Sumamed pills dispersible 1000 mg 1 pc
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Description
Sumamed Dispersible Tablets is a bacteriostatic macrolide-azalide antibiotic. 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. It has a bactericidal effect in high concentrations. It has activity against a number of gram-positive, gram-negative, anaerobes, intracellular and other microorganisms. Microorganisms may initially be resistant to the action of the antibiotic or may become resistant to it.
Active ingredients
Azithromycin
Release form
Pills
Composition
Azithromycin dihydrate 1048.218 mg, which corresponds to the content of azithromycin 1000 mg. Excipients: sodium saccharinate dihydrate - 78 mg, microcrystalline cellulose (Avicel PH 101) - 39.782 mg, microcrystalline cellulose (Avicel PH 102) - 657.6 mg, crospovidone type A - 165.2 mg, povidon K30 - 44 mg, sodium lauryl sulfate - 6.4 mg , colloidal silicon dioxide - 8.8 mg, magnesium stearate - 22 mg, orange flavoring - 52 mg, aspartame - 78 mg.
Indications
Infectious and inflammatory diseases caused by microorganisms susceptible to the drug: - infections of the upper respiratory tract and ENT organs (pharyngitis / tonsillitis, sinusitis, otitis media), lower respiratory infections (acute bronchitis, exacerbation of chronic bronchitis, pneumonia, including caused by atypical pathogens), - infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses, - the initial stage of Lyme disease (borreliosis) - erythema migrans (erythema migrans), - urinary tract infections (urethritis, cervicitis), caused by Chlamydia trachomatis.
Precautionary measures
In case of missing 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 to moderate hepatic impairment due to the possibility of the development of 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, Sumamed therapy should be discontinued and a functional study of the liver should be performed. In case of impaired renal function of mild to moderate severity (CC> 40 ml / min) Sumamed drug therapy should be carried out with caution under the control of the state of the kidney function. As with the use of other antibacterial drugs, Sumamed should follow the therapy It doesn’t regularly examine patients for the presence of immune microorganisms and signs of the development of superinfections, including Fungal. Sumamed 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 data on the possible interaction between azithromycin and ergotamine and dihydroergotamine derivatives, but due to the development of ergotism with the simultaneous use of macrolides with ergotamine and dihydroergotamine derivatives, this combination is not recommended. development of pseudomembranous colitis caused by Clostridium difficile, both 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, pseudomembranous colitis should be excluded. When treated with macrolides, incl. azithromycin, prolonged cardiac repolarization and QT interval were observed, increasing the risk of developing cardiac arrhythmias, including arrhythmias of the "pirouette" type. Care should be taken when using Sumamed in patients with pro-arrhythmogenic factors (especially in elderly patients), including with congenital or acquired lengthening of the QT interval, in patients taking antiarrhythmic drugs of classes IA (quinidine, procainamide), III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotics (pimozide), antidepressants (citalopram), fluoroquinolones levofloxacin), in patients with impaired water and electrolyte balance, especially in the case of hypokalemia or hypomagnesemia, clinically significant bradycardia,arrhythmias of the heart or severe heart failure. The use of the drug Sumamed can trigger the development of myasthenic syndrome or exacerbate myasthenia. The effect on the ability to drive vehicles and control mechanisms and the speed of psychomotor reactions.
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 exceeds the potential risk to the fetus and child. If the drug needs to be used during lactation, breastfeeding should be suspended. WHO recommends azithromycin as the drug of choice for treatment of chlamydial infection in pregnant women.
