Sumamed forte powder for suspension preparation 200mg 5ml 35.57g (37.5ml)
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Active ingredients
Azithromycin
Release form
Powder
Composition
1 gram contains: azithromycin dihydrate 50.094 mg, which corresponds to the content of azithromycin 47.79 mg Auxiliary substances: sucrose - 904.206 mg, sodium phosphate - 20 mg, hyprolose - 1.6 mg, gum xanthan - 1.6 mg, flavoring raspberry - 10.5 mg, titanium dioxide - 5 mg, colloidal silicon dioxide - 7 mg.
Pharmacological effect
Bacteriostatic antibiotic macrolide-azalide group. Possesses a wide range of antimicrobial action. The mechanism of action of azithromycin is associated with the suppression of microbial cell protein synthesis. By binding to the 50S subunit of the ribosome, it inhibits peptide translocation at the translation stage and inhibits protein synthesis, slowing the growth and reproduction of bacteria. In high concentrations has a bactericidal effect. It has activity against a number of gram-positive, gram-negative, anaerobes, intracellular and other microorganisms. Sumamed forte is active against aerobic gram-positive microorganisms: Staphylococcus aureus (methicillin-sensitive strains), Streptococcus pneumoniae (penicillin-sensitive strains), 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., Porphyriomonas spp .; other microorganisms: Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi. Microorganisms capable of developing resistance to azithromycin: Gram-positive aerobes are Streptococcus pneumoniae (penicillin-resistant strains and strains with an average sensitivity to penicillin). Naturally resistant microorganisms: Gram-positive aerobes - Enterococcus faecalis, Staphylococcus aureus (methicillin-resistant strains), Staphylococcus epidermidis (methicillin-resistant strains); anaerobes - Bacteroides fragilis. Cases of cross-resistance between Streptococcus pneumoniae, Streptococcus pyogenes (beta-hemolytic streptococcus group A), Enterococcus faecalis, and Staphylococcus aureus, including Staphylococcus aureus (methicillin-resistant strains) to erythromycin, to the erythromycin, azitrosis, iyymosetis, azitrosis, i have been applied to the erythromycin, azitrosis, iytrothycinus, augus, Irostimidus, Irostimidus, Irostimidus, Irostimidus, Irostimidus, Iyrosterae, and Irosus, Iozyme, and Iozyme, Iozyme, and Iozyme, Iozyme, Irosus, Iythrothycemia, Streptococcus pneumoniae, Streptococcus pyogenes
Pharmacokinetics
Absorption: Cmax in blood plasma is reached in 2-3 hours. Bioavailability is 37%. Distribution: Binding to plasma proteins is inversely proportional to the concentration in the blood and is 12-52%. Vd is 31.1 l / kg. It penetrates cell membranes (effective for infections caused by intracellular pathogens).Transported by phagocytes, polymorphonuclear leukocytes and macrophages to the site of infection, where it is released in the presence of bacteria. It easily penetrates through histohematogenous barriers and enters the tissues. The concentration in tissues and cells is 50 times higher than in plasma, and in the focus of infection - by 24-34% more than in healthy tissues. Metabolism: Demethylated in the liver, losing activity. Withdrawal: Slowly excreted from tissues and has a long T1 / 2 - 2-4 days. The therapeutic concentration of azithromycin is maintained up to 5-7 days after the last dose. Azithromycin is excreted mainly unchanged - 50% of the intestine, 12% - by the kidneys. Pharmacokinetics in special clinical situations In patients with severe renal insufficiency (CC less than 10 ml / min), T1 / 2 is increased by 33%.
Indications
Infectious and inflammatory diseases caused by microorganisms sensitive to the drug, including: Infections of the upper respiratory tract, including pharyngitis / tonsillitis, sinusitis, otitis media. Infections of the lower respiratory tract, including acute bronchitis, exacerbation of chronic bronchitis, community-acquired pneumonia. Infections of the skin and soft tissues, including erysipelas, impetigo, secondary infected dermatosis. Lyme disease (the initial stage of borreliosis) migrating erythema (erythema migrans).
