Properties
What is it?
Composition ASIBROX 200mg 1 effervescent tablet contains Active substance: Acetylcysteine 200 mg Excipients: Ascorbic acid, anhydrous sodium carbonate, sodium bicarbonate, anhydrous citric acid, sorbitol, sodium citrate, macrogol 6000, sodium saccharin, "Lemon" flavor. ASIBROX 600mg 1 effervescent tablet contains Active substance: Acetylcysteine 600 mg Excipients: Ascorbic acid, anhydrous sodium carbonate, sodium bicarbonate, anhydrous citric acid, sorbitol, sodium citrate, macrogol 6000, sodium saccharin, "Lemon" flavor. ATC code of the preparation: R05CB01 Pharmacotherapeutic group Mucolytic agents. Pharmacological properties Pharmacodynamics Acetylcysteine (N-acetyl-L-cysteine) (active substance of ASIBROX) has a strong mucolytic, liquefying effect on mucus and mucopurulent secretions by depolymerizing the mucoprotein complexes and nucleic acids, which give the viscous and purulent components of sputum and other secretions their viscosity. In addition, acetylcysteine itself acts directly as an antioxidant, as it has a free nucleophilic thiol group (-SH), which has the ability to interact directly with electrophilic groups of oxidizing radicals. Acetylcysteine protects alpha1-antitrypsin (an inhibitor of the enzyme elastase) from inactivation by hypochlorous acid (HOCl) - a strong oxidizing agent produced by the enzyme myeloperoxidase in activated phagocytes. In addition, the structure of the molecule facilitates its high permeability through cell membranes. Inside the cell, acetylcysteine is deacetylated to form L-cysteine, an amino acid essential for the synthesis of glutathione (GSH). GSH is a highly reactive tripeptide found in various tissues of living organisms, essential for maintaining functional capacity and morphological integrity of cells, and is the main mechanism for intracellular protection against oxidizing radicals, both exogenous and endogenous, and various cytotoxic substances. This activity makes the preparation particularly useful for the treatment of acute and chronic respiratory diseases characterized by thick and viscous mucous and mucopurulent secretions. Pharmacokinetics Studies with radiolabeled acetylcysteine in humans have confirmed good absorption of the preparation when taken orally. Maximum plasma levels were observed within 2-3 hours in terms of radioactivity. After 5 hours of administration, significant concentrations of acetylcysteine were confirmed in lung tissue. Indications for use Treatment of diseases of the respiratory organs characterized by thick and viscous hypersecretion. Dosage and administration ASIBROX is taken orally. One ASIBROX tablet containing 200mg of acetylcysteine should be dissolved in 100ml of room temperature drinking water, or one tablet with 600mg of acetylcysteine in 200ml of room temperature drinking water. The preparation is taken after meals. Additional fluid intake enhances the mucolytic effect of acetylcysteine. Take immediately after dissolving; in exceptional cases, the prepared solution can be stored for 2 hours. For adults and adolescents aged 14 years and older, the preparation is prescribed 200mg 2-3 times a day or 600mg once a day. For children aged 6-14 years, 200mg is prescribed 2 times a day. For children aged 2-6 years, 200mg once a day. In cystic fibrosis: - For adults and adolescents over 14 years of age, 200mg is prescribed 2-3 times a day or 600mg once a day. - For children from 6 years of age - 200mg 3 times a day. - For children aged 2-6 years - 200mg 2 times a day. - Patients with a body weight over 30kg can take 800mg per day. For short-term colds, the duration of treatment is 5-10 days. For chronic bronchitis and cystic fibrosis, it is taken for a longer period to achieve a prophylactic effect against infections. Contraindications - Hypersensitivity to acetylcysteine and other components of the preparation, as well as to substances of similar chemical nature; - Children under 2 years of age. - Pregnancy and lactation. Adverse reactions Frequency categories for adverse reactions are defined as follows: very common (≥ 1/10); common (≥ 1/100 but < 1/10); uncommon (≥ 1/1000 but < 1/100); rare (≥ 1/10000 but < 1/1000); very rare (< 1/10000); unknown frequency (cannot be estimated from available data). Immune system disorders: Uncommon - hypersensitivity; Very rare - anaphylactic shock, anaphylactic/anaphylactoid reaction. Nervous system disorders: Uncommon - headache. Ear and labyrinth disorders: Uncommon - tinnitus. Cardiac disorders: Uncommon - tachycardia. Vascular disorders: Very rare - hemorrhage. Respiratory, thoracic and mediastinal disorders: Rare - bronchospasm, dyspnea; Unknown frequency - bronchial obstruction. Gastrointestinal disorders: Uncommon - vomiting, diarrhea, stomatitis, abdominal pain, nausea; Rare - dyspepsia. Skin and subcutaneous tissue disorders: Uncommon - urticaria, rash, angioneurotic edema, itching. General disorders and