Active substanceSalmeterol + FluticasoneSalmeterol + Fluticasone
Similar drugsTo uncover
  • Salticasone® aeronaut
    aerosol d / inhal. 
    NATIVA, LLC     Russia
  • Salticasone®-native
    powder d / inhal. 
    NATIVA, LLC     Russia
  • Salmecort®
    aerosol d / inhal. 
  • Seretide®
    aerosol d / inhal. 
  • Seretid® Multidisk
    powder d / inhal. 
  • Seroflo
    capsules d / inhal. 
    Cipla Ltd.     India
  • Tevacomb
    aerosol d / inhal. 
    Cipla Ltd.     India
  • Tevacombe Multihaler
    powder d / inhal. 
    Cipla Ltd.     India
  • Dosage form: & nbsppowder for inhalation dosed
    Composition:

    Name of components

    amount2, mcg / dose

    50 mcg


    +

    100 μg

    /dose

    50 μg

    +

    250 mcg / dose

    50 μg

    500 mcg / dose

    Active substances



    Salmetrotrol xinafoate micronized




    (in terms of salmeterol)

    72,5

    50

    72,5

    50

    72,5 50

    Fluticasone propionate micronized

    100

    250

    500

    Excipient

    Lactose Monohydrate

    before

    12,5

    mg

    up to 12.5 mg

    up to 12.5 mg


    Notes:
    1. The indicated amounts for Fluticasone propionate (micronized) mean 100% m / m activity (purity). The actual amount of the substance Fluticasone propionate (micronized) can be adjusted depending on the purity of the batch of the substance.
    2. To compensate for production losses, a mixture of all substances can be poured into the blister with an excess of up to 6%.
    Description:A round plastic device (inhaler) of two shades of purple (dark purple and light violet) color about 8.5 cm in diameter and about 3 cm in height with a counter of doses showing 28 or 60 doses. The inhaler contains one blister with 28 or 60 cells, each cell contains white or almost white powder.
    Pharmacotherapeutic group:Bronchodilator (beta2-adrenomimetic selective + glucocorticosteroid local).
    ATX: & nbsp

    R.03.A.K   Sympathomimetics in combination with corticosteroids or other drugs, excluding anticholinergic drugs

