Seretid Multidisk
Seretid Multidisk: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Seretide Multidisk
ATX code: R03AK06
Active ingredient: salmeterol (Salmeterol) + fluticasone (Fluticasone)
Producer: Glaxo Wellcome Production (France); Glaxo Operations UK, Limited (UK); GlaxoSmithKline Trading, CJSC (Russia)
Description and photo update: 2018-27-11
Prices in pharmacies: from 998 rubles.
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Seretide Multidisk is a combined bronchodilator drug that includes a selective beta2-adrenergic agonist and a local glucocorticosteroid (GCS).
Release form and composition
Seretide Multidisk is available in the form of a dosed powder for inhalation: almost white or white (28 doses or 60 doses in aluminum blisters, the blister is placed in a plastic inhaler with a dose counter, 1 inhaler in a cardboard box and instructions for use of Seretid Multidisk).
1 dose contains:
- active ingredients: micronized salmeterol xinafoate - 72.5 mcg (equivalent to 50 mcg salmeterol content) + micronized fluticasone propionate - 100, 250 or 500 mcg;
- auxiliary components: lactose monohydrate.
Pharmacological properties
Pharmacodynamics
Seretide Multidisk is a combined drug that has bronchodilator and anti-inflammatory effects. Its therapeutic effect is due to the content of two active components with different mechanisms of action. Salmeterol prevents the onset of symptoms of bronchospasm, fluticasone propionate prevents the exacerbation of the disease, improving lung function. Therefore, the drug is a convenient alternative for patients who need to simultaneously take a beta2-adrenergic agonist and inhaled GCS from different inhalers.
Salmeterol
Salmeterol is a selective, long-acting agonist of beta2-adrenergic receptors, the long side chain of which binds to the outer domain of the receptor. Unlike short-acting beta2-adrenergic receptor agonists, the pharmacological properties of salmeterol provide more effective protection against histamine-induced bronchoconstriction and prolonged (at least 12 hours) bronchodilation.
Research has shown that salmeterol is a potent inhibitor of the release of histamine, leukotrienes, prostaglandin D2 and other long-acting mast cell mediators from the lungs.
Salmeterol suppresses the early and late phase of the response to inhalation allergens. After the introduction of a single dose, the inhibition of the late phase of the response persists for 30 hours or more, the bronchodilating effect is no longer there. A single intake of salmeterol provides a weakening of the hyperreactivity of the bronchial tree.
Fluticasone propionate
Fluticasone propionate - corticosteroids for local use, which has a pronounced anti-inflammatory and anti-allergic effect in the lungs. Its local activity helps to reduce clinical symptoms, reduce the frequency of exacerbations of bronchial asthma, without causing adverse events that often accompany the intake of systemic corticosteroids.
Long-term use of inhaled fluticasone propionate in adults and children, even at the maximum recommended doses, does not cause disturbances in the daily secretion of adrenal cortex hormones. After previous therapy with other inhaled corticosteroids, switching to fluticasone propionate leads to a gradual improvement in the daily secretion of adrenal cortex hormones, even against the background of periodic use of oral steroids. The reserve function of the adrenal cortex also remains within the normal range during long-term therapy with fluticasone propionate. This is confirmed by the normal increase in cortisol production in response to appropriate stimulation. It should be noted here that the residual decrease in adrenal reserve after previous therapy can persist for a long time.
Pharmacokinetics
The joint inhalation use of salmeterol and fluticasone propionate does not have a clinically significant effect of the substances on the pharmacokinetics of each other. In this connection, the pharmacokinetic properties of each active component of Seretide Multidisk can be considered separately.
Salmeterol
The local action of salmeterol in the lung tissues technically limits the availability of information on its pharmacokinetics. When inhaled in therapeutic doses, the Cmax (maximum concentration) of the substance in the blood plasma is about 200 pg / ml and below, therefore, it cannot be an indicator of therapeutic effects. Against the background of regular inhalation in the blood plasma, it is possible to detect hydroxynaphthoic acid at an equilibrium concentration (Css) of about 100 ng / ml, which is 1000 times less than the Css values noted in toxicity studies. In patients with airway obstruction, prolonged (more than a year) regular use of the drug did not cause adverse effects.
