Azitrox (por d/susp/d/int p 200mg/5ml 20ml fl+mer lie+pip)
A country
Russia
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Active substance
Azithromycin
Compound
Active substance: azithromycin dihydrate, expressed as azithromycin.
pharmachologic effect
Azithromycin is a broad-spectrum bacteriostatic antibiotic from the macrolide-azalide group. Has a wide spectrum of antimicrobial action. The mechanism of action of azithromycin is associated with the suppression of protein synthesis in microbial cells. By binding to the 50S ribosomal subunit, it inhibits peptide translocase at the translation stage and suppresses protein synthesis, slowing down the growth and reproduction of bacteria. In high concentrations it has a bactericidal effect. It is active against a number of gram-positive, gram-negative, anaerobic, intracellular and other microorganisms. Sensitive microorganisms: aerobic gram-positive microorganisms - Staphylococcus aureus (methicillin-sensitive strains), Streptococcus pneumoniae (penicillin-sensitive strains), Streptococcus pyogenes, Streptococcus spp. (group C, F and G); aerobic gram-negative microorganisms - Haemophilus influenzae, Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Pasteurella multocida, Neisseria gonorrhoeae; anaerobic microorganisms - Clostridium perfringens, F u sobacterium spp., Prevotella spp., Porphyriomonas spp.; other microorganisms - Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi. Microorganisms with acquired resistance to azithromycin: aerobic gram-positive microorganisms - Streptococcus pneumoniae (penicillin-resistant strains and strains with intermediate sensitivity to penicillin). Microorganism s with natural resistance to azithromycin: aerobic gram-positive microorganisms – Enterococcus faecalis, Staphylococcus aureus (methicillin-resistant strains), Staphylococcus epidermidis (methicillin-resistant strains); anaerobic microorganisms - Bacteroides fragilis. Cases of cross-resistance have been described in Streptococcus pneumoniae, Streptococcus pyogenes (beta-hemolytic streptococcus group A), Enterococcus faecalis and Staphylococcus aureus (including methicillin-resistant strains) to erythromycin, other macrolides, lincosamides and azithromycin. Pharmacokinetics. After oral bioavailability is 37%, the maximum concentration in the blood plasma is created after 2-3 hours, the volume of distribution is 31.1 l/kg. Binding to blood proteins is inversely proportional to the concentration in the blood and ranges from 7-50%. Penetrates through cell membranes (effective against 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. Easily passes through histohematic barriers and enters tissues. The concentration in tissues and cells is 50 times higher than in blood plasma, and in the focus of infection - 24-34% higher than in healthy tissues. It has a long half-life of 2-4 days. The half-life from tissues is significantly longer. The therapeutic concentration of azithromycin lasts up to 5-7 days after taking the last dose. Azithromycin is excreted mainly unchanged - 50% by the intestines, 6% by the kidneys. It is demethylated in the liver, losing activity. In patients with severe renal failure (creatinine clearance (CC) less than 10 ml/min), the half-life of azithromycin increases by 33%.
Indications for use
Infectious and inflammatory diseases caused by microorganisms sensitive to azithromycin, including: upper respiratory tract and ENT organs, including pharyngitis/tonsillitis, sinusitis, otitis media; lower respiratory tract, including acute bronchitis, exacerbation of chronic bronchitis and community-acquired pneumonia; genitourinary infections pathways caused by Chlamydia trachomatis (urethritis, cervicitis); skin and soft tissue infections (moderate acne, erysipelas, impetigo, secondary infected dermatoses); Lyme disease - initial stage (erythema migrans);
Mode of application
Take orally, 1 hour before or 2 hours after meals, 1 time per day. To prepare a suspension, add 9.5 ml of water (distilled or boiled and cooled) to the bottle with powder. Measure the water using the dosing pipette included with the bottle. Shake the contents of the bottle thoroughly until a homogeneous suspension is obtained. The actual volume of the prepared suspension will be 20 ml. Store the prepared suspension in the original packaging for no more than 5 days at a temperature not exceeding 25 ° C. Do not freeze. The suspension must be shaken before each use. To dispense the finished suspension, use a dosing pipette or measuring spoon. Immediately after taking the suspension, you need to drink a few sips of water to rinse and swallow the drug remaining in the mouth. After use, a measuring spoon or pipette, which is previously disassembled, washed with running water, dried and stored with the drug. Children over 6 months. For infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues (except for erythema migrans): at the rate of 10 mg/kg body weight 1 time per day for 3 days (course dose 30 mg/kg). Children weighing up to 10 kg are recommended to take the drug in powder form to prepare an oral suspension with a concentration of 100 mg/5 ml. When treating the initial stage of Lyme disease (erythema migrans): once a day: on the 1st day - at a dose of 20 mg/kg body weight, then from the 2nd to the 5th day at a dose of 10 mg /kg body weight. Course dose – 60 mg/kg body weight. Adults. For infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues (except for erythema migrans): 500 mg 1 time per day for 3 days (course dose – 1 .5 g). For urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis): For uncomplicated urethritis/cervicitis - once 1.0 g. For the treatment of acne (acne vulgaris) of moderate severity. On the 1st, 2nd and 3rd day of treatment take 500 mg once a day, then take a break from the fourth to the seventh day, from the eighth day of treatment take 500 mg once a week for 9 weeks (course dose 6.0 g). Patients with impaired renal function. impaired renal function (creatinine clearance more than 40 ml/min) no dose adjustment is required. Patients with impaired liver function. With moderate impairment of liver function, no dose adjustment is required.