    R.03.A.K.06   Salmeterol and fluticasone

    Pharmacodynamics:
    Mechanism of action
    The drug Seretide® Multidisk is a combined preparation that contains salmeterol and fluticasone propionate, which possess different mechanisms of action. Salmeterol prevents the appearance of symptoms of bronchospasm, fluticasone propionate improves pulmonary function and prevents the exacerbation of the disease. The drug Seretide® Multidisk because of the more convenient dosage regimen can be an alternative for patients,which simultaneously receive the beta2-adrenoreceptor agonist and inhaled glucocorticosteroid (GCS) from different inhalers. Salmeterol is a selective long-acting (up to 12 h) beta2-adrenergic receptor agonist having a long side chain that binds to the receptor's outer domain.
    Pharmacological properties of salmeterol provide more effective protection against histamine-induced bronchoconstriction and longer bronchodilation (duration of at least 12 hours) than short-acting beta2-adrenoreceptor agonists.
    In vitro studies have shown that salmeterol is a potent inhibitor of the release from the human lungs of mast cell mediators, such as histamine, leukotrienes and prostaglandin D2, and has a prolonged period of action. Salmeterol oppresses the early and late phases of the response to inhaled allergens. The inhibition of the late phase of the response persists for more than 30 hours after taking a single dose, while the bronchodilator effect is no longer present. Single administration of salmeterol weakens the hyperreactivity of the bronchial tree. This indicates that salmeterol in addition to bronchodilating activity has an additional effect, not associated with the expansion of bronchi, the clinical significance of which has not been finally established. This mechanism of action is different from the anti-inflammatory effect of GCS.
    Fluticasone propionate belongs to the SCS group for topical application and, when inhaled at recommended doses, it has a pronounced anti-inflammatory and anti-allergic effect in the lungs, which leads to a decrease in clinical symptoms, a decrease in the frequency of exacerbations of bronchial asthma. Fluticasone propionate does not cause undesirable phenomena, which are observed with systemic intake of corticosteroids.
    With prolonged use of inhalation fluticasone propionate, the daily secretion of hormones in the adrenal cortex remains within normal limits in both adults and children, even when using the maximum recommended doses. After transferring patients receiving other inhaled glucocorticosteroids to the administration of fluticasone propionate, the daily secretion of adrenal cortex hormones gradually improves, despite the previous and current recurrent use of oral steroids.This indicates the restoration of the adrenal function against the background of the inhalation application of fluticasone propionate. With prolonged use of fluticasone propionate, the reserve function of the adrenal cortex also remains within normal limits, as evidenced by a normal increase in cortisol production in response to appropriate stimulation (it should be borne in mind that the residual decrease in adrenal reserve caused by previous therapy may persist for a long time).
    Pharmacokinetics:
    There is no evidence that when combined inhalation salmeterol and fluticasone propionate affect the pharmacokinetics of each other, and therefore the pharmacokinetic characteristics of each component of the drug Seretide® Multidisk can be considered separately.
    A study conducted with the participation of 15 healthy volunteers who simultaneously received salmeterol (inhalation 50 μg twice a day) and inhibitor of isoenzyme CYP3A4 - ketoconazole (oral 400 mg once a day) for 7 days showed a significant increase in salmeterol concentration in blood plasma (Cmax increase 1.4 times and AUC 15-fold). There was no increase in salmeterol accumulation when taking repeated doses.In 3 patients, treatment was canceled because of prolongation of the QTc interval or rapid heart rate with sinus tachycardia. In the remaining 12 patients, simultaneous use of salmeterol and ketoconazole did not have a clinically significant effect on heart rate, potassium level in the blood, or the duration of the QTc interval (see the sections "With caution", "Special instructions and precautions for use", "Interaction with other medicinal products ").
    Suction
    Salmeterol acts locally in the lung tissue, so its content in the blood plasma is not an indicator of therapeutic effects. Data on its pharmacokinetics are very limited due to technical problems: when inhaled in therapeutic doses, its maximum plasma concentration is extremely low (about 200 pg / ml and below). After regular inhalation with salmeterol, it is possible to detect hydroxynaphthoic acid in the blood, the equilibrium concentrations of which are about 100 ng / ml. These concentrations are 1000 times lower than the equilibrium concentrations observed in the toxicity studies. No adverse effects were observed with prolonged regular use of the drug (for more than 12 months) in patients with airway obstruction.
    Fluticasone propionate: the absolute bioavailability of inhalation fluticasone propionate in healthy people varies depending on the inhaler used, when a combination of salmeterol and fluticasone propionate is administered with a Multidisk inhaler it is 5.5%. In patients with bronchial asthma and chronic obstructive pulmonary disease (COPD), lower concentrations of fluticasone propionate in blood plasma are observed. Systemic absorption occurs mainly through the lungs. At first it is faster, but then its speed slows down.
    Part of the inhalation dose can be swallowed, but this part contributes minimal contribution to systemic absorption due to the low solubility of fluticasone propionate in water and due to its pre-systemic metabolism; bioavailability from the gastrointestinal tract is less than 1%. As the inhalation dose increases, a linear increase in the concentration of fluticasone propionate in the blood plasma is observed.
    Distribution
    There is no data on the distribution of salmeterol.
    Fluticasone propionate has a large volume of distribution in the equilibrium state (about 300 liters) and has a relatively highthe degree of binding to plasma proteins (91%).
    Metabolism
    The results of the in vitro study showed that salmeterol Extensively metabolized under the action of the CYP3A4 isoenzyme of the cytochrome P450 system to a-hydroxysalmeterol by aliphatic oxidation. In a study with repeated dosing of salmeterol and erythromycin, healthy volunteers did not have clinically significant changes in pharmacodynamic effects when taking 500 mg of erythromycin 3 times a day. However, the study of the interaction of salmeterol and ketoconazole showed a significant increase in the concentration of salmeterol in the blood plasma (see sections "Special instructions and precautions for use", "Interaction with other medicinal products"),
    Fluticasone propionate is rapidly eliminated from the blood, mainly as a result of metabolism under the action of the CYP3A4 isoenzyme of the cytochrome P450 system to the inactive carboxyl metabolite. Caution should be exercised while using known inhibitors of CYP3A4 and fluticasone propionate, since in such situations it is possible to increase the content of the latter in plasma.
