Instructions Fluimucil Antibiotic IT lyophilized powder for preparation of solution for injection 500 mg bottle with solvent in ampoules 4 ml No. 3
Composition
active ingredient: 1 bottle contains thiamphenicol glycinate acetylcysteinate 810 mg (equivalent to 500 mg of thiamphenicol);
excipient: disodium edetate 2.5 mg;
solvent: 1 ampoule contains water for injection - 4 ml.
Dosage form
contents of the bottle: white or light yellow lamellar mass with a slight sulfuric odor;
ampoule contents: clear colorless liquid.
Pharmacotherapeutic group
Antibacterials for systemic use. Amphenicols. ATX code J01B A02.
Pharmacological properties
Pharmacodynamics
The drug Fluimucil antibiotic IT thins mucous and mucopurulent secretions and has a broad spectrum of antibacterial action.
The properties of the drug allow for both intramuscular and topical use with good local tolerability.
The mucolytic effect of the drug in the respiratory tract is confirmed by an intense thinning effect on mucous and viscous mucopurulent secretions and is characterized by high clinical tolerability, higher than that of a simple mixture of acetylcysteine + thiamphenicol.
The presence of a broad-spectrum antibiotic in the composition of the drug allows its use for the treatment of bronchopulmonary infections; the drug is especially active against pathogenic microorganisms that cause respiratory diseases: pneumococci, haemophili, Kl. Pneumonia, etc., including anaerobic microorganisms. Fluimucil antibiotic IT provides effective treatment of respiratory infections due to its ability to dilute viscous secretions and bacterial infections provoked by them, and also facilitates the removal of exudate, which contributes to a faster and more complete manifestation of the bactericidal effect.
Acetylcysteine enhances the therapeutic effect of thiamphenicol, the free sulfhydryl group of acetylcysteine causes lysis of the existing mucus, facilitating the penetration, activity and distribution of the antibiotic in tissues, providing an anti-adhesive effect, which has been proven, for example, against Pseudomonas in preparations of respiratory tract cells.
Pharmacokinetics
Studies of the pharmacokinetics of thiamphenicol glycinate acetylcysteinate in animals and humans have shown that the drug is completely absorbed and excreted by the usual routes, both after oral and parenteral administration of thiamphenicol glycinate acetylcysteinate.
Thiamphenicol plasma and tissue (lung) levels were assessed in rats after oral and parenteral administration of thiamphenicol glycinate acetylcysteine, thiamphenicol glycinate, and thiamphenicol base. No differences in absorption rates were noted for these three compounds.
Peak concentrations of thiamphenicol in blood plasma are observed as early as 15 minutes after intramuscular administration of Fluimucil antibiotic IT to guinea pigs.
In dogs, the plasma half-life (t½) after intravenous administration of thiamphenicol glycinate acetylcysteine is about 70 minutes.
Indication
Treatment of bacterial respiratory infections caused by microorganisms sensitive to the drug.
Topical application:
Acute and chronic bronchitis, pneumonia, lung abscess, obstructive emphysema, bronchiectasis, cystic fibrosis, whooping cough, bronchiolitis.
Treatment of bronchopulmonary complications after thoracic surgeries (bronchopneumonia, atelectasis), relief of bronchoaspiration during anesthesia, prevention of infectious complications.
Nonspecific forms of respiratory infections in mycobacterial infections to improve drainage of cavernous foci.
Catarrhal and purulent otitis, infections of the auditory tube, sinusitis, laryngotracheitis, rhinopharyngitis, prevention and treatment of obstructive and infectious complications of tracheostomy, preparation for bronchoscopy, bronchoaspiration, bronchography.
Systemic application:
In all the above cases of bronchopulmonary diseases, when the doctor recommends combined antimicrobial and mucolytic treatment.
Contraindication
Hypersensitivity to any of the components of the drug, history of bone marrow suppression, anuria, use of the drug by persons with severe liver and kidney diseases, gastric and duodenal ulcer in the acute stage, in the presence of hemoptysis, pulmonary hemorrhage, bronchial asthma without sputum thickening.