Extensive metabolism of salmeterol is carried out by aliphatic oxidation under the influence of the CYP3A4 isoenzyme of the cytochrome P450 system to alpha-hydroxysalmeterol.
There is no data on the distribution and excretion of salmeterol.
Fluticasone propionate
The absolute bioavailability of fluticasone propionate due to its administration using the Multidisk inhaler is 5.5%. In bronchial asthma and chronic obstructive pulmonary disease (COPD), the concentration of fluticasone propionate in the blood plasma is lower. Systemic absorption of the substance occurs mainly through the lungs, the initial absorption rate is higher, but then it slows down.
The swallowed part of the inhalation dose has a minimal effect on systemic absorption due to the low degree of solubility of fluticasone propionate in water and its presystemic metabolism. Bioavailability from the gastrointestinal tract is less than 1%. The level of concentration of fluticasone propionate in blood plasma is linear and increases with increasing inhalation dose.
Plasma protein binding of fluticasone propionate is 91%, Vd (volume of distribution) at equilibrium is about 300 liters.
The elimination of fluticasone propionate from the blood is rapid. It is metabolized mainly by the CYP3A4 isoenzyme of the cytochrome P450 system to form an inactive carboxylic metabolite. Consideration and caution should be exercised if it is necessary to concomitantly use fluticasone propionate with known CYP3A4 inhibitors, since this combination may cause an increase in plasma concentrations of fluticasone propionate.
The final T 1/2 (half-life) is about 8 hours, the total clearance of fluticasone propionate from plasma is 1150 ml / min. The renal clearance of unchanged fluticasone propionate is less than 0.2%. In the form of a metabolite, it is excreted through the kidneys in an amount of 5% of the dose taken.
Indications for use
Seretide Multidisk is intended for regular use in patients with bronchial asthma, who are indicated for combination therapy with a long-acting beta2-adrenergic agonist and inhaled corticosteroid, in the following cases:
- it is necessary to ensure adequate control of the disease during therapy with inhaled corticosteroid and long-acting beta2-adrenergic agonist;
- there is no sufficient control of the disease against the background of systematic monotherapy with inhaled corticosteroids and the periodic use of a short-acting beta2-adrenomimetic;
- requires starting maintenance therapy of persistent bronchial asthma in patients who are prescribed GCS to achieve control of the disease.
In addition, Seretide Multidisk is prescribed as maintenance therapy for patients with COPD with a forced expiratory volume in 1 second of less than 60% of the norm (before inhalation of a bronchodilator), in the presence of repeated exacerbations in the history and persistence of severe symptoms of the disease, despite constant therapy with bronchodilators.
Contraindications
Absolute:
- age up to 4 years;
- hypersensitivity to the components of the drug.
Care should be taken to prescribe Seretide Multidisc for acute or latent pulmonary tuberculosis, cardiovascular diseases (including arrhythmias: supraventricular tachycardia, extrasystole, ventricular extrasystole, atrial fibrillation), thyrotoxicosis, hypokalemia, anesthetic and lactic acidosis, and lactic acidosis, cataracts, diabetes mellitus, fungal, viral or bacterial respiratory infections.
The appointment of Seretide Multidisc during pregnancy and breastfeeding is allowed, but it should be done only in cases where the potential benefit from therapy for the mother outweighs the possible threat to the fetus and child.
Seretide Multidisk, instructions for use: method and dosage
The powder is intended for inhalation administration only.
The procedure is carried out using the Multidisk inhaler, which is equipped with a descending indicator. After each inhalation, the window shows the number of doses remaining. Red numbers on the indicator indicate that no more than 5 doses remain in the inhaler.
The inhaler must be kept closed.
