Sumamox (Azithromycin) 500 mg tablets 3
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Active substance: azithromycin dihydrate 524 mg, which corresponds to the content of azithromycin 500 mg.
Excipients: corn starch - 250 mg, corn starch for paste - 40 mg, calcium phosphate - 150 mg, talc - 3 mg, magnesium stearate - 2 mg, sodium carboxymethyl starch - 3 mg, croscarmellose sodium - 2 mg.
Composition of the film shell: tablet coating "Tabcoate white" - 46 mg (hypromellose - 14.4 mg, macrogol - 5.4 mg, titanium dioxide (E171) - 16.2 mg, talc - 10 mg).
Azithromycin is a macrolide antibiotic of the azalide group. Reversibly binding to the 50S-subunit of ribosomes of bacterial cells, disrupts the translocation of the growing polypeptide chain from the aminoacyl site in the peptidyl, which leads to the suppression of protein synthesis in bacterial cells.
Sensitive: aerobic gram-positive microorganisms - Staphylococcus aureus (methicillin-sensitive), Streptococcus pneumoniae (penicillin-sensitive), Streptococcus pyogenes; aerobic gram-negative microorganisms - Haemophilus influenzae, Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Pasteurella multocida, Neisseria gonorrhoeae; anaerobic microorganisms - Clostridium perfringens, Fusobacterium spp., Prevotella spp., Porphyromonas spp.; others - Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi.
Moderately sensitive or insensitive: aerobic gram-positive microorganisms - Streptococcus pneumoniae (moderately sensitive or resistant to penicillin).
Resistant: aerobic gram-positive microorganisms - Enterococcus faecalis, Staphylococcus spp. (methicillin-resistant); anaerobes: group Bacteroides fragilis, Streptococcus pneumoniae, beta-hemolytic Streptococcus spp. groups A, Enterococcus faecalis and Staphylococcus aureus (including methicillin-resistant strains) resistant to erythromycin and other macrolides, lincosamides are resistant to azithromycin.
After oral administration, the bioavailability is 37%, C max in the blood plasma is created after 2-3 hours, V d - 31 l / kg. Binding to blood plasma proteins is inversely proportional to the concentration in the blood and is 12-52%. Penetrates through cell membranes (effective in infections caused by intracellular pathogens). It is transported by phagocytes, polymorphonuclear leukocytes and macrophages to the site of infection, where it is released in the presence of bacteria. It easily passes through the histohematic barriers and enters the tissues. Concentration in tissues and cells in 50 times higher than in blood plasma, and in the focus of infection - 24-34% more than in healthy tissues. Slowly excreted from tissues and has a long T 1/2 2-4 days. The therapeutic concentration of azithromycin persists up to 5-7 days after taking the last dose. Azithromycin is excreted mainly unchanged - 50% by the intestine, 12% by the kidneys. In the liver, it is demethylated, losing activity. In patients with renal insufficiency (creatinine clearance (CC) less than 10 ml / min) T 1/2 azithromycin increases by 33%.
Indications for use
Infectious and inflammatory diseases caused by microorganisms sensitive to azithromycin:
- infections of the upper respiratory tract and ENT organs (pharyngitis, tonsillitis, sinusitis, otitis media);
- lower respiratory tract infections (acute bronchitis, exacerbation of chronic bronchitis, community-acquired pneumonia, incl. caused by atypical pathogens);
- infections of the skin and soft tissues (simple acne of moderate severity, erysipelas, impetigo, secondarily infected dermatoses);
- the initial stage of Lyme disease (borreliosis) - erythema migrans (erythema migrans);
- uncomplicated urinary tract infections caused by Chlamidia trachomatis (urethritis, cervicitis).
- hypersensitivity to azithromycin, other macrolides, to the constituent components of the drug;
- simultaneous use with ergot derivatives;
- severe hepatic / renal failure;
- children's age up to 12 years.
With caution: syndrome of the extended Q-T interval, chronic renal failure (QC more than 40 ml / min), simultaneous administration with terfenadine, warfarin, digoxin, drugs that prolong the interval Q-T.
Use in pregnancy and lactation
The use of the drug during pregnancy is possible only in cases where the intended benefit to the mother exceeds the potential risk to the fetus. If it is necessary to use the drug during lactation, the issue of stopping breastfeeding should be resolved.
Use in case of impaired liver functionContraindicated in severe liver failure.
Use in renal dysfunction
Contraindicated in severe renal failure.
With caution: chronic renal failure (QC more than 40 ml / min).
Use in children
Contraindicated in children under 12 years of age.
