Sumamed powder for preparation of suspension 100mg 5ml 17g 20ml
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Active ingredients
Azithromycin
Release form
Powder
Composition
1 gram contains: azithromycin dihydrate 25.047 mg, which corresponds to the content of azithromycin 23.895 mg. Excipients: sucrose - 929.753 mg, sodium phosphate - 20 mg, hyprolose - 1.6 mg, xanthan gum - 10 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. Microorganisms may initially be resistant to the antibiotic or may become resistant to it. In most cases, Sumamed is active against aerobic gram-positive bacteria: Staphylococcus aureus (methicillin-sensitive strains), Streptococcus pneumoniae (penicillin-sensitive strains), Streptococcus pyogenes; aerobic gram-negative bacteria: Haemophilus influenzae, Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Pasteurella multocida, Neisseria gonorrhoeae; anaerobic bacteria: Clostridium perfringens, Fusobacterium spp., Prevotella spp., Porphyromonas 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). Initially resistant microorganisms: Gram-positive aerobes - Enterococcus faecalis, Staphylococci (methicillin-resistant strains of staphylococcus show a very high degree of resistance to macrolides); gram-positive bacteria resistant to erythromycin; anaerobes - Bacteroides fragilis.
Pharmacokinetics
Absorption: After oral administration, azithromycin is well absorbed and quickly distributed in the body. After a single dose of 500 mg, the bioavailability is 37% due to the effect of the first passage through the liver. Cmax in plasma is reached in 2-3 hours and is 0.4 mg / l. Distribution: Protein binding is inversely proportional to plasma concentration and is 7-50%. The apparent Vd is 31.1 l / kg. It penetrates cell membranes (effective for infections caused by intracellular pathogens).Transported by phagocytes to the site of infection, where it is released in the presence of bacteria. It easily penetrates through histohematogenous barriers and enters the tissues. Concentration in tissues and cells is 10-50 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: T1 / 2 is very long - 35-50 hours. T1 / 2 from tissues is much larger. The therapeutic concentration of azithromycin is maintained up to 5-7 days after the last dose. Azithromycin is excreted mainly unchanged - 50% through the intestines, 6% by the kidneys.
Indications
Infectious and inflammatory diseases caused by susceptible microorganisms: Infections of the upper respiratory tract and upper respiratory tract (pharyngitis / tonsillitis, sinusitis, otitis media). Infections of the lower respiratory tract (acute bronchitis, exacerbation of chronic bronchitis, pneumonia, including Caused atypical pathogens) .Infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatosis, acne vulgaris of moderate severity (for pills)). The initial stage of Lyme disease (Borreliosis) migrating erythema (erythema migrans) .Inf Urinary tract imaging (urethritis, cervicitis) caused by Chlamydia trachomatis (for pills and capsules).
Contraindications
Hypersensitivity to azithromycin, erythromycin, other macrolides or ketolides, or other components of the drug. Severe liver function disorders. Simultaneous intake with ergotamine and dihydroergotamine. Children under 12 years old with a body weight of <45 kg (for capsules and pills 500 mg). Children's age up to 3 years (for pills 125 mg). Children age up to 6 months (for powder for suspension). Surase / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption (for powder for suspension). With care: myasthenia. Liver dysfunction mild to moderate severity. Terminal renal failure with scf less than 10 ml / min. In patients with pro-arthromogenic factors (especially in old age) with congenital or acquired lengthening of the interval, in patients receiving therapy with antiarrhythmic drugs of classes ia (quinidine, procainamide) and iii (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotics ( pimozide)antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with impaired water and electrolyte balance, especially with hypokalemia or hypomagnesemia, with clinically significant bradycardia, arrhythmia, or with severe heart failure. With simultaneous use of digoxin, warfarin, cyclosporine. Diabetes mellitus (for powder for suspension).