To open the inhaler, you should cover its body with the fingers of one hand, and place the thumb of the other hand in a special recess and press it away from you until it stops and the sound of a click.
In the open state, the inhaler consists of a mouthpiece, a lever and a dose indicator.
Holding the inhaler with the mouthpiece towards your face, in the direction away from you, press the lever all the way until you hear a click. At this moment, the next cell with the drug is opened, and a small hole with a ready dose of powder opens in the mouthpiece. It is necessary to press the lever only before inhalation!
By placing the inhaler at a certain distance from the mouth, a deep exhalation is made without effort. Do not breathe out into the inhaler! Having tightly clasped the mouthpiece with your lips, you need to take a deep, even breath through your mouth and then remove the mouthpiece from your mouth. After inhalation, you should hold your breath for the maximum possible time (at least 10 seconds) and exhale slowly.
At the end of the procedure, the inhaler is closed by placing your thumb in a special recess and pressing it in the opposite direction until it stops (until you hear a click). The lever returns to its original position automatically. The inhaler is ready for use again.
Be sure to rinse your mouth with water after inhalation and spit it out.
The doctor should inform the patient that the optimal effect is achieved only with regular intake of the drug, even if there are no clinical symptoms of bronchial asthma and COPD, and regularly evaluate the results of the therapy.
The doctor determines the dose and duration of the course of therapy.
For bronchial asthma, the lowest effective dose should be used.
If control over symptoms is ensured by taking the drug 2 times a day, then as part of a dose reduction, you can use the frequency of procedures 1 time per day.
When prescribing Seretide Multidisk, the dose content of fluticasone propionate should correspond to the severity of the disease.
The recommended dosage for the combination of salmeterol and fluticasone propionate in the treatment of bronchial asthma:
- children from 4 to 12 years old: 1 inhalation of 50 mcg + 100 mcg (salmeterol + fluticasone propionate) 2 times a day;
- patients aged 12 years and older: 1 inhalation of 50 mcg + 100 mcg (salmeterol + fluticasone propionate), 50 mcg + 250 mcg or 50 mcg + 500 mcg 2 times a day.
The maximum recommended dose for the treatment of chronic obstructive pulmonary disease in adult patients is one inhalation (50 mcg salmeterol + 500 mcg fluticasone propionate) 2 times a day.
In case of impaired renal and / or liver function, as well as the treatment of elderly patients, dose adjustment is not required.
Side effects
Adverse reactions registered during clinical trials:
- from the respiratory system, chest and mediastinal organs: often - dysphonia and / or hoarseness; infrequently - throat irritation;
- from the nervous system: very often - headache; infrequently - tremor;
- mental disorders: infrequently - sleep disturbances, anxiety; rarely - hyperactivity, irritability and other changes in behavior (more often in children);
- infections and parasitic diseases: often - candidiasis of the oral cavity and pharynx, in patients with COPD - pneumonia; rarely - esophageal candidiasis;
- from the immune system: infrequently - shortness of breath, skin hypersensitivity reactions; rarely - anaphylactic reactions;
- from the endocrine system: infrequently - cataract; rarely - glaucoma;
- from the side of metabolism and nutrition: infrequently - hyperglycemia; very rarely - hypokalemia;
- from the heart: infrequently - rapid heartbeat, atrial fibrillation, tachycardia; rarely - arrhythmia (including supraventricular tachycardia, extrasystole, ventricular extrasystole);
- on the part of the musculoskeletal system and connective tissue: often - arthralgia, muscle spasms;
- dermatological reactions: infrequently - bruising.
In addition, the following side effects were recorded in post-registration observations:
- from the respiratory system, chest and mediastinal organs: rarely - paradoxical bronchospasm;
- from the immune system: rarely - bronchospasm, angioedema (more often swelling of the face and oropharynx);
- from the endocrine system: rarely - cushingoid symptoms, Cushing's syndrome, suppression of adrenal function, a decrease in bone mineral density, growth retardation in children and adolescents.