In case of skipping one dose of the drug - the missed dose should be taken as early as possible, and subsequent - with interruptions of 24 hours.
At pharyngitis and tonsillitis caused by Streptococcus pyogenes, the antibiotics of choice are penicillins. The effectiveness of azithromycin for the prevention of rheumatic fever is unknown.
When using azithromycin, as well as with the use of other antibiotics, there is a risk of developing superinfection (including fungal).
With prolonged use of azithromycin, the development of pseudomembranous colitis caused by Clostridium difficile is possible. With the development of diarrhea while taking azithromycin, as well as 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded.
Impact on the ability to drive vehicles and work with mechanisms
In the event of adverse reactions from the nervous system, patients are advised to refrain from driving a car and other mechanisms, as well as to be careful when engaging in activities that require increased concentration and speed. psychomotor reactions.
Symptoms: temporary hearing loss, nausea and vomiting, diarrhea.
Treatment: taking activated charcoal, maintaining the vital functions of the body.
Antacids reduce C max azithromycin by 30%, so azithromycin should be taken 1 hour before or 2 hours after taking antacids. With simultaneous use with cyclosporine, the concentration of cyclosporine in the blood should be monitored.
With simultaneous use with indirect anticoagulants, the frequency of bleeding may increase, prothrombin time and international normalized ratio (MHO) should be monitored.
With simultaneous use with digoxin, an increase in the concentration in the blood of the latter is possible, therefore, the concentration of digoxin in the blood should be monitored. With simultaneous use with ergotamine, ergotism may develop; simultaneous use is not recommended.
The simultaneous use of macrolides and theophylline in some cases led to an increase in the concentration of the latter.
Azithromycin increases the content of zidovudine triphosphate (the active metabolite of zidovudine) in mononuclear cells, the clinical significance of this phenomenon is unknown.
Simultaneous use with rifabutin can lead to neutropenia.
When taken simultaneously, fluconazole reduces C max azithromycin by 18%.
Dosage and Administration
Inside, 1 time / day, at least 1 hour before or 2 hours after eating.
Adults (including the elderly) and children over 12 years of age weighing more than 45 kg.
For infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues: 500 mg (1 tablet) 1 time / day for 3 days (course dose of 1.5 g).
Start stage of Lyme disease: 1 time / day for 5 days: 1st day - 1.0 g (2 tablets), then from the 2nd to the 5th day - 500 mg (1 tablet) (course dose of 3.0 g)
For uncomplicated urinary tract infections caused by Chlamidia trachomatis (urethritis, cervicitis): 1 g (2 tablets) once.
With acne: the course dose is 6 g: 500 mg (1 tablet) 1 time / day for 3 days, then 500 mg 1 time per week for 9 weeks.
Prescription for patients with impaired renal function: For patients with moderate renal impairment (QC > 40 ml / min), dose adjustment is not needed.
From the organs of hematopoiesis: lymphocytopenia, eosinophilia, leukopenia, thrombocytopenia, transient neutropenia, hemolytic anemia.
From the nervous system: dizziness, vertigo, drowsiness, headache, convulsions, paresthesia, hypoesthesia, asthenia, insomnia, hyperactivity, aggressiveness, restlessness, anxiety, nervousness.
From the senses: hearing impairment, deafness, ringing in the ears, perversion of taste or smell, decreased visual acuity.
From the cardiovascular system: a feeling of palpitations, arrhythmia (including ventricular tachycardia, pirouette tachycardia), prolongation of the Q-T interval.
From the digestive system: nausea, vomiting, diarrhea, abdominal pain or abdominal cramps, unformed stool, flatulence, digestive disorders, gastritis, anorexia, constipation, discoloration of the tongue, pseudomembranous colitis, hepatitis, cholestatic jaundice, impaired functional tests of the liver, liver necrosis and liver failure (up to death).
From the musculoskeletal system: arthralgia.
From the genitourinary system: vaginitis, interstitial nephritis, acute renal failure.
Allergic reactions: itching and rash, angioedema, urticaria, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal nscrolysis, anaphylactic reactions.
Laboratory indicators: an increase in the serum concentration of bilirubin, urea, creatinine, potassium ions, a decrease in the concentration of bicarbonates in the serum.
Other: candidiasis, chest pain, swelling, fainting, exacerbation of myasthenia gravis.
In a dry, dark place at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Shelf life - 2 years. Do not take after the expiration date.
- Oxford Laboratories
- Dosage form
- 500 mg
- Number of tablets
- INN Russian
- Russian title