Treatment of the following infections caused by azithromycin-sensitive organisms: acute bacterial sinusitis (properly diagnosed); acute bacterial otitis media (properly diagnosed); pharyngitis, tonsillitis; exacerbation of chronic bronchitis (properly diagnosed); mild to moderately severe community-acquired pneumonia; infection of the skin and soft tissues; uncomplicated urethritis and cervicitis induced byChlamydia trachomatis. Official recommendations on the use of antimicrobial agents should be taken into account.
Composition:
5 ml of the reconstituted suspension contains 100 mg or 200 mg of Azithromycin (as monohydrate); the suspension contains sucrose and aspartame. 1 tabl powl. contains 250 mg or 500 mg azithromycin (as monohydrate); tablets contain soya lecithin.
Action:
Macrolide antibiotic from the azidal group. Species usually sensitive to azithromycin - Gram-negative aerobic bacteria:Haemophilus influenzae, Moraxella catarrhalis; other microorganisms:Chlamydophila pneumoniae, Chlamydia trachomatis, Legionella pneumophila, Mycobacterium avium, Mycoplasma pneumoniae. Species among which there is a problem of acquired resistance:Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Ureaplasma urealyticum. Organisms with congenital resistance:Staphylococcus aureus - methicillin and Erythromycin resistant strains,Streptococcus pneumoniae - penicillin resistant strains,Escherichia coli, Pseudomonas aeruginosa, Klebsiella spp., groupBacteroides fragilis. The oral bioavailability of azithromycin is approximately 37%. Cmax occurs after 2-3 h. Azithromycin penetrates tissues, reaching in them much higher concentrations than in blood. It is excreted mainly in the bile, unchanged and in the form of metabolites. T0,5 Azithromycin is closely related to the half-life in tissues of 2-4 days.
Contraindications:
Hypersensitivity to Azithromycin, Erythromycin, any macrolide or ketolidic antibiotic or any of the excipients.
Precautions:
Do not use for the treatment of infected burn wounds. Azithromycin is not the first-line treatment for the empirical treatment of infections in areas where the isolation resistance of isolated strains is at least 10%. Azithromycin is not the first-line treatment for the treatment of pharyngitis and palatine tonsils caused byStreptococcus pyogenes and in the prevention of acute rheumatic fever (the drug of choice is penicillin). Azithromycin is often not the first-line treatment for the treatment of sinusitis or acute otitis media. When treating infections caused byStreptococcus pneumoniae it should be taken into account that high resistance rates (> 30%) of this bacterium to azithromycin have been found in some European countries. In the case of soft tissue infections, which are often caused byStaphylococcus aureus (often resistant to azithromycin), the sensitivity tests of the microorganism should always be performed before using the preparation. Because of the cross resistance existing among macrolides, in areas with a high frequency of resistance to erythromycin, it is particularly important to consider the possibility of changing the sensitivity profile to azithromycin and other antibiotic. In the case of sexually transmitted diseases, make sure that the patient does not coexist with a syphilis infection. The preparation is not suitable for the treatment of serious infections in which it is necessary to quickly achieve high concentrations of antibiotic in the blood. The safety and efficacy of azithromycin in the prevention or treatment of complex infectionsMycobacterium avium (MAC) in children have not been determined. Do not use simultaneously with derivatives of ergot alkaloids (risk of ergot poisoning). Use with caution in patients with neurological or psychiatric disorders; with myasthenia gravis (risk of exacerbation of symptoms); Elderly; with severe renal impairment - GFR <10 ml / min (an increase of 33% in systemic exposure to azithromycin was observed); with severe hepatic impairment, pre-existing liver disease or patients receiving hepatotoxic drugs. If symptoms of liver dysfunction occur during treatment, e.g.rapidly progressing asthenia with simultaneous jaundice, dark urine, bleeding tendency or hepatic encephalopathy; liver function tests should be performed; if liver dysfunction occurs, azithromycin should be discontinued. Due to the risk of arrhythmia, caution should be exercised when treating patients with congenital or confirmed acquired QT prolongation; treated with other preparations that prolong the QT interval; with electrolyte disturbances (especially hypokalaemia and hypomagnesaemia); with clinically significant bradycardia, cardiac arrhythmias or severe heart failure. During treatment, patients should be observed for superinfection with non-susceptible microorganisms, e.g. fungi. In any patient who has experienced diarrhea due to antibiotic use, the possibility of diarrhea of etiology should be consideredClostridium difficile (CDAD), even after a few months after administration of antibacterial drugs. Due to the sucrose content, the suspension should not be used in patients with fructose intolerance, sucrase-isomaltase deficiency or malabsorption of glucose-galactose. A suspension of 100 mg / 5 ml contains 3.81 g of sucrose in 5 ml, while a suspension of 200 mg / 5 ml contains 3.70 g of sucrose in 5 ml - this should be taken into account when using the drug in patients with diabetes. Due to the content of aspartame, the suspension may be harmful for patients with phenylketonuria. Due to the content of soya lecithin, powl. should not be used in patients with hypersensitivity to soy or peanut.
