Fluimucil®
A mucolytic agent that thins sputum, increases its volume, and facilitates the separation of sputum.
The action is associated with the ability of free sulfhydryl groups of acetylcysteine to break intra- and intermolecular disulfide bonds of acidic mucopolysaccharides of sputum, which leads to depolymerization of mucoproteins and a decrease in sputum viscosity.
In addition, it reduces induced hyperplasia of mucoid cells, enhances the production of surfactants by stimulating type II pneumocytes, and stimulates mucociliary activity, which leads to improved mucociliary clearance.
Remains active against purulent sputum, mucopurulent and mucous sputum.
Increases the secretion of less viscous sialomucins by goblet cells, reduces the adhesion of bacteria to the epithelial cells of the bronchial mucosa. Stimulates mucous cells of the bronchi, the secretion of which is lysed by fibrin. It has a similar effect on the secretions formed during inflammatory diseases of the ENT organs.
It has an antioxidant effect due to the presence of an SH group that can neutralize electrophilic oxidative toxins.
Acetylcysteine easily penetrates into the cell and is deacetylated to L-cysteine, from which intracellular glutathione is synthesized.
Glutathione is a highly reactive tripeptide, a powerful antioxidant, cytoprotector that traps endogenous and exogenous free radicals and toxins.
Acetylcysteine prevents exhaustion and helps increase the synthesis of intracellular glutathione, which is involved in the redox processes of cells, thus promoting the detoxification of harmful substances. This explains the effect of acetylcysteine as an antidote for paracetamol poisoning.
Paracetamol exerts its cytotoxic effect through the progressive depletion of glutathione. The main role of acetylcysteine is to maintain proper levels of glutathione concentration, thereby providing protection to cells.
Protects alpha 1-antitrypsin (elastase inhibitor) from the inactivating effects of HOC1, an oxidizing agent produced by myeloperoxidase of active phagocytes.
It also has an anti-inflammatory effect (by suppressing the formation of free radicals and reactive oxygen-containing substances responsible for the development of inflammation in the lung tissue).
Fluimucil 100mg/ml 3ml 5 pcs. solution for injection and inhalation
pharmachologic effect
Expectorant mucolytic agent.
Composition and release form Fluimucil 100 mg/ml 3 ml 5 pcs. solution for injection and inhalation
Solution for injection - 1 amp.:
- active substance: acetylcysteine - 300 mg;
- excipients: disodium edetate - 3 mg; sodium hydroxide - 74 mg; water for injection - up to 3 ml.
Ampoules 3 ml orange glass with mark for cutting.
5 ampoules in a plastic tray with instructions for medical use are placed in a cardboard pack.
Description of the dosage form
Transparent colorless liquid with a faint sulfuric odor. After opening the ampoule and prolonged contact with air, a faint pink-violet tint may appear.
Directions for use and doses
Inhalation. For aerosol therapy, 3-9 ml of a 10% solution is sprayed in ultrasound devices, and 6 ml of a 10% solution is sprayed in devices with a distribution valve. Duration of inhalation - 15-20 minutes; frequency - 2-4 times a day. When treating acute conditions, the average duration of therapy is 5-10 days; for long-term therapy of chronic conditions, the course of treatment is up to 6 months.
Due to the high safety of the drug, the frequency of administration and the relative dose can be changed by the doctor within acceptable limits, depending on the patient’s condition and the therapeutic effect. There is no need to change the adult dose when using the drug to treat children. In the case of a strong secretolytic effect, the secretion is sucked out, and the frequency of inhalations and the daily dose are reduced. Intratracheal. To wash the bronchial tree during therapeutic bronchoscopy, use 1-2 ampoules or more per day, depending on clinical indications.
Locally. 150-300 mg (1.5-3 ml) are instilled into the external auditory canal and nasal passages per 1 procedure.