    Excretion
    There is no data on salmeterol excretion.
    The distribution of fluticasone propionate is characterized by a rapid clearance from the plasma (1150 ml / min) and a final half-life of about 8 hours. The renal clearance of unchanged fluticasone propionate is negligible (<0.2%), a metabolite with urine displays less than 5% of the dose.
    Indications:
    The drug Seretide® Multidisk is designed for regular treatment of bronchial asthma if combined therapy with long-acting beta2-adrenomimetic and inhaled corticosteroid is indicated:
    - patients with inadequate control of the disease on the background of continuous monotherapy with inhaled corticosteroids in the periodical use of short-acting beta2-adrenomimetics,
    or
    - patients with adequate disease control on the background of inhaled corticosteroid therapy and long-acting beta2-adrenomimetic.
    or
    - as a starting maintenance therapy in patients with persistent bronchial asthma in the presence of indications for the appointment of glucocorticosteroids to achieve control of the disease.
    The drug Seretide® Multidisk is intended for maintenance therapy inpatients with COPD with the value of forced expiratory volume (FEV1) <60% of the proper values ​​(before inhalation bronchodilator) and repeated exacerbations in the history, in which the expressed symptoms of the disease persist despite regular therapy with bronchodilators.
    Contraindications:
    - Hypersensitivity to the components of the drug;
    - children's age up to 4 years.
    Carefully:
    Like all other inhaled preparations containing GCS, Seretide® Multidisk should be used with caution in patients with acute or latent pulmonary tuberculosis.
    Seretide® Multidisk should be given with caution in thyrotoxicosis. The drug Seretide® Multidisk should be used with caution in fungal, viral or bacterial infections of the respiratory system.
    When taking any drugs group of sympathomimetics, especially when the therapeutic dose is exceeded, it is possible to develop cardiovascular events such as an increase in systolic blood pressure and heart rate. For this reason, the Seretide® Multidisk preparation should be administered with caution to patients,suffering from cardiovascular diseases, including arrhythmias, such as supraventricular tachycardia and extrasystole, ventricular extrasystole, atrial fibrillation.
    All simpatomimeticheskie drugs in dosages exceeding the therapeutic, can cause a transient decrease in the level of potassium in the serum. Therefore, the drug Seretide® Multidisk should be administered with caution to patients with hypokalemia. The drug Seretide® Multidisk should be used with caution in individuals with an allergic reaction to lactose and milk protein in the anamnesis, since residual amounts of protein can be included in the composition of lactose.
    Any inhaled GCS can cause systemic effects, especially with prolonged use in high doses. Therefore, the drug should be used with caution in glaucoma, cataracts, osteoporosis (see section "Special instructions and precautions for use").
    There are very rare reports of an increase in blood glucose, so patients with diabetes should use the drug Seretid® Multidisk with caution (see section "Side effects").
    Pregnancy and lactation:
    Pregnant women and women should be prescribed lactation only if the expected benefit to the mother exceeds any possible risk to the fetus or child.
    There is insufficient data on the use of salmeterol and fluticasone propionate in pregnancy and lactation.
    Pregnancy
    Reproductive toxicity of the drug and its components was studied during preclinical studies. Excessive systemic concentration of active beta2-adrenomimetic and GCS affects the fetus.
    Extensive experience in the clinical use of drugs of this class indicates that with the use of therapeutic doses, the described effects are not clinically significant. Salmeterol and fluticasone propionate do not possess genotoxicity.
    Lactation
    The concentration of salmeterol and fluticasone propionate in blood plasma after inhaling the drug in therapeutic doses is extremely low, so their concentration in breast milk should be the same low. This is confirmed by studies in animals in the milk of which low concentrations of salmeterol and fluticasone propionate were measured.There is no data on the concentration of salmeterol and fluticasone propionate in breast milk of women during breastfeeding.
    Dosing and Administration:
    The drug Seretide® Multidisk is intended only for inhalations.
    The patient should be informed that to obtain the optimal effect the drug should be used regularly, even in the absence of clinical symptoms of bronchial asthma and COPD.
    The physician should regularly evaluate the effectiveness of the patient's treatment.
    Determining the duration of the course of therapy and changing the dose of the drug is possible only on the advice of a doctor.
    Bronchial asthma
    The dose of Seretide® Multidisk should be lowered to the lowest dose that provides effective symptom control.
    If taking Seretide® Multidisk twice a day provides control over the symptoms, within the limits of dose reduction to minimally effective it is possible to reduce the frequency of taking the drug up to 1 time per day.
    The patient should be prescribed a form of Seretide® Multidisk, which contains a dose of fluticasone propionate, corresponding to the severity of his disease.If therapy with inhaled glucocorticosteroids does not provide adequate control over the disease, then their replacement with Seretide® Multidisk in a dose therapeutically equivalent to that administered by GCS can improve the control of the course of bronchial asthma. In patients who can monitor the course of bronchial asthma solely with the help of inhaled glucocorticosteroids, their replacement with Seretide® Multidisk can reduce the dose of GCS necessary to control the course of asthma.
    Recommended doses
    Adults and children 12 years and older
    One inhalation (50 μg salmeterol and 100 μg fluticasone propionate) 2 times a day,
    or
    one inhalation (50 μg salmeterol and 250 μg fluticasone propionate) 2 times a day,
    or
    one inhalation (50 μg salmeterol and 500 μg fluticasone propionate) 2 times a day.
    Children 4 years and over
    One inhalation (50 μg of salmeterol and 100 μg of fluticasone propionate) 2 times a day. Currently, there is no data on the use of Seretide® Multidisk in children under 4 years of age.
    Chronic obstructive pulmonary disease (COPD)
    For adult patients, the maximum recommended dose is 1 inhalation (50 μg salmeterol and 500 μg fluticasone propionate) 2 times a day.For this dose of Seretide® Multidisk, the reduction in mortality from any cause was demonstrated.
    Special patient groups
    There is no need to reduce the dose of Seretide® Multidisk in elderly patients, as well as in patients with impaired renal or hepatic function.
    INSTRUCTION FOR USE OF THE INHROLER "MULTIDISK"
    Multidisk is closed