Overdose
- symptoms: headache, tachycardia, tremor, increased systolic blood pressure (BP), hypokalemia. Against the background of an acute overdose of fluticasone propionate, temporary suppression of the hypothalamic-pituitary-adrenal system is possible in which adrenal function is restored to normal within a few days and, as a rule, does not require any emergency measures. With prolonged use of high doses, significant suppression of the function of the adrenal cortex is possible. Acute adrenal crisis - usually occurs in children after prolonged therapy at an overestimated dose. It is manifested by hypoglycemia, seizures, confusion in stressful situations (trauma, infection, surgery, or a sharp decrease in the dose of fluticasone propionate);
- treatment: supportive therapy, careful monitoring of the patient's condition. If an overdose has occurred with prolonged use of high doses, it is recommended to monitor the reserve function of the adrenal cortex.
special instructions
Since Seretide Multidisk is not intended to relieve acute symptoms of the disease, patients should always carry a short-acting inhaled bronchodilator (for example, salbutamol) to relieve such cases.
The use of a combination of salmeterol and fluticasone propionate is indicated for use in the form of initial maintenance therapy of persistent bronchial asthma, if the patient takes a certain dose of GCS to stop the daily attacks.
When paradoxical bronchospasm appears, manifested by an increase in shortness of breath immediately after inhalation, a short-acting inhaled bronchodilator should be applied immediately and treatment with the drug should be replaced with alternative therapy.
When more and more short-acting bronchodilators have to be used to relieve symptoms, this indicates that the dose of the drug does not provide adequate control of the disease. The increasing and sudden deterioration in the control of bronchial asthma is associated with a potential threat to life, therefore, it is necessary to consult a doctor to revise the GCS dosage regimen.
Discontinue treatment with Seretide Multidisc should be by gradually reducing the dose under medical supervision. Abrupt withdrawal of the drug may exacerbate the disease.
Withdrawal of the drug in patients with COPD may be accompanied by symptoms of decompensation. In addition, it should be borne in mind that against the background of the use of a combination of salmeterol and fluticasone propionate, exacerbation of COPD and the clinical picture of pneumonia are similar.
Long-term use in high doses of inhaled GCS can contribute to the development of undesirable systemic effects, therefore, for the treatment of bronchial asthma, it is necessary to use the lowest dose that provides effective control of symptoms.
In stressful situations, it is necessary to take into account the possibility of suppressing the adrenal glands and be ready to receive GCS.
The degree of adrenal insufficiency must be determined during surgery or resuscitation.
Long-term use of the drug in children should be accompanied by regular measurement of the child's growth.
With extreme caution, the transition from taking oral corticosteroids to inhalation therapy with fluticasone propionate is made. It is recommended to regularly monitor the function of the adrenal cortex, due to the risk of adrenal suppression.
Previous therapy with systemic GCS can suppress the manifestations of allergic rhinitis, eczema and other allergic reactions, therefore, after switching to inhalation therapy, their symptoms may be pronounced. For the treatment of such pathologies, it is recommended to symptomatically use antihistamines and / or GCS for topical use.
You can not abruptly stop taking systemic corticosteroids when prescribing inhaled fluticasone propionate. Patients should always have a special patient card with them, which indicates the need for additional administration of GCS in stressful situations.
With exacerbation of bronchial asthma and hypoxia, it is necessary to control the content of potassium ions in the plasma.
The drug can affect blood glucose levels, contributing to its increase, so patients with diabetes should be careful.
Side effects such as tremors, palpitations and headaches are short-lived and decrease in severity with regular therapy.
Influence on the ability to drive vehicles and complex mechanisms
Inhalation of Seretide Multidisk does not affect the ability to drive vehicles and complex mechanisms. But during the period of treatment, patients should take into account the possibility of developing side effects of the drug and be careful.
Application during pregnancy and lactation
Due to the limited information on the use of the drug during gestation and lactation, the appointment of Seretide Multidisc during pregnancy and breastfeeding should be performed only in cases where the potential benefit of therapy for the mother outweighs the possible threat to the fetus and child.
