COMPOSITION

Each film coated tablet contains azithromycin 500 mg.

THERAPEUTIC INDICATIONS

- Infections of upper respiratory tract: angina, pharyngitis, tonsillitis, sinusitis, otitis media;
- Infections of lower respiratory tract: bronchitis, exacerbation of chronic bronchitis, community-aquired and hospital-aquired 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 disease.

CONTRAINDICATIONS

- Hypersensitivity to macrolide antibiotics.

SPECIAL INDICATIONS

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

ADVERSE 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 2nd to 5th 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 disease (borreliosis) for the first stage treatment: 1000 mg at the first day and 500 mg/day from the 2nd to 5th 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 2nd to 5th day of treatment.
At Lyme 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 2nd to 5th day of treatment.

DRUG INTERACTIONS

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.

PREGNANCY AND LACTATION

Medication use when pregnancy is possible only in case when expected benefit for mother exceeds risk for fetus.
Breast-feeding should be stopped during treatment with Ziromin.

MANUFACTURED FORM

3 tablets in blister. 1 blister in carton box with enclosed leaflet.