Parenterally. Administer intravenously (preferably dropwise or slowly in a stream over 5 minutes) or intramuscularly. Adults - 300 mg (3 ml) 1-2 times a day. Children from 6 to 14 years old - 150 mg (1.5 ml) 1-2 times a day. For children under 6 years of age, oral administration of the drug is preferable. The daily dose for children under 6 years of age is 10 mg/kg body weight; for children under 1 year of age, intravenous administration of acetylcysteine is possible only for “vital” indications in a hospital setting. The duration of treatment should be determined based on changes in the patient's condition.
High local and general tolerability of the drug allows for long courses of treatment.
For intravenous administration, the solution is further diluted with 0.9% NaCl solution or 5% dextrose solution in a 1:1 ratio. The duration of therapy is determined individually (no more than 10 days).
In patients over 65 years of age, the minimum effective dose is used.
Pharmacodynamics
A mucolytic agent that thins sputum, increases its volume, and facilitates the separation of sputum. The action is associated with the ability of free sulfhydryl groups of acetylcysteine to break intra- and intermolecular disulfide bonds of acidic mucopolysaccharides of sputum, which leads to depolymerization of mucoproteins and a decrease in sputum viscosity. Remains active against purulent sputum.
Increases the secretion of less viscous sialomucins by goblet cells, reduces the adhesion of bacteria to the epithelial cells of the bronchial mucosa. Stimulates mucous cells of the bronchi, the secretion of which is lysed by fibrin. It has a similar effect on the secretions formed during inflammatory diseases of the ENT organs. It has an antioxidant effect due to the presence of an SH group that can neutralize electrophilic oxidative toxins. Acetylcysteine easily penetrates into the cell and is deacetylated to L-cysteine, from which intracellular glutathione is synthesized. Glutathione is a highly reactive tripeptide, a powerful antioxidant, cytoprotector that traps endogenous and exogenous free radicals and toxins. Acetylcysteine prevents exhaustion and helps increase the synthesis of intracellular glutathione, which is involved in the redox processes of cells, thus promoting the detoxification of harmful substances. This explains the effect of acetylcysteine as an antidote for paracetamol poisoning.
Protects alpha 1-antitrypsin (elastase inhibitor) from the inactivating effects of HOC1, an oxidizing agent produced by myeloperoxidase of active phagocytes. It also has an anti-inflammatory effect (by suppressing the formation of free radicals and reactive oxygen-containing substances responsible for the development of inflammation in the lung tissue).
Pharmacokinetics
With intravenous administration of 600 mg of acetylcysteine, the maximum plasma concentration is 300 mmol/l, the plasma half-life is 2 hours. The total clearance is 0.21 l/h/kg, and the volume of distribution at the plateau is 0.34 l/kg.
In the liver it is deacetylated to cysteine. In the blood, a mobile equilibrium of free acetylcysteine and its metabolites (cysteine, cystine, diacetylcysteine) is observed, free and bound to plasma proteins. Acetylcysteine penetrates into the intercellular space and is predominantly distributed in the liver, kidneys, lungs, and 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 through the placental barrier.
Indications for use Fluimucil 100 mg/ml 3 ml 5 pcs. solution for injection and inhalation
Impaired sputum discharge: bronchitis, tracheitis, bronchiolitis, pneumonia, bronchiectasis, cystic fibrosis, lung abscess, emphysema, laryngotracheitis, interstitial lung diseases, pulmonary atelectasis (due to blockage of the bronchi by mucus plug). Catarrhal and purulent otitis media, sinusitis, sinusitis (facilitation of secretion discharge).
Removal of viscous secretions from the respiratory tract in post-traumatic and postoperative conditions.
Preparation for bronchoscopy, bronchography, aspiration drainage. For washing abscesses, nasal passages, maxillary sinuses, middle ear; treatment of fistulas, surgical field during operations on the nasal cavity and mastoid process.
Contraindications
Hypersensitivity, peptic ulcer of the stomach and duodenum in the acute stage, lactation period.
