Seretid - instructions for use, analogs, testimonials and release forms (aerosol 25 + 50, 25 + 125, 25 + 250 or powder 50 + 100, 50 + 250, 50 + 500 Multidisk for inhalations) of the drug for the treatment of bronchial asthma in adults, children and pregnancy

In this article, you can read the instructions for using the drug Seretid. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Seretid in their practice. A big request is to actively add your feedback about the drug: the hormonal drug helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Seretid with available structural analogues. Use for the treatment of bronchial asthma in adults, children, as well as during pregnancy and lactation.

Seretid - combined preparation, contains salmeterol and fluticasone propionate, which have different mechanisms of action. Salmeterol prevents the occurrence of bronchospasm, fluticasone propionate improves pulmonary function and prevents exacerbations. Seretide may be an alternative for patients who simultaneously receive a beta2-adrenoreceptor agonist and an inhaled glucocorticosteroid (GCS) (from different inhalers).

Salmeterol is a selective long-acting beta2-adrenergic agonist (up to 12 h), which has a long side chain that binds to the receptor's outer domain.

Pharmacological properties of salmeterol provide protection against histamine-induced bronchoconstriction and prolonged bronchodilation (duration of at least 12 h) than short-acting beta2-adrenergic agonists. The beginning of the development of bronchodilator effect is observed within 10-20 minutes.

Salmeterol is a strong and long-acting inhibitor of the release from the human lung tissue of mast cell mediators, such as histamine, leukotrienes and prostaglandin D2.

Salmeterol inhibits the early and late phases of the response to inhaled allergens; the latter lasts more than 30 hours after the administration of one dose, ie, at a time when 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 the bronchodilator effect, has an additional effect, the clinical significance of which has not been finally established. This mechanism of action is different from the anti-inflammatory effect of GCS.

In therapeutic doses, salmeterol has no effect on the cardiovascular system.

Fluticasone propionate-GCS for topical administration, with inhalation at recommended doses, has a pronounced anti-inflammatory and anti-allergic effect in the lungs, which leads to a reduction in clinical symptoms and a reduction in the frequency of exacerbations of diseases accompanied by airway obstruction. Restores patient's reaction to bronchodilators, allowing to reduce the frequency of their use. The effects of fluticasone propionate, prescribed in recommended doses, are not accompanied by adverse reactions characteristic of systemic SCS.

With prolonged use of inhalation fluticasone propionate at the maximum recommended doses, the daily secretion of hormones in the adrenal cortex remains within normal limits in both adults and children. After the transfer of patients receiving other inhaled GCS to the administration of fluticasone propionate, the daily secretion of adrenal cortex hormones gradually normalizes, despite the previous and current recurrent use of oral corticosteroids. 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).

Composition

Salmeterol xinafoate (salmeterol) + Fluticasone propionate + excipients.

Salmeterol (in the form of xinafoate) + Fluticasone propionate + auxiliary substances (Seredid Multidisk).

Pharmacokinetics

With joint inhalation administration, salmeterol and fluticasone propionate do not affect the pharmacokinetics of each other, and therefore the pharmacokinetic characteristics of each component of the Seretide preparation can be considered separately.

Salmeterol

Salmeterol acts locally in the lung tissue, and therefore its plasma content does not correlate with the therapeutic effect.

Data on the pharmacokinetics of salmeterol are very limited due to technical problems: when inhaled at therapeutic doses, its Cmax in plasma is extremely low (about 200 pg / ml and below). After repeated inhalations of salmeterol xinafoate, 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 levels observed in the toxicity studies.

Fluticasone propionate

Absolute bioavailability of inhalation fluticasone propionate in healthy people varies depending on the inhaler used, when using salmeterol / fluticasone propionate with a metered aerosol for inhalations it is 5.3% of the nominal dose.In patients with bronchial asthma and COPD, lower concentrations of fluticasone propionate in plasma are observed. Systemic absorption occurs predominantly through the lungs, at first it is more rapid, but then slows down.

Part of the inhaled dose can be swallowed, but the systemic effect is minimal due to the low solubility of fluticasone propionate in water and presystemic metabolism. Bioavailability of fluticasone propionate when it is absorbed from the gastrointestinal tract is less than 1%. As the inhalation dose increases, a linear increase in the concentration of fluticasone propionate in plasma is observed.

Fluticasone propionate has a relatively high degree of binding to plasma proteins (91%).

Fluticasone propionate is rapidly eliminated from the blood, mainly as a result of metabolism with the participation of the CYP3A4 isoenzyme with the formation of an inactive carboxyl metabolite.

