Azithromycin-Astrapharm
Release Forms:
Composition:
- active substance: azithromycin;
- 1 capsule contains azithromycin (in the form of azithromycin dihydrate in terms of 100% substance) 250 mg or 500 mg
- excipients: microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate
- the composition of the capsule shell: gelatin, titanium dioxide (E 171), indigo (E 132).
Dosage form.Capsules.
Basic physical and chemical properties: cylindrical hard gelatin capsules with hemispherical ends, blue body and lid. The contents of the capsules are white or almost white powder.
250 mg capsules - 6 capsules in a blister, 1 blister in a box.
500 mg capsules - 3 capsules in a blister, 1 blister in a box.
Indications.
Antibacterial agents for systemic use. Macrolides, lincosamides and streptogramins.
Infections caused by microorganisms sensitive to azithromycin:
- upper respiratory tract infections (bacterial pharyngitis, tonsillitis, sinusitis, otitis media);
- lower respiratory tract infections (bacterial bronchitis and exacerbation of chronic bronchitis, community-acquired pneumonia);
- infections of the skin and soft tissues; chronic erythema migrans (stage I of Lyme disease), erysipelas, impetigo, secondary pyoderma;
- genital infections: uncomplicated and complicated urethritis/cervicitis caused by Chlamydia trachomatis.
Contraindications.
Hypersensitivity to the components of the drug, to other antibiotics of the macrolide/ketolide group; severe dysfunction of the liver or kidneys, liver failure, severe bradycardia, arrhythmia, severe heart failure, simultaneous use with ergot derivatives (the possibility of ergotism).
The method of storing.
Adults and children weighing more than 45 kg
Azithromycin should be used once a day, at least 1:00 before meals or 2:00 after meals.
For infectious diseases of the respiratory tract and infectious diseases of the skin and soft tissues (with the exception of chronic migratory erythema), the dose is 500 mg once a day for 3 days.
Chronic erythema migrans: on the 1st day 1 g (2 capsules of 500 mg 1 time), from the 2nd to the 5th day 500 mg (1 capsule of 500 mg).
Uncomplicated and complicated urethritis/cervicitis: once 1 g (2 capsules of 500 mg). Heading dose – 1 g.
Procedure in the event of a missed dose.
The missed dose should be taken as soon as possible, and subsequent doses should be taken 24 hours apart.
Renal failure
Patients with mild renal dysfunction (creatinine clearance> 40 ml/min) do not need to change the dosage. No studies have been conducted in patients with creatinine clearance <40 ml/min. Accordingly, azithromycin should be used with caution in such patients.
Liver failure.
Since azithromycin is metabolized in the liver and excreted in the bile, the drug should not be used in patients with serious liver disease.
No dose adjustment is required for elderly patients.
Elderly patients do not need to change the dosage.
Since elderly patients may be at risk of cardiac electrical conduction disturbances, it is recommended to be careful when using azithromycin due to the risk of cardiac arrhythmias and torsade de pointes arrhythmias.
Children.
The drug in this dosage form is not prescribed for children weighing up to 45 kg.
Children under 6 years of age are advised to prescribe azithromycin in other dosage forms. The drug is prescribed for children from 6 years old, they can swallow the capsule.