Tiamphenicol glycinate acetylcysteinate - instructions for use, dose, side effects, contraindications

Clinical and pharmacological group: & nbsp

Antibiotics

Antitussives

Included in the formulation

Fluimucil®-antibiotic IT

lyophilizate d / inhal. w / m

Zambon SpA Italy

АТХ:

J.01.B.A Amfenicola

J.01.B.A.02 Tiamfenicol

Pharmacodynamics:

The complex drug after absorption is split into an antibiotic - amphenicol and mucolytic - acetylcysteine.

Amphenicol

The chloramphenicol derivative (levomycetin) inhibits peptidyl transferase, disrupts the synthesis of cell wall peptoglycans prokaryotes. It has a bacteriostatic effect against bacteria that cause respiratory tract infections: Gram-positive bacteria (Corynebacterium diphtheriae, Clostridium spp., Staphylococcus spp., Streptococcus pneumoniae, Streptococcus pyogenes, Str. Faecalis, Listeria spp.) And Gram-negative bacteria (Escherichia coli, Haemophilus influenzae, Salmonella , Shigella spp., Neisseria, Bordetella pertussis, Yersinia pestis, Bacteroides spp., Brucella spp.).

Acetylcysteine

Rapidly dilutes sputum, rupturing the disulfide bonds of mucoproteins, reduces the viscosity of the bronchial secretion and promotes its retreat. Oppresses the adhesion of bacteria to the epithelium of the respiratory tract, facilitates the penetration of amphenicol into the lung tissue.

Pharmacokinetics:

Amphenicol

Metabolism in the liver.

The elimination half-life is 3 hours. Elimination by the kidneys, about 70% unchanged.

Acetylcysteine

After intramuscular injection, the maximum concentration in the blood plasma is reached after 15 minutes. The connection with plasma proteins is 50%. It accumulates in the tissues of the respiratory tract, liver and kidneys in 50% of the administered dose. Within the cells, it is deacetylated with release L-cysteine-an amino acid necessary for the synthesis of glutathione, which is an antioxidant factor of intracellular defense. Penetrates through the placental barrier.

Metabolism in the liver to diacetylcysteine, cysteine, cystine.

The elimination half-life is 2 hours. Elimination by the kidneys in the form of inactive metabolites.

Indications:

It is used for the treatment of infectious and inflammatory diseases caused by microorganisms sensitive to amphenicol, with acute and chronic bronchitis, pneumonia, bronchopneumonia, emphysema, pulmonary abscesses, cystic fibrosis, otitis, antritis, laryngotracheitis and pharyngitis. Used to prepare for aspiration drainage, bronchography, bronchoscopy.

ICD-10

IV.E70-E90.E84 Cystic fibrosis

VIII.H65-H75.H66 Purulent and unspecified otitis media

X.J00-J06.J00 Acute nasopharyngitis (runny nose)

X.J00-J06.J01 Acute Sinusitis

X.J00-J06.J02 Acute pharyngitis

X.J00-J06.J03 Acute tonsillitis

X.J00-J06.J04 Acute laryngitis and tracheitis

X.J10-J18.J15 Bacterial pneumonia, not elsewhere classified

X.J20-J22.J20 Acute bronchitis

X.J20-J22.J21 Acute bronchiolitis

X.J30-J39.J31 Chronic rhinitis, nasopharyngitis and pharyngitis

X.J30-J39.J32 Chronic Sinusitis

X.J30-J39.J35.0 Chronic tonsillitis

X.J30-J39.J37 Chronic laryngitis and laryngotracheitis

X.J40-J47.J42 Chronic bronchitis, unspecified

X.J40-J47.J47 Bronchoectasia

X.J85-J86.J85 Abscess of the lung and mediastinum

X.J85-J86.J86 Pythothrace

X.J90-J94.J91 * Pleural effusion in conditions classified elsewhere

XXI.Z40-Z54.Z51.4 Preparatory procedures for subsequent treatment, not elsewhere classified

Contraindications:

Inhibition of hematopoiesis, individual intolerance.

Carefully:

Premature infants and children of the first two years of life (dose: not more than 25 mg / kg).

Pregnancy and lactation:

Recommendations for FDA - Category C. Contraindicated in pregnancy and lactation.

Dosing and Administration:

Use in children

Intramuscularly, up to 2 years: 125 mg 2 times / day;

3-6 years: 250 mg twice a day;

7-12 years: 250 mg three times a day.

The course of treatment is 7-10 days.

Adults

Adults: 500 mg 2-3 times / day.

The highest daily dose: 1,5 g with intramuscular injection, 500 mg - in the form of inhalations.

The highest single dose: 500 mg with intramuscular injection, 250 mg - in the form of inhalations ..

Side effects:

Respiratory system: with inhalation, it is possible to develop reflex cough, stomatitis, rhinitis; in patients with bronchial asthma, bronchospasm is possible.

The system of hematopoiesis: agranulocytosis, leukocytopenia.

Allergic reactions.

Overdose:Changes in bacterial flora, superinfection.

Interaction:

Simultaneous use of antitussive drugs can lead to sputum stagnation due to suppression of the cough reflex.

Special instructions:

Monitoring the composition of peripheral blood. With the development of leukopenia (less than 4 thousand / μl) and agranulocytosis (more than 40%), it is recommended to cancel the drug.

Instructions

Thiamphenicol glycinate acetylcysteinate (Thiamphenicoli glycinas acetylcysteinas)