Active substanceMometasoneMometasone
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  • Dosage form: & nbspPinhalable inhalation powder
    Composition:

    Each twisthailer contains:

    Asmaneks Twistheiler 200 μg / dose:

    Ingredients

    Composition on Twistheiler

    (30 doses)

    Composition on Twistheiler

    (60 doses)

    Content in one gram

    Content in a single dose

    Mometasone furoate

    35.0 mg

    35.0 mg

    147 mg

    200 μg

    Lactose anhydrous

    205.0 mg

    205.0 mg

    853 mg

    1161 μg

    Asmanex Twistheiler 400 μg / dose:

    Ingredients

    Composition on Twistheiler

    (30 doses)

    Composition on Twistheiler

    (60 doses)

    Content in one gram

    Content in a single dose

    Mometasone furoate

    35.0 mg

    35.0 mg

    147 mg

    400 μg

    Lactose anhydrous

    205.0 mg

    205.0 mg

    853 mg

    2321 mcg

    Description:

    White or almost white powder agglomerates without visible foreign matter.

    Pharmacotherapeutic group:Glucocorticosteroid for topical application
    ATX: & nbsp

    R.01.A.D.09   Mometasone

    Pharmacodynamics:
    Asmanex® Twistheiler® (mometasone furoate) - glucocorticosteroid (GCS) preparation for inhalation, which has a local anti-inflammatory effect.

    The mechanism of antiallergic and anti-inflammatory action of mometasone furoate is due to its ability to inhibit the release of inflammatory mediators. In vitro mometasone furoate significantly inhibits the release of leukotrienes from leukocytes. In cell cultures mometasone furoate demonstrated a high ability to inhibit the synthesis and release of interleukins 1, 5 and 6 (IL-1, IL-5, IL-6), as well as tumor necrosis factor alpha (TNF-α); it is also an inhibitor of the product LT (leukotrienes), as well as an extremely potent inhibitor of Th2cytokines, interleukins 4 and 5 Cd4+ Human T cells.

    In mometasone furoate, the affinity and ability to bind to human GCS receptors is 12 times higher than in dexamethasone, 7 times higher than that of triamcinolone acetonide, 5 times higher than that of budesonide and 1.5 times higher than that of fluticasone .

    The use of Asmanex® Twisthaler® at doses of 100 to 800 μg / day improves the function of external respiration (in terms of peak expiratory flow rate and forced expiratory volume in the first second), leads to a more complete control of the symptoms of bronchial asthma and reduces the need for the use of inhalation beta2-adrenomimetics. Improvement of respiratory function is observed in some patients already 24 hours after the start of therapy, but the maximum effect is usually achieved no earlier than in 1-2 weeks.Improvement of the function of breathing is maintained throughout the treatment period.

    In patients with bronchial asthma, with regular use of Asmanex® Twisthaler® for 4 weeks at doses of 200 μg 2 times / day to 1200 μg there are no signs of suppression of the hypothalamic-pituitary-adrenal system, and systemic effects appear only when used at a dose of 1600 mcg / day.

    Pharmacokinetics:

    Systemic bioavailability of mometasone furoate after inhalation is low, in particular, due to low absorption and significant presystemic metabolism of this drug when it is ingested. In various studies evaluating the effects of mometasone furoate in the equilibrium state when administered as an inhalation, and after a single intravenous injection, absolute bioavailability was approximately 16% in healthy patients and approximately 10% in patients with asthma. When administered at recommended doses, the concentration of the drug in the plasma is about or below the detection threshold (50 pg / ml). As a consequence, it is impossible to determine either the half-life or the volume of distribution of mometasone furoate after inhalation.

    Indications:

    - Basic therapy of bronchial asthma (BA) of any severity (including in patients who previously used both inhalation and systemic GCS, as well as inadequate effectiveness of previously used therapy without the use of GCS);

    - Chronic obstructive pulmonary disease (COPD) from moderate to severe.

    Contraindications:

    - Children's age (up to 12 years).

    - Established hypersensitivity to the drug components (mometasone furoate and lactose).

    Carefully:

    Active or latent pulmonary tuberculosis, fungal, bacterial or systemic viral infections, herpetic eye damage (Herpes simplex), pregnancy, lactation.

    Pregnancy and lactation:

    Adequate and well-controlled studies of the use of the drug during pregnancy have not been conducted, and there is no evidence as to whether the drug penetrates mometasone furoate in breast milk. However, after inhalation, the concentration of mometasone furoate in the blood plasma is very low; the impact on the fetus is probably extremely small, the likelihood of toxic effects on reproductive efficiency is very low.The use of Asmanex® Twistheiler® (as well as other inhaled glucocorticosteroids) during pregnancy and in nursing mothers is possible only if the intended benefit to the mother exceeds the potential risk to the fetus or the baby. Newborns, whose mothers received SCS during pregnancy, require monitoring to identify signs of insufficiency of the function of the adrenal cortex.

