Azithromycin 500mg tablets 3 Ozon
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Azithromycin - 500 mg;
excipients: microcrystalline cellulose - 149.7 mg, pregelatinized starch - 36.7 mg, croscarmellose sodium - 7.3 mg, magnesium stearate - 3.3 mg.
Shell composition: opadrai II 85F48105 white - 10 mg, incl. polyvinyl alcohol - 4.69 mg, macrogol 3350 - 2.36 mg, talc - 1.74 mg, titanium dioxide - 1.21 mg.
An antibiotic of the macrolide group is a representative of azalides. It has a wide spectrum of antimicrobial action. The mechanism of action of azithromycin is associated with the suppression of protein synthesis of the microbial cell.
Binding to the 50S subunitating of ribosomes, inhibits peptide translocase at the translation stage, inhibits protein synthesis, slows down the growth and reproduction of bacteria. It acts bacteriostatically. In high concentrations, it has bactericidal action.
It has activity against a number of gram-positive, gram-negative, anaerobic, intracellular and other microorganisms.
Gram-positive cocci are sensitive to azithromycin: Streptococcus pneumoniae (penicillin-sensitive strains), Streptococcus pyogenes, Staphylococcus aureus (methicillin-sensitive strains); aerobic gram-negative bacteria: Haemophilus influenzae, Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Pasteurella multocida, Neisseria gonorrhoeae; some anaerobic microorganisms: Clostridium perfringens, Fusobacterium spp., Prevotella spp., Porphyriomonas spp.; and Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi.
Microorganisms with acquired resistance to azithromycin: aerobic gram-positive microorganisms -Streptococcus pneumoniae (penicillin-resistant strains and strains with moderate sensitivity to penicillin).
Microorganisms with natural resistance: aerobic gram-positive microorganisms - Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis (methicillin-resistant strains), anaerobic microorganisms - Bacteroides fragilis.
Cases of cross-resistance between Streptococcus pneumoniae, Streptococcus pyogenes (beta-hemolytic streptococcus group A), Enterococcus faecalis and Staphylococcus aureus (methicillin-resistant strains) to erythromycin, azithromycin, other macrolides and lincosamides are described.
Azithromycin has not been used to treat infectious diseases caused by Salmonella typhi (MIC < 16 mg/L) and Shigella spp.
After ingestion, azithromycin is well absorbed and quickly distributed in the body. After a single dose of 500 mg, the bioavailability is 37% due to the effect of "first passage" through the liver. C max in the blood plasma is achieved after 2-3 hours and is 0.4 mg / l.
Binding to proteins is inversely proportional to the concentration in the blood plasma and is 7-50%. Apparent V d is 31.1 l / kg. Penetrates through the membranes of cells (effective in infections caused by intracellular pathogens).
It is transported by phagocytes to the site of infection, where it is released in the presence of bacteria. Easily penetrates through the histogematic barriers and enters the tissues. The concentration in tissues and cells is 10-50 times higher than in plasma, and in the focus of infection - 24-34% more than in healthy tissues.
The drug is metabolized in the liver. Metabolites do not have antimicrobial activity.
T 1/2 very long - 35-50 h. T 1/2 much more of the fabrics. The therapeutic concentration of azithromycin persists up to 5-7 days after taking the last dose. Azithromycin is excreted, in mainly, unchanged - 50% through the intestines, 6% by the kidneys.
After intra-intrafusion, azithromycin quickly penetrates from the blood serum into the tissues. Concentrating in phagocytes and without disrupting their function, azithromycin migrates to the focus of inflammation, accumulating directly in infected tissues.
The pharmacokinetics of azithromycin in healthy volunteers after a single intramuscal infusion lasting more than 2 hours at a dose of 1-4 g (solution concentration of 1 mg / ml) has a linear dependence and is proportional to the administered dose.
In healthy volunteers with / in infusion of azithromycin at a dose of 500 mg (solution concentration 1 mg / ml) for 3 hours C max serum was 1.14 μg/ml.
C min in the blood serum (0.18 μg / ml) was noted for 24 hours and the AUC was 8.03 μg×ml / h. Similar pharmacokinetic values were obtained in patients with community-acquired pneumonia who were prescribed intramuscular 3-hour infusions for for 2 to 5 days. V d is 33.3 l/kg.
