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Sumamed 250 mg No. 6 caps.

Instructions for medical use of the drug Sumamed® Trade name Sumamed® International nonproprietary name Azithromycin Dosage form Capsules, 250 mg Composition One capsule contains the active substance - azithromycin dihydrate, 250 mg, excipients: microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate, capsule shell composition : gelatin, titanium dioxide (E171), indigo carmine (E132), sulfur dioxide. Description Hard gelatin capsules size No. 1, with a blue body and a blue lid. The contents of the capsules are crystalline powder from white to light yellow. Pharmacotherapeutic group Antimicrobial drugs for systemic use. Macrolides, lincosamides and streptogramins. Macrolides. Azithromycin. ATC code J01FA10 Pharmacological properties Pharmacokinetics Azithromycin is rapidly absorbed when taken orally, due to its stability in an acidic environment and lipophilicity. After a single oral dose, 37% of azithromycin is absorbed, and peak plasma concentration (0.41 µg/ml) is recorded after 2-3 hours. Vd is approximately 31 l/kg. Azithromycin penetrates well into the respiratory tract, organs and tissues of the urogenital tract, prostate gland, skin and soft tissues, reaching from 1 to 9 µg/ml depending on the type of tissue. The high concentration in tissues (50 times higher than the concentration in plasma) and the long half-life are due to the low binding of azithromycin to plasma proteins, as well as its ability to penetrate eukaryotic cells and concentrate in the low pH environment surrounding lysosomes. The ability of azithromycin to accumulate in lysosomes is especially important for the elimination of intracellular pathogens. Phagocytes deliver azithromycin to sites of infection, where it is released through the process of phagocytosis. But despite the high concentration in phagocytes, azithromycin does not affect their function. The therapeutic concentration lasts 5-7 days after ingestion of the last dose. When taking azithromycin, a transient increase in the activity of liver enzymes is possible. The removal of half the dose from the plasma is reflected in a reduction of half the dose in the tissues within 2-4 days. After taking the drug in the interval from 8 to 24 hours, the half-life is 14-20 hours, and after taking the drug in the interval from 24 to 72 hours - 41 hours, which allows you to take Sumamed once a day. The main route of excretion is with bile. Approximately 50% is excreted unchanged, the other 50% is excreted in the form of 10 inactive metabolites. Approximately 6% of the dose taken is excreted by the kidneys. Pharmacodynamics Azithromycin is a broad-spectrum antibiotic, the first representative of a new subgroup of macrolide antibiotics - azalides. It has a bacteriostatic effect, but when high concentrations are created at the site of inflammation, it causes a bactericidal effect. By binding the 50S ribosomal subunit, azithromycin inhibits protein synthesis in sensitive microorganisms, showing activity against most strains of gram-positive, gram-negative, anaerobic, intracellular and other microorganisms. Minimum inhibitory concentration that inhibits 90% of microorganisms (MIC90)≤ 0.01 µg/ml Mycoplasma pneumoniae Haemophilus ducreyi MIC90 0.01 - 0.1 µg/ml Moraxella catarrhalis Propionibacterium acnes Gardnerella vaginalis Actinomyces species Bordetella pertussis Borrelia burgdorferi Mobiluncus species MIC900 .1 – 2.0 µg/ml Haemophilus influenzae Streptococcus pyogenes Haemophilus parainfluenzae Streptococcus pneumoniae Legionella pneumophila Streptococcus agalactiae Neisseria meningitidis Streptococcus viridans Neisseria gonorrhoeae Streptococcus group C, F, G Helicobacter pylori Peptococcus species Campylobacter jejuni Peptostreptococcus Pasteurella multocida Fusobacterium necrophorum Pasteurella haemolytica Clostridium perfringens Brucella melitensis Bacteroides bivius Bordetella parapertussis Chlamydia trachomatis Vibrio cholerae Chlamydia pneumoniae Vibrio parahaemolyticus Ureaplasma urealyticum Plesiomonas shigelloides Listeria monocytogenes Staphylococcus epidermidis Staphylococcus aureus* (*erythromycin - sensitive strain) MIC902.0 - 8.0 µg/ml Escherichia coli Bacteroides fragilis Salmonella enteritidis Bacteroides oralis Salmonella typhi Clostrid ium difficile Shigella sonnei Eubacterium lentum Yersinia enterocolitica Fusobacterium nucleatum Acinetobacter calcoaceticus Aeromonas hydrophilia Indications for use - pharyngitis, tonsillitis, sinusitis, otitis media - acute and chronic bronchitis, interstitial and alveolar pneumonia - chronic migratory erythema - initial stage of Lyme disease, erysipelas, impetigo, secondary pyodermatoses - diseases of the stomach and duodenum, associated with Helicobacter pylori - gonorrheal and non-gonorrheal urethritis and/or cervicitis Method of administration and dosage Sumamed capsules 250 mg are taken once a day 1 hour before meals or 2 hours after meals. For infections of the upper and lower respiratory tract, infections of the skin and soft tissues, 500 mg/day is prescribed for 3 days (course dose - 1.5 mg). For uncomplicated urethritis and/or cervicitis, a single dose of 1 g (4 capsules of 250 mg) is prescribed. For Lyme disease (borelliosis), for the treatment of the initial stage (erythema migrans), 1 g (4 capsules of 250 mg each) is prescribed on the first day and 500 mg daily from the 2nd to the 5th day (course dose - 3 g). For diseases of the stomach and duodenum associated