Fluticasone propionate has a high plasma clearance (1150 ml / min).

Renal clearance of unchanged fluticasone propionate is negligible (<0.2%), in the form of a metabolite with urine, less than 5% of the dose is excreted.

Caution should be exercised while using known inhibitors of CYP3A4 andfluticasone propionate, since in such situations it is possible to increase the content of the latter in plasma.

It is excreted through the gastrointestinal tract mainly in the form of a hydroxylated metabolite.

Indications

The drug is intended for the treatment of bronchial asthma in patients who are shown combined therapy with long-acting beta2-adrenomimetic and inhaled GCS:

• in patients with insufficient control of the disease against a background of continuous monotherapy with inhaled glucocorticosteroids in the periodical use of short-acting beta2-adrenomimetics;
• in patients with adequate control of the disease on the background of inhaled glucocorticosteroids and long-acting beta2-adrenomimetics;
• as a starting maintenance therapy in patients with persistent asthma (daily occurrence of symptoms, daily use of funds for rapid relief of symptoms) in the presence of indications for the appointment of GCS to achieve control of the disease.

Supportive therapy in COPD and repeated exacerbations in the history, in which the expressed symptoms of the disease persist despite regular therapy with bronchodilators.

Forms of release

Aerosol for inhalations dosed with 25 μg + 50 μg, 25 + 125, 25 + 250 in 1 dose (Seretide).

Powder for inhalation 50 mcg + 100 mcg, 50 + 250, 50 + 500 in 1 dose (Seretide Multidisk).

Instructions for use and dosage

Aerosol

Seretide is for inhalations only.

To obtain the optimal effect, the drug should be used regularly, even in the absence of clinical symptoms of bronchial asthma and COPD.

The doctor determines the course of treatment and dose change individually.

The patient should be prescribed a drug in such a dosage form that contains a dose of fluticasone propionate, corresponding to the severity of the disease.

Bronchial asthma

If the patient does not receive appropriate therapy, taking only inhaled GCS, then replacing them with Seretide in a dose therapeutically equivalent to the dose administered by GCS can improve the control of asthma. In patients who can monitor the course of asthma solely with the help of inhaled GCS, their replacement with Seretide may help reduce the dose of GCS necessary to control the course of asthma.

Recommended doses for adults and children aged 12 years and older are 2 inhalations (25 μg salmeterol and 50 μg fluticasone propionate) 2 times a day,or 2 inhalations (25 μg salmeterol and 125 μg fluticasone propionate) 2 times a day, or 2 inhalations (25 μg salmeterol and 250 μg fluticasone propionate) 2 times a day.

For children aged 4 years and older, 2 inhalations (25 μg salmeterol and 50 μg fluticasone propionate) are recommended 2 times a day.

In adults over 18 years, when doubling the dose, when using any form of Seretide (Seredid Multidisk) for up to 14 days, the same safety and tolerability is maintained as with the regular use of this combination for one inhalation 2 times a day. The dose can be doubled in those cases when patients need additional short-term (up to 14 days) inhaled glucocorticosteroid therapy, as described in some guidelines for the treatment of bronchial asthma.

At present, there is no data on the use of Seretide in children under 4 years of age.

The dose of Seretide should be reduced to the lowest effective dose. If symptom control is provided by 2 Seretid inhalations per day, the minimum effective dose can be 1 inhalation per day.

COPD

For adults, the maximum recommended dose is 2 inhalations (25 μg salmeterol and 250 μg fluticasone propionate) 2 times a day.

Special patient groups

In elderly patients and patients with impaired liver or kidney function, a dose reduction is not required.

Instructions for use of the inhaler (for the patient)

Checking the inhaler

Before using the inhaler for the first time, or if the inhaler has not been used for a week or longer, remove the cap from the mouthpiece by slightly squeezing the cap off the sides, shake the inhaler well and discharge one jet into the air to make sure it works.

Use of an inhaler

1. Remove the cap from the mouthpiece, slightly squeezing the cap from the sides.
2. Inspect the inhaler from the outside and inside, including the mouthpiece, for uncovered parts.
3. Shake the inhaler well to ensure that any loose parts are removed and that the contents of the inhaler are evenly mixed.
4. Take the inhaler between the thumb and the other four fingers vertically upside down, with the thumb on the base under the mouthpiece.
5. Exhale as deeply as possible, then put the mouthpiece in the mouth between your teeth, closing your lips around it, but not biting.
6. Immediately after the beginning of inspiration through the mouth, press the top of the inhaler to spray the Seretide drug, while continuing to deeply and slowly inhale.
7. Holding the breath, remove the inhaler from the mouth and remove the finger from the top of the inhaler. Continue to hold your breath as long as possible.
8. To carry out the second spray, hold the inhaler vertically and repeat steps 3-7 in about 30 seconds.
9. After using the inhaler, rinse your mouth with water and then spit it out.
10. Close the mouthpiece cap by pressing and snapping in the desired position.

