Sumamed forte powder for suspension preparation 200mg 5ml 16.74g (15ml)
Condition: New product
1000 Items
Rating:
Be the first to write a review!
More info
Active ingredients
Azithromycin
Release form
Powder
Composition
Active ingredient: Azithromycin Concentration of active ingredient (mg): 200 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. binding to the 50s subunit of the ribosome, inhibits peptide translocation at the translational stage and inhibits protein synthesis, slowing the growth and reproduction of bacteria. in high concentrations has a bactericidal effect. has activity against a number of gram-positive, gram-negative, anaerobes, intracellular and other microorganisms. 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; natural resistance: Gram-positive aerobes - enterococcus faecalis, staphylococcus aureus (methicillin-resistant strains), staphylococcus epidermidis (methicillin-resistant strains); anaerobes are a bactero sensitivity of microorganisms to azithromycin (mic, mg / l) * microorganisms mic (mg / l) sensitive resistantstaphyloccus ≤1> 2streptococcus a, b, c, g ≤0.25> 0.5streptococcus pneumoniae ≤0.25> 0.5haemophilus influenzae ≤0.12> 4moraxe 0.5> 0.5neisseria gonorrhoeae ≤0.25> 0.5 * - azithromycin was used for treatment Infections of infectious diseases caused by salmonella typhi (mic no more than 16 mg / l) and shigella spp.
Pharmacokinetics
Cmax in plasma is reached in 2–3 hours. Bioavailability is 37%. Distribution Binding to plasma proteins is inversely proportional to blood concentration 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. Concentration in tissues and cells is 50 times higher than in plasma, and in the focus of infection is 24–34% more than in healthy tissues. Metabolism Demethylates in the liver, losing activity. Excretion is 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 in unchanged form - 50% of the intestines, 12% - by the kidneys. Pharmacokinetics in special clinical situations In patients with severe renal insufficiency (CC less than 10 ml / min) T1 / 2 increases by 33%.
Indications
Infections of ENT organs (bacterial pharyngitis / tonsillitis, sinusitis, otitis media); Lower respiratory tract infections (bacterial bronchitis, interstitial and alveolar pneumonia, exacerbation of chronic bronchitis); Skin and soft tissue infections (chronic migrating erythema - the initial stage of Lyme disease, erysipelas , impetigo, secondary pyodermatosis); Sexually transmitted infections (urethritis, cervicitis) Diseases of the stomach and duodenum associated with Helicobacter pylori.
Contraindications
Hypersensitivity to macrolide antibiotics; Severe abnormal liver function. With care: newborns (due to the lack of sufficient clinical experience), during pregnancy and lactation, i.e. in cases where the expected benefit from its use outweighs the potential risk that exists when using any drug during these periods; For abnormal liver function, patients who are impaired or prone to arrhythmias and lengthening the QT interval (according to literature data in 0.001% of cases) also take the drug with caution.
Precautionary measures
The drug should be stored out of reach of children at a temperature not exceeding 25 ° C.
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. During azithromycin treatment, breastfeeding should be suspended.
Dosage and administration
Inside, 1 time per day, at least 1 hour before or 2 hours after a meal. When infections of the upper and lower respiratory tract, skin and soft tissues (except for chronic erythema migrans), the total dose is 30 mg / kg, tons. e.10 mg / kg of body weight once a day for 3 days. Children are metered on the basis of weight: Body weight Volume of the drug, in ml (amount of azithromycin in mg) 10-14 kg2.5 ml (100 mg) 15-24 kg5.0 ml (200 mg) 25-34 kg7.5 ml (300 mg) 35-44 kg10.0 ml (400 mg) ≥ 45 kg12.5 ml (500 mg) With a chronic erythema migrans, the total dose of the drug is 60 mg / kg: once per day, 20 mg / kg - on the 1st day and 10 mg / kg - on the following days, from 2 to 5 days. For diseases of the stomach and duodenum associated with Helicobacter pylori: 20 mg / kg of body weight once per day in combination with antisecretory and other If medication dose was missed, it is necessary, if possible, immediately take, and then subsequent doses taken at an interval of 24 hours. In sexually transmitted infections Uncomplicated urethritis / cervicitis - 1 g once . Complicated, long-lasting urethritis / cervicitis caused by Chlamydia trachomatis - 1 g three times with an interval of 7 days (1-7-14). Course dose 3 g. Method of preparation of the suspension To prepare 15 ml of suspension (nominal volume) is necessary in a vial containing 600 mg of azithromycin, add 8 ml of water (actual volume - 20 ml of suspension). To prepare 30 ml of suspension (nominal volume) a vial containing 1200 mg of azithromycin add 14.5 ml of water (the actual volume is 35 ml of suspension). To prepare 37.5 ml of suspension (nominal volume) it is necessary to add 16.5 ml of water to the vial containing 1500 mg of azithromycin (actual volume - 42.5 ml of suspension). In each f Hakone slurry should contain a 5 ml longer course dose for a more complete extraction of drug from flakona.Srok shelf prepared suspension for 5 days at a temperature not higher than 25 ° SS via syringe for dispensing metered necessary amount of water was added to the vial with the powder. Before taking the contents of the vial thoroughly shaken to obtain a homogeneous suspension. To dispense the finished suspension using a syringe or measuring spoon. Immediately after taking the suspension, the child is allowed to drink a few sips of tea or juice in order to wash off and swallow the remaining amount of the suspension in the oral cavity. After use, the syringe is disassembled and washed with running water, dried and stored with the preparation.
