Active substanceAcetylcysteineAcetylcysteine
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  • Dosage form: & nbspPowder for solution for oral administration
    Composition:

    2 g of powder contain:

    active substance: acetylcysteine ​​100 mg

    or

    acetylcysteine ​​200 mg

    Excipients:

    isomalt (FE and C), lemon-garnet flavors, sodium saccharinate, lemon oil.


    3 g of powder contain:

    active substance: acetylcysteine ​​600 mg

    Excipients:

    xylitol, aspartame, raspberry flavor, lemon oil.

    Description:White crystalline powder with the smell of pomegranate and lemon - dosages of 100 and 200 mg.
    White crystalline powder with a raspberry smell - 600 mg dosage.
    Pharmacotherapeutic group:Expectorant mucolytic agent
    ATX: & nbsp

    S.01.X.A.08   Acetylcysteine

    R.05.C.B.01   Acetylcysteine

    Pharmacodynamics:

    Acetylcysteine ​​shows secretolitic and secretion-motor action in the area of ​​the bronchial tract. Dissolves phlegm by increasing its volume, facilitating its separation. It retains its activity even in the presence of purulent sputum. The mechanism of action is based on the ability of sulfhydryl groups of acetylcysteine ​​to break the disulfide bonds of acid mucopolysaccharides of sputum, which leads to depolarization of mucoproteins and a reduction in the viscosity of mucus.

    Promotes the synthesis of glutathione, which is an important antioxidant factor of intracellular protection and ensures the maintenance of functional activity and the morphological integrity of the cell, which, in particular,explains its effectiveness as an antidote for paracetamol poisoning.


    Pharmacokinetics:Therapeutic effect is observed after 30-90 minutes and persists for 2-4 hours.
    Indications:

    Diseases of the respiratory system and condition, accompanied by the formation of viscous difficult to separate mucopurulent sputum:

    - acute and chronic bronchitis;

    - tracheitis due to bacterial and / or viral infection;

    - bronchiolitis;

    - pneumonia; bronchial asthma; bronchiectatic disease;

    - atelectasis due to congestion of the bronchi by a mucous plug;

    - cystic fibrosis (as part of combination therapy);

    - removal of a viscous secretion from the respiratory tract during post-traumatic and postoperative conditions;

    - facilitating secretion and secretion of mucus in sinusitis.

    Contraindications:

    known hypersensitivity to acetylcysteine ​​or other ingredients of the finished dosage form;

    peptic ulcer of the stomach and duodenum in the phase of exacerbation.

    For a dosage of 600 mg:

    phenylketonuria;

    children and adolescence (up to 14 years).

    Carefully:

    Bronchial asthma, diseases of the liver, kidneys, adrenals, varicose veins of the esophagus,arterial hypertension; propensity to pulmonary hemorrhage, hemoptysis, children under 2 years old.

    Infants and children under 2 years of age can be prescribed only for vital signs, under hospital conditions and under direct medical supervision at a dose of 10 mg / kg of body weight.

    Pregnancy and lactation:

    The use of the drug during pregnancy and lactation is possible only if the intended benefit to the mother exceeds the potential risk to the fetus or baby.

    Dosing and Administration:

    Inside, after eating, pre-dissolving the powder in a glass of water. Usually the following dosages are recommended:

    adults and adolescents older than 14 years: 400-600 mg of acetylcysteine ​​per day, divided into 2-3 doses;

    children older than 6 years: 400 mg of acetylcysteine ​​per day, divided by 2-3 admission;

    children 2-6 years: 200 mg of acetylcysteine ​​per day, divided into 2-3 doses.

    in newborns are used only for vital indications in a dose of 10 mg / kg 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 / only under strict medical supervision) Assign 100-200 mg of acetylcysteine ​​per day, divided into 2-3 doses.

    Treatment of cystic fibrosis:

    children older than 6 years: 600 mg of acetylcysteine ​​per day, divided into 3 doses;

    children 2-6 years: 400 mg of acetylcysteine ​​per day, divided into 4 doses;

    infants from 10 days and children up to 2 years: 100-150 mg of acetylcysteine ​​per day, divided into 2-3 admission under strict medical supervision.

    The duration (continuity) of application depends on the characteristics of the disease. In the treatment of chronic bronchitis and cystic fibrosis treatment can be long (up to several months).

    Side effects:

    From the digestive system: rarely - heartburn, nausea, vomiting, diarrhea, sensation of stomach overflow.

    Allergic reactions: rarely - skin rash, itching, urticaria, bronchospasm. Other: rarely - nosebleeds, tinnitus, drowsiness, fever. If undesirable side effects occur, you should consult a doctor.

    Overdose:

    To date, cases of overdose of acetylcysteine ​​with oral use have not been described.

    Symptoms: with the occasional use of very large doses, nausea, vomiting, and diarrhea are possible.

    Treatment: symptomatic.

    Interaction:

    With the simultaneous use of acetylcysteine ​​and antitussive drugs, sputum stagnation may increase due to the suppression of the cough reflex, so this combined treatment should be carried out only under direct medical supervision.

    There is evidence that the thiol group of acetylcysteine ​​can neutralize the activity of certain antibiotics (amphotericin B, ampicillin, tetracyclines, excluding doxycycline, semi-synthetic penicillins, cephalosporins, aminoglycosides). Therefore, it is advisable to take these antibiotics orally 2 hours after taking acetylcysteine.

    It is also established that such antibiotics as amoxicillin, doxycycline, erythromycin, triamterene, cefuroxime do not interact with acetylcysteine. Acetylcysteine reduces the hepatotoxic effect of paracetamol.

    Special instructions:

    When using the drug in patients with bronchial asthma, it is necessary to provide sputum drainage, to combine with bronchodilators.

    During the period of application of the drug, the patient is recommended to drink plenty of liquid, which supports the secretion effect of the drug.

    When using the drug, it is necessary to use glassware, avoid contact with metals, rubber, oxygen, easily oxidizing substances.

    Patients with diabetes should remember that one packet (sachet) of 100 mg contains 1.85 g of carbohydrates, and one sachet (200 mg) contains 1.75 g of carbohydrates, which corresponds to about 0.15 XE.

    Form release / dosage:

    Powder for the preparation of a solution for ingestion 100 mg or 200 mg, 600 mg.

    Packaging:

    2 g of the drug in the sachet (aluminum foil sachet); for 20 or 50 sachets, along with instructions for use in a cardboard bundle.

    3 g of the drug in the sachet (aluminum foil sachet); for 20 or 50 sachets, along with instructions for use in a cardboard bundle.

    Storage conditions:

    At a temperature not higher than 25 ° C, out of the reach of children.

    Shelf life:

    5 years.

    Do not use after the expiration of the period indicated on the package!
    Terms of leave from pharmacies:Without recipe
    Registration number:LS-000334
    Date of registration:31.03.2010
    The owner of the registration certificate:ratiofarm GmbHratiofarm GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspratiofarm РУС ООО ratiofarm РУС ООО Russia
    Information update date: & nbsp31.03.2010
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