    When you remove the Seretide® Multidisk from the box, it is in the closed position.

    Housing

    The inhaler opens in this direction
    Deepening for the thumb
    (to open and close the inhaler)

    Multidisk is open
    Multidisk is open
    Housing
    dose indicator
    Full Empty

    60 0

    The drug Seretide® Multidisk contains 28 or 60 doses in the form of a powder. Each dose is measured and hygienically protected. No maintenance of the dose level is required, nor its additional filling.
    The inhaler has an indicator, which, after the inhalation, shows the number of remaining doses. The numbers go in descending order from 60 to 0 or from 28 to 0. The numbers from 5 to 0 are red, warning that only a few doses remain in the inhaler. The appearance in the window of the digit 0 means that the inhaler is empty and unsuitable for further use.

    For inhalation, perform five consecutive actions:
    1.open the inhaler;
    2. Press the lever;
    3. inhale the dose of the drug;
    4. close the inhaler;
    5. Rinse your mouth.

    How the inhaler works
    When you turn the lever inhaler opens a small hole in the mouthpiece, one dose is ready for inhalation. When the inhaler closes, the lever automatically returns to its original position, thus remaining ready to receive the next required dose. The packaging protects the inhaler when not in use.

    1. Open the inhaler
    Hold the body with one hand, placing the thumb of the other hand in a special recess. To open the inhaler, press your thumb against yourself until you hear a click.


    2. Press the lever

    Hold the inhaler with a mouthpiece to your face. The inhaler can be held with your right or left hand. Push the lever in the direction from yourself to the stop until you hear a click. The inhaler is now ready for use. When you press the lever, another cell with powder for inhalation is opened. At the same time, the number of remaining doses decreases, which is indicated in the indicator window. Push the lever only before inhalation, otherwise it will lead to a waste of the drug.


    3. Inhale the dose of the medicine
    Before inhalation, read this section carefully.

    - Keep the inhaler some distance from the mouth and make a deep exhalation without effort. Remember: never breathe out into the inhaler!
    - Tightly grasp the mouthpiece with your lips. Take a uniform and deep breath through your mouth (not through your nose).
    - Remove the inhaler from the mouth.
    - Hold your breath for about 10 seconds or longer, as far as you can.
    - Make a slow exhalation.


