pharmacologic properties
PHARMACODYNAMICS
Ziromin (azithromycin) belongs to subclass of macrolide antibiotics – azalides and has a broad spectrum of antibacterial coverage. Azithromycin binds to the 50S subunit of the bacterial ribosome, and thus inhibits translation of mRNA in microbial cell.

Azithromycin is active against several:

- gram-positive microorganisms: Streptococcus pneumoniae, Str. pyogenes, Str. agalactiae, Str.   viridans, streptococci of groups С, F and G, Staphylococcus aureus and Stap. epidermidis,  Corynebacterium diphtheriae.
- gram-negative microorganisms: Haemophilus influenzae, H.parainfluenzae and H. ducreyi, Moraxella catarrhalis, Bordetella pertussis и В.parapertussis, Neisseria gonorrhoeae and N.  meningitidis, Brucella melitensis, Helicobacter pylori, Gardnerella vaginalis.
- anaerobic bacteria: Clostridium spp., Peptostreptococcus spp. and Peptococcus spp.
- intracellular and other microorganisms: Legionella pneumophila, Chlamydia trachomatis and С.pneumoniae, Mycoplasma pneumoniae, Mycoplasma hominis, Mycoplasma avium, Ureaplasma urealyticum, Lysteria monocytogenes, Treponema pallidum, Borrelia burgdorferi, Toxoplasma gondii.

pharmacokinetics
Azithromycin is readily diffused from plasma into most tissues and distributed throughout the body, achieving high and sustained concentrations. Azithromycin accumulates at infection sites due to phagocytes transporting it to inflamed tissues.
Azithromycin pharmacokinetics shows linear dependency and is dose proportional. Azithromycin’s half-life is 65-72 hours.

therapeutic indicationS
- infections of upper respiratory tract: angina, pharyngitis, tonsillitis, sinusitis, otitis media;
- infections of lower respiratory tract: bronchitis, exacerbation of chronic bronchitis, non-hospital and hospital pneumonia;
- skin and soft tissues infections: erythema chronicum migrans, erysipelas, impetigo, secondary pyoderma;
- diseases which are genital tract transmissible (including urethritis, cervicitis, genital and extragenital clamidiosis);
- gastric and duodenal diseases associated with Helicobacter pylori;
- Lyme’s disease.

CONTRAINDICATIONS
- hypersensitivity to macrolide antibiotics.

SPECIAL INDICATIONS
The preparation should be prescribed with cautious for the patients with renal and hepatic insufficiency.

SIDE EFFECTS
Temporary slight adverse effects not causing therapy interruption are possible.
From gastrointestinal tract: diarrhea, nausea, abdominal pain, flatulence, vomiting, cholestatic jaundice, transient raise of liver ferments level.
From cardiovascular system:  tachycardia, chest pain.
From nervous system: vertigo, headache, somnolence.
From urogenital system: vaginal candidiasis, nephritis.
Allergic reactions: skin eruption, nettle rash, itching, angioneurotic edema.
Other effects: asthenia, photosensitization.

DOSAGE AND ADMINISTRATION
The preparation is taken 1 hour before 1or 2 hours after meal.

Adults:
At upper and lower respiratory tract infections; at skin and soft tissues infections (except chronic mobile erythema chromicum migrans): acute administration of 500 mg/day during 3 days.
At erythema chromicum migrans: acute administration of 1000 mg/day and at the first day, then - 500 mg/day daily from the 2^nd to 5^th day of treatment.
At sexually transmitted diseases: non-complicated urethritis/cervicitis – single application of 1000 mg. Complicated, urethritis/cervicitis, caused by Chlamydia trachomatis – 1000 mg 3 times with interval of 7 days (1-7-14 days). The course dose: 3000 mg.
At Lyme’s disease (borreliosis) for the first stage treatment: 1000 mg at the first day and 500 mg/day from the 2^nd to 5^th day of treatment.
At peptic ulcer associated with Helicobacter pylori: 1000 mg/day during 3 days in combination with antisecrory agent and other preparations.

Children:
The application of Ziromin is not recommended for children up to 3 years /or with body weight less than 25 kg.
It is prescribed based on 10 mg/kg of body weight 1 time/day during 3 day or in the first day 10 mg/kg of body weight, then 5-10 mg/kg of body weight per day during 3 days.
At erythema chromicum migrans: a dose makes 20 mg/kg of body weight at the first day and 10 mg/kg of body weight from the 2^nd to 5^th day of treatment.

At Lyme’s disease (borreliosis) for the first stage treatment: a dose makes 20 mg/kg of body weight at the first day and 10 mg/kg of body weight from the 2^nd to 5^th day of treatment.

OVERDOSE
Information on azithromycin overdose is not available.
Symptoms characteristic of macrolide antibiotics overdose are temporary hearing loss, nausea, vomiting and diarrhea. Symptomatic therapy. 

INTERACTION WITN OTHER MEDICAMENTS
Azithromycin increases toxic effect of carbamazepine, valporic acid, phenytoin, disopyramide, theophyllin, xanthines, peroral hypoglycemic agents. It also increases the effect of ergot alkoids, dihydroergotonin. Tetracyclines and chloramphenicol increase the effect of azithromycin, and lincosamines decrease their effect. Azithromycin administration increases concentration of ciclosporins, indirect anticoagulant, methylprednisolone and felodipine in plasma.

APPLICATION DURING PREGNANCY AND BREAST-FEEDING
Medication use when pregnancy is possible only in case when expected good for mother exceeds risk for fetus.
Breast-feeding should be stopped during treatment with Ziromin.

PACKAGING
Film coated tablets. 3 tablets in blister.
1 blister in carton box with enclosed leaflet.

STORAGE CONDITIONS
Store in a dry place at temperature not exceeding 25°С.
Keep out of reach of children.

SHELF LIFE
3 years from the manufacture date.
Do not use if the labeled working life is expired.

SALES TERMS
Sold under prescription.