Contraindications
Violations of the liver severe. Simultaneous reception of ergotamine and dihydroergotamine. Children age up to 6 months. Surase / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption. Hypersensitivity to azithromycin, erythromycin, other macrolides or ketolides, or other components of the drug. With caution, it is necessary to prescribe a drug for myasthenia, mild and moderate liver dysfunction, terminal renal failure with a clearance of less than 10 ml / min, patients with pro-arrhythmic factors (especially older patients): with congenital or acquired lengthening of the interval, patients receiving therapy antiarrhythmic drugs of classes ia (quinidine, procainamide), iii (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotic drugs (pimozide), antidepressants (citalopram), phto quinolones (moxifloxacin and levofloxacin), with violations of water-electrolyte balance, especially in the case of hypokalemia or hypomagnesemia, clinically significant bradycardia, cardiac arrhythmia, heart failure, or severe. With simultaneous use of digoxin, warfarin, cyclosporine. With diabetes.
Precautionary measures
The drug should be prescribed with caution in myasthenia, mild and moderate liver dysfunction, terminal renal failure with GFR less than 10 ml / min, patients with pro-arrhythmogenic factors (especially elderly patients): with congenital or acquired prolongation of the QT interval, patients receiving therapy with antiarrhythmic drugs of classes IA (quinidine, procainamide), III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotic drugs (pimozide), antidepressants (citalopram), ft rhinolonami (moxifloxacin and levofloxacin), impaired with fluid and electrolyte balance, particularly in the case of hypokalemia or hypomagnesemia, clinically significant bradycardia, cardiac arrhythmia, heart failure or severe; with simultaneous use of digoxin, warfarin, cyclosporine; with diabetes.
Use during pregnancy and lactation
In pregnancy, the use of the drug is possible only if the potential benefit of therapy for the mother outweighs the possible risk to the fetus and child. At the time of treatment with azithromycin, breastfeeding should be suspended.
Dosage and administration
The drug is administered orally 1 time / day, 1 hour before or 2 hours after a meal. After taking the drug Sumamed forte, the child must offer to drink a few sips of water so that he can swallow the rest of the suspension. Before each use of the drug, the contents of the vial are thoroughly shaken until a homogeneous suspension is obtained, if the required volume of the suspension has not been removed from the vial within 20 minutes after agitation, the suspension should be shaken again, selected the required volume and given to the child. The required dose is measured using a dosing syringe with a graduation rate of 1 ml and a nominal suspension capacity of 5 ml (200 mg azithromycin) or a measuring spoon with a nominal suspension capacity of 2.5 ml (100 mg azithromycin) or 5 ml (200 mg azithromycin) enclosed in cardboard packing together with a bottle. After use, the syringe (having previously disassembled it) and the measuring spoon are washed with running water, dried and stored in a dry place until the next dose of Sumamed Forte.In infectious and inflammatory diseases of the upper and lower respiratory tract, skin and soft tissues, the drug is prescribed at the rate of 10 mg / kg of body weight 1 time / day for 3 days, the course dose is 30 mg / kg. For accurate dosing of the drug Sumamed forte in accordance with the body weight of the child should use the table below. Body weight Required volume of suspension (ml) for 1 dose 10-14 kg 2.5 ml suspension (100 mg azithromycin) 15-24 kg 5 ml suspension (200 mg azithromycin) 25-34 kg 7.5 ml suspension (300 mg azithromycin) 35-44 kg 10 ml suspension (400 mg azithromycin) not less than 45 kg 12.5 ml suspension (500 mg azithromycin) (corresponds to the dose for adult patients) For pharyngitis / tonsillitis caused by Streptococcus pyogenes, Sumamed forte is used in a dose of 20 mg / kg / day for 3 days (course dose 60 mg / kg). The maximum daily dose is 500 mg. Children weighing up to 10 kg should be prescribed Sumamed in powder form to prepare a suspension for oral administration with a concentration of 100 mg / 5 ml. In Lyme disease (the initial stage of borreliosis) - erythema migrans migrating (erythema migrans) the drug is prescribed on the 1st day at a dose of 20 mg / kg / day, then from 2 to 5 days - at a dose of 10 mg / kg / day (course dose - 60 mg / kg). When used in patients with impaired renal function with GFR 10-80 ml / min, dose adjustment is not required. When used in patients with impaired liver function, mild and moderate severity, dose adjustment is not required. Elderly patients dose adjustment is not required. In elderly patients, when using the drug Sumamed forte, it is recommended to take special care in connection with the possible presence of proarrhythmogenic factors that may increase the risk of developing cardiac arrhythmias and pirouette-type arrhythmias.
