Fluimucil-antibiotic IT lyophilisate d / prig. solution for injections and inhalations 500mg, No. 3

• Diseases of the upper respiratory tract and ENT organs: exudative otitis media, sinusitis, laryngotracheitis;

• diseases of the lower respiratory tract: acute and chronic bronchitis, lingering pneumonia, lung abscess, emphysema, bronchiectasis, cystic fibrosis, bronchiolitis, whooping cough; prevention and treatment of bronchopulmonary complications after thoracic surgery (bronchopneumonia, atelectasis);

• prevention and treatment of obstructive and infectious complications of tracheostomy, preparation for bronchoscopy, bronchoaspiration;

• with concomitant nonspecific forms of respiratory infections to improve drainage, including cavernous foci, with mycobacterial infections.

FluimucilЃ-antibiotic IT is administered intramuscularly, used for inhalations, applications, washing of cavities.

Inhalation: adults - 250 mg 1-2 times a day; children - 125 mg 1-2 times a day.

Endotracheally: through a bronchoscope, an endotracheal tube, a tracheostomy - 1-2 ml of solution (for adults, dissolve in 4 ml of water for injection - 500 mg of dry matter, for children - 250 mg).

Topically: for injection into the paranasal sinuses, as well as for washing cavities after surgical interventions in the area of ??the nose and mastoid, 1-2 ml of solution (for adults, dissolve in 4 ml of water for injection - 500 mg of dry matter, for children - 250 mg ).

For diseases of the nasopharynx and ear, instill 2-4 drops in each nasal passage or external auditory canal.

Intramuscularly: adults - 500 mg 2-3 times a day; children under 3 years old - 125 mg 2 times a day; 3-7 years old - 250 mg 2 times a day; 7-12 years old - 250 mg 3 times a day.

For premature babies and newborns up to 2 weeks, the average dose is 25 mg / kg per day.

If necessary, the dose can be doubled (in the first 2-3 days of treatment in severe cases). Do not increase the dose in premature and newborn infants, as well as in patients over 65 years of age. The course of treatment is no more than 10 days.

Lyophilisate for preparation of solution for injection and inhalation 1 fl.

thiamphenicol glycinate acetylcysteinate 810 mg,

including thiamphenicol 500 mg

Excipients: disodium edetate.

• Anemia;

• leukopenia;

• thrombocytopenia;

• hypersensitivity to one of the components of the drug.

  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.

pharmachologic effect

Thiamphenicol glycinate acetylcysteine ??is a complex compound that combines the antibiotic thiamphenicol and the mucolytic acetylcysteine. After absorption of thiaminphenicol, glycinate acetylcysteinate is split into acetylcysteine ??and thiamphenicol. Thiamphenicol is a chloramphenicol derivative, the mechanism of action is associated with inhibition of bacterial cell protein synthesis. Thiamphenicol has a wide spectrum of antibacterial action, is effective in vitro against bacteria that most often cause respiratory tract infections: gram-positive (Streptococcus pneumoniae, Corynebacterium diphtheriae, Staphylococcus spp., Streptococcus pyogenes, Listeria spp., Clostridium spp.) Neisseria spp., Salmonella spp., Escherichia coli, Shigella spp., Bordetella pertussis, Yersinia pestis, Brucella spp.,Bacteroides spp.). Acetylcysteine, breaking the disulfide bonds of mucoproteins, quickly and effectively liquefies phlegm, pus, reduces their viscosity and promotes excretion. 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

Thiamphenicol is rapidly distributed in the body, accumulates in the tissues of the respiratory tract in therapeutic concentrations. (the tissue / plasma concentration ratio is about 1). Cmax in plasma is reached 1 hour after intramuscular administration. T1 / 2 is about 3 hours, the volume of distribution is 40-68 liters. Plasma protein binding up to 20%. It is excreted by the kidneys through glomerular filtration, 24 hours after administration, the amount of unchanged thiamphenicol in the urine is 50-70% of the administered dose. Penetrates the placental barrier. Acetylcysteine ??after application is quickly distributed in the body, T1 / 2 is 2 hours. In the liver, it is deacetylated to cysteine. A mobile equilibrium of free and plasma protein-bound acetylcysteine ??and its metabolites (cysteine, cystine, diacetylcysteine) is observed in the blood.Acetylcysteine ??penetrates into the intercellular 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 part is excreted unchanged through the intestines. Penetrates the placental barrier.

Side effect

Allergic reactions. With intramuscular injection, a slight burning sensation is possible at the injection site, rarely - reticulocytopenia, anemia, leukopenia, neutropenia, thrombocytopenia. When administered by inhalation - reflex cough, local irritation of the respiratory tract, stomatitis, rhinitis, nausea. Bronchospasm is possible, in this case bronchodilators are prescribed.

Application during pregnancy and lactation

During pregnancy, the drug is prescribed only when the potential benefit to the mother outweighs the potential risk to the fetus. If it is necessary to prescribe the drug during lactation, breastfeeding should be discontinued for the duration of treatment.

Application for violations of liver function

With caution in liver failure.

Application for impaired renal function

With caution in chronic renal failure.

Application in children

With caution in children during the first two years of life due to age-related features of kidney function.

Use in elderly patients

Do not increase the dose in patients over 65 years of age

special instructions

During treatment, the picture of peripheral blood should be monitored. With a decrease in the number of leukocytes (less than 4 thousand / ?l) and granulocytes (more than 40%), the drug is canceled. Fluimucil-antibiotic IT solution should not come into contact with metal and rubber surfaces. FluimucilЃ-antibiotic IT does not affect the ability to drive vehicles and other mechanisms.

Overdose

Symptoms: changes in bacterial flora, superinfection. Possible increased side effects of the drug (with the exception of allergic reactions). Supportive therapy is recommended.

Drug interactions

The simultaneous administration of antitussives can increase sputum congestion due to suppression of the cough reflex. It is not recommended to mix with other drugs in an aerosol.