Dosage and administration
The drug is administered orally 1 time / day, at least 1 h before or 2 h after a meal. Tablets and capsules Adults (including elderly patients) and children over 12 years old with a body weight> 45 kg In infections of the ENT organs, upper and lower respiratory tract, skin and soft tissues, the drug is prescribed at a dose of 500 mg 1 time / day for 3 days, an exchange rate dose of 1.5 g. day 1 - 1 g, then from 2 to 5 days - 500 mg, course dose - 3 g. Urinary tract infections caused by Chlamydia trachomatis (urethritis, cervix m) prineoslozhnennom urethritis / cervicitis drug administered in a dose of 1 g odnokratno.Pri acne vulgaris moderate drug administered in pills of 500 mg 1 time / day for 3 days, then 500 mg 1 time per week for 9 weeks. The course dose is 6 g. The first weekly dose should be taken 7 days after taking the first daily dose (the 8th day from the start of treatment), the next 8 weekly doses should be taken at an interval of 7 days. Children aged 3 to 12 years with body weight In case of infections of the upper respiratory tract, 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. The drug in the form of pills 125 mg is metered according to the body weight of the child, as shown in table 1. Table 1. Body weight Azithromycin dose (125 mg pills) 18-30 kg 2 pills (250 mg) 31-44 kg 3 pills (375 mg) ≥45kg doses recommended for adultsWhen pharyngitis / tonsillitis caused by Suptococcus 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 the initial stage of Lyme disease (Borrelia) - 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 - based on 10 mg / kg 1 time / day. The course dose is 60 mg / kg. Tablets should be taken without chewing. For ease of use in children, a course dose of 60 mg / kg Sumamed is recommended to be used in powder form to prepare a suspension for oral administration of 100 mg / 5 ml and Sumamed forte in powder form to prepare suspension for oral administration 200 mg / 5 ml.
Side effects
The frequency of side effects is classified according to WHO recommendations: very often (≥10%), often (≥1% - <10%), infrequently (≥0.1% - <1%), rarely (≥0.01% - <0.1%) , very rarely (<0.01%), unknown frequency (impossible to estimate on the basis of available data). Infectious diseases: rarely - candidiasis (including oral mucosa and genital mucosa), pneumonia, pharyngitis, gastroenteritis, respiratory diseases, rhinitis , unknown frequency - pseudomembranous colitis. From the side of blood and lymphatic system: infrequently - leukopenia, neutropenia, eosinophilia, very p caustic - thrombocytopenia, hemolytic anemia. Metabolism: infrequently - anorexia. Allergic reactions: infrequent - angioedema, hypersensitivity reaction, unknown frequency - anaphylactic reaction. , paresthesia, drowsiness, insomnia, nervousness, rarely - agitation, unknown frequency - hypoesthesia, anxiety, aggression, fainting, convulsions, psychomotor hyperactivity, loss of smell, perception of smell, losing taste, myasthenia, delirium, hallucinations. On the part of the organ of vision: infrequently - visual impairment. On the side 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, unknown frequency - lowering blood pressure, increasing the QT interval on the ECG, arrhythmia type "pirouette", ventricular tachycardia. On the respiratory system: infrequently - shortness of breath, nasal bleeding. With side of the digestive 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 - changing the color of the tongue, pancreatitis. and biliary tract: infrequently - hepatitis, rarely - abnormal liver function, cholestatic jaundice, unknown frequency - hepatic failure (in rare cases with fatal outcome mainly due to severe abnormal liver function), liver necrosis, fulminant epatitis. On the side of skin and subcutaneous tissues: infrequently - skin rash, itching, urticaria, dermatitis, dry skin, sweating, rarely - photosensitization reaction, unknown frequency - Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme. On the side of the locomotor system apparatus: infrequently - osteoarthritis, myalgia, back pain, neck pain, unknown frequency - arthralgia. From the side of the kidneys and urinary tract: infrequently - dysuria, pain in the area of the kidneys, unknown frequency - interstitial nephritis, acute renal insufficiency awn. From the side of the genital organs and the mammary gland: infrequently - metrorrhagia, dysfunction of the testicles. Other: infrequently - asthenia, malaise, feeling tired, swelling of the face, chest pain, fever, peripheral edema. Laboratory data: often - 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 bicarbonate in the blood plasma, infrequently - an increase in the activity of AST, ALT, an increase in the concentration of bilirubin in the plasma increase the plasma urea concentration, increase plasma creatinine concentration, change plasma potassium levels, increase the plasma alkaline phosphorus plasma activity, increase plasma chlorine levels, increase blood glucose concentration, increase platelet count, increase hematocrit, increasing the concentration of bicarbonate in the blood plasma, changing the sodium content in the blood plasma.