with Helicobacter pylori, Sumamed is prescribed 1 g (4 capsules of 250 mg) per day for 3 days as part of combination therapy. If you miss one dose of the drug, you should take the missed dose as soon as possible, and subsequent doses should be taken at intervals of 24 hours. In elderly people and in patients with impaired renal function, there is no need to change the dosage. For the treatment of children, it is necessary to use children's forms of Sumamed: Sumamed 125 mg and Sumamed 100 mg/5 ml, Sumamed Forte 200 mg/5 ml. Side effects Often (>1/100, <1/10) - nausea, vomiting, diarrhea, abdominal pain Not often (>1/1000, <1/100) - loose stools, flatulence, indigestion, loss of appetite Rarely ( >1/1000, <1/100) - headache, dizziness, drowsiness, convulsions, dysgeusia - thromocytopenia - aggressiveness, agitation, anxiety, nervousness, insomnia - paresthesia and asthenia - hearing impairment, deafness and tinnitus - tachycardia, arrhythmia with ventricular tachycardia, prolongation of the QT interval - discoloration of the tongue, constipation, pseudomembranous colitis - transient increase in the level of liver aminotransferases, bilirubin, cholestatic jaundice, hepatitis - hypersensitivity reactions (redness, skin rash, itching, urticaria, angioedema, photosensitivity), erythema multiforme , Steven-Johnson syndrome and toxic epidermal necrolysis, - arthralgia Very rarely (>1/10000, <1/1000) - interstitial nephritis, acute renal failure - fatigue, convulsions - changes in taste and smell - arthralgia - vaginitis, candidiasis, superinfections - anaphylactic shock including edema (in rare cases leading to death) Contraindications - known hypersensitivity to macrolide antibiotics - severe dysfunction of the liver and kidneys - children under 18 years of age (due to the presence of a dye) - first trimester of pregnancy and lactation period Medicinal interactions Antacids significantly reduce the absorption of Sumamed, so the drug should be taken one hour before or two hours after taking these drugs. Macrolide antibiotics interact with cyclosporine, astemizole, triazolam, midazolam, or alfentanil. Close monitoring is recommended if these drugs are used concomitantly. Azithromycin does not affect cytochrome P-450 and therefore does not interact with theophylline, terfenadine, carbamazepine, methylprednisolone, didanosine and cimetidine. With the simultaneous use of azithromycin and indirect anticoagulants, bleeding is possible. Therefore, it is necessary to monitor prothrombin time. When azithromycin and digoxin are combined, the concentration of digoxin in the blood may increase, so it is necessary to monitor the level of digoxin in the blood and adjust its dose. It is not recommended to prescribe azithromycin and ergotamine drugs at the same time, as ergotism may develop. Zidovudine: Azithromycin increases the concentration of the active phosphorylated metabolite of zidovudine in the blood. However, the clinical significance of this pharmacokinetic interaction is currently unclear. Rifabutin: the combined use of azithromycin and rifabutin did not change their plasma concentrations. However, neutropenia was observed; the cause and effect relationship between the development of an adverse reaction and the use of this combination has not been established. Special instructions The following side effects have been reported when taking macrolide antibiotics: ventricular arrhythmia, including ventricular tachycardia and torsades de pointes (ventricular fibrillation), in patients with a prolonged QT interval. It is extremely rare that during treatment with azithromycin there may be flutter-fibrillation (ventricular fibrillation) and subsequent myocardial infarction in persons with a history of arrhythmia. Prolonged cardiac repolarization and QT interval, which increase the risk of developing cardiac arrhythmias and torsades de pointes, have been observed with other macrolide antibiotics. A similar effect of azithromycin cannot be completely excluded in patients with an increased risk of prolonged cardiac repolarization. Pregnancy The use of the drug in the second and third trimesters of pregnancy is possible when the expected benefit outweighs the potential risk to the fetus. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms During treatment with the drug, you must refrain from driving vehicles and engaging in potentially hazardous activities. Overdose There is no data on overdose with Sumamed. Overdose of macrolide antibiotics results in reversible hearing loss, severe nausea, vomiting and diarrhea. Treatment: it is necessary to induce vomiting and immediately carry out symptomatic therapy. Release form 6 capsules are placed in a blister pack made of aluminum foil and polyvinyl chloride film. One contour package, together with instructions for medical use in the state and Russian languages, is placed in a cardboard pack. Storage conditions Store at a temperature not exceeding 25°C Keep out of the reach of children! Shelf life: 3 years Do not use after expiration date. Conditions for dispensing from pharmacies By prescription Prilaz Barun Filippovicha 25, 10 000 Zagreb, Croatia Owner of the registration certificate "Teva Pharmaceutical Enterprises Ltd", Israel Address of the organization that accepts claims from consumers on the quality of products (products) in the Republic of Kazakhstan Ratiopharm Kazakhstan LLP 050000 Republic of Kazakhstan, Almaty, Al-Farabi Avenue 19, Nurly Tau Business Center 1B, office 603 Telephone, fax, 311-07-34