With caution: peptic ulcer of the stomach and duodenum in remission, varicose veins of the esophagus, hemoptysis, pulmonary hemorrhage, bronchial asthma (with intravenous administration there is a risk of developing bronchospasm), diseases of the adrenal glands, liver and/or kidney failure, arterial hypertension , children under 6 years of age. For children under 1 year of age, intravenous administration of acetylcysteine is possible only for “vital” indications in a hospital setting.
Application Fluimucil 100 mg/ml 3 ml 5 pcs. solution for injection and inhalation during pregnancy and lactation
The drug is prescribed during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus.
If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.
special instructions
For patients with bronchial asthma and obstructive bronchitis, acetylcysteine should be prescribed with caution under systematic monitoring of bronchial patency.
With a shallow intramuscular injection of the drug and in the presence of increased sensitivity, a slight and quickly passing burning sensation may appear, and therefore it is recommended to inject the drug deep into the muscle.
The Fluimucil ampoule is opened before use. An opened ampoule can be stored in the refrigerator for 24 hours, during which time the drug can only be used for inhalation.
Fluimucil solution should not come into contact with rubber and metal surfaces.
Overdose
Acetylcysteine when taken at a dose of 500 mg/kg/day does not cause signs and symptoms of overdose.
Side effects Fluimucil 100 mg/ml 3 ml 5 pcs. solution for injection and inhalation
With aerosol therapy: reflex cough, respiratory tract irritation, rhinorrhea; rarely - stomatitis, bronchospasm. With intramuscular injection - burning at the injection site, skin rash, urticaria; with long-term treatment - impaired liver and/or kidney function.
Drug interactions
The combined use of acetylcysteine with antitussives may increase sputum stagnation due to suppression of the cough reflex.
When used simultaneously with antibiotics such as tetracyclines (excluding doxycycline), ampicillin, amphotericin B, they may interact with the thiol group of acetylcysteine, which leads to a decrease in the activity of both drugs. Therefore, the interval between doses of these drugs should be at least 2 hours.
Pharmaceutically incompatible with other drug solutions. The simultaneous use of acetylcysteine and nitroglycerin can lead to an increase in the vasodilatory effect of the latter.
Acetylcysteine eliminates the toxic effects of paracetamol.
Fluimucil (tab. spike. 600 mg No. 10)
A country
Italy, Switzerland
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.
Active substance
Acetylcysteine
Compound
1 tablet contains: acetylcysteine 600 mg.
Excipients: citric acid, sodium bicarbonate, aspartame, lemon flavor. Effervescent tablets are white, round, with a rough surface. With a lemony, slightly sulfuric odor. The solution prepared by reconstituting the tablets in water should be slightly opalescent, with a characteristic odor and taste of lemon flavor.
pharmachologic effect
Mucolytic drug. Liquefies mucus, increases its volume and facilitates its separation. The action of acetylcysteine is associated with the ability of its sulfhydryl groups to break intra- and intermolecular disulfide bonds of acidic mucopolysaccharides of sputum, which leads to depolarization of mucoproteins and a decrease in sputum viscosity. Remains active in the presence of purulent sputum. Increases the secretion of less viscous sialomucins by goblet cells, reduces the adhesion of bacteria to the epithelial cells of the bronchial mucosa. Stimulates mucous cells of the bronchi, the secretion of which is lysed by fibrin. It has a similar effect on the secretions formed during inflammatory diseases of the ENT organs. It has an antioxidant effect due to the presence of an SH group that can neutralize electrophilic oxidative toxins. Acetylcysteine easily penetrates into the cell and is deacetylated to L-cysteine, from which intracellular glutathione is synthesized. Glutathione is a highly reactive tripeptide, a powerful antioxidant and cytoprotector that neutralizes endogenous and exogenous free radicals and toxins. Acetylcysteine prevents exhaustion and helps increase the synthesis of intracellular glutathione, which is involved in the redox processes of cells, promoting the detoxification of harmful substances. This explains the effect of acetylcysteine as an antidote for paracetamol poisoning. Protects alpha1-antitrypsin (elastase inhibitor) from the inactivating effects of HOCl, an oxidizing agent produced by myeloperoxidase of active phagocytes. It also has an anti-inflammatory effect (by suppressing the formation of free radicals and reactive oxygen-containing substances responsible for the development of inflammation in the lung tissue).