Precautionary measures
From the nervous system: often - headache; infrequently - dizziness, disturbance of taste, paresthesia, drowsiness, insomnia, nervousness; rarely - agitation; unknown frequency - hypoesthesia, anxiety, aggression, fainting, convulsions, psychomotor hyperactivity, loss of smell, sense of smell, loss of taste, myasthenia, delusions, hallucinations. On the part of the organ of vision: infrequently - visual impairment. On the part of the organ of hearing and labyrinth disorders: infrequently - hearing loss, vertigo; Unknown frequency - hearing impairment until deafness and / or tinnitus. Since the cardiovascular system: infrequently - a feeling of heartbeat, flushing of the face; unknown frequency - decrease in blood pressure, prolongation of QT interval on ECG, pirouette-type arrhythmia, ventricular tachycardia. On the part of the respiratory system: infrequently - shortness of breath, nosebleeds. On the part of the digestive tract: very often - diarrhea; often - nausea, vomiting, abdominal pain; infrequently - flatulence, dyspepsia, constipation, gastritis, dysphagia, bloating, dryness of the oral mucosa, belching, ulcers of the oral mucosa, increased secretion of the salivary glands; very rarely - change the color of the tongue, pancreatitis. With care: myasthenia gravis; liver dysfunction mild to moderate severity; terminal renal failure with GFR less than 10 ml / min; in patients with pro-arthromogenic factors (especially in old age) - with congenital or acquired prolongation of the QT interval, in patients receiving therapy with class IA antiarrhythmic drugs (quinidine, procainamide) and III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotic drugs (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with impaired water and electrolyte balance, especially with hypokalemia or hypomagnesemia, with clinically significant bradycardia, and rhythm or severe heart failure; with simultaneous use of digoxin, warfarin, cyclosporine; diabetes mellitus (for powder for suspension).On the part of the liver and biliary tract: infrequently - hepatitis; rarely, liver dysfunction, cholestatic jaundice; unknown frequency - liver failure (in rare cases with a fatal outcome, mainly due to severe liver dysfunction), liver necrosis, fulminant hepatitis. On the part 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, erythema multiforme. On the part of the musculoskeletal system: infrequently - osteoarthritis, myalgia, back pain, neck pain; unknown frequency - arthralgia. On the part 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: infrequently - metrorrhagia, impaired testicular function.
Use during pregnancy and lactation
During pregnancy and during breastfeeding, the use of the drug is possible only if the expected potential benefit of therapy for the mother outweighs the potential risk to the fetus and child. If necessary, the use of the drug during lactation breastfeeding should be suspended.
Dosage and administration
Assign children aged 6 months to 3 years. Suspension is prescribed by mouth 1 time / day, 1 hour before or 2 hours after a meal. After taking Sumamed, the child should be offered to drink a few sips of water so that he can swallow the rest of the suspension. Before each drug intake, the contents of the vial are thoroughly shaken until a homogeneous suspension is obtained. If the required volume of the suspension was not taken from the vial within 20 minutes after agitation, the suspension should be agitated again, the required volume should be removed and given to the child. The required dose is measured using a syringe for dosing with the cost of dividing 1 ml and a nominal suspension capacity of 5 ml (100 mg azithromycin) or a measuring spoon with a nominal suspension capacity of 2.5 ml (50 mg azithromycin) or 5 ml (100 mg azithromycin) embedded in a 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. For infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues, the drug is prescribed at the rate of 10 mg / kg 1 time / day for 3 days (course dose 30 mg / kg).For accurate dosing of the drug Sumamed in accordance with the body weight of the child, the following table should be used. Body weight Suspension volume (ml) for 1 dose 5 kg 2.5 ml (50 mg azithromycin), 6 kg 3 ml (60 mg azithromycin), 7 kg 3.5 ml (70 mg azithromycin), 8 kg 4 ml (80 mg azithromycin), 9 kg 4.5 ml (90 mg azithromycin), 10 kg 5 ml (100 mg azithromycin). For pharyngitis / tonsillitis caused by Streptococcus pyogenes, Sumamed is prescribed at a dose of 20 mg / kg / day for 3 days. Heading dose - 60 mg / kg. The maximum daily dose is 500 mg. In Lyme disease (the initial stage of borreliosis) - erythema migrans (erythema migrans) is prescribed on the 1st day at a dose of 20 mg / kg 1 time / day, then from 2 to 5 days - at the rate of 10 mg / kg / day Heading dose - 60 mg / kg. Method of preparation and storage of the suspension: To the contents of the vial intended for the preparation of 20 ml of suspension (nominal volume), add 12 ml of water using a syringe for dosing and shake until a homogeneous suspension is obtained. The volume of the suspension obtained will be about 25 ml, which exceeds the nominal volume by approximately 5 ml. This is intended to compensate for the inevitable loss of suspension when dispensing the drug. The prepared suspension can be stored at a temperature not exceeding 25 ° C for not more than 5 days. In case of impaired renal function: in patients with GFR 10-80 ml / min dose adjustment is not required. In violation of liver function: when used in patients with impaired liver function mild and moderate severity dose adjustment is not required.