    Dosing and Administration:
    In the form of inhalation. The recommended dose depends on the severity of the disease.

    With a stable course of asthma, mild to moderate The recommended initial dose of Asmanex® Twisthaler® is 400 μg once a day. Inhalation recommended to do in the evening. In some patients (for example, who received prior inhaled glucocorticosteroids in high doses), more adequate control of the course of the disease is achieved when the daily dose of 400 μg is divided into 2 inhalations. In a number of patients with maintenance therapy, it is possible to reduce the daily dose to 200 μg once a day in the evening. In these cases, you should use the drug Asmanex® Twisthaler® with a content of mometasone furoate 200 μg in 1 dose.

    The dose should be selected individually (until a minimum dose is provided that provides adequate control over the course of asthma).

    In severe AD the initial recommended dose is 400 μg 2 times a day, which corresponds to the maximum recommended daily dose of 800 μg. After achieving effective control of asthma symptoms, the dose of Asmanex® Twisthaler® should be gradually reduced to a minimum effective dose.

    When switching from oral GKC to therapy with Asmanex® Twisthaler® first, both drugs are used simultaneously. After about a week of simultaneous application, the oral GCS gradually begins to be canceled, reducing its daily dose or skipping one dose. The next dose reduction is carried out after 1 or 2 weeks, depending on the patient's condition. The dose should not be reduced by more than 2.5 mg prednisolone per day (or its equivalent). Cancellation must be carried out gradually. This requires careful monitoring of the patient's condition, including indicators of the function of breathing (in order not to miss the moment of worsening of the course of bronchial asthma) and adrenal function (to exclude the failure of adrenal cortex function).

    With COPD the recommended dose is 800 mcg / day.Most patients can take the entire dose once a day in the evening. For some patients, the drug is more effective 400 μg 2 times a day.

    Terms of use of the inhaler-Twistheiler

    Before opening the Twistheiler, make sure that it is in an upright position, and the counter and the pointer on the cover are aligned. Then Twistheiler is opened by sliding the white cover counterclockwise while holding the Twistheiler base in a fixed position. The dose counter notes the use of 1 dose.

    Further Twistheyler should be placed in the mouth and, with a mouthpiece around his mouth, inhale quickly and deeply. Then take the mouthpiece out of your mouth and hold your breath for 10 seconds or for as long as it is comfortable for the patient. The patient should not exhale through Twistheiler.

    To close the Twistheyler, you must return the lid to its place immediately after inhalation and turn the lid clockwise, while gently pushing it down until it clicks and the lid completely closes. The arrow on the lid is fully aligned with the counter window.At the same time, a new dose of the drug is loaded for the next inhalation.

    The patient should be advised to rinse the mouth after each inhalation. This reduces the risk of oral candidiasis.

    The counter display will show when the last dose is loaded. After dose 01, the counter will show 00 and the lid will be locked. After this, the inhalation will become impossible and Twistheiler should be discarded.

    Twistheiler must be kept dry and clean. The mouthpiece from the outside can be wiped with dry gauze or cloth. Twistheiler can not be washed with water.

    Application in pediatric practice

    The safety and efficacy of Asmanex® Twistheiler® in children under 12 years of age have not been studied.

    It is recommended to regularly monitor the growth of adolescents who received long-term therapy for inhalation. If the growth slows down, the current therapy should be reviewed to reduce the dose of inhaled glucocorticosteroids to a minimum, at which effective control over the symptoms of the disease is achieved.

    Side effects:
    Most often: Candidiasis of the oral cavity, pharyngitis, dysphonia, headache.

    Rarely: dry mouth and throat, dyspepsia, weight gain, palpitations.

    There are no data that indicate that the risk of developing adverse events is higher in adolescents or in patients 65 years of age or older.

    Possible development of systemic side effects, characteristic of inhaled glucocorticosteroids, especially when used in high doses and for a long time.

    When using inhaled GCS for the treatment of asthma, it is possible to develop bronchospasm and increase the number of wheezing in the lungs immediately after inhalation; may also arise systemic side effects (especially when used in high doses and for a long time). These effects include inhibition of adrenal cortex function, growth retardation in children and adolescents, demineralization of bone tissue, glaucoma, increased intraocular pressure, and cataract development.

    During the post-marketing application single reports of hypersensitivity reactions, such as rash, itchy skin, angioedema and anaphylactic reaction, have been reported. It was reported that the course of asthma worsening, which can be manifested by coughing, shortness of breath, wheezing and bronchospasm.

    Overdose:

    Due to the low systemic bioavailability of the Asmanex® Twistheiler® drug, an overdose does not require any special therapy, other than monitoring the patient's condition. Then the drug should be resumed at the therapeutic dose.