Interaction
Antacids (aluminum and magnesium-containing) do not affect the bioavailability of azithromycin, but reduce its Cmax by 30%, so the drug should be taken at least one hour before or two hours after taking these drugs. Azithromycin does not affect the concentration of carbamazepine, cimetidine, didanosine, efavirenz, fluconazole, indinavir, midazolam, theophylline, triazolam, trimethoprim/sulfamethoxazole, cetirizine, sildenafil, atorvastatin, rifabutin and methylprednisolone in the blood when used simultaneously. If simultaneous use with cyclosporine is necessary, it is recommended to monitor the concentration of cyclosporine in the blood. while taking digoxin and azithromycin, it is necessary to control the concentration of digoxin in the blood, since many macrolides increase the absorption of digoxin in the intestine, thereby increasing its Cmax. When used simultaneously with derivatives of ergotamine and dihydroergotamine, an increase in the toxic effect (vasospasm, dysesthesia) of the latter is possible. If simultaneous use is necessary When taken with indirect anticoagulants (warfarin and other coumarin-type anticoagulants), it is recommended to monitor the prothrombin time. It has been established that the simultaneous use of terfenadine or cisapride and macrolide antibiotics causes arrhythmia and prolongation of the QT interval. Based on this, the above complications cannot be excluded when azithromycin and terfinadine are used together. When azithromycin and zidovudine are taken together, azithromycin does not affect the pharmacokinetic parameters of zidovudine in the blood plasma or the excretion of it and its glucuronide metabolite by the kidneys. However, the concentration of the active metabolite, phosphorylated zidovudine, in monocytes increases. When used simultaneously with nelfinavir, an increase in the frequency of adverse reactions of azithromycin (hearing loss, increased activity of “liver” transaminases) is possible. The possibility of inhibition of the CYP3A4 isoenzyme by azithromycin should be taken into account when used simultaneously with cyclosporine, terfenadine, ergot alkaloids, cisapride, pimozide, quinidine, astemizole and other drugs whose metabolism occurs with the participation of this enzyme.
Side effect
From the circulatory and lymphatic systems: often – lymphocytopenia, eosinophilia; uncommon – leukopenia, neutropenia; very rarely - thrombocytopenia, hemolytic anemia. From the nervous system: often - dizziness, headache, paresthesia, anorexia; infrequently – nervousness, hyposthesia, insomnia, drowsiness; rarely – agitation; very rarely - fainting, convulsions, psychomotor hyperactivity, exacerbation of myasthenia gravis, anxiety, aggression. From the senses: often - decreased hearing acuity, decreased visual acuity, impaired perception of taste; uncommon – tinnitus, deafness; rarely - vertigo; very rarely - anosmia, loss of taste, parosmia. From the cardiovascular system: infrequently - palpitations; very rarely - arrhythmia, ventricular tachycardia, increased QT interval, arrhythmias, decreased blood pressure. From the digestive system: very often - nausea, diarrhea, abdominal pain, flatulence; often – vomiting, dyspepsia; infrequently – gastritis, constipation; very rarely - discoloration of the tongue, pseudomembranous colitis, pancreatitis. From the liver and biliary tract: infrequently - hepatitis, increased activity of “liver” transaminases, hyperbilirubinemia; rarely - liver dysfunction; very rarely - cholestatic jaundice, liver failure, fulminant hepatitis, liver necrosis. Allergic reactions: often - itching, rash; uncommon – angioedema, hypersensitivity reactions, Stevens-Johnson syndrome, photosensitivity, urticaria; very rarely - anaphylactic reactions, toxic epidermal necrolysis, erythema multiforme. From the musculoskeletal system: often - arthralgia. From the urinary system: infrequently - increased concentrations of urea and creatinine in the blood plasma; very rarely - interstitial nephritis, acute renal failure. Others: often - weakness; uncommon – chest pain, peripheral edema, soreness, asthenia, vaginitis, candidiasis of various localizations.