Side effects
Infectious diseases are rare - candidiasis (including oral mucosa and genital mucosa), pneumonia, pharyngitis, gastroenteritis, respiratory diseases, rhinitis. unknown frequency - pseudomembranous colitis. Of the blood and lymphatic system infrequently - leukopenia, neutropenia, eosinophilia. very rarely - thrombocytopenia, hemolytic anemia. On the side of metabolism it is not common - anorexia. Allergic reactions are not common - 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, perception of smell, loss of taste, myasthenia, delirium,hallucinations. On the part of the organ of vision, infrequently - impaired vision. On the part of the organ of hearing and labyrinth disorders infrequently - hearing loss, vertigo. unknown frequency - hearing impairment up to deafness and / or tinnitus. On the side of the cardiovascular system, it is rarely a feeling of palpitations, flushing of the face. unknown frequency - decrease in blood pressure, an increase in the QT interval on the ECG, arrhythmia such as pirouette, ventricular tachycardia. On the part of the respiratory system infrequently - shortness of breath, epistaxis. On the side of the gastrointestinal tract, very often - diarrhea. often - nausea, vomiting, abdominal pain. rarely - 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 a fatal outcome mainly on the background of severe liver dysfunction), liver necrosis, fulminant hepatitis. On the side of the skin and subcutaneous tissues rarely - skin rash, itching, urticaria, dermatitis, dry skin, sweating. rarely - photosensitivity reaction. unknown frequency - Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme. 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 - increased activity of AST, ALT, increased concentration of bilirubin in the blood plasma, increased concentration of urea in the blood plasma,increased plasma creatinine, changes in plasma potassium, increased plasma alkaline phosphatase activity, increased plasma chlorine, increased blood glucose, increased platelet count, elevated hematocrit, increased plasma bicarbonate, modified sodium content in blood plasma.
Overdose
Symptoms: nausea, temporary hearing loss, vomiting, diarrhea. Treatment: symptomatic therapy.
Interaction with other drugs
Antacid drugs: Antacid drugs do not affect the bioavailability of azithromycin, but decrease Cmax in the blood by 30%, so Sumamed 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 parameters 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 the pharmacokinetic interaction similar to erythromycin and other macrolides.Azithromycin is not an inhibitor and inducer of isoenzymes of the cytochrome P450 system. 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 of the effect of cimetidine when taken in a single dose on the pharmacokinetics of azithromycin, no changes in the pharmacokinetics of azithromycin were detected, provided that cimetidine was used 2 hours before azithromycin. Indirect anticoagulants (coumarin derivatives): In pharmacokinetic studies, azithromycin did not affect the anticoagulant effect of warfarin when taken in a single dose of 15 mg 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, should 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 T1 / 2 of azithromycin did not change with simultaneous use of fluconazole, however, a decrease in Cmax of azithromycin was observed (by 18%), 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 / 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 Css azithromycin in blood plasma. 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 the blood plasma. 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: With simultaneous use of trimethoprim / sulfamethoxazole with azithromycin, no significant effect on Cmax, total exposure or excretion by kidneys of trimethoprim or sulfamethoxazole was found. Serum azithromycin concentrations were consistent with those found in other studies.
special instructions
In case of skipping a single dose of the drug - the missed dose should be taken as early as possible, and the next - with interruptions of 24 hours. Sumamed should be taken at least 1 hour before or 2 hours after taking antacids. Sumamed should be used with caution in patients with mild or moderately impaired liver function due to the possibility of developing fulminant hepatitis and severe hepatic insufficiency. If there are symptoms of abnormal liver function, such as rapidly increasing asthenia, jaundice, dark urine, bleeding tendency, hepatic encephalopathy, treatment with Sumamed 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, patients should be regularly examined for the presence of refractory microorganisms and signs of the development of superinfections, including fungal. Sumamed drug 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 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, 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 pirouette. Care should be taken when using Sumamed 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), antidepressants (citalopram), anti-depressants (moxifloxacin, anti-depressants) electrolyte balance, especially in the case of hypokalemia or hypomagnesaemia, clinically significant bradycardia, cardiac arrhythmia, or severe heart failure. The use of the drug Sumamed can trigger the development of myasthenic syndrome or cause exacerbation of myasthenia. When used in patients with diabetes mellitus, as well as in patients on a low-calorie diet, it is necessary to take into account that sucrose (0.32 XE / 5 ml) is included in the powder for preparing Sumamed suspension. Impact on the ability to drive motor vehicles and control mechanisms: In the development of undesirable effects from the nervous system and the organ of vision, care should be taken when performing actions that require increased concentration of attention and quickness of psychomotor reactions.