Composition
Active ingredient: Â
azithromycin dihydrate (in terms of azithromycin)Â 250 mg;
Auxiliary substances: Â
milk sugar;
corn starch;
aerosil;
sodium lauryl sulfate;
magnesium stearate;
PVP
Pharmacological action
of Zi factor – antibacterial.
When creating high concentrations in the focus of inflammation, it has a bactericidal effect.
Pharmacodynamics
The spectrum of action is wide and includes gram-positive cocci: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, CF and G group streptococci, Staphylococcus aureus, Staphylococcus viridans, gram-negative bacteria Haemophilus influenzae, Moraxella catarrhalis, Bordetella pertussis, Bordetella parapertussis, Legionella pneumophila, H. ducreyi, Campylobacter jejuni, Neisseria gonorrhoeae, Gardnerella vaginalis, some anaerobic microorganisms: Bacteroides bivius, Clostridium perfringens, Peptostreptococcus spp., as well as Chlamydia trachomatis, Mycoplasma pneumoniae, Ureaplasma urealyticum, Treponema pallidum, Borrelia burgdorferi. Inactive against gram-positive bacteria resistant to erythromycin.
Pharmacokinetics
It is stable in an acidic environment, lipophilic, and is rapidly absorbed in the gastrointestinal tract. After oral use at a dose of 500 mg, Cmax in plasma is 0.4 mg / l and is reached in 2.5-2.96 hours. Bioavailability — 37%. It penetrates well into the respiratory tract, organs and tissues of the urogenital tract (in particular, the prostate gland), the skin, and soft tissues.
The concentration in tissues and cells is 10-50 times higher than in plasma, and in the foci of infection is 24-34% higher than in healthy tissues (correlates with the degree of inflammatory edema). It is transported by phagocytes to the focus of infection, where it is released during phagocytosis. The apparent volume of distribution is 31.1 l / kg.
A high antibacterial level persists in the focus of inflammation for 5-7 days. It is metabolized in the liver by demethylation to form inactive metabolites.
Withdrawal takes place in 2 stages;Â T1 / 2 is 14-20 hours (in the range of 8-24 hours after taking the drug) and 41 hours (in the range of 24-72 hours).
Indications
Infections of the upper (pharyngitis, tonsillitis) and lower (bacterial and atypical pneumonia, bronchitis) respiratory tract, ENT organs (otitis media, sinusitis), skin and soft tissues (erysipelas, impetigo, secondary infected dermatoses), urogenital tract (uncomplicated urethritis and/or cervicitis), Lyme disease (treatment of erythema migrans), stomach and duodenal diseases, associated with Helicobacter pylori (as part of combination therapy).
Use during pregnancy and lactation
It is possible if the expected effect of therapy exceeds the potential risk to the fetus.
Breast-feeding should be discontinued for the duration of treatment.
Contraindications
Hypersensitivity (including to other macrolides), hepatic and / or renal failure, breast-feeding, infancy up to 1 year.
Side effects
Nervous system and sensory disorders:  <1% — dizziness, headache, drowsiness; in children-hyperkinesia, anxiety, neurosis, sleep disorders.
Cardiovascular and blood disorders (hematopoiesis, hemostasis):  ≤1% — palpitations, chest pain.
From the digestive tract:  diarrhea (5%), nausea, abdominal pain (3%); < 1% – dyspepsia, flatulence, vomiting, melena, cholestatic jaundice, increased activity of hepatic transaminases; in children — constipation, anorexia, gastritis.
From the genitourinary system:  ≤1% — vaginal candidiasis, nephritis.
Allergic reactions: Â rash, photosensitivity, angioedema.
Other services: Â increased fatigue, in children-conjunctivitis, pruritus, urticaria.
Interaction
Antacids (aluminum and magnesium-containing ones), ethanol, and food slow and reduce absorption.
Increases the concentration of digoxin, slows down the excretion and increases the plasma concentration and toxicity of cyclosporine, indirect anticoagulants, methylprednisolone, felodipine, carbamazepine, terfenadine, hexobarbital, ergot alkaloids, valproic acid, disopyramide, bromocriptine, phenytoin, oral hypoglycemic agents, theophylline and other xanthine derivatives.
Lincosamides weaken the effectiveness, tetracycline and chloramphenicol increase Pharmacologically incompatible with heparin.
How to take, course of use and dosage
Inside,1 hour before or 2 hours after meals 1 time a day.
Adults with infections of the upper and lower respiratory tract of 500 mg/day for 3 days (course dose — 1500 mg);
infections of skin and soft tissues — 1000 mg/day on the first day, then (2-5 days) — 500 mg/day (dose — 3000 mg);
in acute infections of the urinary organs (uncomplicated urethritis or cervicitis) — 1000 mg once;
for Lyme disease (the treatment of early stage — erythema migrans) — 1000 mg/day on the first day, then (2-5 days) — 500 mg/day (dose — 3000 mg); ulcer disease of stomach and duodenum, associated with Helicobacter pylori, and 1000 mg/day for 3 days as part of complex therapy. Children — 10 mg/kg body weight for 3 days in the first day or 10 mg/kg, then 4 days at 5 mg/kg/day(dose 30 mg/kg), in the treatment of erythema migrans — 20 mg/kg on the first day, then (2-5 days) — 10 mg/kg.
Overdose
Symptoms: Â severe nausea, temporary hearing loss, vomiting, diarrhea.
Form of production
Capsules
Storage conditions
In a dry place, at a temperature not exceeding 25 °C
Shelf life
2 years
Active ingredient
Azithromycin
Conditions of release from pharmacies
By prescription
Dosage form
Capsules
Description
Adults as prescribed by a doctor, Pregnant women as prescribed by a doctor, Children as prescribed by a doctor
Indications
Tonsillitis, Pneumonia, Urethritis, Sore Throat, Sinusitis, Otitis Media, Skin Infections, Infectious Diseases, Pharyngitis, Respiratory Tract Infections, Bronchitis
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Side effects of Zi-Factor, 250mg capsules, 6pcs.
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