Azimed of the capsule

General characteristics. Structure:

Active ingredient: 1 capsule contains azithromycin in terms of 100% substance of 0,25 g (250 mg);
excipients: cellulose microcrystallic, aerosil, calcium stearate.

Pharmacological properties:

Pharmacodynamics. Azithromycin – the representative of new group of makrolidny antibiotics – azaleads. Possesses a wide range of antimicrobic (bacteriostatic) action. Some are sensitive to azithromycin gram-positive (Streptococcus pneumoniae, S. pуogenes, S. agalactiae, S. viridans, streptococci of groups C, F and G, Staphylococcus aureus, S. epidermidis), gram-negative (Haemophilus influenzae, H. parainfluenzae, Moraxella catarrhalis, Bordetella pertussis, B. parapertussis, Legionella pneumophila, H. ducrei, Campylobacter jejuni, Neisseria gonorrhoeae, Gardnerella vaginalis), anaerobic (Bacteroides bivius, Clostridium perfringens, Peptostreptococcus spp., Peptococcus) microorganisms, and also Chlamydia trachomatis, Chlamydia pneumoniae, Mycobacteria avium complex, Mycoplasma pneumoniae, Ureaplasma urealyticum and spirochetes (Treponema pallidum, Borrelia burgdorferi). Does not affect the gram-positive microorganisms steady against erythromycin.
Antimicrobic action is carried out due to linkng with 50S-subunit of ribosomes, oppression of a peptidtranslokaza at a stage of broadcasting and suppression of biosynthesis of protein that leads to delay of growth and reproduction of bacteria.

Pharmacokinetics. Azithromycin is quickly soaked up from the digestive channel that is caused by its stability in acid medium and lipophilicity. The maximum concentration in blood serum is reached in 2,5–2,96 hours and makes 0,4 mg/l at intake of 0,5 g of azithromycin. After a single dose of 0,5 g of drug bioavailability – 37%. Drug well gets into respiratory tracts, bodies and fabrics of an urogenital path, in particular, in a prostate, in skin and soft tissues. Concentration of drug in fabrics and cells 10-15 times higher, than in serum. The elimination half-life makes 68 hours. High concentration in fabrics and slow removal from fabrics are caused by low linkng of azithromycin with serum proteins, and also ability to get into eukaryotic cells and to concentrate in the environment with a low rn, a surrounding lysosome. It determines, in turn, the large seeming distribution volume (31,1 l/kg) and high plasmatic clearance. It is proved that phagocytes deliver drug to places of an infection where release it. Good penetration of azithromycin into cells and accumulation in phagocytes with which it is transported in the inflammation centers promotes antimicrobic activity of drug. Despite high concentration in phagocytes, azithromycin has no significant effect on their function.
Elimination of azithromycin from blood serum is carried out in two stages: the elimination half-life makes 14–20 hours between 8 and 24 hours after administration of drug and 41 hour - in the range from 24 till 72 o'clock that allows to use drug of 1 times a day.
Meal considerably changes pharmacokinetics - the maximum concentration of drug in plasma decreases by 52%. Azithromycin demetilirutsya in a liver, the formed metabolites are not active. 6% - with urine are removed with bile of 50% in not changed look.
At men of old age (65–85 years) parameters of pharmacokinetics do not change, at women – the maximum concentration of drug in plasma increases by 30–50%.

Indications to use:

The infections of ENT organs, upper respiratory tracts caused by activators, sensitive to drug: quinsy, pharyngitis, tonsillitis, sinusitis, average otitis; lower respiratory tract infections: an acute bronchitis, chronic bronchitis in an aggravation stage, pneumonia; infections of skin and soft tissues (Lyme's disease, an ugly face, impetigo for the second time infected dermatitis); infections, sexually transmitted (uncomplicated urethritis, cervicitis).

Route of administration and doses:

Apply inside once a day in 1 hour prior to food or in 2 hours after food. Upper respiratory tract infections. Lower respiratory tract infections. Infections of skin, soft tissues (except the chronic migrating erythema).

Children. Азимед® children are recommended to appoint capsules of 250 mg with the body weight from 25 to 50 kg. Appoint at the rate of 10 mg/kg of body weight for 3 days. Weighing 50 kg and above – doses, as for adults are appointed. For children with body weight less than 25 kg use drug in the form of suspension. At use of the capsule not to open and not to divide!

Adults and teenagers (since 12 years or weighing 50 kg and more):
500 mg (2 capsules) a day for 1 reception within 3 days.

The chronic migrating erythema:
The 1st day – 1 g (4 capsules) once; 2 – the 5th days – 500 mg (2 capsules) a day. A course dose – 3 g.

Infections are sexually transmitted. Clamidiosis, ureaplasmosis:
1 g (4 capsules) of drug in the 1st day once, then 500 mg (2 capsules) a day for 1 reception within 4 days. The general course of therapy – 5 days. A course dose – 3 g.

Acute uncomplicated gonorrhea:
1 g (4 capsules) – once.

Features of use:

There is no need to use drug during more long time, than it is specified in the instruction and to change a dose for elderly people.
It is necessary to appoint with care Azimed® the patient with a heavy renal failure and a liver, at cardiac arrhythmias (ventricular arrhythmias and lengthening of an interval of QT are possible). Data on influence of azithromycin on ability to manage vehicles and other mechanisms are absent. When performing such works it is necessary to consider possibility of side reactions (weakness, dizziness).

Side effects:

Азимед® seldom causes side reactions in the form of nausea, vomiting, diarrhea, locks, an abdominal pain, a meteorism, cholestatic jaundice, increase in level of hepatic transaminases in blood serum; stethalgias, the accelerated heartbeat, weakness; headache, dizziness, drowsiness; nephrite, vaginitis, neutropenia or neutrophilia; candidiasis, photosensitization, pseudomembranous colitis, rash, Quincke's disease, eosinophilia.

Interaction with other medicines:

Antiacid means slow down absorption of Azimeda® therefore it is recommended to observe an interval (not less than 2 h) between reception of Azimeda® and antiacid means. At a concomitant use makrolidny antibiotics can strengthen effect of theophylline, a terfenadin, warfarin, carbamazepine, Phenytoinum, triazolam, digoxin, ergotamine, cyclosporine, but unlike the majority of macroleads, Azimed® does not contact enzymes of a complex of P450 cytochrome and so far interaction of Azimeda® with the specified drugs was not observed.

Contraindications:

Drug is contraindicated at hypersensitivity to makrolidny antibiotics, heavy abnormal liver functions, pregnancy, feeding by a breast (for the period of treatment feeding is stopped).

Overdose:

At overdose of Azimeda® are possible: temporary hearing loss, severe nausea, vomiting and diarrhea.
Treatment – symptomatic.

Storage conditions:

To store in the dry place protected from light, at a temperature from 15 °C to 25 °C. A period of storage - 3 years. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

On 6 or 10 capsules in the blister. 1 blister in a pack.