Флуимуцил®-антибиотик IT

General characteristics. Structure:

Active ingredient: 810 mg of a tiamfenikol of a glitsinat of an atsetiltsisteinat (in terms of тиамфеникол - 500 mg).

Excipient: dinatrium эдетат + 1 ampoule of solvent: water for injections.

Pharmacological properties:

Pharmacodynamics. Tiamfenikola глицинат ацетилцистеинат is the complex connection combining in the structure an antibiotic тиамфеникол and Mucolyticum Acetylcysteinum. After absorption of a tiaminfenikol глицинат ацетилцистеинат it is split on Acetylcysteinum and тиамфеникол. Tiamfenikol is derivative chloramphenicol, the mechanism of action is connected with inhibition of synthesis of protein of a bacterial cell.

Tiamfenikol possesses a wide range of antibacterial action, in vitro concerning the bacteria which are most often causing respiratory infections is effective: gram-positive (Streptococcus pneumoniae, Corynebacterium diphtheriae, Staphylococcus spp., Streptococcus pyogenes, Listeria spp., Clostridium spp.) and gram-negative (Haemophilus influenzae, Neisseria spp., Salmonella spp., Escherichia coli, Shigella spp., Bordetella pertussis, Yersinia pestis, Brucella spp., Bacteroides spp.).

Acetylcysteinum, terminating disulfide bridges of mukoproteid, quickly and effectively liquefies a phlegm, pus, reduces their viscosity and promotes an otkhozhdeniye. Acetylcysteinum facilitates penetration of an antibiotic of a tiamfenikol into tissues of lungs, oppresses adhesion of bacteria on an epithelium of respiratory tracts.

Pharmacokinetics. Tiamfenikol is quickly distributed in an organism, collects in tissues of airways in therapeutic concentration (a concentration ratio fabric/plasma makes about 1). The maximum concentration in plasma is reached in 1 hour after intramuscular introduction. The period to a floor of removal makes about 3 hours, the volume of distribution makes 40 - 68 l. Linkng with proteins of plasma to 20%. It is removed by kidneys by means of glomerular filtering, in 24 hours after introduction the quantity of not changed tiamfenikol in urine makes 50-70% of the entered dose. Gets through a placental barrier.

Acetylcysteinum after use is quickly distributed in an organism, the elimination half-life makes 2 hours. In a liver it is deacetylated to cysteine. In blood mobile balance of the free and connected with proteins of plasma Acetylcysteinum and its metabolites (cysteine, cystine, diacetylcysteinum) is observed. Acetylcysteinum gets into intercellular space, is preferential distributed in a liver, kidneys, lungs, a bronchial secret. It is removed by kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteinum), an insignificant part is allocated in not changed look through intestines. Gets through a placental barrier.

Indications to use:

IT fluimucil antibiotic is applied to treatment of the infectious and inflammatory diseases caused by microorganisms, sensitive to drug, and which are followed mukostazy.

Diseases of upper respiratory tracts and ENT organs: exudative average otitis, sinusitis, laryngotracheitis.

Diseases of the lower respiratory tracts: acute and chronic bronchitis, long pneumonia, abscess of lungs, emphysema, bronchoectatic disease, mucoviscidosis, bronchiolitis, whooping cough.

Prevention and treatment of bronchopulmonary complications after thoracic surgical interventions (bronchial pneumonia, an atelectasis). Prevention and treatment of obstructive and infectious complications of a tracheostomy, preparation for a bronkhoskopiya, bronkhoaspiration.

At the accompanying nonspecific forms of respiratory infections for drainage improvement, including the cavernous centers, at mikobakterialny infections.

Route of administration and doses:

IT fluimucil antibiotic is entered intramusculary, applied to inhalations, applications, washing of cavities.

It is inhalation: the adult - on 250 mg 1-2 times a day; to children - on 125 mg 1-2 times a day.

Endotrakhealno: via the bronchoscope, an endotracheal tube, a tracheostoma - on 1-2 ml of solution (for adults dissolve in 4 ml of water for injections - 500 mg of dry matter, for children - 250 mg).

Locally: for introduction to okolonosovy bosoms, and also for washing of cavities after surgical interventions in a nose and a mastoid, on 1-2 ml of solution (for adults dissolve in 4 ml of water for injections - 500 mg of dry matter, for children - 250 mg).

At diseases of a nasopharynx and ear to dig in 2-4 drops in each nasal course or outside acoustical pass.

Intramusculary: the adult - on 500 mg 2-3 times a day; to children up to 3 years - on 125 mg 2 times a day; 3-7 years - on 250 mg 2 times a day; 7-12 years - on 250 mg 3 times a day.

For premature and newborn children up to 2 weeks an average dose - 25 mg/kg a day.

In need of a dose can be increased twice (in the first 2-3 days of treatment in especially hard cases). It is impossible to increase a dose at premature and newborn children, and also at patients 65 years are more senior.

Course of treatment - no more than 10 days.

Features of use:

Use at pregnancy and in the period of a lactation. At pregnancy drug is appointed only when the potential advantage for mother exceeds potential risk for a fruit. In need of purpose of drug in the period of a lactation it is necessary to stop breastfeeding for the period of treatment.

During treatment it is necessary to control a pattern of peripheral blood. At decrease in quantity of leukocytes (less than 4 thousand / мкл) and granulocytes (more than for 40%) drug is cancelled.

IT Fluimutsila®-antibiotika solution should not contact to metal and rubber surfaces. Флуимуцил®-антибиотик IT does not influence a possibility of control of vehicles and other mechanisms.

Side effects:

Allergic reactions.

At intramuscular introduction perhaps easy burning in an injection site, is rare - a reticulocytopenia, anemia, a leukopenia, a neutropenia, thrombocytopenia.

At inhalation introduction - reflex cough, local irritation of respiratory tracts, stomatitis, rhinitis, nausea. The bronchospasm is possible, in this case appoint bronchodilators.

Interaction with other medicines:

Co-administration of antibechics can increase stagnation of a phlegm because of suppression of a tussive reflex. It is not recommended to mix with other drugs in an aerosol.

Contraindications:

Hypersensitivity to one of drug components; anemia, leukopenia, thrombocytopenia.

With care. At a liver failure and a chronic renal failure. Children of the first two years have lives in connection with age features of function of kidneys.

Overdose:

Symptoms: change of a bacterial flora, superinfection. Strengthening of side effect of drug is possible (except for allergic reactions). The maintenance therapy is recommended.

Storage conditions:

To store at a temperature from 15 °C to 25 °C. To store in the places unavailable to children. Lyophilisate for preparation of solution for injections and inhalations 500 mg (bottles) 3 years. Solvent: water for injections (ampoule) of 5 years. Set 3 years. Note: The period of validity of a set is determined by a component with the smallest period of validity. Not to use after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Lyophilisate for preparation of solution for injections and inhalations of 500 mg. On 810,0 mg of lyophilisate for preparation of solution for injections and inhalations in the bottles of colourless glass (type I) corked by a chlorbutylrubber stopper and an aluminum cap under a running in. On 4,0 ml of water for injections in ampoules of colourless glass (type I).

On 3 bottles of lyophilisate complete with 3 ampoules solvents in the plastic pallet together with the application instruction in a pack cardboard.