Sumatrolide Solution Tablets pills 250 mg 6 pcs
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Active ingredients
Azithromycin
Release form
Pills
Composition
Azithromycin (in the form of dihydrate) 250 mg; Excipients: microcrystalline cellulose 225.9 mg, crospovidone 60.3 mg, pregelatinized starch 67.0 mg, blackcurrant flavoring 5.0 mg, magnesium stearate 6.0 mg, sodium saccharinate 15.0 mg, vanillin 1.5 mg, silicon dioxide .
Pharmacological effect
Azithromycin is a macrolide antibiotic of the azalide group. By reversibly binding to the 50S subunit of the ribosomes of bacterial cells, it disrupts the translocation of growing tartar from the aplicates of the abstinent pech, which leads to the suppression of protein synthesis in bacterial cells. ), Streptococcus pyogenes, Streptococcus groups A, B, C, G; aerobic gram-negative microorganisms - Haemophilus influenzae, Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Pasteurella multocida, Neisseria gonorrhoeae; anaerobic microorganisms — Clostridium perfringens, Fusobacterium spp., Prevotella spp., Porphyromonas spp .; others - Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi. Moderately sensitive or insensitive: aerobic gram-positive microorganisms — Streptococcus pneumoniae (moderately sensitive or resistant to penicillin); Aerobic gram-positive microorganisms are resistant — Enterococcus faecalis, Staphylococcus spp. (methicillin-resistant); anaerobes: Bacteroides fragilis group, Streptococcus pneumoniae, beta-hemolytic Streptococcus spp. Groups A, Enterococcus faecalis and Staphylococcus aureus (including methicillin-resistant strains) resistant to erythromycin and other macrolides, linkosamides are resistant to azithromycin.
Pharmacokinetics
Absorption and distribution; After oral administration, bioavailability is 37%. Cmax in plasma is created in 2-3 hours, Vd is 31 l / kg. Binding to plasma proteins is inversely proportional to the concentration in the blood and is 12-52%. 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 passes 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 - by 24–34% more than in healthy tissues. Slowly excreted from tissues and has a long T1 / 2 2-4 days. The therapeutic concentration of azithromycin lasts up to 5-7 days after the last dose.; Metabolism and excretion; Azithromycin is excreted mainly unchanged - 50% of the intestine,12% of the kidneys. In the liver it is demethylated, losing activity.; Pharmacokinetics in special clinical situations; In patients with renal insufficiency (QA less than 10 ml / min), T1 / 2 azithromycin increases by 33%.
Indications
Infectious and inflammatory diseases caused by microorganisms sensitive to azithromycin: - infections of the upper respiratory tract and LOR-organs (pharyngitis, tonsillitis, sinusitis, otitis media); - lower respiratory tract infections (acute bronchitis, exacerbation of chronic bronchitis, community-acquired pneumonia, including those caused by atypical pathogens); - infections of the skin and soft tissues (common acne of moderate severity, erysipelas, impetigo, and secondarily infected dermatosis); - the initial stage of Lyme disease (borreliosis) - erythema migrans (erythema migrans); - uncomplicated urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis); With caution: prolonged QT syndrome, chronic renal failure (CC more than 40 ml / min), liver failure (class A on the scale of Child-Pugh), myasthenia simultaneous administration with terfenadine, warfarin, digoxin, drugs that extend the QT interval.
Contraindications
- hypersensitivity to azithromycin, other macrolides or to other components of the drug; - simultaneous use with ergot derivatives; - severe liver failure (class B and C on the Child-Pugh scale); - severe renal failure (CC less than 40 ml / min); - children's age up to 6 months.; With care: prolonged QT syndrome, chronic renal failure (QA more than 40 ml / min), liver failure (class A on the Child-Pugh scale), myasthenia gravis, simultaneous use with terfenadine, warfarin, digoxin , drugs that extend the QT interval.
Use during pregnancy and lactation
Use of the drug during pregnancy is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus. If necessary, use of the drug during lactation should decide whether to stop breastfeeding.
Dosage and administration
The drug is administered orally, 1 time / day, at least 1 hour before or 2 hours after a meal.; Adults (including elderly patients) and children over 12 years old with a body weight above 45 kg; For infections of the upper and lower respiratory tract , ENT organs, skin and soft tissues are prescribed 500 mg each (2 tab.) 1 time / day for 3 days (course dose 1.5 g); In the initial stage of Lyme disease 1 time / day for 5 days: 1- the first day - 1.0 g (4 tab.),then from the 2nd to the 5th day - 500 mg (2 pills) (course dose 3.0 g); For uncomplicated urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis) - 1 g (4 pills) once;; Acne course dose is 6 g; 500 mg (2 tab.) 1 time / day for 3 days, then 500 mg 1 time per week for 9 weeks.; Children from 6 months to 12 years; For infections of the respiratory tract, ENT organs, skin and soft tissues are prescribed at the rate of 10 mg / kg of body weight 1 time / day for 3 days (course dose 30 mg / kg); For streptococcal pharyngitis, the drug is prescribed at the rate of 10-20 mg / kg 1 time / day for 3 days .; At the initial stage of Lyme disease: on the 1st day at a dose of 20 mg / kg of body weight and then from 2 to 5th day - daily at a dose of 10 mg / kg of the gel mass (course dose 60 mg / kg) .; For patients with moderate impairment There is no need for dose adjustment in the kidney function (CC> 40 ml / min.); Dispersible pills can be taken in various ways: the tablet can be swallowed whole with water or dissolved in water beforehand. Tablets should be dissolved in at least 50 ml of water. Stir the resulting suspension well before taking it.
