/l at intake of 500 mg of azithromycin. Drug well gets into respiratory tracts, bodies and fabrics of an urogenital path, in particular into a prostate, into skin and soft tissues. Concentration of drug in fabrics and cells 10 - 100 times higher, than in blood serum. Stable level in plasma is reached in 5 - 7 days. Drug in a large number collects in the phagocytes transporting it in the centers of an infection and an inflammation where gradually release in the course of phagocytosis.

Contacts proteins in inverse proportion to concentration in blood (7 - 50% of drug). About 35% are metabolized in a liver by demethylation, losing activity.

More than 50% of a dose are removed with bile in not changed look, about 4,5% – with urine for 72 h.

Plasma elimination half-life makes 14 - 20 h (in the range of 8 - 24 h after administration of drug) and 41 h (in the range of 24 - 72 h). Meal considerably changes pharmacokinetics.

With age parameters of pharmacokinetics do not change at husband's (65 - 85 years), at women the maximum concentration increases by 30 - 50%.

 armatsevtichesky characteristics.

Main physical and chemical properties: tablets, coated, white color, the extended form, with a biconvex surface.

Indications to use:

Indications. The infections caused by the microorganisms sensitive to azithromycin:

- infections of ENT organs (bacterial pharyngitis / тонзилит, sinusitis, average otitis);

- respiratory infections (bronchitis, pneumonia);

- infections of skin and soft tissues;

- infections, sexually transmitted, caused by chlamydias;

- the infections of a stomach and a duodenum caused by Helicobacter pylori.

Route of administration and doses:

Азицин® it is necessary to apply for an hour to food or two hours after food as the concomitant use breaks azithromycin absorption. Drug is accepted once a day.

At infections of ENT organs, respiratory tracts, skin and soft tissues: 500 mg (1 tablet once) in days for 3 days.

At infections, sexually transmitted: 1 g once (2 tablets on 500 mg).

At a peptic ulcer of a stomach and duodenum: 1 g (2 tablets on 500 mg) in boughs for 3 days together with anti-secretory means and other medicines on doctor's orders.

In case of the admission of reception of 1 dose of drug, it is necessary to accept the passed dose as soon as possible, and the following – bucketed in 24 h.

People of advanced age and at patients with renal failures have no need to change dosing.

Features of use:

It is necessary to apply with care to the patients having disturbance of a cordial rhythm (arrhythmias and lengthening of an interval of QT on the cardiogram).

Considering that drug is metabolized in a liver and is excreted with bile, patients should not appoint azithromycin with heavy hepatic pathology. When developing a heavy liver failure treatment by azithromycin has to be stopped.

During treatment it is necessary to refrain by drug from the use of alcoholic drinks.

Drug contains glucose. What should be considered the patient with hereditary intolerance of lactose galactose.

Ability to influence the speed of reactions at control of motor transport or work with other mechanisms. During treatment it is necessary to abstain from driving of motor transport and from the occupations requiring special attention and speed of mental and motor reactions.

Side effects:

From a digestive tract: nausea, vomiting, diarrhea, lock, loss of appetite, gastritis, reversible moderate increase in activity of hepatic transaminases, cholestatic jaundice, pseudomembranous colitis, meteorism, stomach ache.

From urinogenital system: nephrite, vaginal candidiasis.

From cardiovascular system: heart consciousness, thorax pain.

Allergic reactions: skin rashes, Quincke's disease, small tortoiseshell, conjunctivitis, multiformny erythema, Stephens-Johnson's syndrome, toxic epidermal necrolysis.

Dermatological reactions: photosensitization, itch.

From laboratory indicators: neutropenia, eosinophilia. The changed indicators are returned to norm in 2–3 weeks after the end of treatment.

From the central nervous system: dizziness, headache, вертиго, drowsiness; hyperkinesia, uneasiness, neurosis, sleep disorder (1% and less).

Others: hyperpotassemia, arthralgia, deterioration in hearing.

Interaction with other medicines:

Antiacid means slow down azithromycin absorption. It is recommended to adhere not less than a two-hour interval between administration of drug and an antacid. It is necessary to pay attention to a concomitant use of drug with theophylline, terfenadiny, warfarin, carbamazepine, Phenytoinum, triazolamy, digoxin, ergotamine, cyclosporine as makrolidny antibiotics can strengthen effect of above-mentioned drugs. Unlike the majority of macroleads, azithromycin does not contact P450 cytochrome complex enzymes.

Contraindications:

Hypersensitivity to makrolidny antibiotics.

Drug in this dosage form is not intended for treatment of children with body weight to 45 kg.

Use during pregnancy or feeding by a breast. It is not recommended to appoint drug during pregnancy, except for cases when use is necessary according to vital indications.

In case of drug use by women in the period of a lactation feeding by a breast needs to be stopped.

Children. Азицин® over 45 kg are appointed to children with body weight.

Overdose:

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

Treatment: symptomatic.

Storage conditions:

Issue conditions:

According to the recipe

Packaging:

On 3 tablets in a blister strip packaging, on 1 blister strip packaging in a pack.