Active substanceAcetylcysteineAcetylcysteine
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  • Dosage form: & nbspGranules for solution for oral administration
    Composition:One packet contains: active substance: acetylcysteine ​​- 200 mg;
    excipients: aspartame 25 mg, beta-carotene 12.3 mg, orange flavor 100 mg, sorbitol 662.7 mg.
    Description:The granules are white-yellow with orange inclusions with a characteristic orange, slightly sulphurous odor.
    Pharmacotherapeutic group:Expectorant mucolytic agent
    ATX: & nbsp

    S.01.X.A.08   Acetylcysteine

    R.05.C.B.01   Acetylcysteine

    Pharmacodynamics:

    Mucolytic agent, dilutes sputum, increases its volume, facilitates the separation of sputum. The effect is related to the ability of free sulfhydryl groups of acetylcysteine ​​to disrupt intra- and intermolecular disulfide bonds of acid mucopolysaccharides of sputum, which leads to depolymerization of mucoproteins and a reduction in the viscosity of sputum. Keeps active with purulent sputum.

    Increases the secretion of less viscous sialomucins by goblet cells, reduces the adhesion of bacteria to epithelial cells of the mucosa shell of the bronchi. Stimulates mucous cells of bronchi, the secret of which lyses fibrin. A similar effect has on the secret formed by inflammatory diseases of the ENT organs. Has an antioxidant effect due to the presence of SH-group, capable of neutralizing electrophilic oxidative toxins. Acetylcysteine easily penetrates the cell, deacetylates to L-cysteine, from which intracellular glutathione is synthesized. Glutathione is a highly reactive tripeptide, a powerful antioxidant, a cytoprotector that captures endogenous and exogenous free radicals and toxins. Acetylcysteine prevents depletion and contributes to an increase in the synthesis of intracellular glutathione involved in oxidation-reduction processes of cells, thus contributing to the detoxification of harmful substances. This explains the effect of acetylcysteine ​​as an antidote in paracetamol poisoning.

    Protects alpha 1-antitrypsin (elastase inhibitor) from inactivating action of HOC1 - oxidant, produced by myeloperoxidase active phagocytes. It also has an anti-inflammatory effect (by suppressing the formation of free radicals and active oxygen-containing substances responsible for the development of inflammation in the lung tissue).

    Pharmacokinetics:

    Fluimucil is well absorbed when taken orally. It is immediately deacetylated to cysteine ​​in the liver.In the blood, a mobile equilibrium of the free and protein-bound plasma of acetylcysteine ​​and its metabolites (cysteine, cystine, diacetylcysteine) is observed. Because of the high "first pass" effect through the liver, the bioavailability of acetylcysteine ​​is about 10%. Acetylcysteine penetrates into the intercellular space, is mainly distributed in the liver, kidneys, lungs, bronchial secretions.

    The maximum concentration in plasma is achieved 1-3 hours after oral intake and is 15 mmol / l, the connection with plasma proteins is 50%.

    T1 / 2 - about 1 hour, with cirrhosis increases to 8 hours. It is excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine), a small part is released unchanged through the intestine. Penetrates through the placental barrier.

    Indications:

    Disruption of sputum discharge: bronchitis, tracheitis, bronchiolitis, pneumonia, bronchiectasis, cystic fibrosis, lung abscess, pulmonary emphysema, laryngotracheitis, interstitial lung diseases, lung atelectasis (due to congestion of the bronchial mucosa). Catarrhal and purulent otitis, sinusitis, sinusitis (relief of secretion).

    Removal of a viscous secretion from the respiratory tract in post-traumatic and postoperative conditions.

    Contraindications:

    Hypersensitivity to acetylcysteine, peptic ulcer of the stomach and duodenum in the acute stage, children under 2 years old, lactation period.

    Use in children younger than 2 years is possible only if there are life indications and under strict medical supervision.

    Carefully:

    Peptic ulcer of the stomach and duodenum, varicose veins of the esophagus, hemoptysis, pulmonary hemorrhage, phenylketonuria, bronchial asthma, adrenal diseases, hepatic and / or renal insufficiency, arterial hypertension.

    Pregnancy and lactation:

    The drug in pregnancy is prescribed only if the intended benefit for the mother exceeds the potential risk to the fetus.

    If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

    Dosing and Administration:

    Inside. The granules are dissolved in 1/3 cup of water.

    In newborn infants are used only for vital indications in a dose of 10 mg / kg of body weight under the strict supervision of a doctor.Children of the first year of life are allowed to drink the resulting solution from a spoon or a bottle for feeding. Children from 1 year to 2 years - 100 mg 2 times a day.

    Children from 2 to 6 years - 200 mg 2 times a day, or 100 mg 3 times a day.

    Children older than 6 years and adults - 200 mg 2-3 times a day. The duration of treatment should be assessed individually. In acute diseases, the duration of treatment is from 5 to 10 days; several months in the treatment of chronic diseases (on the recommendation of a doctor).

    Side effects:

    In rare cases, nausea, heartburn, a feeling of stomach overflow, vomiting, diarrhea, skin rash, itching, urticaria, nosebleeds, tinnitus are possible. When taking acetylcysteine, cases of development of bronchospasm, collapse, stomatitis, and decrease in platelet aggregation are described.

    Overdose:

    Acetylcysteine ​​at a dose of 500 mg / kg / day does not cause signs and symptoms of an overdose.

    Interaction:

    Combined use of acetylcysteine ​​with antitussive drugs can increase sputum stagnation due to suppression of the cough reflex.

    When used concomitantly with antibiotics such as tetracyclines (excluding doxycycline), ampicillin, amphotericin B, possibly their interaction with the thiol group of acetylcysteine, which leads to a decrease in the activity of both drugs. Therefore, the interval between the methods of these drugs should be at least 2 hours.

    The simultaneous administration of acetylcysteine ​​and nitroglycerin may lead to an increase in the vasodilator and disaggregant action of the latter. Acetylcysteine eliminates the toxic effects of paracetamol.

    Special instructions:

    Patients with bronchial asthma and obstructive bronchitis acetylcysteine should be administered with caution under the systematic control of bronchial patency.

    The preparation contains aspartame, therefore, its use in patients with phenylketonuria is not recommended.

    The presence of a light sulfuric odor is a characteristic odor of the active substance.

    When dissolving acetylcysteine, use glassware, avoid contact with metal and rubber surfaces.

    Form release / dosage:

    Granules for solution for oral administration 200 mg.

    Packaging:

    By 1.0 g of granules into a contour non-jawed package (bag) of multi-layer material [paper / aluminum / polyethylene].

    For 20 or 60 bags (pellets of 200 mg), together with the instructions for use are placed in a cardboard box.

    Storage conditions:

    At a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:

    3 years. Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N012975 / 02
    Date of registration:14.09.2007
    The owner of the registration certificate:Zambon Switzerland Co., Ltd.Zambon Switzerland Co., Ltd. Switzerland
    Manufacturer: & nbsp
    Representation: & nbspZAMBON SpA ZAMBON SpA Italy
    Information update date: & nbsp01.06.2012
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