Overdose
Symptoms: nausea, temporary hearing loss, vomiting, diarrhea. Treatment: symptomatic therapy.
Interaction with other drugs
Antacid drugsAntacid drugs do not affect the bioavailability of azithromycin, but reduce Cmax in the blood by 30%, so Sumamed should be taken at least 1 hour before or 2 hours after taking these drugs and food. Cetirizine is a simultaneous use for 5 days in healthy Azithromycin volunteers with cetirizine (20 mg) did not lead to pharmacokinetic interactions and a significant change in the QT interval. Didanosine (didpoxyinosine) Simultaneous use of azithromycin (1200 mg / day) and didanosine (400 mg / day) in 6 HIV-infected pa 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 take into account the possibility of increasing the concentration of digoxin in the blood serum. 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. Azitromycin weakly 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 the cytochrome P450 system. atorvastatin (10 mg daily) and azithromycin (500 mg daily) n Atorvastatin caused changes in plasma concentrations (based inhibition assay MMC-CoA reductase).However, in the post-registration period, there were separate reports of cases of rhabdomyolysis in patients receiving azithromycin and statins at the same time. Carbamazepine In pharmacokinetic studies involving healthy volunteers, no significant effect was found on the concentration of carbamazepine and its active metabolite in the blood plasma of patients receiving azithromycin simultaneously. studies of the effect of a single dose of cimetidine on azithromycin pharmacokinetics revealed no changes in pharmacoqui YETİK azithromycin, cimetidine, subject to application 2 hours before azitromitsina.Antikoagulyanty indirect (coumarin derivatives) The pharmacokinetic studies azithromycin had no effect on the anticoagulant effect of a single dose of 15 mg warfarin received healthy volunteers. The potentiation of the anticoagulant effect has been reported after the simultaneous use of azithromycin and indirect anticoagulants (coumarin derivatives). Despite the fact that a causal relationship has not been established, consideration should be given to the need for frequent monitoring of prothrombin time when azithromycin is used in patients who receive oral anticoagulants of indirect action (coumarin derivatives). Cyclosporine In a pharmacokinetic study involving healthy volunteers who took 3 days azithromycin (500 mg / day once), and then cyclosporine (10 mg / kg / day once), there was a significant increase in plasma Cmax and AUC0-5 cyclosporine on. Caution should be exercised with the simultaneous use of these drugs. If necessary, the simultaneous use of these drugs, should be monitored concentrations 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 Simultaneous use of azithromycin (1200 mg once) did not change the pharmacokinetics of fluconazole (800 mg once). The total exposure and T1 / 2 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 the pharmacokinetics of indinavir (800 mg 3 times a day for 5 days). Methylprednisolone Azithromycin does not significantly affect the pharmacokinetics of methylprednisolone. mg) and nelfinavir (750 mg 3 times / day) causes an increase in Css azithromycin in serum. No clinically significant side effects were observed, and dose adjustment of azithromycin when used simultaneously with nelfinavir is not required. Rifabutin Simultaneous use of azithromycin and rifabutin does not affect the concentration of each of the drugs in the blood 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 relationship between the use of azithromycin and rifabutin and neutropenia has not been established. Sildenafil When used in healthy volunteers, no evidence of the effect of azithromycin (500 mg / day for 3 days) on AUC and Cmax of sildenafil or its major 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 lengthening of the QT interval. trimethoprim / sulfamethoxazole with azithromycin showed no significant effect on Cmax, the total exposure Theological or renal excretion of trimethoprim or sulfamethoxazole. Serum azithromycin concentrations were consistent with those found in other studies.