Indications for use
- diseases of the respiratory system, accompanied by impaired sputum discharge (including bronchitis, tracheitis, bronchiolitis, pneumonia, bronchiectasis, cystic fibrosis, lung abscess, pulmonary emphysema, laryngotracheitis, interstitial lung diseases, pulmonary atelectasis /due to blockage of the bronchi by mucus plug/) ; - catarrhal and purulent otitis media, sinusitis, incl. sinusitis (to facilitate the passage of secretions); - to remove viscous secretions from the respiratory tract in post-traumatic and postoperative conditions.
Mode of application
The drug in the form of effervescent tablets is prescribed to adults at 600 mg (1 tablet) 1 time/day. Before use, the effervescent tablet is dissolved in 1/3 glass of water. Granules for the preparation of a solution for oral administration are prescribed to adults and children over 6 years old - 200 mg 2-3 times a day; children aged 2 to 6 years - 200 mg 2 times / day or 100 mg 3 times / day; children aged 1 to 2 years - 100 mg 2 times a day. In newborns, the drug is used only for health reasons at a dose of 10 mg/kg body weight under the strict supervision of a physician. Before use, the required amount of granules is dissolved in 1/3 glass of water. Children of the first year of life are given the resulting solution to drink from a spoon or feeding bottle. The duration of treatment is determined individually. For acute diseases, the duration of treatment is from 5 to 10 days, for chronic diseases - up to several months.
Interaction
The simultaneous use of Fluimucil with antitussives may increase sputum stagnation due to suppression of the cough reflex. When used simultaneously with antibiotics, such as tetracyclines (excluding doxycycline), ampicillin, amphotericin B, their interaction with the thiol group of acetylcysteine is possible, which leads to a decrease in the activity of both drugs, therefore the interval between taking acetylcysteine and antibiotics should be at least 2 hours. Simultaneous taking Fluimucil and nitroglycerin can lead to an increase in the vasodilatory and antiplatelet effects of the latter. Acetylcysteine reduces the hepatotoxic effect of paracetamol.
Side effect
From the digestive system: - rarely - heartburn, nausea, feeling of fullness in the stomach, vomiting, diarrhea; — cases of stomatitis development are described. Allergic reactions: - rarely - skin rash, itching, urticaria; — cases of bronchospasm development have been described. Other: - rarely - nosebleeds, tinnitus; — cases of collapse development and decreased platelet aggregation have been described.
Contraindications
- peptic ulcer of the stomach and duodenum in the acute phase; - lactation period; - children under 2 years of age (for granules for the preparation of a solution for oral administration); - children and adolescents up to 18 years of age (for effervescent tablets); - hypersensitivity to acetylcysteine. The use of the drug in the form of granules for the preparation of a solution for oral administration in children under 2 years of age is possible only if there are vital indications and under strict medical supervision. Prescribed with caution for peptic ulcers of the stomach and duodenum, varicose veins of the esophagus, hemoptysis, pulmonary hemorrhage, phenylketonuria, bronchial asthma, diseases of the adrenal glands, liver and/or kidney failure, arterial hypertension.
Overdose
Fluimucil® when taken at a dose of 500 mg/kg/day does not cause signs and symptoms of overdose.
special instructions
For patients with bronchial asthma and obstructive bronchitis, Fluimucil® can be prescribed with caution under systematic monitoring of bronchial conduction. The drug contains aspartame, so it should not be prescribed to patients with phenylketonuria. When dissolving the drug, you must use glass containers and avoid contact with metal and rubber surfaces. When opening a bag of granules, there may be a smell of sulfur, which is the smell of the active substance.
Storage conditions
Room temperature
