Active substanceAcetylcysteineAcetylcysteine
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  • Dosage form: & nbsptablets, effervescent
    Composition:One tablet contains:
    active substance - acetylcysteine ​​600 mg;
    auxiliary substances: citric acid 680 mg, sodium hydrogen carbonate 500 mg, aspartame 20 mg, flavoring lemon 100 mg.
    Description:

    White round with a rough surface of a tablet of lemon, slightly sulfuric smell.

    The drug solution obtained as a result of the reduction of tablets in water should be slightly opalescent, with a characteristic odor and taste of the lemon flavor.

    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 rupture intra- and intermolecular disulfide bonds of acid mucopolysaccharides sputum, which leads to depolymerization of mucoproteins and a decrease 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 the epithelial cells of the bronchial mucosa. 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 alpha1-antitrypsin (elastase inhibitor) from inactivation NOS1 - oxidant active myeloperoxidase produced by 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, liver cirrhosis increases to 8 hours excreted by the kidneys in the form of inactive metabolites (inorganic sulfates diatsetiltsistein), a small part is released in an unmodified form 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 18 years old, lactation period.

    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 use of 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. Adults: 1 tablet effervescent 600 mg is dissolved in 1/3 cup water and taken once a day.

    The duration of treatment should be assessed individually.In acute diseases, the duration of treatment is from 5 to 10 days; in the treatment of chronic diseases - up to several months (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:

    The effervescent tablets are 600 mg.

    Packaging:

    2 or 10 tablets in a contour mesh package (blister) made of laminated aluminum foil [polyamide-aluminum-polyethylene L-polyethylene-aluminum].

    For 1 or 2 blisters (10 tablets each) or 5 or 10 blisters (2 tablets each), along with the instructions for use are placed in a cardboard box.

    Storage conditions:

    Store at a temperature not exceeding 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 / 01
    Date of registration:18.09.2007
    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: & nbsp31.05.2012
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