    4. Close the inhaler
    To close the inhaler, place your thumb in a special recess and push towards you until it clicks into place. The lever automatically returns to its original position. The inhaler is again ready for use.


    5. Rinse your mouth
    After using the inhaler, rinse the mouth with water and then spit it out.

    Remember
    Keep the inhaler dry.
    Keep it closed when not in use.
    Never breathe out into the inhaler.
    Turn the lever only when you are ready to take a dose. Do not exceed the prescribed dose. Keep the inhaler out of the reach of children.

    Side effects:All the undesirable reactions presented below are typical for the active substances of the drug - salmeterol and fluticasone propionate alone.The profile of undesirable reactions of the drug Seretide® Multidisk does not differ from the profile of undesirable reactions of its active substances. The undesirable reactions presented below are listed in accordance with the damage to organs and organ systems and frequency of occurrence. Frequency of occurrence is defined as follows: very often (> 1/10). often (>1/100 and <1/10), infrequently (> 1/1 000 and <1/100). rarely (> 1/10 000 and <1/1 000), very rarely (<1/10 000), including individual cases). Frequency categories were formed on the basis of clinical trial data and post-registration surveillance.
    Clinical Trials Data
    Frequency of occurrence of undesirable reactions
    Infectious and parasitic diseases
    Often: candidiasis of the oral cavity and pharynx, pneumonia (in patients with COPD).
    Rarely: Candidiasis of the esophagus.
    Immune system disorders
    Hypersensitivity reactions
    Infrequent: skin reactions
    hypersensitivity, dyspnea.
    Rarely: anaphylactic reactions.
    Disorders from the endocrine system
    Possible system effects (see section "Special instructions")
    Infrequently: cataract.
    Rarely: glaucoma.
    Disorders from the metabolism and nutrition
    Infrequently: hyperglycemia.
    Rarely: hypokalemia.
    Disorders of the psyche
    Infrequently: anxiety, sleep disturbances.
    Rarely: changes in behavior, including hyperactivity and irritability (especially in children).
    Disturbances from the nervous system
    Often: headache (see section "Special instructions").
    Infrequently: tremor (see section "Special instructions").
    Heart Disease
    Infrequently: heart palpitations (see "With caution" and "Special instructions"), tachycardia, atrial fibrillation.
    Rarely: arrhythmia, including ventricular extrasystole, supraventricular tachycardia and extrasystole.
    Violations from the respiratory system, chest organs and the mediastinum
    Often: hoarseness of voice and / or dysphonia.
    Infrequently: irritation of pharynx.
    Disturbances from the skin and subcutaneous tissues
    Infrequently: bruising.
    Disturbances from musculoskeletal and connective tissue
    Often: muscle spasms, arthralgia.
    Data post-registration observations
    Frequency occurrence of undesirable reactions
    Immune system disorders
    Hypersensitivity reactions
    Rarely: angioedema (mainly, edema of the face and oropharynx), bronchospasm.
    Disorders from the endocrine system
    Possible system effects (see section "Special instructions")
    Rarely: Cushing's syndrome, cushingoid symptoms, suppression of adrenal function, growth retardation in children and adolescents, reduction of bone mineral density.
    Disturbances from the respiratory system, chest and mediastinal organs
    Rarely: paradoxical bronchospasm (see section "Special instructions").
    Overdose:
    It is not recommended to administer the drug at doses exceeding those specified in the section "Method of administration and dose". It is very important to regularly review the patient's dosing regimen and reduce the dose to the lowest recommended dose, which provides effective symptom control ("Dosage and Administration").
    Symptoms
    The expected symptoms and signs of an overdose of salmeterol are typical for excessive beta2-adrenergic stimulation and include tremor, headache, tachycardia, increased systolic blood pressure, and hypokalemia. Acute overdose of fluticasone propionate with inhalation can provoke a temporary suppression of the hypothalamic-pituitary-adrenal system.Usually this does not require taking any emergency measures, since the normal function of the adrenal glands is restored within a few days.
    When taking the drug at a dose higher than recommended for a long period of time, it is possible to significantly suppress the function of the adrenal cortex. Rare cases of acute adrenal crisis, which occurred mainly in children who received doses of the drug above recommended for a long time (several months or years), are described. Acute adrenal crisis is manifested by hypoglycemia, accompanied by confusion and / or convulsions. Situations that can serve as triggers for an acute adrenal crisis include trauma, surgery, infection, or any rapid reduction in the dose of the drug Seretide® Multidisk Fluticasone Propionate.