Side effects
Infectious diseases infrequently - candidiasis, incl. oral mucosa and genitalia, pneumonia, pharyngitis, gastroenteritis, respiratory diseases, rhinitis. very rarely - pseudomembranous colitis. From the side of blood and lymphatic system infrequently leukopenia, neutropenia, eosinophilia. very rarely - thrombocytopenia, hemolytic anemia. On the side of metabolism and nutrition infrequently - anorexia. Allergic reactions infrequently - angioedema, hypersensitivity reaction. unknown frequency is an anaphylactic reaction. Often, the nervous system is a headache. infrequently - dizziness, disturbance of taste, paresthesia, drowsiness, insomnia, nervousness. rarely - agitation.unknown frequency - hypoesthesia, anxiety, aggression, fainting, convulsions, psychomotor hyperactivity, loss of smell, perverse sense of smell, loss of taste, myasthenia, delusions, hallucinations. On the part of the organ of vision, it is not often - a violation of sight. hearing loss, vertigo. unknown frequency - hearing impairment, incl. deafness and / or tinnitus. From the side of the cardiovascular system it is not often - a feeling of heartbeat, flushing of the face. unknown frequency - a decrease in blood pressure, an increase in the QT interval on the ECG, arrhythmia of the "pirouette" type, ventricular tachycardia. On the part of the respiratory system it is not often - shortness of breath, epistaxis. On the side of the gastrointestinal tract, very often - diarrhea. often - nausea, vomiting, abdominal pain infrequently - flatulence, dyspepsia, constipation, gastritis, dysphagia, abdominal distension, dryness of the oral mucosa, belching, ulcers of the oral mucosa, increased secretion of the salivary glands. very rarely - a change in the color of the tongue, pancreatitis. On the side of the liver and biliary tract rarely - hepatitis. rarely - liver dysfunction, cholestatic jaundice. unknown frequency - liver failure (in rare cases with fatal outcome mainly due to severe liver dysfunction), liver necrosis, fulminant hepatitis. On the side of the skin and subcutaneous tissues infrequently - skin rash, itching, urticaria, dermatitis, dry skin, sweating . rarely - photosensitivity reaction. unknown frequency - Stevens-Johnson syndrome, toxic epidermal necrolysis, mmniform erythema. On the part of the musculoskeletal system infrequently - osteoarthritis, myalgia, back pain, neck pain. unknown frequency - arthralgia. From the side of the kidneys and urinary tract infrequently - dysuria, pain in the kidneys. unknown frequency - interstitial nephritis, acute renal failure. On the part of the genital organs and the mammary gland, it is not common - metrorrhagia, dysfunction of the testicles. - a decrease in the number of lymphocytes, an increase in the number of eosinophils, an increase in the number of basophils, an increase in the number of monocytes, an increase in the number of neutrophils, a decrease in the concentration of bicarbonates in the blood plasma.infrequently - an increase in AST, ALT activity, an increase in plasma bilirubin concentration, an increase in plasma urea concentration, an increase in plasma creatinine concentration, a change in plasma potassium content, an increase in alkaline phosphorus plasma activity, an increase in plasma chlorine, increasing the concentration of glucose in the blood, increasing the number of platelets, increasing hematocrit, increasing the concentration of bicarbonate in the blood plasma, changing the sodium content in the blood plasma.
Overdose
Symptoms (similar to the side effects that occur when taking the drug in the recommended doses): severe nausea, temporary hearing loss, vomiting, diarrhea. Treatment: reception of activated carbon, conducting symptomatic therapy, monitoring vital functions.
