Seretide aerosol for inhalation 25 mcg+250 mcg/dose 120 doses buy in Moscow, price from 1941.00 rub. 89 pharmacies in Moscow

Pharmacological properties of the drug Seretide™

Pharmacodynamics. Seretide is a combination drug containing salmeterol and fluticasone propionate, which have different mechanisms of action. Salmeterol is a selective, long-acting (12 hour) β2-agonist that has a side chain that binds to the outer domain of the receptor. Provides effective protection against histamine-induced bronchoconstriction and longer-lasting bronchodilation (at least 12 hours) than recommended doses of traditional short-acting β2-agonists. Salmeterol is a strong, long-acting inhibitor of the release of mast cell mediators such as histamine, leukotrienes and prostaglandin D2 from human lung tissue. Inhibits the early and late phases of the response to inhaled allergens; the latter lasts more than 30 hours after administration of one dose, that is, at a time when the bronchodilator effect is no longer present. The administration of a single dose of salmeterol weakens the hyperreactivity of the bronchial tree. This is evidence that salmeterol, in addition to the bronchodilator effect, has an additional effect, the clinical significance of which has not been fully established. This mechanism of action differs from the anti-inflammatory effect of GCS. Fluticasone propionate is a corticosteroid for topical use; when administered by inhalation, it has a pronounced anti-inflammatory and antiallergic effect on the lungs. This is manifested by a decrease in the severity of symptoms and a decrease in the frequency of asthma attacks without the side effects characteristic of systemic corticosteroids. With long-term use of inhaled fluticasone propionate at the maximum recommended doses, daily excretion of adrenal hormones remains within normal limits in both adults and children. After patients receiving other inhaled corticosteroids switch to fluticasone propionate, the daily excretion of adrenal hormones gradually normalizes, despite the previous and concomitant periodic use of oral corticosteroids. This indicates restoration of adrenal function with inhaled use of fluticasone propionate. With prolonged use of fluticasone propionate, adrenal reserve function remains within normal limits, as evidenced by a normal increase in cortisol production in response to appropriate stimulation. However, it should be taken into account that the residual decrease in adrenal reserve caused by previous therapy may persist for a long time. Research has found:

71% of patients treated with salmeterol/fluticasone achieved a “good level of control”* of asthma symptoms compared to 59% of patients treated only with GCS;
41% of patients treated with salmeterol/fluticasone achieved “complete control”** of asthma symptoms compared to 28% of patients treated only with GCS;
the incidence of exacerbations was 29% lower in patients treated with salmeterol/fluticasone compared with inhaled corticosteroids without salmeterol;
when “good” or “complete control” of asthma symptoms is achieved, quality of life indicators improve, according to a specially developed questionnaire regarding indicators of the quality of life of patients with asthma.

*“Complete control” of asthma symptoms means the absence of disease symptoms and the absence of the need to use short-acting β2-adrenergic receptor agonists; the level of pulmonary function is ≥80% of predicted, there are no night awakenings, there are no exacerbations and side effects requiring a change in treatment; **“Good control” of asthma symptoms means the presence of occasional symptoms or an intermittent need for the use of short-acting β2-adrenergic agonists or a level of pulmonary function ≤80% predicted plus no night awakenings, no exacerbations and no side effects requiring a change in treatment.

