Azitromitsin-Zdorovye, kaps.250mg No. 6/kaps.500mg No. 3
Producer: LLC Pharmaceutical Company Zdorovye Ukraine
Code of automatic telephone exchange: J01FA10
Release form: Firm dosage forms. Capsules.
General characteristics. Structure:
International and chemical names: Azithromycin; 9-диокси-9a-аза-9a-метил-9a-хомоэритромицин A dihydrate; main physical and chemical properties: solid gelatin capsules No. 00 of blue color (for a dosage of 500 mg), 0 C No. a lid of red color and the case of red color (for a dosage of 250 mg), No. 2 of yellow color (for a dosage of 125 mg), containing powder of white or almost white color; structure: 1 capsule contains azithromycin in terms of 100% substance of 125 mg, 250 mg or 500 mg; excipients: lactoses monohydrate, sodium lauryl sulfate, magnesium stearate.
Pharmacological properties:
Pharmacodynamics. The antibiotic of a broad spectrum of activity, belongs to subgroup of makrolidny antibiotics – azaleads. At high concentration the bactericidal effect is possible.
Azithromycin active rather aerobic gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus spp. groups C,F and G, Streptococcus viridans, Staphylococcus aureus; aerobic gram-negative bacteria: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Bordetella pertussis, Bordetella parapertussis, Legionella pneumophila, Campilobacter jejuni, Helicobacter pylori, Neisseria gonorrhea, Gardnerella vaginalis; anaerobic bacteria: Bacteroides bivius, Clostridium perfringens, Peptostreptococcus spp.
Drug also active Chlamydia pneumoniae, Chlamydia trachomatis, Mycroplasma pneumoniae, Ureaplasma urealyticum, Borellia burgdorferi is relative.
Pharmacokinetics. Absorption: azithromycin is quickly absorbed in digestive tract. After administration of drug inside in a dose of 500 mg the maximum concentration of azithromycin in a blood plasma is reached in 2,5–2,96 hours and makes 0,4 mg/l. Bioavailability makes 37%.
Distribution: azithromycin well gets into respiratory tracts, bodies and fabrics of an urogenital path (in particular, into a prostate), into skin and soft tissues. High concentration in fabrics and long half-life are caused by low linkng of azithromycin with proteins of a blood plasma.
Azithromycin remains in bactericidal concentration in the inflammation centers for 5–7 days after reception of the last dose.
Metabolism: it is metabolized in a liver, losing activity. Use of food considerably changes pharmacokinetics.
Vivedennya: 50% vivoditsya with bile in not changed look, 6% – with urine.
Indications to use:
The infectious and inflammatory diseases caused by activators, sensitive to drug:
infections of ENT organs (quinsy, sinusitis, tonsillitis, average otitis);
scarlet fever;
respiratory infections (bacterial and atypical pneumonia, bronchitis);
infections of skin and soft tissues (ugly face, impetigo, secondary infected
dermatosis);
infections of an urogenital path (uncomplicated urethritis and/or cervicitis);
disease Laima (borreliosis) in treatment of an initial stage (erythema migrans);
the diseases of a stomach and duodenum associated with Helicobacter
pylori.
Route of administration and doses:
Inside for 1 h to or in 2 h after meal.
The adult at infections of upper and lower parts of respiratory tracts, infections of skin and soft tissues appoint on 500 mg/days for 3 days (a course dose – 1,5 g). To children with body weight from 15 kg appoint at the rate of 10 mg/kg of body weight of 1 times a day within 3 days. A course dose – 30 mg/kg.
At an uncomplicated urethritis and/or a cervicitis the adult appoint disposable 1 g.
At Lyme's disease (borreliosis) the adult for treatment of an initial stage (erythema migrans) appoint 1 g in the 1st day and 500 mg every day from the 2nd to the 5th day (a course dose – 3 g). To children with body weight from 15 kg – in the first day in a dose of 20 mg/kg of body weight, from the 2nd to the 5th day – on 10 mg/kg of body weight of 1 times a day within 5 days.
At the diseases of a stomach and duodenum associated with Helicobacter pylori adult appoint 1 g a day for 3 days as a part of a combination therapy.
To children with body weight more than 15 kg are appointed at the rate of 10 mg/kg of body weight of 1 times a day within 3 days. A course dose – 30 mg/kg. To children 12 years are more senior appoint drug in doses for adults.
In case of the admission of reception of 1 dose of drug the passed dose should be accepted as soon as possible. And the following – with a break in 24 h.
Features of use:
With care appoint drug sick with an abnormal liver function and/or kidneys.
At pregnancy and in the period of a lactation drug is appointed only if the expected advantage for mother exceeds potential risk for a fruit or the child.
This dosage form (capsules) for use for children under 5 years is not shown.
Side effects:
From system of digestion: nausea, diarrhea, an abdominal pain are possible; seldom – vomiting, a meteorism, tranzitorny increase in activity of liver enzymes.
Skin rash, cholestatic jaundice, headache, drowsiness, nephrite, vaginitis, neutropenia or neutrophilia, photosensitization, eosinophilia is possible. Children have an excitement, sleeplessness, conjunctivitis, a hyperkinesia.
Interaction with other medicines:
The antacids containing magnesium hydroxide or aluminum reduce absorption of Azitromitsina-Zdorovye. Therefore it is recommended to adhere to a break, at least 2 hours, between reception of azithromycin and antiacid drugs.
Azithromycin does not contact P450 cytochrome complex enzymes therefore does not enter interaction with peroral anticoagulants, carbamazepine, dipheninum, digoxin, cyclosporine, ergotamine, but it is necessary to adhere to care at their simultaneous use.
Contraindications:
Hypersensitivity to antibiotics of group of macroleads.
Overdose:
Nausea, vomiting, diarrhea, temporary hearing loss. Therapy is symptomatic.
Storage conditions:
To store in the dry, protected from light place at a temperature from 15 °C to 25 °C. To store in the place, unavailable to children.
Period of validity – 2 years.
Issue conditions:
According to the recipe
Packaging:
Capsules on 500 mg No. 3; capsules on 250 mg and 125 mg No. 6 in blister strip packagings and containers.