Pregnancy and lactation:
Only use pregnancy when the benefits of therapy outweigh the risks. You should not breast-feed during treatment with azithromycin and up to 2 days after its completion.
Side effects:
Very often: diarrhea. Common: headache, vomiting, abdominal pain, nausea, decreased lymphocyte count, increased eosinophil counts, decreased bicarbonate levels in blood, increased basophil counts, increased monocytes, increased neutrophil counts. Uncommon: candidiasis (including oral cavity), vaginal infection, pneumonia, fungal infections, bacterial infections, pharyngitis, gastroenteritis, respiratory disorders, rhinitis, leukopenia, neutropenia, eosinophilia, angioneurotic edema, hypersensitivity reactions , anorexia, nervousness, insomnia, dizziness, drowsiness, taste disturbances, paresthesia, visual disturbances, hearing disorders, diarrheal vertigo, palpitations, hot flushes, shortness of breath, nosebleeds, constipation, bloating, indigestion, gastritis , swallowing disorders, abdominal distension, dry mouth, belching, mouth ulcers, excessive salivation, hepatitis, rash, pruritus, urticaria, dermatitis, dry skin, excessive sweating, osteoarthritis, muscle pain, back pain, neck pain, dysuria, kidney pain, bleeding with genital tract, testes disorders, edema, weakness, malaise, fatigue, facial edema, chest pain, fever, pain, peripheral sounds, increased AST, ALT, increased bilirubin in the blood, increased blood urea, increased blood Creatinine in the blood, abnormal blood potassium, increased alkaline phosphatase, increased chloride, increased Glucose, increased platelet count, decreased hematocrit, increased levels of bicarbonate in the blood, abnormal sodium concentration, post-treatment complications. Rare: agitation, depersonalization, abnormal liver function, cholestatic jaundice, hypersensitivity reaction to light. Not known: pseudomembranous colitis, thrombocytopenia, haemolytic anemia, anaphylactic reaction, aggression, anxiety, delirium, hallucinations, fainting, convulsions, hypoaesthesia, hyperactivity, lack of smell, lack of taste, odor disorders, myasthenia gravis, impaired hearing (incl. deafness and / or tinnitus),torsade de pointes, arrhythmia (including ventricular tachycardia), QT prolongation in ECG, hypotension, pancreatitis, tongue discoloration, liver failure (rarely fatal), fulminant hepatitis, hepatic necrosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, joint pain, acute renal failure, interstitial nephritis. Adverse reactions related to the use of azithromycin in the prevention and treatment of infectionMycobacterium avium complex demonstrated on the basis of experience from clinical trials and follow-up after the introduction of azithromycin on the market. Very common: diarrhea, abdominal pain, nausea, bloating, discomfort in the abdomen, loose stools. Common: anorexia, dizziness, headache, paresthesia, disturbed taste, blurred vision, deafness, rash, pruritus, joint pain, fatigue. Uncommon: hypoaesthesia, impaired hearing, tinnitus, palpitations, hepatitis, Stevens-Johnson syndrome, hypersensitivity reaction to light, weakness, and unwellness.
Dosage:
Orally.Adults. For the treatment of uncomplicated urethritis and cervicitis caused byChlamydia trachomatis: 1000 mg once. In all other indications: 500 mg once daily for 3 consecutive days; alternatively, the same total dose (1500 mg) can be given for 5 days: 500 mg on day 1 of treatment and 250 mg on day 2 to day 5 of treatment.Children and youth. In children and adolescents > 45 kg tablets can be used, in doses recommended for adults. In children about the month <45 kg use a suspension. Children> 1 year: 10 mg / kg once a day for 3 days; alternatively, the same total dose (30 mg / kg) can be given for 5 days: 10 mg / kg on day 1 of treatment, followed by 5 mg / kg for the Next 4 days. Data on the use of the drug in children under the age of 1 are limited. Dosing for the treatment of pharyngitis caused byStreptococcus pyogenes is an exception. In this indication, azithromycin was shown to be effective in children given at a single dose of 10 mg / kg. or 20 mg / kg for 3 days. The maximum daily dose was 500 mg. Both doses produced a comparable clinical effect, although a dose of 20 mg / kg. caused more significant eradication of bacteria. However, penicillin is the first-choice drug in pharyngitis caused byStreptococcus pyogenes and in the prevention of later acute rheumatic fever.Special groups of patients. In patients with mild or moderate renal impairment (GFR 10-80 ml / min), no dose adjustment is necessary in patients with mild or moderate hepatic impairment as well as in elderly patients.Way of giving. The drug should be administered in a single daily dose; can be taken during a meal. Table. 500 mg can be divided into equal doses.
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