Azithral capsules 500 mg 3 pcs
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Active ingredients
Azithromycin
Release form
Capsules
Composition
1 capsule contains: azithromycin 500 mg, excipients: anhydrous lactose, corn starch, sodium lauryl sulfate, magnesium stearate, titanium dioxide, purified water, methyl paraben, propyl paraben, gelatin.
Pharmacological effect
A broad-spectrum antibiotic from the macrolide group, an azalide derivative. When creating in the focus of inflammation of high concentrations has a bactericidal effect. Active against gram-positive cocci: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus groups C, F and G, Staphylococcus viridans, Staphylococcus aureus; Gram-negative bacteria: Haemophilus influenzae, Moraxella catarrhalis, Bordetella pertussis, Bordetella parapertussis, Legionella pneumophila, Haemophilus ducreyi, Campylobacter jejuni, Helicobacter pylori, Neisseria gonorrhoe, chiènene, aphinus, jeyuni some anaerobic microorganisms: Bacteroides bivius, Clostridium perfringens, Peptostreptococcus spp .; it is also active against other microorganisms: Chlamydia trachomatis, Mycoplasma pneumoniae, Ureaplasma urealyticum, Treponema pallidum, Borrelia burgdoferi. Azithromycin is inactive against gram-positive bacteria that are resistant to erythromycin.
Pharmacokinetics
Absorption: Azithromycin is rapidly absorbed from the gastrointestinal tract, due to its stability in an acidic environment and lipophilicity. After Azithral is taken orally, a dose of 500 mg of azithromycin Cmax in the blood plasma is reached in 2.5-2.96 hours and is 0.4 mg / l. Bioavailability is 37%. Distribution: Azithromycin penetrates well into the respiratory tract, organs and tissues of the urogenital tract (in particular the prostate gland), skin and soft tissues. High tissue concentrations (10–50 times higher than in plasma) and prolonged T1 / 2 are due to the low binding of azithromycin to plasma proteins, as well as its ability to penetrate into eukaryotic cells and concentrate in a low pH environment surrounding the lysosomes. This, in turn, determines a large Vd = 31.1 l / kg and a high plasma clearance. The ability of azithromycin to accumulate primarily in lysosomes is especially important for the elimination of intracellular pathogens. It has been proven that phagocytes deliver azithromycin to the site of infection, where it is released during phagocytosis. The concentration of azithromycin in the foci of infection is significantly higher than in healthy tissues (by an average of 24–34%) and correlates with the severity of inflammatory edema. Despite the high concentration in phagocytes, azithromycin does not significantly affect their function.Azithromycin remains in bactericidal concentrations in the inflammatory focus for 5–7 days after the last dose, which allowed the development of short (3-day and 5-day) courses of treatment. Metabolism: In the liver it is demethylated to form inactive metabolites. Removal: Removal of azithromycin from blood plasma occurs in 2 stages: T1 / 2 is 14-20 hours in the range from 8 hours to 24 hours after taking the drug and 41 hours in the range from 24 hours to 72 hours, which allows you to use the drug 1 time per day
Indications
Infectious and inflammatory diseases caused by susceptible microorganisms: Infections of the upper respiratory tract and upper respiratory tract (tonsillitis, sinusitis, tonsillitis, pharyngitis, otitis media). Infections of the lower respiratory tract (bacterial and atypical pneumonia, bronchitis). Scarlet fever. Infections skin and soft tissues (erysipelas, impetigo, secondarily infected dermatosis). Infections of the urogenital tract (gonorrheal urethritis and / or cervicitis). Lyme disease (borreliosis) for the treatment of the initial stage (erythema migrans). Ulcer disease udka and duodenal ulcer associated with helicobacter pylori (in a combination therapy).
Contraindications
Renal dysfunction with CC less than 60 ml / min (for capsules), children under 12 years old, hypersensitivity to cephalosporins and penicillins. The drug should be prescribed with caution in elderly patients, with chronic renal failure, and pseudomembranous colitis (in history).
Precautionary measures
With caution prescribed for arrhythmias (possible ventricular arrhythmia and prolongation of the QT interval), pregnancy, as well as children with severe impaired liver or kidney function.