    Treatment
    There is no specific treatment for an overdose of salmeterol and fluticasone propionate. In case of an overdose, supportive therapy should be followed and the patient's condition monitored. In chronic overdose, it is recommended to monitor the reserve function of the adrenal cortex.
    Interaction:
    Because of the risk of developing bronchospasm, selective and nonselective beta-blockers should be avoided, unless they are extremely necessary for the patient.
    In usual situations, inhalations of fluticasone propionate are accompanied by low plasma concentrations due to intensive metabolism in the "first" passage and high systemic clearance under the influence of the CYP3A4 isoenzyme of the cytochrome P450 system in the intestine and liver. Due to this, clinically significant interactions involving fluticasone propionate are unlikely.
    The study of drug interactions in healthy volunteers showed that ritonavir - a highly active inhibitor of the isoenzyme CYP3A4 - can cause a sharp increase in the concentration of fluticasone propionate in the plasma, resulting in a significant decrease in serum cortisol concentrations.
    During post-registration observations, clinically significant drug interactions were reported in patients who simultaneously received fluticasone propionate (intranasally or by inhalation) and ritonavir. These interactions caused systemic side effects peculiar to SCS, such as Cushing's syndrome and suppression of adrenal function. Given this, simultaneous use of fluticasone propionate and ritonavir should be avoided, unless the potential benefit to the patient exceeds the risk of systemic side effects of GCS.
    Studies have shown that other inhibitors of the CYP3A4 isoenzyme cause negligible (erythromycin) and insignificant (ketoconazole) an increase in the content of fluticasone propionate in plasma, in which the concentrations of serum cortisol are practically not reduced. Nevertheless, caution should be exercised when using fluticasone propionate and strong inhibitors of CYP3A4 (eg, ketoconazole), since such combinations do not exclude the possibility of an increase in the concentration of fluticasone propionate in the plasma, which can potentially increase the systemic effects of fluticasone propionate.
    When investigating the interaction of drugs, it was found that the use of ketoconazole as a concomitant systemic therapy significantly increases the concentrationsalmeterol in blood plasma (an increase of Cmax by 1.4 times and AUC by 15 times). This can lead to an elongation of the QTc interval. Caution should be exercised when co-administration of strong inhibitors of CYP3A4 (eg, ketoconazole) and salmeterol.
    The derivatives of xanthine, GCS and diuretics increase the risk of hypokalemia (especially in patients with exacerbation of bronchial asthma, hypoxia). Monoamine oxidase inhibitors and tricyclic antidepressants increase the risk of developing side effects from the cardiovascular system. The drug Seretide® Multidisk is compatible with cromoglycic acid.
    Special instructions:
    The drug Seretide® Multidisk is not intended to alleviate acute symptoms, because in such cases, a rapid and short-acting inhalation bronchodilator should be used (for example, salbutamol). Patients should be informed that they always have at hand a drug to stop acute symptoms.
    The combination of salmeterol and fluticasone propionate can be used for initial maintenance therapy in patients with persistent asthma (daily occurrence of symptoms or dailyuse of funds to stop seizures), if there are indications for the appointment of GCS and when determining their approximate dosage.
    The more frequent use of short-acting bronchodilators to relieve symptoms indicates a worsening of disease control, and in such situations the patient should consult a doctor.
    The sudden and increasing deterioration in the control of bronchial asthma poses a potential threat to life, and in such situations, the patient should also consult a doctor. It is possible that the doctor will prescribe a higher dose of GCS. If the dose of Seretide® Multidisk does not provide adequate control over the disease, the patient should also consult a doctor.
    Patients with asthma can not abruptly stop treatment with Seretide® Multidisk because of the risk of developing an exacerbation, the dose of the drug should be reduced gradually under the supervision of a doctor.
    In patients with COPD, the withdrawal of the drug may be accompanied by symptoms of decompensation and requires the supervision of a physician.