The drug can also be administered via a spacer.

Attention!

Doing points 5, 6 and 7, you can not hurry.

Start inhaling as slowly as possible, just before pressing the inhaler valve.

In the first few times it is recommended to practice before the mirror.

If you see a "fog" coming from the top of the inhaler or from the corners of the mouth, you should start over from step 2.

If the doctor gave you other instructions for using the inhaler, then strictly observe them. Contact your doctor if you have difficulty using the inhaler.

Children

Small children can not use the inhaler themselves, and adults should help them.Wait for the child to breathe out and bring the inhaler into operation at the time of inspiration. Practice using the inhaler along with the baby. Older children and adults with weak hands should hold the inhaler with both hands. Thus both index fingers should settle down on the top part of an inhaler, and both greater fingers - on the basis below a mouthpiece. For children, the drug is administered with the help of an inhaler through a spacer with a face mask.

Cleaning the inhaler

The inhaler should be cleaned at least once a week. Remove the protective cap from the mouthpiece. Do not remove the metal can from the plastic casing. Dry cloth or cotton swab wipe the mouthpiece from the inside and outside and the plastic cover - outside. Close the mouthpiece with a protective cap. Do not immerse the metal can into the water.

Multidisk

Seretid Multidisk is intended only for inhalations.

To obtain the optimal effect, the drug should be used regularly, even in the absence of clinical symptoms of bronchial asthma and COPD.

The doctor determines the course of treatment and dose change individually.

The patient should be prescribed Seretide Multidisk in a dosage form that contains a dose of fluticasone propionate corresponding to the severity of the disease.

If the patient does not manage to achieve adequate disease control with monotherapy with inhaled corticosteroids, switching to combination therapy with salmeterol and fluticasone propionate in an equivalent dose of a corticosteroid may lead to improved control of bronchial asthma. For patients with inhaled corticosteroid monotherapy providing adequate control of bronchial asthma, switching to inhalation therapy with a combination of salmeterol and fluticasone propionate may help to reduce the dose of a corticosteroid without losing control of bronchial asthma.

Recommended doses for adults and children aged 12 years and older are 1 inhalation (50 μg salmeterol and 100 μg fluticasone propionate) 2 times a day, or 1 inhalation (50 μg salmeterol and 250 μg fluticasone propionate) 2 times a day, or 1 Inhalation (50 μg salmeterol and 500 μg fluticasone propionate) 2 times a day.

In adults over the age of 18, when the dose is doubled, with the use of any form of Seretide Multidisk release, the same safety and tolerability remain for 14 days,as with the regular use of this combination of 1 inhalation 2 times a day. The dose can be doubled in those cases when patients need additional short-term (up to 14 days) inhaled glucocorticosteroid therapy, as described in some guidelines for the treatment of bronchial asthma.

Children aged 4 years and older - 1 inhalation (50 μg salmeterol and 100 μg fluticasone propionate) 2 times a day.

At present, there is no data on the use of Seredida Multidisk in children under 4 years of age.

For COPD for adults, the maximum recommended dose is 1 inhalation (50 μg salmeterol and 500 μg fluticasone propionate) 2

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.

Instructions for the use of the inhaler "Multidisk" (for patients)

The "Multidisk" inhaler has an indicator, which, after the inhalation, shows the number of remaining doses. The numbers go in descending order from 60 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.

Carrying out inhalations

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 (right or left hand) with the mouthpiece to the face; Push the lever in the direction from yourself to the stop until you hear a click. The inhaler is now ready for use. By pressing the lever, another cell with powder for inhalation is opened; while 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 drug: keep the inhaler at some distance from the mouth and make a deep exhalation without effort. Never breathe out into the inhaler. Tightly grasp the mouthpiece with your lips. Take a slow 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. Do not breathe out into the inhaler.
4. Close the inhaler: place your thumb in a special recess and push towards you, until it stops,until you hear a click. The lever automatically returns to its original position.

Cleaning the inhaler

After using the inhaler, the mouthpiece is wiped with a dry cloth.