Contraindications
Hypersensitivity to azithromycin, other macrolides or other components of the drug; severe liver dysfunction (no data on efficacy and safety); impaired renal function (creatinine clearance less than 40 ml/min (no data on efficacy and safety)); sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption; children up to 6 months; breast-feeding; simultaneous use of ergotamine and dihydroergotamine.
Overdose
When taking high doses of the drug, an increase in dose-dependent side effects may be observed: temporary hearing loss, severe nausea, vomiting, diarrhea. Treatment: administration of activated carbon, symptomatic therapy, monitoring of vital functions.
special instructions
With caution. With moderate liver dysfunction; impaired renal function (creatinine clearance more than 40 ml/min); predisposition to arrhythmia and prolongation of the QT interval, combined use with antiarrhythmic drugs of classes IA, III, cisapride, in the presence of hypokalemia or hypomagnesemia, clinically significant bradycardia, arrhythmia or severe heart failure; simultaneous use of terfenadine, warfarin, digoxin, pregnancy, myasthenia gravis, diabetes mellitus. Use during pregnancy and breastfeeding. Animal studies have not revealed any harmful effects on the fetus; data on the effectiveness and safety of azithromycin in pregnant women are limited. Azithromycin is used during pregnancy only if the expected benefit to the mother outweighs the possible risk to the fetus. Breastfeeding should be suspended during treatment with azithromycin. When prescribing to patients with diabetes mellitus, as well as on a low-calorie diet, it is necessary to take into account that the suspension contains sucrose (3.7 g/5 ml or 0.3 XE/5 ml). If you miss taking one dose of the drug, the missed dose should be taken as early as possible, and subsequent doses should be taken at intervals of 24 hours. It is necessary to follow the regimen recommended in the instructions and the duration of the drug. Azithromycin is contraindicated in patients with severe liver dysfunction. In patients with moderate hepatic impairment, azithromycin should be administered with caution due to the possibility of developing fulminant hepatitis and severe liver failure. If there are symptoms of liver dysfunction (rapidly increasing asthenia, jaundice, darkening of the color of urine, tendency to bleeding, hepatic encephalopathy), azithromycin therapy should be stopped and a study of the functional state of the liver should be performed. In case of moderate renal failure (creatinine clearance more than 40 ml/min), azithromycin should be taken be carried out under the control of renal function. There is no data on the possible interaction between azithromycin and ergotamine and dihydroergotamine derivatives, but due to the development of ergotism while taking macrolides with ergotamine and dihydroergotamine derivatives, this combination is contraindicated. With long-term use of azithromycin, the development of pseudomembranous colitis caused by Clostridium difficile is possible , both in the form of mild diarrhea and severe colitis. If diarrhea develops while taking azithromycin, as well as 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded. With delayed ventricular repolarization syndrome - QT interval prolongation syndrome - while taking macrolides, including azithromycin, the risk of developing arrhythmia increases. Caution when prescribing azithromycin should be observed in patients with prolongation of the QT interval, receiving therapy with antiarrhythmic drugs of classes IA, III, cisapride, in the presence of hypokalemia or hypomagnesemia, clinically significant bradycardia, arrhythmia or severe heart failure. The use of azithromycin may provoke the development of myasthenic syndrome or cause exacerbation myasthenia gravis. As with the use of other antibacterial drugs, during therapy with azithromycin, patients should be regularly examined for the presence of non-responsive microorganisms and signs of the development of superinfections, including fungal ones. Impact on the ability to drive vehicles and machines. If adverse reactions from the central nervous system occur in patients It is recommended to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention, speed of psychomotor and motor reactions.