administration site conditions: Uncommon - pyrexia; Unknown frequency - facial edema. Effects on laboratory and instrumental investigations: Uncommon - low blood pressure. Rare cases of severe skin reactions, such as Stevens-Johnson syndrome and Lyell's syndrome, have been reported in association with acetylcysteine administration. In most cases, at least one other suspected medicinal product was involved in the pathogenesis of the aforementioned syndromes of skin and mucous membranes; in addition, consult a doctor in case of changes in the skin and mucous membranes. In such cases, acetylcysteine administration should be discontinued. Some studies have confirmed a reduction in platelet aggregation during acetylcysteine administration. Clinical significance has not been established. Special instructions In patients with chronic asthma, strict monitoring during therapy is necessary; treatment should be immediately discontinued if bronchospasm develops. Mucolytic preparations can cause bronchial obstruction in children under 2 years of age. In fact, the ability to drain bronchial mucus is limited in this age group due to the physiological characteristics of the airways. Therefore, the use of mucolytic preparations is not recommended in children under 2 years of age. Administration of the preparation requires special attention in patients with peptic ulcer or a history of peptic ulcer, especially when taken with other drugs that have a negative effect on the stomach. Administration of N-acetylcysteine, especially at the beginning of treatment, can thin bronchial secretions and increase their volume. If the patient cannot effectively cough up sputum, postural drainage and aspiration of bronchial secretions are necessary to rule out secretion retention. ASIBROX contains sorbitol and sodium saccharin, so it is necessary to consult a doctor before using the preparation. ASIBROX 200mg preparation contains 403.1mg of sodium. ASIBROX 600mg preparation contains 356.8mg of sodium. The amount of sodium should be considered in the treatment of patients with impaired kidney function or those on a low-sodium diet. Effects on ability to drive and use machines ASIBROX does not affect the ability to drive a car and perform work that requires high speed of psychomotor reactions. Use during pregnancy and lactation Studies of acetylcysteine in animals have not shown teratogenic effects; however, like other preparations, this preparation can be taken during pregnancy and lactation only if necessary under the direct supervision of a doctor. Use in pediatrics The preparation is contraindicated in children under 2 years of age. Interactions with other medicinal products Drug interactions Drug interaction studies have only been conducted in adult patients. The simultaneous administration of antitussives and acetylcysteine is not allowed, as suppression of the cough reflex can lead to accumulation of bronchial secretions. Activated charcoal may weaken the effect of acetylcysteine. It is not recommended to mix with other preparations. Data on the interaction of antibiotics and acetylcysteine are based on in vitro studies where two substances were mixed and a weakened antibiotic effect was confirmed. Therefore, for safety reasons, it is recommended to take antibiotics orally with an interval of at least 2 hours from acetylcysteine administration. It has been shown that the simultaneous administration of nitroglycerin and acetylcysteine causes significant hypotension and temporary dilation of the arteries with possible headache. In case of simultaneous use of nitroglycerin and acetylcysteine, if necessary, the patient's blood pressure should be monitored, as a severe form of hypotension may occur. Patients should also be warned about the development of headache. Interaction "medicinal product - laboratory test" Acetylcysteine may interfere with the colorimetric method of salicylate analysis. Acetylcysteine may interfere with the test for determination of ketones in urine. In contact with metals, sulfides are formed with rubber, which have a characteristic odor. Overdose Cases of overdose with oral administration have not been described. In healthy volunteers, daily doses of 11.6g of acetylcysteine for three months did not cause severe adverse events. A dose of 500mg of acetylcysteine per body weight taken orally was tolerated without signs of intoxication. Symptoms Overdose may cause gastrointestinal symptoms such as nausea, vomiting, and diarrhea. Treatment No specific antidotes are provided; overdose therapy is based on symptomatic treatment. Storage conditions Store in a dry place at a temperature not exceeding 25℃. Keep out of reach of children! The tube must be tightly closed after removing the tablet. Shelf life 3 years from the date of manufacture. Do not use after the expiry date. Conditions of dispensing from the pharmacy Pharmaceutical product group III, dispensed without a prescription.