After the administration of azithromycin daily at a dose of 500 mg (infusion duration 1 h) for 5 days, an average of 14% of the dose is excreted by the kidneys during the 24-hour dosing interval.
T 1/2 is 65-72 h. Big V d (33.3 l/kg) and high plasma clearance (10.2 ml/min/kg) suggest that prolonged T 1/2 is a consequence of the accumulation of the antibiotic in the tissues with its subsequent slow release.
Indications for use
- Infections of the upper respiratory tract and ENT organs caused by sensitive pathogens: pharyngitis, tonsillitis, sinusitis, otitis media;
- infections of the lower respiratory tract: pneumonia (including atypical, exacerbation of chronic), bronchitis;
- skin and soft tissue infections: acne vulgaris (medium art. severity), erysipelas, impetigo, secondarily infected dermatoses;
- urinary tract infections: gonorrheal and non-urary urethritis, cervicitis;
- Lyme disease (initial stage - erythema migrans).
- Hypersensitivity to azithromycin, erythromycin, other macrolides or ketholids;
- hypersensitivity to excipients of the drug used;
- severe liver dysfunction;
- severe renal dysfunction (CK <40 ml / min);
- simultaneous use with ergotamine and dihydroergotamine; children's age up to 18 years (for intra-in infusions).
- mild to moderate impairment of liver function;
- mild to moderate renal impairment (CK > 40 ml / min);
- patients with proarrhythmogenic factors (especially in old age) - with congenital or acquired prolongation of the QT interval, patients receiving therapy with antiarrhythmic drugs of classes IA (quinidine, procainamide) and III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotic drugs (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with impaired water-electrolyte balance, especially with hypokalemia or hypomagnesemia, with clinically significant bradycardia, arrhythmia or with severe heart failure;
- simultaneous use of digoxin, warfarin, cyclosporine.
Dosage and Administration
The drug is taken orally 1 time / day 1 hour before or 2 hours after meals, without chewing.
Adults and children over 12 years of age and weighing more than 45 kg
With infections of the upper and lower respiratory tract, ENT organs, with infections of the skin and soft tissues (with the exception of chronic erythema migrans) - 500 mg / day for 1 dose for 3 days (course dose - 1.5 g).
With acne of ordinary moderate severity - 500 mg 1 time / day for 3 days, then 500 mg 1 time per week for 9 weeks; course dose - 6 g.
The first weekly dose should be taken 7 days after taking the first
daily dose (8th day from the start of treatment), followed by 8 weekly doses - with an interval of 7 days.
In acute infections of the genitourinary organs (uncomplicated urethritis or cervicitis) - 1 g once.
In Lyme disease (borreliosis) for the treatment of stage I (erythema migrans) - 1 g on the 1st day and from the 2nd to the 5th day - 500 mg daily (course dose - 3 g).
For the treatment of elderly patients over 65 years of age, the same doses are used as for adults. Since this category of patients may have proarrhythmogenic factors, it is necessary to pay special attention to the possibility of developing arrhythmias and ventricular tachycardia of the "pirouette" type.
In case of impaired renal function (CK more than 40 ml / min), dose adjustment is not required.
With a moderate violation of liver function, dose adjustment is not required.
For I/C infusions
Injected intravenously drip, for 3 hours - at a concentration of 1 mg / ml, for 1 h - at a concentration of 2 mg / ml. It is necessary to avoid administration in higher concentrations due to the risk of reactions at the injection site of the drug.
Do not enter in/in the jet or in/m!
With community-acquired pneumonia, a dose of 500 mg is prescribed 1 time / day for at least 2 days. If necessary, by decision of the attending physician, the course of treatment can be extended, but should be no more than 5 days.
After the end of intravenous administration, it is recommended to prescribe azithromycin inside in a daily dose of 500 mg 1 time / day until the complete completion of the 7-10-day general course of treatment.
In infectious and inflammatory diseases of the pelvic organs, it is prescribed at a dose of 500 mg 1 time / day for 2 days. The maximum course of treatment with the drug with / in the administration is 5 days.
After the end of intravenous administration, it is recommended to prescribe azithromycin inside at a dose of 250 mg / day until the complete completion of the 7-day general course of treatment.
