Fluimucil antibiotic IT powder lyophilisate for injection vial 500mg N3
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Active ingredients
Thiamphenicol glycinate acetylcysteinate
Release form
Solution
Composition
Active ingredient: thiamphenicol glycinate acetylcysteinate - 810 mg (in terms of thiamphenicol. - 500 mg) Auxiliary substances: disodium edetate. Solvent: water for injection (ampoules) Active ingredient concentration (mg): 500 mg
Pharmacological effect
Thiamphenicol glycinate acetylcysteinate is a complex compound that combines the antibiotic thiamphenicol and the mucolytic acetylcysteine. after the absorption of thiaminephenicol, glycinate acetylcysteinate is cleaved to acetylcysteine and thiamphenicol. Thiamphenicol is a derivative of chloramphenicol, the mechanism of action is associated with inhibition of bacterial cell protein synthesis. Thiamphenicol has a broad spectrum of antibacterial action, is effective in vitro against bacteria that most commonly cause respiratory tract infections: gram-positive (streptococcus pneumoniae, corynebacterium diphtheriae, staphylococcus spp., streptococcus pyogenes, listeria spp., clostridium, I can work.). neisseria spp., salmonella spp., escherichia coli, shigella spp., bordetella pertussis, yersinia pestis, brucella spp., bacteroides spp.). acetylcysteine breaking disulfide bonds mukoproteidov quickly and effectively liquefies mucus, pus, reduces their viscosity and contributes outgoing acetylcysteine facilitates the penetration of the antibiotic thiamphenicol into the lung tissue, inhibits the adhesion of bacteria to the epithelium of the respiratory tract.
Pharmacokinetics
Tiamphenicol is rapidly distributed in the body, accumulates in the tissues of the respiratory tract in therapeutic concentrations. (the ratio of tissue / plasma concentration is about 1). Cmax in plasma is achieved 1 hour after intramuscular injection. T1 / 2 is about 3 hours, the volume of distribution is 40-68 l. Plasma protein binding up to 20%. Excreted by the kidneys by glomerular filtration, 24 hours after administration, the amount of unchanged thiamphenicol in the urine is 50-70% of the injected dose. It penetrates the placental barrier. After application, acetylcysteine is rapidly distributed in the body, T1 / 2 is 2 hours. In the liver it is deacetylated to cysteine. In the blood, there is a moving equilibrium of free and plasma-bound acetylcysteine and its metabolites (cysteine, cystine, diacetylcysteine). Acetylcysteine penetrates into the extracellular space, mainly distributed in the liver, kidneys, lungs, bronchial secretions. It is excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine), a small portion is excreted in unchanged form through the intestines. It penetrates the placental barrier.
Indications
Fluimucil-antibiotic IT is used to treat infectious and inflammatory diseases caused by susceptible microorganisms and accompanied by mucostasis. Diseases of the upper respiratory tract and upper respiratory tract: otitis media with effusion, sinusitis, laryngotracheitis. , lung abscess, emphysema, bronchiectasis, cystic fibrosis, bronchiolitis, whooping cough. Prevention and treatment of bronchopulmonary complications after thoracic surgery eshatelstv (pneumonia, atelectasis). Prevention and treatment of obstructive and infectious complications of tracheostomy, preparation for bronchoscopy, bronchoaspiration. With accompanying nonspecific forms of respiratory infections to improve drainage, including cavernous foci, with mycobacterial infections.
Contraindications
Hypersensitivity to one of the components of the drug; anemia, leukopenia, thrombocytopenia. With caution With liver failure and chronic renal failure. In children of the first two years of life due to age-related features of the kidney function.
Precautionary measures
At a temperature of 15 ° C to 25 ° C. Keep out of reach of children.
Use during pregnancy and lactation
In pregnancy, the drug is prescribed only when the potential benefit to the mother outweighs the potential risk to the fetus. If necessary, the use of the drug during lactation should stop breastfeeding for the duration of treatment.
Dosage and administration
Fluimucil-antibiotic IT is administered intramuscularly, used for inhalation, applications, washing cavities. Inhalation: for adults - 250 mg 1-2 times a day; children - 125 mg 1-2 times a day. Endotracheal: through a bronchoscope, endotracheal tube, tracheostomy - 1-2 ml of solution (for adults, 500 mg of dry matter is dissolved in 4 ml of water for injection, 250 mg for children) . Local: for the introduction into the paranasal sinuses, as well as for washing the cavities after surgical interventions in the nose and mastoid process, 1-2 ml of solution (for adults dissolve in 4 ml of water for injection - 500 mg of dry matter, for children - 250 mg). In case of diseases of the nasopharynx and ear, instill 2-4 drops in each nasal passage or ny hearing prohod.Vnutrimyshechno: adults - 500 mg 2-3once a day; children under 3 years old - 125 mg 2 times a day; 3-7 years - 250 mg 2 times a day; 7-12 years - 250 mg 3 times a day. For premature and newborn babies up to 2 weeks, the average dose is 25 mg / kg per day. If necessary, the doses can be increased twice (in the first 2-3 days of treatment in particular severe cases). It is impossible to increase the dose in premature and newborn children, as well as in patients over 65 years of age. The course of treatment is not more than 10 days.
Side effects
Allergic reactions. When intramuscular injection may be a slight burning sensation at the injection site, rarely - reticulocytopenia, anemia, leukopenia, neutropenia, thrombocytopenia. When inhaled, reflex cough, local irritation of the respiratory tract, stomatitis, rhinitis, nausea. Possible bronchospasm, in this case, appoint bronchodilators.
Overdose
Symptoms: change in bacterial flora, superinfection. Perhaps increased side effects of the drug (with the exception of allergic reactions). Supportive therapy is recommended.
Interaction with other drugs
The simultaneous appointment of antitussive drugs can increase the stagnation of sputum due to the suppression of the cough reflex. It is not recommended to mix with other drugs in an aerosol.
special instructions
During treatment, a picture of peripheral blood should be monitored. By reducing the number of leukocytes (less than 4 thousand / μl) and granulocytes (more than 40%), the drug is canceled. The Fluimucil-antibiotic IT solution should not come into contact with metal and rubber surfaces. Fluimucil antibiotic IT does not affect the ability to drive vehicles and others mechanisms.