Azithromycin – macrolide antibiotic azalide group.
Reversibly binding to the 50S-ribosomal subunit of bacterial cells gives translocation of the nascent polypeptide chain of the aminoacyl site in the peptide that leads to a suppression of protein synthesis in bacterial cells.
Aerobic gram-positive microorganisms – Staphylococcus aureus (methicillin sensitive), Streptococcus pneumoniae (penicillin sensitive), Streptococcus pyogenes;
aerobic Gram-negative organisms – Haemophilus influenzae, Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Pasteurella multocida, Neisseria gonorrhoeae;
anaerobic microorganisms – Clostridium perfringens, Fusobacterium spp, Prevotella spp, Porphyromonas spp .;.. Other – Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi.
Streptococcus pneumoniae (moderately sensitive, or resistant to penicillin).
Aerobic gram-positive microorganisms – Enterococcus faecalis, beta-hemolytic Streptococcus spp. group A, Staphylococcus spp. (Methicillin-resistant), including: Staphylococcus aureus, resistant to erythromycin and other macrolides, lincosamides; anaerobes: Bacteroides fragilis.
Adults are prescribed by a doctor
1 vial. Azithromycin dihydrate 524 mg which is 500 mg azithromycin content
Citric acid monohydrate – 110 mg
Mannitol – 146 mg
Sodium hydroxide – q.s.
Cystitis, infections of the skin, from sinusitis, bronchitis, angina, urethritis, tonsillitis, pharyngitis, respiratory tract infection, from infectious disease, otitis media, pneumonia
- Community-acquired pneumonia is severe due to Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus or Streptococcus pneumoniae;
- Infectious-inflammatory diseases of the pelvic organs severe (endometritis and salpingitis) due to Chlamydia trachomatis, Neisseria gonorrhoeae, or Mycoplasma hominis.
- hypersensitivity to azithromycin or any other components of the drug;
- increased sensitivity to erythromycin, other macrolides, ketolides;
- liver dysfunction, severe;
- disorders severe renal impairment (creatinine clearance less than 40 mL / min);
- Children under the age of 16;
- Simultaneous administration with ergotamine and dihydroergotamine.
Myasthenia gravis, liver dysfunction and mild to moderate severity, renal dysfunction mild and moderate severity (creatinine clearance of 40 ml / min), patients with the presence of factors
(Especially in elderly patients) with congenital or acquired prolongation of the interval QT, in patients receiving therapy with antiarrhythmic drugs class IA (quinidine, procainamide) and III (dofetilide,
amiodarone and sotalol), cisapride, terfenadine, antipsychotics (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin),
violations of water-electrolyte balance, especially in the case of hypokalemia or hypomagnesemia, clinically significant bradycardia, cardiac arrhythmia or severe heart failure; concurrent use of digoxin, warfarin, cyclosporine.
CNS: dizziness / vertigo, headache, drowsiness, convulsions; paresthesia, fatigue, insomnia, irritability, fear, aggression, anxiety, nervousness.
From the senses: tinnitus, hearing impairment reversible until deafness (at high doses for a long time), visual disturbances, impaired perception of taste and smell.
Cardio-vascular system: palpitations, arrhythmias, including ventricular tachycardia, increase the interval QT, bidirectional ventricular tachycardia, decreased blood pressure.
From the digestive system: nausea, vomiting, diarrhea, abdominal pain and smazmy, diarrhea, flatulence, dyspepsia, cholestatic jaundice, hepatitis, gastritis, changes in laboratory
liver function, constipation, change the language of color, pseudomembranous colitis, pancreatitis, hepatic necrosis, hepatic failure (possibly fatal).
On the part of the circulatory and lymphatic systems: thrombocytopenia, neutropenia, leukopenia, neutrophils.
Allergic reactions include itching, skin rashes, angioedema, rash, photosensitivity, anaphylactic reaction, including edema (rarely fatal), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
On the part of the musculoskeletal system: arthralgia.
Genitourinary: nephritis, acute renal failure.
Local reactions: pain and inflammation at the injection site.
Other: candidiasis, including oral and genital organs, fatigue, malaise, anorexia, vaginitis.
How to accept, acceptance rate and dosage
The drug should be used only in stationary medical facilities!
The recommended dose for intravenous administration of azithromycin for the treatment of adults and patients older than 18 years in the following diseases:
Community-acquired pneumonia (CAP)
500 mg once a day intravenously (/ v) for at least 2 days (if necessary, by the decision of the physician on / in the course can be extended, but should not constitute more than 5 days).