The timing of the transition from intravenous administration of azithromycin to oral administration is determined by the doctor in accordance with the data of the clinical examination.
Patients with mild to moderate renal impairment (CK > 40 ml / min) dose adjustment is not required.
Patients with mild to moderate impairment of liver function do not need dose adjustment.
In elderly patients, dose adjustment is not required. Since this category of patients may have proarrhythmogenic conditions, azithromycin should be used with caution due to the high risk of developing arrhythmias, including ventricular arrhythmias of the type "pirouette".
The efficacy and safety of azithromycin for iv infusions in children and adolescents under the age of 18 years has not been established.
Infectious diseases: infrequently - candidiasis (including oral mucosa and genitals), pneumonia, pharyngitis, gastroenteritis, respiratory diseases, rhinitis; unknown frequency - pseudomembranous colitis.
From the blood and lymphatic system: infrequently - leukopenia, neutropenia, eosinophilia; very rarely - thrombocytopenia, hemolytic anemia.
From the side of metabolism: infrequently - anorexia.
Allergic reactions: infrequently - angioedema, hypersensitivity reaction; unknown frequency - anaphylactic reaction.
From the nervous system: often - headache; infrequently - dizziness, impaired taste, paresthesia, drowsiness, insomnia, nervousness; rarely - agitation; unknown frequency - hypesthesia, anxiety, aggression, fainting, convulsions, psychomotor hyperactivity, loss of smell, perversion of the sense of smell, loss of taste, myasthenia grafting, delusions, hallucinations.
From the side of the organ of vision: infrequently - visual impairment.
From the side of the hearing organ and labyrinth disorders: infrequently - hearing disorder, vertigo; unknown frequency - hearing impairment up to deafness and / or tinnitus.
From the cardiovascular system: infrequently - a feeling of palpitations, hot flashes of blood to the face; unknown frequency - a decrease in blood pressure, an increase in the QT interval on the ECG, arrhythmia of the "pirouette" type, ventricular tachycardia.
From the respiratory system: infrequently - shortness of breath, nosebleeds.
From the digestive system: very often - diarrhea; often - nausea, vomiting, abdominal pain; infrequently - flatulence, dyspepsia, constipation, gastritis, dysphagia, bloating, dryness of the oral mucosa, belching, ulcers of the oral mucosa, increased secretion of salivary glands; very rarely - a change in the color of the tongue, pancreatitis.
From the liver and biliary tract: infrequently - hepatitis; rarely - impaired liver function, cholestatic jaundice; unknown frequency - liver failure (in rare cases with a fatal outcome mainly against the background of severe impairment of liver function), liver necrosis, fulminant hepatitis.
From the skin and subcutaneous tissues: infrequently - skin rash, itching, urticaria, dermatitis, dry skin, sweating; rarely - photosensitization reaction; unknown frequency - Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.
From the musculoskeletal system: infrequently - osteoarthritis, myalgia, back pain, neck pain; unknown frequency - arthralgia.
From the kidneys and urinary tract: infrequently - dysuria, pain in the kidney area; unknown frequency - interstitial nephritis, acute renal failure.
With sides of the genitals and mammary gland: infrequently - metrorrhagia, impaired testicular function.
Local reactions: often - pain and inflammation at the injection site.
Other: infrequently - asthenia, malaise, feeling tired, swelling of the face, chest pain, fever, peripheral edema.
Laboratory data: often - a decrease in the number of lymphocytes, an increase in the number of eosinophils, an increase in the number of basophils, an increase in the number of monocytes, an increase in the number of neutrophils, a decrease in the concentration of bicarbonates in the blood plasma; infrequently - an increase in the activity of AST, ALT, an increase in the concentration of bilirubin in the blood plasma, an increase in the concentration of urea in the blood plasma, an increase in the concentration of creatinine in the blood plasma, a change in the potassium content in the blood plasma, an increase in the activity of ALP in the blood plasma, an increase in the chlorine content in the blood plasma, an increase in the concentration of glucose in the blood, an increase in the number of platelets, an increase in hematocrit, an increase in the concentration of bicarbonates in the blood plasma, a change in the sodium content in the blood plasma.
In a dry, dark place at a temperature not exceeding 25 ° C. Keep out of the reach of children.
- Dosage form
- 500 mg
- Number of tablets
- INN Russian