Side effects
Most of the reported adverse reactions from mild to moderately severe and reversible after the end of treatment or withdrawal of the drug. On the part of the gastrointestinal tract: nausea, vomiting,flatulence, constipation, abdominal pain, diarrhea, rarely cholestatic jaundice, loss of appetite, gastritis, very rarely - Candidomycosis of the oral mucosa. Allergic reactions: rash, itchy skin, urticaria; rarely angioedema and anaphylactic shock. From laboratory parameters: a reversible increase in the activity of hepatic transaminases, bilirubin, the number of eosinophils; these indicators return to normal levels after 2-3 weeks after the end of therapy. In extremely rare cases, a possible decrease in the number of neutrophils during azithromycin therapy, but no causal relationship was found. On the side of the cardiovascular system: palpitations, chest pain For the nervous system: dizziness, vertigo, headache, paresthesias, agitation, drowsiness, in children - headache (with otitis media therapy), irritability, hyperkinesia, anxiety, neurosis, sleep disorders From the urogenital system: vaginal candidiasis, nefrit.Prochie: conjunctivitis, photosensitivity, fatigue, the occurrence of any side effects, inform your doctor.
Overdose
Symptoms (similar to the side effects that occur when taking the drug in recommended doses): severe nausea, temporary hearing loss, vomiting, diarrhea. Treatment: taking activated carbon, conducting symptomatic therapy, monitoring vital functions.
Interaction with other drugs
Antacid drugsAntacid 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 food. CetirizinConsiderable use for 5 days at healthy volunteers of azithromycin with cetirizine (20 mg) did not lead to pharmacokinetic interaction and a significant change in the QT interval. Didanosine (didzoxyinosine) Simultaneous use of azithromycin (1200 mg / day) and didanosine (400 mg / day) in 6 HIV-infected These patients showed no changes in the pharmacokinetic indications of didanosine compared with the placebo group. Digoxin (R-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. Azithromycin poorly interacts with cytochrome P450 isoenzymes. It was not revealed that azithromycin is involved in pharmacokinetic interactions similar to erythromycin and other macrolides. Azithromycine is not an inhibitor of inocula (10 mg daily) and azithromycin (500 mg daily) does not cause atorvastatin on change in blood plasma concentration (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 with healthy volunteers who took 3 days for inside (500 mg / day once), and then cyclosporine (10 mg / kg / day once), a significant increase in plasma Cmax and AUC0-5 cyclosporine was detected a. 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 Simultaneous use of azithromycin (1200 mg once) did not change the pharmacokinetics of fluconazole (800 mg once). The total exposure and half-life of azithromycin did not change with simultaneous use of fluconazole, however, a decrease in azithromycin Cmax was observed (by 18%), which had no clinical significance. Indinavir (simultaneous use of azithromycin) did not cause a statistically significant effect on indinavir 800 mg 3 times a day for 5 days). Methylprednisolone Azitromycin has no significant effect on the pharmacokinetics of methylprednisolone. Nelfinavir Simultaneous use of azithromycin (1 200 mg) and nelfinavir (750 mg 3 times / day) causes an increase in the equilibrium concentration of azithromycin in the blood 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 no concrete evidence that such an interaction took place. It was established that the simultaneous use of terfenadine and macrolides could cause arrhythmia and prolongation of the QT interval. Theophylline No interaction between azithromycin was detected and theophylline. Triazolam / midazolam: Significant changes in pharmacokinetic parameters with simultaneous use of azithromycin with triazolam or midazolam in t No therapeutic doses were found. 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. Sumamed drug Forte should be taken with caution in patients with mild and moderately impaired liver function due to the possibility of developing fulminant hepatitis and severe liver failure. If there are symptoms of abnormal liver function, such as ak rapidly increasing asthenia, jaundice,darkening of the urine, bleeding tendency, hepatic encephalopathy, treatment with Sumamed forte should be stopped and a study of the functional state of the liver should be performed. If the kidney function is impaired in patients with GFR 10-80 ml / min, dose adjustment is not required, Sumamed should be treated with caution under control state of renal function. As with other antibacterial drugs, when treating with Sumamed forte, patients should be regularly examined for the presence of immune microorganisms nodules and signs of development of superinfections, including Fungal. The drug Sumamed Forte should not be used longer courses than indicated 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. 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. When treating with macrolides, incl. azithromycin, prolonged cardiac repolarization and QT interval were observed, increasing the risk of developing cardiac arrhythmias, including arrhythmias such as pirouette, which 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 case of hypokalemia or hypomagnesemia, clinically significant bradycardia, cardiac arrhythmia, or severe heart failure. The use of Sumamed Forte may trigger the development of myasthenic syndrome or cause myasthenia exacerbation. Effect on ability to drive vehicles and mechanisms caution should be exercised when performing actions that require increased concentration and psychomot speed molecular reactions.