Intravenous administration should be replaced, followed by oral administration of azithromycin in a single daily dose of 500 mg to completion 7-10 day total course of treatment.
Infectious-inflammatory diseases of the pelvic organs
500 mg once a day intravenously for at least 2 days (on / in the course of treatment is not more than 5 days).
Intravenous administration should be replaced, followed by oral administration of azithromycin in a single daily dose of 250 mg to completion 7 day total course of treatment.
Timing switch to oral treatment are determined in accordance with the data of clinical examination.
Patients with impaired renal function
When applied in patients with impaired renal mild and moderate severity (creatinine clearance > 40 ml / min) a dose adjustment is required.
Patients with impaired liver function
When applied in patients with impaired liver function mild or moderate dose adjustment is required.
In elderly patients, a dose adjustment is required.
The infusion solution is prepared in two stages:
Stage 1 – Preparation of repairing solution:
into a vial with 500 mg drug was added 4.8 mL sterile water for injection and carefully shaken until complete dissolution of the powder.
In 1 ml of the solution contains 100 mg azithromycin.
The prepared solution is stable for 24 h at room temperature.
Stage 2 – dilution of the reconstituted solution (100 mg / ml) is carried out immediately before the administration according to the following table.
|The concentration of azithromycin in the infusion solution||The amount of solvent|
|1.0 mg / ml||500 ml|
|2.0 mg / ml||250 ml|
The reduced solution was added to the vial with the solvent (0.9% sodium chloride solution, 5% dextrose, Ringer’s solution) to give a final concentration of azithromycin 1,0-2,0 mg / ml in the infusion solution.
Hemomitsin solution should not be administered intravenously or intramuscularly!
Recommended prepared solution administered intravenously over 3 watches – for infusion solution at a concentration of 1 mg / ml, for 1 hours – kontsentratsii2 mg / ml.
Before the introduction of the solution is visually inspected. If the finished solution contains particulate matter, it should not be used.
The prepared solution is stable at room temperature for 24 hours.
In the dark place at a temperature not higher than 20 ° C.
Azithromycin has no effect on the concentration of carbamazepine, cimetidine, didanosine, efavirenz, fluconazole, indinavir, midazolam, theophylline, triazolam, trimethoprim / sulfamethoxazole, and rifabutin in the blood of methylprednisolone in a joint application.
If necessary, concomitant use with cyclosporin, it is advisable to control the content of cyclosporin in the blood.
When the joint application of digoxin and azithromycin is necessary to monitor the concentration of digoxin in the blood, because Many macrolides enhance absorption of digoxin in the gut, thereby increasing its concentration in blood plasma.
When combined with indirect anticoagulants (warfarin, etc. Anticoagulant coumarin) recommended patients careful monitoring of the prothrombin time.
The simultaneous use of terfenadine and macrolide antibiotics causes arrhythmia and QT interval elongation. You should consider these data in the combined use of terfenadine, and azithromycin.
When combined with nelfinavir may increase the frequency of side effects of azithromycin.
It must consider the possibility of inhibition of CYP3A4 isoenzyme azithromycin or combined with cyclosporine, terfenadine, ergot alkaloids, cisapride, pimozide, quinidine, astemizole and other drugs, metabolism which occurs with the enzyme.
If concomitant use of azithromycin and zidovudine, azithromycin does not affect the pharmacokinetic parameters of zidovudine in the blood plasma or its excretion by the kidneys and its metabolite glucuronide.
However, increasing the concentration of the active metabolite – phosphorylated AZT in mononuclear cells of peripheral blood vessels. Not yet determined the clinical significance of this fact.
If concomitant use of azithromycin with ergotamine and dihydroergotamine can manifest their toxic effect (vasospasm, dysesthesia).
Pharmaceutical incompatible with heparin.
Do not set the safety and efficacy of the use of the injection form Hemomitsin the drug in children under 16 years old.
It should not be administered the drug over long courses than specified in the instruction, since pharmacokinetic properties of azithromycin allows for short dosing regimen.
Connection of superinfection (including fungal) in the treatment of drug Hemomitsin (and during any antibiotic).
If use of the drug may develop Hemomitsin diarrhea / pseudomembranous colitis caused by Clostridium difficile. In this regard, patients with diarrhea should be carefully monitored.
After discontinuation of treatment hypersensitivity reactions in some patients may persist, which requires specific therapy under medical supervision.
Effects on ability to drive vehicles and mechanisms
Given the likelihood of side effects from the central nervous system, caution should be exercised when driving vehicles and mechanisms.
Symptoms: severe nausea, temporary hearing loss, vomiting, diarrhea, abdominal pain, abnormal liver function.