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Sumamed forte 200 mg/5 ml 15 ml portion d/susp. for oral administration

Instructions for medical use of the drug Sumamed® forte Trade name Sumamed® forte International nonproprietary name Azithromycin Dosage form Powder for the preparation of suspension for oral administration, 200 mg/5 ml Composition One bottle contains the active substance - azithromycin (in the form of azithromycin dihydrate) - 600 mg ( for a volume of 15 ml), 1200 mg (for a volume of 30 ml), 1500 mg (for a volume of 37.5 ml). Excipients: sucrose, sodium phosphate anhydrous, hydroxypropycellulose, xanthan gum, colloidal silicon anhydrous, cherry flavor, banana flavor and vanilla flavor. Description Granular powder from white to light yellow color with a characteristic odor of banana and cherry. The prepared solution is a homogeneous suspension of white or light yellow color with a characteristic odor of banana and cherry. Pharmacotherapeutic group Antibacterial 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 resistance to acidic conditions and lipophilicity. After a single oral dose, 37% of azithromycin is absorbed, and peak plasma concentration (0.41µg/ml) is recorded after 2-3 hours. The volume of distribution 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 blood 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® forte 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 The active substance of the drug Sumamed® forte - 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. Azithromycin suppresses protein synthesis in sensitive microorganisms, showing activity against most strains of gram-positive, gram-negative, anaerobic, intracellular and other microorganisms: Mycoplasma pneumoniae, Haemophilus ducreyi, Moraxella catarrhalis, Propionibacterium acnes, Gardnerella vaginalis, Actinomyces species, Bordetella pertussis, Borrelia burgdorferi, Mobiluncus species; Haemophilus influenzae, Streptococcus pyogenes, Haemophilus parainfluenzae, Streptococcus pneumoniae, Legionella pneumophila, Streptococcus agalactiae, Neisseria meningitides, Streptococcus viridans, Neisseria gonorrhoeae, Streptococcus group C, F, G, Helicobacter pylori, Peptococcus species, Campylobacter jejun i, 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 ); Escherichia coli, Bacteroides fragilis, Salmonella enteritidis, Bacteroides oralis, Salmonella typhi, Clostridium difficile, Shigella sonnei, Eubacterium lentum, Yersinia enterocolitica, Fusobacterium nucleatum, Acinetobacter calcoaceticus, Aeromonas hydrophilia. Indications for use - upper respiratory tract infections (bacterial pharyngitis/tosillitis, sinusitis, otitis media) - lower respiratory tract infections (bronchitis, community-acquired pneumonia, exacerbation of chronic bronchitis) - skin and soft tissue infections (chronic migratory erythema - the initial stage of Lyme disease, erysipelas, impetigo, secondary pyodermatoses) - infections of the stomach and duodenum caused by Helicobacter pylori Method of administration and dosage Sumamed® forte in the form of an oral suspension is taken 1 time per day 1 hour before or 2 hours after meals using a measuring spoon or dosage syringe . Infections of the upper and lower respiratory tract, skin and soft tissues (except for chronic migratory erythema) The course dose is 30 mg/kg. Two treatment regimens are used: 1) 10 mg/kg body weight once a day for 3 days 2) 10 mg /kg body weight on the first day and 5 mg/kg body weight from the 2nd to the 5th day. For children, the drug is prescribed based on weight: Body weight Sumamed®forte powder for the preparation of oral suspension 200 mg/5 ml 10-14 kg 2.5 ml (100 mg) 15-25 kg 5 ml (200 mg) 25-34 kg 7.5 ml (300 mg) 35-44 kg 10 ml (400 mg) ≥ 45 kg 12.5 ml (500 mg) Azithromycin has been noted to be effective in the treatment of streptococcal pharyngitis in children as a single dose of 10 mg/kg or 20 mg/kg for 3 days. Penicillin is used to prevent pharyngitis caused by Streptococcus pyogenes with possible rheumatic fever as a concomitant disease. Chronic migratory erythema The course dose of the drug is 60 mg/kg: once a day, 20 mg/kg on the 1st day and 10 mg/kg on the subsequent days, from 2 to 5. Diseases of the stomach and duodenum associated with Helicobacter pylori: 20 mg/kg body weight 1 time per day in combination with antisecretory agents and other drugs. If a dose of the drug is missed, it must be taken immediately, and then subsequent doses should be taken at intervals of 24 hours. Kidney failure. In patients with mild renal dysfunction (GFR 10-80 ml/min), there is no need to change the dose. Patients with severely impaired renal function (GFR <10 ml/min) should use azithromycin with caution. Liver failure. Because azithromycin is metabolized in the liver and excreted in the bile, the