Interaction with other drugs
Antacid drugs: Antacid drugs do not affect the bioavailability of azithromycin, but reduce Cmax in the blood by 30%, so Sumamed Forte should be taken at least 1 hour before or 2 hours after taking these drugs and eating. Cetirizine: Simultaneous use of azithromycin with cetirizine (20 mg) in healthy volunteers for 5 days did not lead to a pharmacokinetic interaction and a significant change in the QT interval. Didanosine (didoxyinosine): The simultaneous use of azithromycin (1200 mg / day) and didanosine (400 mg / day) in 6 HIV-infected patients showed no changes in the pharmacokinetic indications of didanosine compared with the placebo group. Digoxin (P-glycoprotein substrates): Simultaneous use of macrolide antibiotics, incl. azithromycin, with P-glycoprotein substrates, such as digoxin, leads to an increase in serum P-glycoprotein substrate concentration. Thus, with simultaneous use of azithromycin and digoxin, it is necessary to consider the possibility of increasing the concentration of digoxin in the blood serum. Zidovudine: Simultaneous use of azithromycin (single dose of 1000 mg and repeated administration of 1200 mg or 600 mg) has a slight effect on the pharmacokinetics, including kidney excretion of zidovudine or its glucuronide metabolite. However, the use of azithromycin caused an increase in the concentration of phosphorylated zidovudine, a clinically active metabolite in peripheral blood mononuclear cells. The clinical significance of this fact is unclear. Azithromycin poorly interacts with cytochrome P450 isoenzymes.It was not revealed that azithromycin is involved in pharmacokinetic interactions similar to erythromycin and other macrolides. Azithromycin is not an inhibitor and inducer of cytochrome P450 isoenzymes. Ergot alkaloids: Given the theoretical possibility of ergotism, the simultaneous use of azithromycin with ergot alkaloids is not recommended. Pharmacokinetic studies have been carried out on the simultaneous use of azithromycin and drugs whose metabolism occurs with the participation of isoenzymes of the cytochrome P450 system. Atorvastatin: The simultaneous use of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not cause changes in plasma concentrations of atorvastatin (based on the analysis of inhibition of MMC-CoA reductase). However, in the post-registration period, there were separate reports of cases of rhabdomyolysis in patients receiving both azithromycin and statins. Carbamazepine: Pharmacokinetic studies involving healthy volunteers did not reveal a significant effect on the concentration of carbamazepine and its active metabolite in blood plasma in patients who received azithromycin at the same time. Cimetidine: In pharmacokinetic studies, the effect of a single dose of cimetidine on azithromycin pharmacokinetics showed no changes in azithromycin pharmacokinetics, provided that cimetidine was used 2 hours before azithromycin. Indirect anticoagulants (coumarin derivatives) In pharmacokinetic studies, azithromycin did not affect the anticoagulant effect of a single dose of 15 mg of warfarin taken by healthy volunteers. The potentiation of the anticoagulant effect has been reported after the simultaneous use of azithromycin and indirect anticoagulants (coumarin derivatives). Although a causal relationship has not been established, consideration should be given to the need for frequent monitoring of prothrombin time with azithromycin in patients who receive oral anticoagulants of indirect action (coumarin derivatives). Cyclosporine: In a pharmacokinetic study involving healthy volunteers, who took azithromycin orally inside for 3 days (500 mg / day once), and then cyclosporine (10 mg / kg / day once), a significant increase in plasma Cmax and AUC0- 5 cyclosporine. Caution should be exercised with the simultaneous use of these drugs.If necessary, the simultaneous use of these drugs, it is necessary to monitor the concentration of cyclosporine in the blood plasma and adjust the dose accordingly. Efavirenz: Simultaneous use of azithromycin (600 mg / day once) and efavirenz (400 mg / day) daily for 7 days did not cause any clinically significant pharmacokinetic interaction. Fluconazole: The simultaneous use of azithromycin (1200 mg once) did not change the pharmacokinetics of fluconazole (800 mg once). The total exposure and elimination half-life of azithromycin did not change with simultaneous use of fluconazole, however, a decrease in azithromycin Cmax (by 18%) was observed, which had no clinical significance. Indinavir: Simultaneous use of azithromycin (1200 mg once) did not cause a statistically significant effect on indinavir pharmacokinetics (800 mg 3 times a day for 5 days). Methylprednisolone: Azithromycin has no significant effect on the pharmacokinetics of methylprednisolone. Nelfinavir: Simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times / day) causes an increase in the equilibrium concentration of azithromycin in the blood serum. No clinically significant adverse effects were observed and dose adjustment of azithromycin, when used simultaneously with nelfinavir, is not required. Rifabutin: The simultaneous use of azithromycin and rifabutin does not affect the concentration of each of the drugs in serum. With simultaneous use of azithromycin and rifabutin, neutropenia has sometimes been observed. Despite the fact that neutropenia was associated with the use of rifabutin, a causal link between the use of a combination of azithromycin and rifabutin and neutropenia has not been established. Sildenafil: When used in healthy volunteers, there is no evidence of the effect of azithromycin (500 mg / day for 3 days) on AUC and Cmax of sildenafil or its main circulating metabolite. Terfenadine: In pharmacokinetic studies, no evidence of interaction between azithromycin and terfenadine was obtained. It was reported on isolated cases where the possibility of such an interaction could not be completely excluded, but there was not a single concrete proof that such an interaction took place.It was found that the simultaneous use of terfenadine and macrolides can cause arrhythmia and prolongation of the QT interval. Theophylline: There was no interaction between azithromycin and theophylline. Triazolam / midazolam: There were no significant changes in pharmacokinetic parameters with simultaneous use of azithromycin with triazolam or midazolam at therapeutic doses. Trimethoprim / sulfamethoxazole: The simultaneous use of trimethoprim / sulfamethoxazole with azithromycin did not reveal a significant effect on Cmax, the total exposure or excretion of trimethoprim or sulfamethoxazole by the kidneys. Serum azithromycin concentrations were consistent with those found in other studies.
