Active substanceAcetylcysteineAcetylcysteine
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  • Dosage form: & nbspsolution for injection and inhalation
    Composition:1 ampoule solution contains the active substance: acetylcysteine ​​- 300 mg; auxiliary substances: sodium hydroxide to pH 6.5 (~ 74 mg), disodium edetate 3 mg, water for injection up to 3 ml.

    Description:Transparent colorless liquid with a weak sulfuric odor. After opening the ampoule with prolonged contact with air, a faint pink-violet shade may appear.
    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 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 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:

    With intravenous administration of 600 mg of acetylcysteine, the maximum plasma concentration is 300 mmol / L, the plasma half-life is 2 hours.The total clearance is 0.21 l / h / kg, and the volume of distribution with the plateau is 0.34 l / kg.

    In the liver, it is deacetylated to cysteine. In the blood, a mobile equilibrium of the free and protein-bound acetylcysteine ​​plasma and its metabolites (cysteine, cystine, diacetylcysteine). Acetylcysteine penetrates into the intercellular space, is mainly distributed in the liver, kidneys, lungs, bronchial secretions.

    It is excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine), a small part is excreted 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.

    Preparation for bronchoscopy, bronchography, aspiration drainage.For washing abscesses, nasal passages, maxillary sinuses, middle ear; fistula treatment, operative field during operations on the nasal cavity and mastoid process.

    Contraindications:

    Hypersensitivity, peptic ulcer of the stomach and duodenum in the stage of exacerbation, lactation period.

    Carefully:Stomach ulcer and duodenal ulcer in remission, varicose veins of the esophagus, hemoptysis, pulmonary hemorrhage, bronchial asthma (with / in the introduction of risk of bronchospasm), adrenal disease, hepatic and / or renal insufficiency, arterial hypertension, children's age up to 6 years. Children at the age of up to 1 year in / in the introduction of acetylcysteine ​​is possible only for "vital" indications in a hospital.
    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:

    Inhalation. For aerosol therapy in ultrasound devices, spray 3-9 ml of 10% solution, in devices with a control valve - 6 ml of 10% solution.The duration of inhalation is 15-20 min; multiplicity - 2-4 times a day. In the treatment of acute conditions, the average duration of therapy is 5-10 days; with prolonged therapy of chronic conditions treatment course - up to 6 months.

    Due to the high safety of the drug, the frequency of taking and the relative amount of the dose can be changed by the doctor within the permissible limits, depending on the patient's condition and the therapeutic effect. There is no need to change the adult dose in the case of using the drug to treat children. In the case of a strong secretolytic action, the secretion is aspirated, and the frequency of inhalations and the daily dose are reduced. Intratracheal. For washing the bronchial tree with therapeutic bronchoscopy, 1-2 ampoules or more per day are used depending on the clinical indications.

    Locally. Bury in the external auditory meatus and nasal passages of 150-300 mg (1.5-3 ml) per 1 procedure.

    Parenteral. Enter IV / (preferably drip or slow struino - for 5 minutes) or IM. Adults - 300 mg (3 ml) 1-2 times a day. Children from 6 to 14 years - 150 mg (1.5 ml) 1-2 times a day. Children under the age of 6 years are preferably taking the drug orally.The daily dose for children under 6 years - 10 mg / kg of body weight, children under the age of 1 year in / in the introduction of acetylcysteine ​​is possible only for "vital" indications in a hospital. The duration of treatment should be determined by the results of a change in the patient's condition.

    High local and general tolerability of the drug allows for long-term treatment.

    For iv administration, the solution is further diluted with 0.9% solution NaCl or 5% dextrose solution in a ratio of 1: 1. The duration of therapy is determined individually (no more than 10 days).


    In patients older than 65 years - use the lowest effective dose.
    Side effects:

    In aerosol therapy: reflex cough, irritation of the respiratory tract, rhinorrhea; rarely - stomatitis, bronchospasm. With the / m introduction - burning at the injection site, skin rash, urticaria; with long-term treatment - a violation of the liver and / or kidney function.

    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 activity of both drugs. Therefore, the interval between the methods of these drugs should be at least 2 hours.

    Pharmaceutically incompatible with other drug solutions. Simultaneous intake of acetylcysteine ​​and nitroglycerin may lead to an increase in the vasodilator effect 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.

    At shallow administration of the drug and in the presence of hypersensitivity, there may appear a light and rapidly burning sensation, and therefore it is recommended to inject the drug deep into the muscle.

    Ampoule Fluimucil is opened before use. The opened ampoule can be stored in the refrigerator for 24 hours, during this time the drug can be used only for inhalations.

    The Fluimutsil solution should not come in contact with rubber and metal surfaces.

    Form release / dosage:

    Solution for injection and inhalation 100 mg / ml.

    Packaging:

    Ampoules 3 ml of orange glass with a notch for notching.

    5 ampoules in a plastic pallet with instructions for medical use are placed in a cardboard pack.

    Storage conditions:

    At temperatures from 15 ° C to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    Shelf life 5 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:П N012974 / 01
    Date of registration:17.08.2007
    The owner of the registration certificate:Zambon SpAZambon SpA Italy
    Manufacturer: & nbsp
    Representation: & nbspZAMBON SpA ZAMBON SpA Italy
    Information update date: & nbsp31.05.2012
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