drug should not be used in patients with severe liver disease. No studies have been conducted to examine the effect of azithromycin on liver function. Elderly patients Elderly patients are prescribed the same dose as adults. Among elderly patients, proarrhythmogenic conditions are possible, so the drug is used with caution due to the risk of developing cardiac arrhythmia and bidirectional tachycardia. Method of preparing the suspension Each bottle should contain a suspension 5 ml more than the course dose. To prepare 15 ml of suspension, add 9.5 ml of water (20 ml of suspension) to a bottle containing 600 mg of azithromycin. To prepare 30 ml of suspension, add 16.5 ml of water (35 ml of suspension) to a bottle containing 1200 mg of azithromycin. To prepare 37.5 ml of suspension, add 20 ml of water (42.5 ml of suspension) to a bottle containing 1500 mg of azithromycin. Before use, shake the contents of the bottle thoroughly until a homogeneous suspension is obtained. Immediately after taking the suspension, the child is given a few sips of liquid to rinse and swallow the remaining amount of the suspension in the mouth. Side effects Common: - vomiting, diarrhea, abdominal pain, nausea, abdominal discomfort, paresthesia, taste disturbances, headache, arthralgia, fatigue Uncommon: - nervousness, insomnia, drowsiness, rapid heartbeat, shortness of breath, nosebleeds, constipation, flatulence , dyspepsia, gastritis, bloating, dry mouth, belching, salivary gland hypersecretion, urticaria, dermatitis, dry skin, vaginal infections, fungal infections, bacterial infection, gastroenteritis, respiratory disorders, oral candidiasis, leukopenia, neutropenia, eosinophilia, angioedema edema, hypersensitivity, visual impairment, hearing impairment, osteoarthritis, myalgia, back pain, dysuria, renal pain, metrorrhagia, testicular damage, malaise, fatigue, edema, chest pain, fever, peripheral edema, increased aspartate aminotransferase levels, increased levels alanine aminotransferase, increased blood bilirubin, increased blood urea, increased blood creatinine, abnormal blood potassium level, increased blood alkaline phosphatase level, increased glucose level, increased platelet level, decreased hematocrit, increased bicarbonate, abnormal sodium level, hypoesthesia , tinnitus, hepatitis, Stevens-Johnson syndrome, asthenia Rarely: - emotional agitation (agitation) - abnormal liver function, cholestatic jaundice - photosensitivity reactions Unknown: - pseudomembranous colitis, thrombocytopenia, hemolytic anemia, anaphylactic reaction, aggression, anxiety, delirium, hallucinations, fainting, convulsions, psychomotor hyperactivity, anosmia, ageusia, parosomia, myasthenia, hearing impairment, bidirectional tachycardia and arrhythmia including ventricular tachycardia, prolongation of the QT interval on the ECG, hypotension, pancreatitis, discoloration of the tongue, liver failure, fulminant hepatitis, liver necrosis, toxic epidermal necrolysis, erythema multiforme, arthralgia, acute liver failure, interstitial nephritis Contraindications Hypersensitivity to azithromycin, erythromycin or macrolide and ketolide antibiotics, or other components of the drug. Drug interactions Antacids: When studying the effect of simultaneous use of antacids on the pharmacokinetics of azithromycin, no changes in bioavailability were noted, although the maximum concentration of azithromycin in blood plasma decreased by 25%. Patients should not take azithromycin and antacids at the same time. Cetirizine: In healthy volunteers, co-administration of a 5-day course of azithromycin with cetirizine 20 mg at steady state did not result in pharmacokinetic interaction or significant changes in the QT interval. Didanosine (dideoxyinosine): Co-administration of 1200 mg/day azithromycin and 400 mg/day didanosine in 6 HIV-positive patients did not affect the steady-state pharmacokinetics of didanosine compared with placebo. Digoxin (P-gp substrates): Concomitant use of macrolide antibiotics, including azithromycin, with P-gp substrates such as digoxin results in increased serum levels of P-gp substrates. Therefore, when azithromycin is used concomitantly with P-glycoprotein substrates such as digoxin, be aware of the possibility of increased serum concentrations of P-glycoprotein substrates. Zidovudine: With a single dose of 1000 mg and repeated doses of 1200 mg or 600 mg of azithromycin, there was little effect on the plasma pharmacokinetics or urinary excretion of zidovudine or its glucuronide metabolites. However, taking azithromycin increased the concentration of phosphorylated zidovudine (a clinically active metabolite) in peripheral blood mononuclear cells. The clinical significance of these indicators remains uncertain, but they may be useful to patients. Azithromycin does not interact with the