Composition
1 tablet contains azithromycin dihydrate 500 mg
Pharmacological action
An antibiotic of the macrolide group-azalide. It has a wide spectrum of antimicrobial action. Binds to the 50S subunit of the ribosome, inhibits protein biosynthesis of microorganisms. In high concentrations, it has a bactericidal effect.
Azithromycin is active against gram-positive aerobic bacteria: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus viridans, group C, F and G streptococci, Staphylococcus aureus, Staphylococcus epidermidis; some Gram-positive anaerobic bacteria: Clostridium perfringens.
Azithromycin is active against gram-negative aerobic bacteria: Haemophilus influenzae, Haemophilus parainfluenzae, Haemophilus ducreyi, Moraxella catarrhalis, Bordetella pertussis, Bordetella parapertussis, Neisseria gonorrhoeae, Neisseria meningitidis, Helicobacter pylori, Gardnerella vaginalis, Campylobacter jejuni.
Azithromycin is also active against intracellular and other microorganisms: Mycobacterium avium complex, Legionella pneumophila, Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Ureaplasma urealyticum, Listeria monocitogenes, Borrelia burgdorferi, Treponema pallidum.
Gram-positive bacteria resistant to erythromycin are resistant to the drug.
Indications
Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:  – infections of the upper respiratory tract and ear (bacterial pharyngitis, tonsillitis, sinusitis, otitis media); – infections of the lower respiratory tract (bacterial bronchitis, interstitial and alveolar pneumonia, exacerbation of chronic bronchitis); infections of skin and soft tissues (chronic erythema migrans, the initial stage, Lyme disease, erysipelas, impetigo, secondary dermatoses); infection, sexually transmitted infections (urethritis, cervicitis); – diseases of the stomach and duodenum, associated with Helicobacter pylori.
Use during pregnancy and lactation
During pregnancy, the drug should only be administered if the expected benefit to the mother exceeds the potential risk to the fetus.
If it is necessary to introduce Sumamed to women during lactation, it is necessary to decide whether to stop breastfeeding.
Contraindications
-severe liver and kidney dysfunction; – hypersensitivity to macrolide antibiotics;
With caution: during pregnancy and lactation, with impaired liver and kidney function, patients with disorders or predisposition to arrhythmias and prolongation of the QT interval.
Side effects
They are rare (in 1% of cases or less).
From the digestive system: melena, cholestatic jaundice, nausea, vomiting, diarrhea, constipation, decreased appetite, gastritis, reversible moderate increase in the activity of liver enzymes.
From the urinary system: nephritis.
From the genital system: vaginal candidiasis.
From the cardiovascular system: palpitations, chest pain.
From the central nervous system and peripheral nervous system: dizziness, headache, vertigo, drowsiness, increased fatigue; in children-headache (in the treatment of otitis media), hyperkinesia, anxiety, neurosis, sleep disorders.
Allergic reactions: skin rashes, angioedema, urticaria, conjunctivitis.
Dermatological reactions: photosensitization, pruritus.
On the part of laboratory parameters: in some cases – neutrophilia, eosinophilia (changed indicators return to normal 2-3 weeks after discontinuation of treatment).
Interaction
Antacids (containing aluminum, magnesium), ethanol and food intake significantly reduce the absorption of azithromycin (capsules and suspension), so the drug should be taken at least 1 hour before or 2 hours after taking these drugs and eating. Azithromycin, unlike other macrolide antibiotics, does not bind to cytochrome P450 isoenzymes. To date, no interactions with theophylline, terfenadine, carbamazepine, triazolam, or digoxin have been observed.
Macrolides when taken concomitantly with cycloserine, indirect anticoagulants, methylprednisolone, felodipine and drugs undergoing microsomal oxidation (cyclosporine, hexobarbital, ergot alkaloids, valproic acid, disopyramide, bromocriptine, phenytoin, oral hypoglycemic agents), slow down the elimination, increase the concentration and toxicity of these drugs, while when used in combination with cycloserine, indirect anticoagulants, methylprednisolone, felodipine and drugs undergoing microsomal oxidation (cyclosporine, hexobarbital, ergot alkaloids, valproic acid, disopyramide, bromocriptine, phenytoin, oral hypoglycemic agents). No such interaction of azalides has been observed to date.
If co-use with warfarin is necessary, careful monitoring of prothrombin time is recommended. When macrolides are taken simultaneously with ergotamine and dihydroergotamine, their toxic effect may manifest (vascular spasm, dysesthesia).
Lincosamines reduce, and tetracycline and chloramphenicol increase the effectiveness of azithromycin.
Pharmacologically, azithromycin is incompatible with heparin.
How to take, course of use and dosage
The drug is prescribed orally 1 time a day. The bioavailability of the drug in tablet form does not depend on food intake. Children 6 months and older are recommended to use the drug in the form of an oral suspension or 125 mg tablets
With infections of the upper and lower respiratory tract, skin and soft tissues (with the exception of chronic erythema migrans)for adults the drug is prescribed in a dose of 500 mg 1 time/day for 3 days, a dose – 1.5 g. Children administered at 10 mg/kg of body weight 1 time/day for 3 days, a dose – 30 mg/kg.
For chronic erythema migrans: for adults, the drug is prescribed 1 time/day for 5 days: 1 day – 1 g (2 tablets. 500 mg), then from 2 to 5 days at the 500 mg dose of 3 g. Children administered on day 1 at a dose of 20 mg/kg of body weight and then from 2 to 5 days – a daily dose of 10 mg/kg of body weight, dose of 60 mg/kg.
In diseases of the stomach and duodenum associated with Helicobacter pylori,1 g (2 tablets of 500 mg) is prescribed per day for 3 days in combination with an antisecretory agent and other medications.
For sexually transmitted infections, for the treatment of uncomplicated urethritis/cervicitis, a dose of 1 g is prescribed once;for the treatment of complicated long-term urethritis / cervicitis caused by Chlamydia trachomatis,1 g is prescribed 3 times with an interval of 7 days (1,7,14 days), the course dose is 3 g
Overdose
Symptoms: nausea, vomiting, diarrhea, temporary hearing loss.
Treatment: symptomatic.
Special instructions
If you miss taking one dose of the drug, the missed dose should be taken as early as possible, and the subsequent ones should be taken at intervals of 24 hours.
The patient should be warned about the need to inform the doctor about the occurrence of any side effect.
Form of production
Tablets
Storage conditions
Keep out of reach of children at temperatures between 15° and 25°C.
Shelf
life is 3 years.
Active ingredient
Azithromycin
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
Description
Children over 12 years of age, Pregnant women as prescribed by a doctor, Adults as prescribed by a doctor, Children as prescribed by a doctor
Indications
Sore throat, Tonsillitis, Skin Infections, Otitis media, Pneumonia, Sinusitis, Infectious diseases, Pharyngitis, Bronchitis, Urethritis
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