special instructions
When using the drug Sumamed forte in patients with diabetes mellitus, as well as with a low-calorie diet, it is necessary to take into account that sucrose is included in the suspension (0.32 XE / 5 ml). If you miss taking one drug Sumamed forte, you should take the missed dose as early as possible, and follow-up - with intervals of 24 hours. Sumamed Forte should be taken at least 1 hour before or 2 hours after taking antacids. The drug Sumamed forte should be taken with caution in patients with impaired liver function of mild to moderate severity due to the possibility of the development of fulminant hepatitis and severe liver failure. If there are symptoms of abnormal liver function, such as rapidly increasing asthenia, jaundice, dark urine, bleeding tendency, hepatic encephalopathy, treatment with Sumamed forte should be stopped and a study of the functional state of the liver should be carried out. In case of impaired renal function in patients with GFR 10-80 ml / min, dose adjustment is not required, therapy with Sumamed should be carried out with caution under the control of the state of renal function. As with the use of other antibacterial drugs, during therapy with Sumamed Forte, patients should be regularly examined for the presence of unresponsive microorganisms and signs of the development of superinfections, including fungal. The drug Sumamed forte should not be used for longer courses than specified in the instructions, because The pharmacokinetic properties of azithromycin allow us to recommend a short and simple dosing regimen.There is no evidence of a possible interaction between azithromycin and ergotamine and dihydroergotamine derivatives, but due to the development of ergotism with simultaneous use of macrolides with ergotamine and dihydroergotamine derivatives, this combination is not recommended. With long-term use of the drug Sumamed forte may develop pseudomembranous colitis caused by Clostridium difficile, as in the form of mild diarrhea, and severe colitis. With the development of antibiotic-associated diarrhea while taking the drug Sumamed Forte, as well as 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded. Do not use drugs that inhibit intestinal peristalsis. In the treatment of macrolides, incl. azithromycin, prolonged cardiac repolarization and QT interval were observed, increasing the risk of developing cardiac arrhythmias, including arrhythmias such as pirouettes that can lead to cardiac arrest. Care should be taken when using Sumamed Forte in patients with pro-arrhythmogenic factors (especially in elderly patients), including with congenital or acquired prolongation of the QT interval; in patients taking class I antiarrhythmic drugs (quinidine, procainamide), III (dofetilide, amiodarone, and sotalol), cisapride, terfenadine, antipsychotic drugs (pimozide), antidepressants (citalopram), anti-depressants (cimeopram), anti-depressants (moxifloxacin), antidepressants (citalopram), anti-depressants (cimeopram), anti-depressants (moxifloxacin), anti-depressants (citalopram), anti-depressants (cimeopram), anti-depressants (cimopram) balance, especially in the case of hypokalemia or hypomagnesemia, clinically significant bradycardia, cardiac arrhythmia, or severe heart failure. The use of the drug Sumamed Forte may trigger the development of myasthenic syndrome or cause exacerbation of myasthenia. Influence on the ability to drive vehicles and mechanisms. When undesirable effects develop on the part of the nervous system and the organ of vision, care should be taken when performing actions that require an increased concentration of attention and quickness of psychomotor reactions.