    In clinical studies, data have been obtained on the increase in the incidence of pneumonia in patients with COPD receiving Seretide® Multidisk (see below).see "Side effects"). Doctors should be aware of the possibility of developing pneumonia in COPD, as the clinical picture of pneumonia and exacerbations of COPD are often similar. Any inhaled GCS can cause systemic effects, especially with prolonged use in high doses; it should be noted, however, that the likelihood of such symptoms is much lower than when treated with oral GCS. Possible systemic effects include Cushing's syndrome, cushingoid features, suppression of adrenal function, growth retardation in children and adolescents, reduction of bone mineral density, cataract and glaucoma. Therefore, in the treatment of bronchial asthma, it is important to reduce the dose to the lowest dose, which provides effective control of symptoms.
    In emergency and planned situations, which can cause stress, it is always necessary to remember the possibility of suppressing the adrenal glands and to be ready for application of GCS. When carrying out resuscitation measures or surgical interventions, it is required to determine the degree of adrenal insufficiency.
    It is recommended to regularly measure the growth of children who receive long-term inhaled glucocorticosteroids.
    Because of the possibility of adrenal suppression, patients transferred from oral corticosteroids to inhalation of fluticasone propionate therapy should be treated with extreme caution and regular monitoring of their function of the adrenal cortex. When transferring patients from taking systemic GCS to inhalation therapy, allergic reactions (for example, allergic rhinitis, eczema), which were suppressed by systemic GCS, may appear. In such situations it is recommended to carry out symptomatic treatment with antihistamines and / or topical preparations, incl. GCS for topical application.
    After initiation of treatment with inhaled fluticasone propionate, systemic GCS should be discontinued gradually, and such patients should carry a special patient card containing an indication of the possible need for additional administration of SCS in stressful situations.
    In patients with exacerbation of bronchial asthma, hypoxia, it is necessary to monitor the concentration of K + ions in the plasma.
    There are very rare reports of an increase in blood glucose levels, and this should be remembered by prescribing a combination of salmeterol and fluticasone propionate to patients with diabetes mellitus.
    During the post-marketing period, reports were received of a clinically significant drug interaction between fluticasone propionate and ritonavir leading to systemic effects of GCS, including Cushing's syndrome and suppression of adrenal function. Therefore, it is advisable to avoid the simultaneous use of fluticasone propionate and ritonavir, unless the potential benefit to the patient exceeds the risk associated with systemic effects of GCS (see section "Interaction with other drugs").
    A clinical study of the safety of salmeterol added to ongoing asthma therapy compared with placebo showed that the incidence of lethal outcomes due to bronchial asthma was higher in the salmeterol group. In patients of African American origin, presumably, the risk of serious adverse events from the respiratory system or lethal outcome is higher with salmeterol compared with placebo than in other patients. The importance of pharmacogenetic factors or other causes is unknown. The effect associated with the use of GCS in this study has not been studied.Like other inhaled drugs, the drug Seretide® Multidisk can cause a paradoxical bronchospasm, manifested by the increase of dyspnea immediately after use. In this case, a short-acting inhaled bronchodilator should be immediately applied, the Seretide® Multidisk should be discontinued and alternative therapy should be started, if necessary.
    There are reports of side effects associated with the pharmacological action of betach antagonists, such as a subjective feeling of the heartbeat. However, these phenomena are of a short-term nature, and their severity decreases with regular therapy.

    Effect on the ability to drive transp. cf. and fur:In clinical trials, no evidence of the effect of the drug on the ability to drive vehicles and other mechanisms has been obtained, but side effects that the drug may cause should be considered.
    Form release / dosage:
    The powder for inhalation is dosed, 50 μg + 100 μg / dose, 50 μg + 250 μg / dose, 50 μg + 500 μg / dose.
    Packaging:
    A laminated aluminum blister with 28 or 60 cells (each cell contains 1 dose of the drug) is placed in a round plastic inhaler of two shades of purplecolor (dark purple and light purple). 1 inhaler along with instructions for use in a cardboard pack.
    Storage conditions:
    18 months.
    Do not use after the expiration date stated on the package.
    Shelf life:
    2 years.
    Do not use after the expiration date stated on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N011630 / 01
    Date of registration:10.06.2010
    The owner of the registration certificate:GlaxoSmithKline Trading, ZAO GlaxoSmithKline Trading, ZAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp17.08.2015
    Illustrated instructions
      Instructions
      Up