liver cytochrome P450 system. It does not participate in pharmacokinetic drug interactions, like erythromycin and other macrolides. Azithromycin does not induce or inactivate cytochrome P450 via the cytochrome-metabolite complex. Ergotamine derivatives: Due to the theoretical possibility of developing ergotism, simultaneous use of azithromycin with ergot derivatives is not recommended. Pharmacokinetic studies were conducted with azithromycin and the following drugs with known cytochrome P450-mediated metabolism. Atorvastatin: Coadministration of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not change plasma concentrations of atorvastatin (based on HMG CoA reductase assay). However, post-marketing cases of rhabdomyolysis have been reported in patients receiving azithromycin with statins. Carbamazepine: In a pharmacokinetic interaction study of azithromycin in healthy volunteers, the drug did not have a significant effect on plasma levels of carbamazepine or its active metabolites. Cimetidine: No change in the pharmacokinetics of azithromycin was noted in a pharmacokinetic study examining the effect of a single dose of cimetidine taken 2 hours before azithromycin on the pharmacokinetics of azithromycin. Coumarin oral anticoagulants: In pharmacokinetic interaction studies, azithromycin did not alter the anticoagulant effect of a single 15 mg dose of warfarin administered to healthy volunteers. In the post-marketing period, there have been reports of increased anticoagulation after co-administration of azithromycin and oral coumarin anticoagulants. Although a causal relationship has not been established, the frequency of prothrombin time monitoring should be considered when prescribing azithromycin to patients receiving oral anticoagulants such as coumarin. Cyclosporine: In a pharmacokinetic study in healthy volunteers who received 500 mg/day oral azithromycin for 3 days followed by a single oral dose of 10 mg/kg cyclosporine, the Cmax and AUC0-5 of cyclosporine were significantly increased. Therefore, caution should be exercised before concomitant administration of these drugs is considered. If coadministration of these drugs is necessary, monitor cyclosporine levels and adjust the dose accordingly. Efavirenz: Coadministration of a single dose of azithromycin 600 mg and efavirenz 400 mg daily for 7 days does not result in clinically significant pharmacokinetic interactions. Fluconazole: Coadministration of a single dose of 1200 mg azithromycin does not alter the pharmacokinetics of a single dose of 800 mg fluconazole. The overall exposure and half-life of azithromycin were not altered by coadministration with fluconazole, however, a clinically insignificant decrease in Cmax (18%) of azithromycin was observed. Indinavir: Co-administration of a single dose of 1200 mg azithromycin did not have a statistically significant effect on the pharmacokinetics of indinavir administered at a dosage of 800 mg three times daily for 5 days. Methylprednisolone: In a pharmacokinetic interaction study in healthy volunteers, azithromycin did not show a significant effect on the pharmacokinetics of methylprednisolone. Midazolam: In healthy volunteers, coadministration with azithromycin 500 mg/day for 3 days did not cause clinically significant changes in the pharmacokinetics and pharmacodynamics of a single dose of 15 mg midazolam. Nelfinavir: Co-administration of azithromycin (1200 mg) and nelfinavir at steady state (750 mg three times daily) resulted in increased azithromycin concentrations. No clinically significant side effects were observed and no dose adjustment is required. Rifabutin: Concomitant use of azithromycin and rifabutin did not affect the plasma concentrations of these drugs. Neutropenia was detected with simultaneous use of azithromycin and rifabutin. Although neutropenia has been associated with the use of rifabutin, a causal relationship with concomitant use of azithromycin has not been established. Sildenafil: In normal healthy male volunteers, there is no evidence of an effect of azithromycin (500 mg daily for 3 days) on the AUC and Cmax of sildenafil or its major circulating metabolite. Terfenadine: No interaction between azithromycin and terfenadine has been reported in pharmacokinetic studies. In some cases, it is not possible to completely exclude the possibility of an interaction. However, no concrete evidence was obtained that such an interaction occurred. Theophylline: There is no evidence of a clinically significant pharmacokinetic interaction between azithromycin and theophylline when administered concomitantly to healthy volunteers. Triazolam: In 14 healthy volunteers, coadministration of azithromycin 500 mg on day 1 and 250 mg on day 2 with 0.125 mg triazolam on day 2 had no significant effect on any of the pharmacokinetic variables