Treatment of the following bacterial 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); moderate to severe community-acquired pneumonia; mild to moderately severe skin and soft tissue infections, e.g. folliculitis, cellulitis, rose; uncomplicated urethral and cervical infections caused byChlamydia trachomatis. Local official guidelines on the proper use of antibacterial agents should be considered.
Composition:
1 tabl powl. contains 500 mg of Azithromycin (in the dihydrate form).
Action:
Macrolide antibiotic from the azidal group. Species usually sensitive to azithromycin: Gram-positive aerobes:Mycobacterium avium, Streptococcus pyogenes; Gram-negative aerobic bacteria:Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae; other microorganisms:Chlamydophila pneumoniae, Chlamydia trachomatis, Legionella spp., Mycoplasma pneumoniae. Species among which the problem of acquired resistance may occur:Staphylococcus aureus (sensitive to methicillin),Staphylococcus aureus (resistant to methicillin),Streptococcus pneumoniae, Streptococcus agalactiae. Microorganisms with congenital resistance:Escherichia coli, Klebsiella spp., Pseudomonas aeruginosa. The bioavailability of azithromycin after oral administration is approximately 37%. Cmax is achieved after 2-3 h. Azithromycin penetrates into the tissue in the tissues, reaching many times higher concentrations than in the blood. It is excreted mainly in the bile, unchanged and in the form of metabolites. T0,5 in the elimination phase is closely related to the half-life in tissues, ranging from 2-4 days.
Contraindications:
Hypersensitivity to Azithromycin, Erythromycin, other macrolide or ketolid antibiotics and any of the excipients.
Precautions:
Do not use for the treatment of infected burn wounds. In the case of sexually transmitted diseases, make sure that the patient does not coexist with a syphilis infection. 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 usually effective in the treatment of strep throat infections, no studies have been performed to confirm its effectiveness in the prevention of acute rheumatic fever. The use of azithromycin in the treatment of bacterial pharyngitis is recommended only when it is impossible to use β-lactam antibiotics as first-line agents. 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. In areas where resistance to Erythromycin A is very common, it is particularly important to consider gradual changes in sensitivity to azithromycin and other antibiotics. A large percentage of strains were recorded in some European countriesStreptococcus pneumoniae refractory to azithromycin; this should be taken into account when treating infections caused byStreptococcus pneumoniae. The preparation is not suitable for the treatment of serious infections, in which it is necessary to quickly achieve high concentrations of antibiotic. The safety and effectiveness of the drug in the prevention or treatment of a complex infection Mycobacterium 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 liver disease or taking hepatotoxic drugs. Azithromycin is metabolised in the liver and excreted in the bile, so it should not be used in patients with severe hepatic impairment. 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. 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. During treatment, patients should be observed for superinfection with non-susceptible microorganisms, e.g. fungi. The drug (ret. Table) is not suitable for use in patients with an <45 kg; other pharmaceutical forms are available for this group of patients.
Pregnancy and lactation:
Use pregnancy only if it is absolutely necessary. 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, uterine bleeding Keywords: testicular disorders, edema, weakness, malaise, fatigue, facial edema, chest pain, fever, pain, peripheral edema, increased AST, ALT, increased bilirubin in the blood, increased urea in the blood, increased creatinine in the blood, abnormal levels of potassium in the blood, increased alkaline phosphatase, increased chloride, increased Glucose, increased platelet count, decreased hematocrit, increased blood bicarbonate, abnormal sodium. Rare: agitation, 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 and adolescents and children about the month of > 45 kg: 500 mg once daily for 3 days (alternatively, the same total dose, i.e. 1500 mg can be given for 5 days: 500 mg on day 1 and 250 mg on day 2 to 5); in uncomplicated infections caused byChlamydia trachomatis: 1 g once.Special flu patients. No dose adjustment is required in patients with mild to moderate renal impairment (GFR 10-80 ml / min), mild or moderate hepatic impairment (Child-Pugh A and B) and in elderly patients. Do not use in patients with severe liver disease.Way of giving. The drug should be administered once a day. Can be taken with or without food, washed down with water.
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