Use during pregnancy and lactation
In pregnancy, Azithral can be used when the intended benefit of such therapy significantly exceeds the risk that exists when using medicines during pregnancy. When prescribing the drug during lactation, breastfeeding should be suspended for the duration of treatment.
Dosage and administration
The drug is taken 1 time / day for 1 hour before meals or 2 hours after meals. For infections of the upper and lower respiratory tract adults appoint 500 mg / day in 1 reception for 3 days; course dose is 1.5 g.With infections of the skin and soft tissues, adults are prescribed 1 g on the 1st day in 1 dose; then - 500 mg in 1 reception daily from the 2nd to the 5th day; course dose is 3 g. In case of uncomplicated urethritis and / or cervicitis, 1 g is prescribed once in 1 administration. In Lyme disease (borreliosis), for the treatment of the initial stage (erythema migrans), 1 g is prescribed on the 1st day and 500 mg per 1 dose daily from the 2nd to the 5th day (course dose 3 g). In case of gastric ulcer and duodenal ulcer associated with Helicobacter pylori, the drug is prescribed at 1 g / day for 3 days as part of a combination anti-helicobacter therapy. For children, the drug is prescribed at the rate of 10 mg / kg of body weight 1 time / day for 3 days or on the 1st day - 10 mg / kg, then for 3 days - 5-10 mg / kg / day (the dose rate is determined at the rate of 30 mg / kg). In the treatment of erythema migrans, the dose is 20 mg / kg on the 1st day and 10 mg / kg from the 2nd to the 5th day.
Side effects
On the part of the digestive system, nausea (3%), diarrhea (5%), abdominal pain (3%). dyspepsia, vomiting, flatulence, melena, cholestatic jaundice, increased activity of hepatic transaminases (1% or less). In children - constipation, anorexia, gastritis. For the cardiovascular system, heartbeat, chest pain (1% or less). For the central nervous system, headache, dizziness, drowsiness. in children - headache (in the treatment of otitis media), hyperkinesia, anxiety, neurosis, sleep disturbance (1% or less). From the urogenital system nephritis, vaginal candidiasis (1% or less). Allergic reactions rash, photosensitization, Quincke edema .Other increased fatigue, oral candidiasis. children have conjunctivitis, pruritus, urticaria.
Overdose
Symptoms: severe nausea, temporary hearing loss, vomiting, diarrhea. Treatment: symptomatic treatment.
Interaction with other drugs
Antacids (aluminum and magnesium), ethanol, food slow down and reduce the absorption of azithromycin. When combined use of warfarin and Azithral in the recommended doses, changes in prothrombin time were not detected, however, given that the interaction of macrolides and warfarin may increase the anticoagulant effect, control of the prothrombin time is necessary. When combined, azithromycin increases the concentration of digoxin. With simultaneous use of azithromycin enhances the toxic effect of ergotamine and dihydroergotamine (vasospasm and dysesthesia). When combined, azithromycin slows down the excretion and enhances the pharmacological effects of triazolam.When combined, azithromycin slows down the excretion, increases plasma concentration and enhances the toxicity of cycloserine, indirect anticoagulants, methylprednisolone, felodipine. Azithromycin, inhibiting microsomal oxidation in hepatocytes, slows down excretion, increases serum concentration and enhances the toxicity of carbamazepine, terfenadine, cyclosporine, hexobarbital, ergot alkaloids, valproic acid, phenytoin, disopyramide, bromocryptin, isoprophthalmic acid, valproic acid, phenytoin, disopyramide, bromocryptin, isoprophin, alkopoids, hemoglobin . When combined, lincosamines weaken the effectiveness of azithromycin, and tetracyclines and chloramphenicol increase.
special instructions
If you miss a dose, you should take the missed dose as early as possible, and follow-up - with an interval of 24 hours. It should be noted that after discontinuation of the drug allergic reactions in some patients may persist, which requires appropriate therapy and medical supervision. It is recommended to observe a break of at least 2 hours between taking Azithral and antacid.