According to the following 2 studies, an improvement in pulmonary function and an increase in the number of days without asthma symptoms were demonstrated; the use of emergency medications was reduced by 60% when taking a dose of inhaled GCS as part of Seretide than when taking only inhaled GCS, provided that adequate control of the inflammatory process in the airways was maintained (according to bronchial biopsy and bronchoalveolar lavage). This improvement lasts for at least 12 months. Pharmacokinetics. Simultaneous inhalation administration of salmeterol and fluticasone does not affect the pharmacokinetics of each of these substances. Salmeterol Salmeterol acts locally in the bronchi, so its therapeutic effect does not depend on the concentration in the blood plasma. The plasma concentration of salmeterol when administered in inhalation at therapeutic doses is very low (approximately 200 pg/ml or less). With regular use of inhaled salmeterol xinafoate, hydroxynaphthoic acid is detected in the systemic circulation at a concentration of up to 100 ng/ml. This concentration is approximately 1000 times lower than the steady-state concentrations determined during toxicological studies. No side effects were identified with regular long-term use (for more than 12 months) of the drug in patients with airway obstruction. According to a study of drug interactions between salmeterol and ketoconazole, when used in combination, the concentration of salmeterol in the blood plasma significantly increases. Fluticasone propionate The absolute bioavailability of fluticasone propionate for each of the available inhalation devices was assessed from comparative pharmacokinetic studies using the inhalation and intravenous routes of administration. In healthy adults, the absolute bioavailability for fluticasone propionate Discus was 7.8%, for fluticasone propionate Evohaler - 10.9%; for Seretide Evohaler - 5.3%, for Seretide Discus - 5.5%, respectively. In patients with asthma and COPD, the degree of systemic influence of inhaled fluticasone propionate is less. Systemic absorption occurs mainly through the lungs, quickly at first, then over a longer period of time. The remainder of the inhalation dose is swallowed, producing minimal systemic effects due to the low solubility of fluticasone propionate in water and first-pass metabolism of the drug. Thus, its oral bioavailability is ≤1%. There is a linear dose dependence of the systemic effect with increasing inhalation dose of the drug. Fluticasone propionate is characterized by high plasma clearance (1150 ml/min), a large volume of distribution (approximately 300 l) and an elimination half-life of about 8 hours. The degree of binding to plasma proteins is moderately high - about 91%. Fluticasone propionate is rapidly eliminated from the systemic circulation, mainly by metabolism to inactive compounds with the participation of the cytochrome CYP 3A4 enzymatic system. The renal clearance of fluticasone propionate is very low (≤0.2%), of which ≤5% is excreted as metabolites. CYP3A4 inhibitors should be co-administered with caution due to the possibility of increased systemic exposure to fluticasone propionate.

Seretide aerosol.d/inhaled dose.25mcg+250mcg/dose 120doses

Indications

The drug Seretide® is intended for the regular treatment of bronchial asthma if combination therapy with a long-acting beta2-adrenergic agonist and inhaled corticosteroids is indicated:

patients with insufficient disease control on the background of constant monotherapy with inhaled corticosteroids with periodic use of a short-acting beta2-adrenergic agonist;
patients with adequate disease control during therapy with inhaled GCS and a long-acting beta2-adrenergic agonist;
as initial maintenance therapy in patients with persistent bronchial asthma if there are indications for prescribing GCS to achieve disease control.

The drug Seretide® is intended for maintenance therapy in patients with COPD with an FEV1 value

pharmachologic effect

Mechanism of action

The drug Seretide® is a combination drug that contains salmeterol and fluticasone propionate, which have different mechanisms of action. Salmeterol prevents the occurrence of symptoms of bronchospasm, fluticasone propionate improves pulmonary function and prevents exacerbation of the disease. Due to its more convenient dosing regimen, Seretide® may be an alternative for patients who simultaneously receive a β2-adrenergic receptor agonist and inhaled corticosteroids from different inhalers.

Salmeterol

is a selective long-acting (up to 12 hours) β2-adrenergic receptor agonist, which has a long side chain that binds to the outer domain of the receptor.

The pharmacological properties of salmeterol provide more effective protection against histamine-induced bronchoconstriction and longer-lasting bronchodilation (lasting at least 12 hours) than short-acting β2-adrenergic receptor agonists.

In vitro studies have shown that salmeterol is a potent inhibitor of the release of mast cell mediators such as histamine, leukotrienes and prostaglandin D2 from the human lung, and has a long period of action.

Salmeterol inhibits the early and late phases of the response to inhaled allergens. Inhibition of the late phase response persists for more than 30 hours after taking a single dose, at a time when the bronchodilator effect is no longer present.

Fluticasone propionate

belongs to the group of corticosteroids for local use and, when administered by inhalation in recommended doses, has a pronounced anti-inflammatory and antiallergic effect in the lungs, which leads to a decrease in clinical symptoms and a decrease in the frequency of exacerbations of bronchial asthma. Fluticasone propionate does not cause the adverse effects that are observed with systemic administration of corticosteroids.