Dispensing conditions in pharmacies
On prescription
Buy Azitrox powder for oral suspension 100mg/5ml 15.9g in pharmacies
Buy Azitrox in pharmacies Azitrox in the medicine directory DOSAGE FORMS powder for the preparation of suspension for oral administration 100mg/5ml
MANUFACTURERS Pharmstandard (Russia)
GROUP Antibiotics - macrolides and azalides
COMPOSITION Active substance - azithromycin.
INTERNATIONAL NON-PROPENTED NAME Azithromycin
SYNONYMS Azivok, Azimicin, Azitral, Azithromycin, Azithromycin Zentiva, Azithromycin Forte, Azithromycin-OBL, Azithromycin-Akos, AzitRus, AzitRus forte, Azicide, Vero-Azithromycin, Zetamax retard, Zi-Factor, Zimax, Zitrolide, Zitrolide forte, Zithrocin, Sumazid, Sumamed forte, Sumamecin, Sumamox, Sumatrolide Solutab, Hemomycin, Ecomed
PHARMACOLOGICAL ACTION Pharmacological action - antibacterial. Suppresses protein biosynthesis, slowing down the growth and reproduction of bacteria; at high concentrations, a bactericidal effect is possible. Stable in an acidic environment, lipophilic, quickly absorbed from the gastrointestinal tract. The maximum concentration is created after 2-3 hours, the half-life is 68 hours. Stable plasma levels are achieved after 5-7 days. Easily passes histohematic barriers and enters tissues. Concentrations in tissues and cells are 10-50 times higher than in plasma, and at the site of infection - 24-34% higher than in healthy tissues. A high level (antibacterial) remains in tissues for 5-7 days after the last injection. Excreted unchanged in bile (50%) and in urine (6%). The spectrum of action is wide and includes gram-positive (Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, streptococci of groups C, F, G, Streptococcus viridans ), except for those resistant to erythromycin, and gram-negative (Haemophilus influenzae, Moraxella catarrhalis, Bordetella pertussis, Bordetella parapertussis, Campylobacter jejuni, Legionella pneumophila, Neisseria gonorrhoeae, Gardnerella vaginalis) microorganisms, anaerobes (Bacteroides bivius, Peptostreptococcus spp., Peptococcus, Clostridium perfringens) , chlamydia (Chlamydia trachomatis, Chlamydia pneumoniae), mycobacteria (Mycobacteria avium complex), mycoplasma (Mycoplasma pneumoniae), ureoplasma (Ureaplasma urealyticum), spirochetes (Treponema pallidum, Borrelia burgdorferi).
INDICATIONS FOR USE Infections of the upper and lower respiratory tract (streptococcal pharyngitis and tonsillitis, bacterial exacerbation of chronic obstructive pneumonia, interstitial and alveolar pneumonia, bacterial bronchitis), ENT organs (otitis media, laryngitis and sinusitis), genitourinary system (urethritis and cervicitis), skin and soft tissues (erysipelas, impetigo, secondary infected dermatoses), chronic stage of erythema migrans (Lyme disease).
CONTRAINDICATIONS Hypersensitivity to macrolides, severe liver dysfunction, pregnancy, lactation.
SIDE EFFECTS Nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea, melena, cholestatic jaundice, chest pain, palpitations, weakness, drowsiness, headache, dizziness, nephritis, vaginitis, candidiasis, neutropenia or neutrophilia, pseudomembranous colitis, photosensitivity , rash, angioedema, eosinophilia; in children, in addition, hyperkinesia, agitation, nervousness, insomnia, conjunctivitis.
INTERACTIONS Antacids containing aluminum or magnesium hydroxide reduce absorption and maximum concentrations.
METHOD OF APPLICATION AND DOSAGE Orally, 1 hour before meals or 2 hours after meals, 1 time per day.
OVERDOSE No information available.
SPECIAL INSTRUCTIONS Use with caution in cases of severe dysfunction of the liver, kidneys, and cardiac arrhythmias. After discontinuation of treatment, hypersensitivity reactions may persist in some patients, which requires specific therapy under medical supervision.
STORAGE CONDITIONS List B. Store in a dry place, protected from light, at room temperature, out of reach of children.
