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Fluimucil effervescent pills 600mg №20
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Mechanism of action
Mucolytic drug. It dilutes sputum, increases its volume and facilitates its separation. The action of acetylcysteine is associated with the ability of its sulfhydryl groups to break the intra- and intermolecular disulfide bonds of acid mucopolysaccharides of sputum, which leads to depolarization of mucoproteins and a decrease in the viscosity of sputum. 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 mucosal cells of the bronchi, the secret of which lyses fibrin. It has a similar effect on the secret produced in inflammatory diseases of the upper respiratory tract.
It has an antioxidant effect due to the presence of a SH group capable of neutralizing electrophilic oxidative toxins.
Acetylcysteine easily penetrates into the cell, it 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 enhances the synthesis of intracellular glutathione,involved in the redox processes of cells, promoting detoxification of harmful substances. This explains the effect of acetylcysteine as an antidote for Paracetamol poisoning.
It protects alpha1-antitrypsin (an elastase inhibitor) from the inactivating effect of HOCL, an oxidizing agent produced by myeloperoxidase of active phagocytes. It also has an anti-inflammatory effect (due to the suppression of the formation of free radicals and active oxygen-containing substances responsible for the development of inflammation in the lung tissue).
Pharmacokinetics
Suction
When ingestion is well absorbed from the digestive tract. After ingestion Cmax in plasma it is reached in 1-3 hours and is 15 mmol / l. Bioavailability is 10% due to the pronounced effect of "first pass" through the liver.
Distribution
It penetrates into the extracellular space, mainly distributed in the liver, kidneys, lungs, bronchial secretions. It penetrates the placental barrier. Binding to plasma proteins - 50%.
Metabolism
Quickly deacetylated to cysteine in the liver. In plasma, there is a mobile equilibrium of free and plasma-bound acetylcysteine and its metabolites (cysteine, cystine, diacetylcystine).
Removal
T1/2 when ingestion is 1 hour, with cirrhosis of the liver increases to 8 hours
Indications
- respiratory diseases, accompanied by disturbance sputum discharge (including bronchitis, tracheitis, bronchiolitis, pneumonia, bronchiectasis, cystic fibrosis, lung abscess, pulmonary emphysema, laryngotracheitis, interstitial lung disease, pulmonary atelectasis / occlusion due to bronchial mucus plug /);
- catarrhal and purulent otitis, sinusitis, incl. sinusitis (to facilitate the secretion of the secret);
- to remove viscous secretions from the respiratory tract in post-traumatic and postoperative conditions.
Dosage and administration
The drug is in the form ofeffervescent tablets prescribefor adults 600 mg (1 tab.) 1 time / day. Before use, the effervescent pill is dissolved in 1/3 cup of water.
Granules for the preparation of oral solution prescribeadults and children over 6 years - 200 mg 2-3 times / 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 / day.
Havenewborns 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 give to drink the resulting solution from a spoon or bottle for feeding.
The duration of treatment is set individually. In case of acute diseases, the duration of treatment is from 5 to 10 days, in case of chronic diseases - up to several months.
Side effect
Gastrointestinal: rarely - heartburn, nausea, feeling of fullness in the stomach, vomiting, diarrhea; described cases of development of stomatitis.
Allergic reactions: rarely - skin rash, itching, urticaria; described cases of bronchospasm.
Other: rarely - nosebleeds, tinnitus; described cases of the development of collapse, reduce platelet aggregation.
Contraindications
- peptic ulcer of the stomach and duodenum in the acute phase;
- lactation period;
- children's age up to 2 years (for granules to prepare a solution for oral administration);
- children's and teenage age up to 18 years (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 the age of 2 years is possible only if there are vital indications and with strict medical supervision.
with cautionprescribed for gastric ulcer and duodenal ulcer, varicose veins of the esophagus, hemoptysis, pulmonary hemorrhage, phenylketonuria, bronchial asthma, diseases of the adrenal glands, liver and / or renal failure, hypertension.
Use during pregnancy and lactation
In pregnancy, Fluimucil can be used only if the intended benefit to the mother outweighs the potential risk to the fetus.
If necessary, the appointment of the drug during lactation should stop breastfeeding.
Application for violations of the liver
Precautions should be prescribed to patients with liver diseases.
Application for violations of kidney function
Precautions should be prescribed to patients with kidney disease.
Use in children
Contraindicated in children up to 2 years (for granules to prepare a solution for oral administration); in children and adolescents up to 18 years (for effervescent tablets).
Special notes
Patients with bronchial asthma and obstructive bronchitis Fluimucil® can be administered with caution under the systematic control of bronchial conduction.
The drug contains aspartame, so it should not be prescribed to patients with phenylketonuria.
When dissolving the drug, it is necessary to use glassware, avoid contact with metal and rubber surfaces. When opening a bag of granules, the smell of sulfur is possible, which is the smell of the active substance.
Overdosage
Fluimucil® when taken in a dose of 500 mg / kg / day does not cause signs and symptoms of overdose.
Drug interaction
Simultaneous use of Fluimucil with antitussives can increase the stagnation of sputum due to the 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 intake of Fluimucil and Nitroglycerin can lead to increased vasodilator and antiplatelet effects of the latter.
Acetylcysteine reduces the hepatotoxic effect of paracetamol.
Terms and conditions of storage
The drug should be stored in a dry place inaccessible to children at a temperature not higher than 25 ° C. Shelf life - 3 years.