Interaction with other medicinal products and other types of interactions
Adult and pediatric patients.
Interaction studies have not been conducted.
Cases of interaction with other drugs, as well as specific incompatibilities with the drug, have not been described. Laboratory studies on interaction are absent. Although thiamphenicol is not metabolized in the liver, there is evidence of inhibition of liver enzymes and a possible effect on the metabolism of other drugs.
Concomitant administration of antitussives may increase sputum congestion due to suppression of the cough reflex.
Application features
The drug is an antibiotic, the duration of treatment with the drug should be limited to the minimum period necessary to treat the infection. If after the infection is cured there is a need for mucolytic therapy, acetylcysteine should be used separately.
Fluimucil antibiotic IT is obtained by esterification and salification of thiamphenicol, therefore the precautions prescribed for this antibiotic also apply to this drug, given that thiamphenicol injections can cause transient hematological changes (especially slowing of erythropoiesis, such as reticulocytopenia and anemia, less often - leukopenia and thrombocytopenia). These changes are reversible and are associated with the concentration of the drug in the blood. The severity of hematological changes depends on the dose and duration of treatment.
Such changes may be more pronounced and prolonged in overdose associated with renal failure, except in the presence of a history of medullary failure.
The drug should only be used to treat diseases caused by microorganisms sensitive to it; it should not be used for the prevention and treatment of simple infections.
If long-term treatment is necessary (more than 10 days), it is recommended to periodically monitor the blood composition. If the number of leukocytes decreases to less than 4000/μl and the number of granulocytes decreases by more than 40%, the drug should be discontinued.
In case of moderate or severe renal impairment, it is recommended to prescribe the mucolytic and antibiotic separately, as the dose of thiamphenicol should be reduced.
For premature infants and newborns under 2 weeks of age, it is recommended to adhere to a special dosage regimen (average 25 mg/kg) due to functional immaturity of the kidneys.
The administration of an aerosolized drug, preferably at the beginning of treatment, should dilute bronchial secretions and increase their volume. If the patient cannot cough effectively, postural drainage and bronchoaspiration should be performed.
The use of the drug in aerosol form in patients with asthmatic diseases should be carried out under the supervision of a physician; if bronchospasm develops, the drug should be immediately discontinued, and then, if possible, resumed with the previous bronchodilators.
This medicinal product contains less than 1 mmol (23 mg) sodium/dose, i.e. essentially sodium-free.
Use during pregnancy or breastfeeding
Fertility: A chronic toxicity and fertility study in rats showed dose-dependent inhibition of spermatogenesis at doses exceeding therapeutic levels. Fertility was fully restored after discontinuation of treatment.
Pregnancy There are limited data (less than 300 pregnancy outcomes) on the use of thiamphenicol in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
During pregnancy, the use of the drug is possible only under the supervision of a doctor if the intended benefit to the mother outweighs the potential risk to the fetus.
Breast-feeding
Thiamphenicol passes into breast milk in amounts that may affect newborn infants during breastfeeding.
If it is necessary to prescribe a medicine, breastfeeding should be discontinued for the period of treatment.
The ability to influence the reaction speed when driving or working with other mechanisms
There is no data confirming the effect on reaction rate.
Method of administration and doses
Fluimucil antibiotic IT is intended for intramuscular and topical use.
Dilute the lyophilisate with the solvent contained in the kit immediately before use.
Locally Inhalation: adults - 250 mg 1-2 times a day; children over 1 year old - 125 mg 1-2 times a day.
Place the medicinal product in solution in a container for inhalation.
Endotracheobronchial: adults and children over 1 year of age - 1-2 ml of the prepared solution for each procedure according to the selected instrument (bronchoscope, catheter or other).
Rinsing cavities and sinuses: adults and children over 1 year old - 1-2 ml per procedure.