Side effect

• paradoxical bronchospasm;
• frequent cases of pneumonia (in patients with COPD);
• hoarseness of voice / dysphonia;
• irritation of pharynx;
• headache;
• candidiasis of the oral cavity and pharynx;
• palpitation;
• hypersensitivity reactions, incl. manifested in the form of skin reactions, angioedema (mainly edema of the face and oropharynx), breathing disorders (dyspnea and / or bronchospasm), and in very rare cases - anaphylactic reactions;
• anxiety;
• behavioral disorders (including hyperactivity and irritability, mainly in children);
• sleep disorders;
• hyperglycemia;
• tremor;
• arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystole);
• arthralgia;
• nervousness;
• nausea, vomiting;
• peripheral edema;
• growth retardation in children and adolescents;
• decrease in bone mineral density;
• cataract;
• glaucoma.

Contraindications

• children under 4 years;
• hypersensitivity to the components of the drug.

Application in pregnancy and lactation

During pregnancy and lactation (breastfeeding), Seretide can be given only if the intended benefit to the mother exceeds any possible risk to the fetus or the baby.

Application in elderly patients

In elderly patients, dose reduction is not required.

Use in children

Contraindicated in children under 4 years.

special instructions

Treatment of bronchial asthma is recommended to be carried out step by step, controlling the patient's clinical response to treatment and lung function. The patient must be taught how to use the inhaler correctly.

Seretide is not intended to alleviate acute symptoms, because in such cases, a rapid and short-acting inhaled bronchodilator (eg salbutamol) should be used. Patients should be informed that they always have at hand a drug to stop acute symptoms.

Salmeterol / fluticasone propionate can be used for initial maintenance therapy in patients with persistent asthma (daily occurrence of symptoms or daily use of agents to stop seizures), if there is evidence of SCS administration 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.

A sudden and increasing deterioration in the control of bronchospasm syndrome poses a potential threat to life, and in such situations, the patient must also consult a doctor. It is possible that the doctor will prescribe a higher dose of GCS. If the used dose of Seretide does not provide adequate control of the disease, the patient should also consult a doctor who can prescribe additional SCS, and if the exacerbation is caused by an infection, then antibiotics.

Because of the danger of aggravation, treatment with Seretide should not be abruptly discontinued for patients with asthma, the dose should be gradually reduced 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 doctor.

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. Given the above, the dose of inhaled GCS should be titrated to a minimum, which ensures the maintenance of effective control.

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.

Some patients may be more sensitive to the effects of inhaled glucocorticosteroids than most patients.

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, including SCS for topical application.

After initiation of treatment with inhaled fluticasone propionate, systemic GCS should be discontinued gradually, and such patients should carry a special 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 potassium ions in the plasma.

There are very rare reports of an increase in blood glucose levels, and this should be remembered by assigning a combination of salmeterol with fluticasone propionate to a diabetic patient.

When treating patients with COPD, patients with COPD should remember that the clinical signs of developing pneumonia often resemble an exacerbation of the underlying disease.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 / lethal outcome is higher than in other patients. The importance of pharmacokinetic factors or other causes is unknown. The concomitant use of GCS in this study has not been studied.

Impact on the ability to drive vehicles and manage mechanisms

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.

Drug Interactions

Because of the risk of developing bronchospasm, selective and nonselective beta-blockers should be avoided, unless they are extremely necessary for the patient.

In ordinary situationsinhalations of fluticasone propionate are accompanied by low concentrations in the plasma 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 interaction with the participation of fluticasone propionate is unlikely.

A study of drug interaction showed that ritonavir, a highly active inhibitor of the isoenzyme CYP3A4, can cause a dramatic increase in the concentration of fluticasone propionate in the plasma, resulting in a significant decrease in serum cortisol concentrations. There are reports of clinically significant drug interactions in patients who simultaneously received fluticasone propionate and ritonavir. This interaction caused such side effects 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.

Other inhibitors of the CYP3A4 isoenzyme cause a negligible (erythromycin) and insignificant (ketoconazole) increase in plasma fluticasone propionate, in which the serum cortisol concentrations are virtually unchanged. 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 studying the interaction of drugs, it was found that the use of Ketoconazole as an accompanying systemic therapy enhances the action of salmeterol. This can lead to an elongation of the QT 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).

MAO inhibitors and tricyclic antidepressants increase the risk of cardiovascular side effectssystem.

The drug Seretide is compatible with cromoglycic acid.

Analogues of the drug Seretid

Structural analogs for the active substance:

• Seredid Multidisk;
• Tevakomb.

Analogues for the pharmacological group (beta-adrenomimetics in combinations):

• Berodual;
• Biasten;
• Ditek;
• Zhenheil;
• Intal plus;
• Iprimol Steri Neb;
• Cough;
• Combination;
• Kombipack;
• Symbicort Turbuhaler;
• Tevakomb;
• Foradyl Combi.

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