The effect of the drug on human fertility has not been established.
Pediatric use
It is contraindicated to prescribe Seretide Multidisk to children under the age of 4 years.
Long-term use of inhaled GCS should be accompanied by regular monitoring of the dynamics of the child's growth.
With impaired renal function
No dose reduction is required for patients with impaired renal function.
For violations of liver function
No dose reduction is required in patients with impaired liver function.
Use in the elderly
For the treatment of elderly patients, a general dosage regimen is used.
Drug interactions
The simultaneous use of beta-blockers (selective and non-selective) increases the risk of developing bronchospasm, therefore, their use should be avoided, except in cases of extreme necessity.
Inhalation of fluticasone propionate is accompanied by its low plasma concentration, therefore, its clinically significant interaction is unlikely.
Ritonavir, being a highly active inhibitor of the isoenzyme CYP3A4, can cause a sharp increase in the level of fluticasone propionate, resulting in a significant decrease in the concentration of serum cortisol. Due to the high risk of systemic effects of corticosteroids, a combination of fluticasone propionate and ritonavir should be avoided, unless the expected therapeutic effect exceeds the threat of adverse events (Cushing's syndrome, adrenal suppression).
Caution is advised when concomitant administration of strong CYP3A4 inhibitors (including ketoconazole) is recommended, as this can cause a significant increase in plasma concentrations of fluticasone propionate and salmeterol and increase the risk of systemic effects of fluticasone propionate and prolongation of the QTc interval.
Concomitant therapy with corticosteroids, xanthine derivatives and diuretics during the period of use of Seretide Multidisc increases the risk of hypokalemia.
MAO (monoamine oxidase) inhibitors and tricyclic antidepressants can cause cardiovascular side effects.
The simultaneous use of the drug with cromoglycic acid does not cause negative consequences.
Analogs
The analogues of Seretid Multidisk are Seretid, Salticason-aeronativ, Saltikason-native, Salmecort, Seroflo, Tevacomb, Berodual, Symbicort Turbuhaler, Biasten, Foradil Combi, Foster, Zenheil, etc.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 30 ° C.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews of Seretid Multidisk
Reviews of Seretid Multidisk are often positive. For many patients, the use of the drug helps control asthma, restores the ability to breathe and lead a full life. The advantages of the drug include its ability to block attacks and treat bronchial asthma. Already after a few weeks of therapy, the intervals between attacks are significantly reduced. Users note the convenience of using the inhaler and recommend that you rinse your mouth with water after inhalation.
The disadvantages include the high cost of the drug and the fairly frequent development of undesirable phenomena in the form of candidiasis, pain in the kidney and joints.
Price for Seretid Multidisk in pharmacies
The price of Seretide Multidisk for a package containing 60 doses (50 mcg salmeterol + 100 mcg fluticasone propionate) can be from 1194 rubles, 50 mcg + 250 mcg - from 1559 rubles, 50 mcg + 500 mcg - from 2069 rubles.
Seretid Multidisk: prices in online pharmacies
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Drug name Price Pharmacy |
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Seretide Multidisk 50 mcg + 100 mcg / dose 60 doses powder for inhalation metered 1 pc. 998 RUB Buy |
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Seretide Multidisk 50 mcg + 250 mcg / dose 60 doses powder for inhalation dosed 1 pc. RUB 1002 Buy |
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Seretide Multidisk powder for in. dosage. 50 mcg + 100 mcg / dose 60 doses 1150 RUB Buy |
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Seretide Multidisk powder for in. dosage. 50 mcg + 250 mcg / dose 60 doses 1400 RUB Buy |
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Seretide Multidisk 50 mcg + 500 mcg / dose 60 doses powder for inhalation dosed 1 pc. 1742 RUB Buy |
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Seretide Multidisk powder for in. dosage. 50 mcg + 500 mcg / dose 60 doses 1794 RUB Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
