Properties
What is it?
Composition: One tablet contains: Active substance – 600mg Acetylcysteine; Excipients: Citric acid, Sodium bicarbonate, Aspartame, Lemon flavor. Description: White tablets with a lemon scent. Pharmacological properties: Pharmacodynamics. The preparation is a mucolytic agent. It thins mucus, increases its volume, and facilitates its expectoration and coughing process. Acetylcysteine's action is related to the property of its sulfhydryl group to disrupt the disulfide bonds of acidic mucopolysaccharides in mucus, leading to depolymerization of mucoproteins and reduction of mucus viscosity. It retains activity in the presence of purulent sputum. It reduces bacterial adhesion to the epithelial cells of the bronchial mucosa. The preparation has antioxidant action, caused by the presence of free SH-groups. Acetylcysteine easily penetrates the cell, is deacetylated to L-cysteine, from which intracellular glutathione is synthesized. Glutathione – a highly reactive tripeptide, a powerful antioxidant, cytoprotector, which binds to endogenous and exogenous free radicals and toxins. Acetylcysteine increases glutathione synthesis, which aids in the detoxification of harmful substances and participates in cellular redox processes. This explains acetylcysteine's action as an antidote in paracetamol poisoning. It protects alpha1-antitrypsin (elastase inhibitor) from the inactivating action of the oxidant HOCl released by phagocyte myeloperoxidase. Additionally, acetylcysteine has anti-inflammatory action (reduces the synthesis of free radicals and active oxygen-containing substances that cause inflammation of lung tissue). Pharmacokinetics: Fluimucil is well absorbed after oral administration, rapidly deacetylated in the liver. In the blood, there is a variable ratio of free and plasma protein-bound acetylcysteine and its metabolites (cysteine, cystine, diacetylcysteine). The bioavailability of acetylcysteine is 10%. It penetrates the intercellular space, is predominantly distributed in the liver, kidneys, lungs, and bronchial secretions. Maximum plasma concentration is reached 1-3 hours after oral administration and is 15 mmol/L, plasma protein binding – 50%. It is excreted by the kidneys in the form of inactive metabolites (inorganic sulfate, diacetylcysteine), a negligible amount is excreted unchanged through the intestines. It crosses the placental barrier. Indications: Respiratory system diseases with secretion of viscous, difficult-to-expectorate sputum: bronchitis, tracheitis, bronchiolitis, pneumonia, bronchiectatic disease, cystic fibrosis, lung abscess, emphysema, laryngotracheitis, interstitial lung disease, atelectasis of the lungs. Catarrhal and purulent otitis, maxillary sinusitis, sinusitis (improves secretion discharge), discharge of viscous mucus from the respiratory tract in the post-traumatic and postoperative periods. Dosage and administration: Administered orally. For adults: 1 effervescent tablet 600mg dissolved in 1/3 glass of water and taken once daily. The duration of treatment is determined individually. For acute diseases, the course of treatment is 5-10 days, for chronic diseases – for several months (as recommended by a doctor). Side effects: In rare cases: nausea, heartburn, feeling of fullness in the stomach, vomiting, diarrhea, skin rash, itching, urticaria, nosebleeds, tinnitus. Cases of bronchospasm, collapse, stomatitis, and reduced platelet aggregation have also been described with acetylcysteine. Contraindications: Hypersensitivity to acetylcysteine, peptic ulcer disease of the stomach and duodenum in the exacerbation stage, children under 18 years of age, lactation period. Administer with caution in: peptic ulcer disease of the stomach and duodenum, esophageal varices, bloody sputum, pulmonary hemorrhage, phenylketonuria, bronchial asthma, adrenal gland disease, renal and hepatic insufficiency, arterial hypertension. Pregnancy and lactation: The preparation is prescribed during pregnancy when the expected benefit to the mother outweighs the potential risk of adverse effects on the fetus. If the preparation needs to be taken during lactation, breastfeeding should be discontinued. Special instructions: In bronchial asthma and obstructive bronchitis, acetylcysteine is prescribed under systematic monitoring of bronchial patency. The preparation contains aspartame, therefore it is not recommended for use in phenylketonuria. When dissolving acetylcysteine, glass containers should be used, avoiding contact with rubber and metal surfaces. Overdose: Administration of acetylcysteine at a dose of 500mg/kg/day does not cause symptoms of overdose. Drug interactions: Simultaneous use of acetylcysteine with other antitussive drugs may lead to mucus stasis due to suppression of the cough reflex. Acetylcysteine administration with antibiotics such as tetracycline (except doxycycline), ampicillin, amphotericin B, may lead to their binding with the thiol group of acetylcysteine, which reduces antibiotic absorption, so the interval between their administration should be at least 2 hours. Acetylcysteine administration with nitroglycerin may enhance the latter's vasodilating and deaggregating effects. Acetylcysteine reduces the toxic effects of paracetamol. Storage conditions and shelf life: Store the preparation at a temperature not exceeding 25°C, out of reach of children. Shelf life is 3 years. Do not use after the expiry date indicated on the packaging. Dispensing from pharmacy: Over-the-counter.