for triazolam compared with coadministration of triazolam and placebo. Trimethoprim/sulfamethoxazole: Coadministration of trimethoprim/sulfamethoxazole DS (160 mg/800 mg) for 7 days with azithromycin 1200 mg on day 7 had no significant effect on the maximum concentration, total exposure, or elimination of trimethoprim or sulfamethoxazole. Azithromycin serum concentrations were similar to those observed in other studies. Special instructions The duration of use of the drug should not exceed the periods specified in the instructions. As in the case of other macrolides, rare serious allergic reactions were reported, including Quincke's edema and anaphylaxia. Some of these reactions to azithromycin lead to the development of recurrent symptoms and require a longer period of observation and treatment. It is the main organ for the removal of azithromycin, therefore, azithromycin should be prescribed with caution with a pronounced liver disease. In the case of signs and symptoms of liver dysfunction, such as rapidly developing asthenia associated with jaundice, dark urine, a tendency to bleeding or liver encephalopathy, and immediately conduct functional stamps of the liver / tests. With the development of liver dysfunction, stop the azithromycin intake. In patients receiving derivatives, the appearance of ergotism was provoked by the simultaneous intake of some macrolide antibiotics. There is no data regarding the possibility of interaction between knotweed and azithromycin. Nevertheless, due to the theoretical possibility of developing ergotism, azithromycin and derivatives are accepted separately. As with any antibiotics, it is recommended to monitor signs of superinfection caused by resistant microorganisms, including mushrooms. Diarrhea caused by Clostridium difficile (CDAD) was reported in all cases of using antibacterial agents, including azithromycin, and may vary by severity from mild diarrhea to severe colitis. Treatment with antibacterial agents changes the normal flora of the intestine, which leads to excessive growth C. Difficile. In patients with severe renal failure (SKF <10 ml / min), 33% an increase in the systemic effects of azithromycin was observed. Caution should be observed when using Sumamed® Forte in patients with the presence of pro -arrithmogenic facts (especially in elderly patients), including the congenital or acquired extension of the QT interval; In patients taking antiarrhythmic preparations of classes IA (quinidine, prokainamide), III (pre-Pofilida, amioodaron and Sotalol), cizidine, terphenadin, antipsychotic drugs (pimoside), antidepressants (citraloprams), fluoroquinolins (moxifloxacin), in violations of water-electro. cast Baoans, especially in the case of hypokalemia or hypomagnesia, clinically significant bradycardia, heart arrhythmias or severe heart failure. The use of Sumamed® Forte can provoke the development of myasthenic syndrome or cause an exacerbation of myasthenia. Sugarose drug contains sucrose. Patients with rare hereditary diseases of fructose intolerance, glucose and galactose malabsorption syndrome, or sugrazo-amomaltase deficiency should not take this drug. Pregnancy The use of the drug during pregnancy is possible when the expected benefit exceeds the potential risk to the fetus. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms Sumamed® Forte do not affect the reaction rate when driving vehicles and working with other mechanisms. An overdose of data on an overdose of Sumamed® Forte is not. An overdose of macrolide antibiotics is manifested by nausea, vomiting and diarrhea. In the case of an overdose, it is necessary to take activated carbon and carry out symptomatic therapy aimed at maintaining the life functions of the body. The release form and packaging at 16.7 g, 29.30 g or 35.6 g of the powder of the drug are placed in a high -density polyethylene bottle, with a twisting lid with children's opening. 1 bottle with a measured spoon and/or syringe for dosing along with instructions for use in the state and Russian languages are placed in a pack of cardboard. Store storage conditions at a temperature of not higher than 25 ° C to store in an inaccessible place for children! Shelf life 2 years. Cooked suspension: 15 ml - 5 days, 30 ml and 37.5 ml - 10 days. Do not use after the expiration date. Conditions of vacation from pharmacies according to the recipe manufacturer Pliva Krvatsk D.O.O. Proslaz Baruna Filippovich 25, 10000 racket, Croatia name and country of the owner of the registration certificate of Pliva Krvatsk D.O.O., Croatia, Croatia Address of the Organization Accepting Consumers from Consumers on Product Quality (Product): Ratiofarm Kazakhstan LLP 050000 Republic of Kazakhstan, Almaty, Al-Farabi Avenue 19, business center Nurly Tau 1b of 603.604 telephone, fax; 311-07-34 e-mail