Side effects
On the part of the hematopoietic system: lymphocytopenia, zozinofiliya, leukopenia, thrombocytopenia, transient neutropenia, hemolytic anemia. anxiety, nervousness. From the sense organs: hearing loss, deafness, ringing in the ears, taste or smell distortion, decreased visual acuity. From the side of the cardiovascular system: feeling of heartbeat, lowering blood pressure, ar itmia (including ventricular tachycardia, pirouette type arrhythmias), prolongation of the QT interval; On the part of the digestive system: nausea, vomiting, diarrhea, abdominal pain or abdominal cramps, unformed stools, flatulence, indigestion, gastritis, anorexia, constipation, discoloration of the tongue, pseudomembranous colitis, hepatitis, cholestatic jaundice, impaired liver function tests, liver necrosis and liver failure (even fatal), pancreatitis, fulminant hepatitis.; Dermatological reactions: itching and rash, angioneuro matic edemaurticaria, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylactic reactions. From the musculoskeletal system: arthralgia. From the urogenital system: vaginitis, interstitial nephritis, acute renal failure. From laboratory indicators: increased serum concentrations of bilirubin, urea, creatinine, potassium ions, reduced serum bicarbonate concentrations.; Other: candidiasis, chest pain, peripheral edema, syncope, o ostrenie myasthenia gravis, malaise, hyperglycemia.
Overdose
Symptoms: temporary hearing loss, nausea, vomiting, diarrhea; Treatment: taking activated charcoal, maintaining vital body functions
Interaction with other drugs
Antacids reduce the maximum concentration of azithromycin in 30%, so the azithromycin should be taken 1 hour before or 2 hours after ingestion of antacids;. Note the possibility of inhibiting the isozyme CYP3A4 azithromycin while applying c cyclosporin, terfenadine, ergot alkaloids, cisapride, pimozide, quinidine, astemizole and other drugs whose metabolism occurs with the participation of this isoenzyme. With simultaneous use with cyclosporine, the concentration of cyclosporine in the blood should be monitored.; If used simultaneously with indirect anticoagulants, the frequency of bleeding can increase, prothrombin time and international normalized ratio (MPO) should be monitored; With simultaneous use with digoxin, the concentration of the latter can be increased, therefore the concentration of digoxin in the blood should be monitored. If used concomitantly with ergotamine, ergotism may develop; simultaneous use is not recommended.; Care should be taken when using terfenadine and azithromycin together, since it has been found that taking terfenadine and macrolides at the same time causes arrhythmia and prolonged QT interval. Based on this, it is impossible to exclude the above-mentioned complications when taking azithromycin and terfenadine together.; If used simultaneously with neofinavir, the frequency of side reactions of azithromycin may increase (hearing loss,increased activity of hepatic transaminases; Azithromycin increases the content of zidovudintriphosphate (active zidovudine metabolite) in mononuclear cells, the clinical significance of this phenomenon is unknown.; Simultaneous use with rifabutin can lead to neutropenia. fluconazole, indinavir, midazolam, theophylline, triazolam, trimethoprim, sulfamethoxazole, cetirizine, sildenafil, atorvastatin, rifabutin, methylprednisolone while the application.
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 one - with interruptions of 24 hours. For pharyngitis and tonsillitis caused by Streptococcus pyogenes, penicillins are the antibiotics of choice. The efficacy of azithromycin for the prevention of rheumatic fever is unknown.; Take with caution in patients with hepatic impairment (class A on the Child-Pugh scale) because of the possibility of the development of fulminant hepatitis and severe hepatic insufficiency in these patients. If there are symptoms of abnormal liver function (rapidly increasing asthenia, jaundice, dark urine, bleeding tendency, hepatic encephalopathy), azithromycin therapy should be discontinued and a functional state of the liver should be investigated.; In renal failure (CC more than 40 ml / min), azithromycin should be used under the control of kidney function.; With the use of azithromycin, as well as with the use of other antibiotics, there is a risk of development of superinfection (including fungal); With long-term administration of azithrome Icine may develop pseudomembranous colitis caused by Clostridium difficile. With the development of diarrhea in the presence of azithromycin, as well as 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded. In mild cases, it is enough to cancel the treatment and use of ion exchange resins (Kolestiramine, Kolestipol). In severe cases, the recovery of fluid, electrolytes and protein, the prescription of vancomncin, bacitracin or metronidazole is shown. You can not use drugs that inhibit intestinal peristalsis.; Since it is possible to prolong the QT interval in patients receiving macrolides,including azithromycin, when using azithromycin, caution should be exercised in patients with known risk factors for prolonging the QT interval: old age, electrolyte imbalance (hypokalemia, hypomagnesaemia), congenital long QT syndrome, heart disease (heart failure, myocardial infarction, bradycardia), simultaneous medication that can lengthen the QT interval (including class I and III antiarrhythmic drugs, tricyclic and tetracyclic antidepressants, oleptics, fluoroquinolones); When using azithromycin, myasthenic syndrome may develop or myasthenia exacerbation.; Influence on ability to drive vehicles and control mechanisms; In the event of adverse reactions from the nervous system, patients are advised to refrain from driving and other mechanisms, and also to observe caution when engaging in activities that require increased concentration of attention and speed of psychomotor reactions.