Instillations into the nose and ears: adults and children over 1 year of age - 2-4 drops per dose.
Systemic application
Intramuscularly
Adults: 500 mg in 2-3 doses per day at equal intervals.
Children: under 3 years old - 25 mg/kg 2 times a day;
aged 3 to 7 years - 250 mg 2 times a day;
aged 7 to 12 years - 250 mg 3 times a day.
If necessary, the dose can be increased by 2 times (in the first 2-3 days of treatment in especially severe cases). The dose should not be increased in premature and newborn children, as well as in patients over 65 years of age.
The course of treatment should not exceed 10 days.
Children
It should be used with caution in the treatment of premature infants and children under 3 years of age (average dose - 25 mg/kg) due to underdevelopment of renal function.
Overdose
No cases of overdose in adults or children have been reported.
Symptoms
In general, the symptoms of overdose should not differ from the described side effects and possible nonspecific complications associated with an overdose of broad-spectrum antibiotics (dysbacteriosis, superinfections).
Prescribe supportive therapy.
Side effects
The main side effects of systemic thiamphenicol are bone marrow suppression with moderate anemia, thrombocytopenia, and leukopenia. These effects are dose-dependent and reversible upon discontinuation of treatment. The following side effects have been reported with systemic use of Fluimucil antibiotic IT, the frequency of which cannot be estimated from the available data:
| Organ system class | Side effects |
| On the part of the immune system | Anaphylactic reactions |
| Blood and lymphatic system disorders | Anemia, thrombocytopenia, leukopenia |
| From the nervous system | Optic neuritis, peripheral neuropathy (as a result of long-term use) |
| Gastrointestinal tract | Nausea, vomiting, diarrhea |
| Skin and subcutaneous tissue disorders | Rash |
| General disorders and administration site conditions | Hyperthermia |
Newborns and premature babies may develop a syndrome that initially manifests as abdominal distension, pale skin, and cyanosis, and can progress to severe cardiocirculatory disorders and even death.
With the inhalation use of Fluimucil antibiotic IT, the following side effects have been reported, the frequency of which cannot be estimated based on the available data:
| Organ system class | Side effects |
| On the part of the immune system | Hypersensitivity reactions |
| Respiratory, thoracic and mediastinal disorders | Laryngeal edema, bronchospasm (predominantly in patients with bronchial asthma), rhinorrhea |
| Gastrointestinal tract | Stomatitis, nausea |
| General disorders and administration site conditions | Rash |
Clinical studies and post-marketing surveillance with the external use of Fluimucil antibiotic IT for the treatment of children have not shown clinically significant differences in the nature, frequency, severity and reversibility of adverse reactions between the safety profile in adults and children or any other age groups.
Expiration date
Lyophilisate for solution for injection (vials): 3 years.
Solvent: water for injections (ampoules) 5 years.
Set: 3 years.
The expiration date of the kit is determined by the shortest expiration date of the component.
After dilution, the lyophilisate can be stored in the refrigerator for 24 hours, during which time the drug can be used only for topical application. A slight opalescence of the solution is possible, which does not indicate a change in its properties and does not prevent its use.
Do not use after the expiration date indicated on the package.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Incompatibility
For local and systemic use, it is not recommended to mix Fluimucil antibiotic IT with other medications.
When using the drug, it is necessary to use glassware, avoid contact of the solution with metal (except stainless steel) and rubber surfaces. Used dishes and nebulizer components should be washed with plenty of water.
Packaging
3 vials of lyophilisate and 3 ampoules of solvent of 4 ml each (water for injections) in a cardboard box.
Vacation category
According to the recipe.
Producer
Zambon S.P.A. / Zambon SPA
Address
Via Lillo del Duca, 10 – 20091 Bresso, Milan, Italy / Via Lillo del Duca, 10 – 20091 Bresso, Milan, Italy.
Applicant
Zambon S.P.A./ Zambon SPA