    It should be borne in mind that prolonged use of GCS for inhalations in elevated doses can lead to suppression of the function of the hypothalamic-pituitary-adrenal system. In such cases, symptomatic therapy, gradual withdrawal of the drug, correction of electrolyte disorders are carried out.

    Interaction:With concomitant use of Asmanex® Twisthaler® and an enzyme inhibitor CYP3A4 ketoconazole increased the concentration of mometasone furoate in blood plasma. However, it is unlikely that these changes are of clinical significance.
    Special instructions:
    As with the use of other corticosteroids, one should remember the possibility of developing hypersensitivity reactions, including rash, hives, itching, erythema, as well as swelling of the eyes, face, lips and throat.

    Asmanex® Twisthailer® is not intended for rapid relief of bronchospasm.The patient should be warned that for this purpose, inhalation bronchodilators of rapid action should be used.

    The patient should also be warned about the need to seek immediate medical attention if the episodes of asthma exacerbation can not be controlled by the use of bronchodilators against the background of therapy with Asmanex® Twistheiler®. In these cases, an increase in the dose of Asmanex® Twisthaler® (up to the maximum recommended daily dose) or / and the administration of systemic GCS may be required.

    It is necessary to explain to the patient the necessity of the constant use of the drug Asmanex® Twistheiler® (even in the absence of symptoms of the disease) and the inadmissibility of abrupt discontinuation of inhalations.

    When switching from systemic GCS to inhalation with Asmanex® Twisthaler®, special care is required because of the possible risk of adrenal insufficiency. After the abolition of systemic SCS, it takes several months to restore the function of the hypothalamic-pituitary-adrenal system.

    During stressful situations, including trauma, surgical interventions, infectious diseases or a severe attack of bronchial asthma,previously receiving SCS for systemic use, additional short-term administration of systemic SCS is required, which then, as the symptoms subsided, are gradually canceled. Such patients should be advised to carry a small amount of GCS for oral administration along with a cautionary card. It should indicate the need to use in stressful situations systemic GCS and their recommended dose. In this category of patients, it is necessary to regularly monitor the function of the adrenal glands (in particular, morning cortisol in the blood plasma).

    When switching from systemic GCS to Asmanex® Twistheiler®, it is possible to develop concomitant allergic diseases, the symptoms of which were previously suppressed by corticosteroid systemic therapy. During this period, some patients may have signs of abolition of systemic SCS, including muscle and / or joint pain, depression, fatigue, even though lung function indicators are stable or even improving. Such patients should be persuaded of the need to continue therapy with Asmanex® Twisthaler®, but carefully monitor their condition in connection with the possible development of adrenal insufficiency.If there are signs of adrenal insufficiency, you should temporarily increase the dose of GCS for systemic application, and in the future their cancellation is more smooth.

    As with the use of other inhalants, after the use of the drug Asmanex® Twistheiler®, paradoxical bronchospasm may develop. In this case, immediate application of inhaled rapid-acting bronchodilators is required, followed by withdrawal of Asmanex® Twisthaler® and the use of alternative therapies.

    Patients who receive SCS or other immunosuppressants should be advised to avoid contact with patients with certain infections (chicken pox, measles) and be sure to consult with a doctor if such contact occurs (especially when used in adolescents (over 12 years old).

    To maintain a low hypothalamic-pituitary-adrenal-suppression system, do not exceed recommended doses, and in each patient, the dose of Asmanex® Twisthaler® should be titrated to achieve a minimum effective dose. When prescribing the drug Asmanex® Twistheiler®, the doctor should take into account that the effect of the drug on the production of cortisol can vary in different patients.

    Data that the use of the drug Asmanex® Twistheiler® in doses exceeding the recommended leads to an increase in its therapeutic effect, is not available.

    The onset of candidiasis may require appropriate antifungal therapy or discontinuation of Asmanex® Twisthaler®.

    Effect on the ability to drive transp. cf. and fur:Asmanex® Twistheiler® does not or does not have a significant effect on the ability to drive vehicles and work with machinery.
    Form release / dosage:Pinhalation powder dosed, 200 mcg / dose and 400 μg / dose.
    Packaging:

    240 mg powder for inhalation in an inhaler-twistheiler (30 or 60 doses). Twistheiler is packed in aluminum foil, laminated with a polymer film.

    Packed in foil, the twisthailer along with the instruction for use is placed in a cardboard box.

    Storage conditions:

    In a place inaccessible to children, at a temperature of 8 to 30 ° C.

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Use within 3 months after opening the foil packaging.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-000594
    Date of registration:31.08.2010 / 27.04.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:Schering-Plau N. Labo.Schering-Plau N. Labo. Belgium
    Manufacturer: & nbsp
    Representation: & nbspMSD Pharmaceuticals Ltd.MSD Pharmaceuticals Ltd.
    Information update date: & nbsp27.09.2017
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