Active substanceCromoglycic acidCromoglycic acid
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  • Dosage form: & nbspinhalation solution
    Composition:

    1 disposable plastic ampoule contains 2 ml of solution Active ingredient: sodium cromoglicate - 20 mg.

    Excipients: purified water.

    Description:

    Transparent, colorless or slightly yellowish solution without mechanical inclusions.

    Pharmacotherapeutic group:Antiallergic agent - stabilizer of membranes of mast cells
    ATX: & nbsp

    S.01.G.X.01   Cromoglycic acid

    R.03.B.C.01   Cromoglycic acid

    Pharmacodynamics:

    Cromohexal refers to anti-allergic anti-inflammatory anti-asthmatic agents. The active substance in this preparation is cromoglycic acid. When systematically applied, it leads to a reduction in the symptoms of allergic inflammation in the respiratory system. Cromoglycic acid inhibits both early and late stages of an allergic reaction, preventing the degranulation of mast cells and the release of inflammatory mediators (histamine, bradykinin, slowly reacting substance, leukotrienes) from them. Due to these properties, Cromohexal prevents bronchospasm caused by contact with an allergen or other provoking factor (cold air, physical stress, stress). In addition, it allows you to reduce the intake of other anti-asthmatic agents (bronchodilators, glucocorticoids). The effect of the drug develops gradually.After 4-6 weeks of using the drug, the frequency of asthma attacks decreases. Treatment should be long. When the drug is withdrawn, resumption of asthma attacks is possible. To stop the attacks of bronchial asthma, the drug is not used.

    Pharmacokinetics:

    After administration by inhalation, the maximum concentration of cromoglycic acid is reached after approximately 15 minutes. Cromoglycic acid slightly absorbed from the respiratory tract. Only 8% of the administered dose is subject to systemic absorption. The half-life is 46-99 minutes (an average of about 80 minutes). Cromoglycic acid not metabolized. It is excreted from the body in unchanged form with urine and bile in approximately equal amounts. The rest of the drug is removed from the lungs with a current of exhaled air, or settles on the walls of the oropharynx, then swallowed (and without significant absorption - less than 2%) and is excreted from the body through the digestive tract.

    Indications:

    Prevention and treatment of bronchial asthma (including asthma of physical effort) in children and adults.

    Contraindications:

    - Hypersensitivity to any components of the drug.

    - Children under 5 years

    Carefully:

    Treatment of patients with impaired liver and kidney function should occur under the constant supervision of a physician (should consider the feasibility of reducing the dose).

    Pregnancy and lactation:

    The drug should not be given to women during the first 3 months of pregnancy and during lactation. Cromoglycic acid may be prescribed by a doctor only when the expected benefit to the mother exceeds the possible risk to the fetus or infant. There is no data on the penetration of the drug into breast milk.

    Dosing and Administration:

    Inhalation.

    Adults (including the elderly) and children:

    According to the contents of one ampoule (20 mg / 2ml) 4 times a day, if possible, at equal time intervals. Frequency of application can be increased up to 6 times if necessary.

    When the optimal therapeutic effect is achieved, it is possible to switch to a maintenance dose, which ensures optimal control of the disease. The initial course of therapy should be at least 4 weeks. The duration of therapy is determined by the attending physician.

    After achieving a therapeutic effect, do not suddenly stop using the drug. If necessary, discontinuation of the drug cancellation is carried out gradually within a week. When the dose is reduced, it is possible to resume the symptoms of the disease.

    Inhalation should be performed with a special inhaler - a nebulizer, through a face mask or mouthpiece. To open the ampoule, the upper marked part of the ampoule is broken off.

    Side effects:

    The drug can cause irritation of the upper respiratory tract, hoarseness, cough, short-term bronchospasm. In the case of recurrent bronchospasm, the bronchodilator is pre-inhaled, and the cough is soothed by the intake of water immediately after inhalation.

    To rare undesirable phenomena are: anaphylaxis, headaches and dizziness, painful or difficult urination, nausea and rash. After drug cancellation, exacerbation of bronchial asthma, eosinophilic lung infiltrate is possible.

    Overdose:Cromoglycic acid has low toxicity, so the risk of overdose and the development of any toxic phenomena is small.
    Interaction:

    Bethe-adrenostimulators, glucocorticosteroids, antihistamines and theophylline enhance the effect.

    Combined appointment of cromoglycic acid and glucocorticosteroids can reduce the dose of the latter, and in some cases completely cancel.

    In an inhalation solution, it is pharmaceutically incompatible with bromhexine or ambroxol.

    When combined with bronchodilators, they must be taken (inhaled) before inhalation of the drug.

    Special instructions:

    For the relief of acute attacks of bronchial asthma, the drug is not used. Treatment of patients with impaired renal and hepatic function should occur under the constant supervision of a physician (should consider the feasibility of reducing the dose). During the reduction of the dose of glucocorticosteroids, the patient should be under the careful supervision of the doctor: the rate of dose reduction should not exceed 10% per week.

    Form release / dosage:

    Solution for inhalation 10 mg / ml.

    Packaging:2 ml each in transparent ampoules made of polyethylene. 10 ampoules per tape. For 5 or 10 tapes together with instructions for use 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 the medicinal product after the expiration date indicated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N014056 / 01
    Date of registration:14.08.2008 / 25.07.2014
    Expiration Date:Unlimited
    Date of cancellation:2016-07-11
    The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia
    Manufacturer: & nbsp
    Representation: & nbspSANDOZ SANDOZ Switzerland
    Information update date: & nbsp11.07.2016
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