With long-term use of inhaled fluticasone propionate, the daily secretion of adrenal hormones remains within normal limits in both adults and children, even when used in the maximum recommended doses. After switching patients receiving other inhaled corticosteroids to fluticasone propionate, the daily secretion of adrenal hormones gradually improves, despite previous and current intermittent use of oral steroids. This indicates restoration of adrenal function with inhaled use of fluticasone propionate. With long-term use of fluticasone propionate, the reserve function of the adrenal cortex also remains within normal limits, as evidenced by the normal increase in cortisol production in response to appropriate stimulation (it must be taken into account that the residual decrease in adrenal reserve caused by previous therapy may persist for a long time).

Drug interactions

Due to the risk of developing bronchospasm, the use of selective and non-selective beta-blockers should be avoided, unless they are absolutely necessary for the patient.

In normal situations, inhalation of fluticasone propionate is accompanied by low plasma concentrations due to intensive first-pass metabolism and high systemic clearance under the influence of the CYP3A4 isoenzyme of the cytochrome P450 system in the intestine and liver. This makes a clinically significant interaction involving fluticasone propionate unlikely.

A drug interaction study showed that ritonavir, a highly active inhibitor of the CYP3A4 isoenzyme, can cause a sharp increase in plasma fluticasone propionate concentrations, resulting in a significant decrease in serum cortisol concentrations. During post-marketing surveillance, there were reports of clinically significant drug interactions in patients who simultaneously received fluticasone propionate (intranasal or inhaled) and ritonavir. These interactions caused systemic side effects characteristic of GCS, such as Cushing's syndrome and adrenal suppression. Considering the above, the simultaneous use of fluticasone propionate and ritonavir should be avoided, unless the potential benefit to the patient outweighs the risk of systemic side effects of GCS.

Studies have shown that other inhibitors of the CYP3A4 isoenzyme cause a negligible (erythromycin) and insignificant (ketoconazole) increase in plasma fluticasone propionate, with virtually no decrease in serum cortisol concentrations. Despite this, caution is recommended during concomitant use of fluticasone propionate and strong CYP3A4 inhibitors (e.g., ketoconazole), as such combinations may increase plasma concentrations of fluticasone propionate, which could potentially increase the systemic effects of fluticasone propionate.

When studying drug interactions, it was found that the use of ketoconazole as concomitant systemic therapy significantly increases the concentration of salmeterol in the blood plasma (increase in Cmax by 1.4 times and AUC by 15 times). This may lead to prolongation of the QTc interval. Caution should be exercised when co-administering strong CYP3A4 inhibitors (eg, ketoconazole) and salmeterol.

Xanthine derivatives, corticosteroids and diuretics increase the risk of developing hypokalemia (especially in patients with exacerbation of bronchial asthma, during hypoxia).

MAO inhibitors and tricyclic antidepressants increase the risk of side effects from the cardiovascular system.

Seretide® is compatible with cromoglycic acid.

Dosage regimen

Seretide® is intended for inhalation only.

The patient should be informed that to obtain 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 recommendation of a doctor.

Bronchial asthma

The dose of Seretide should be reduced to the lowest dose that provides effective control of symptoms.

If taking Seretide® 2 times a day provides control over symptoms, as part of reducing the dose to the minimum effective, it is possible to reduce the frequency of taking the drug to 1 time a day.

The patient should be prescribed a form of Seretide that contains a dose of fluticasone propionate appropriate to the severity of his disease.

If therapy with inhaled corticosteroids does not provide adequate control of the disease, then replacing them with the drug Seretide® at a dose therapeutically equivalent to the dose of administered corticosteroids may improve control of bronchial asthma. In patients in whom the course of bronchial asthma can be controlled exclusively with the help of inhaled corticosteroids, replacing them with the drug Seretide® may reduce the dose of corticosteroids required to control the course of asthma.

Recommended Doses

Adults and children 12 years and older:

two inhalations (25 mcg salmeterol and 50 mcg fluticasone propionate) 2 times/day, or two inhalations (25 mcg salmeterol and 125 mcg fluticasone propionate) 2 times/day, or two inhalations (25 mcg salmeterol and 250 mcg fluticasone propionate) 2 times /day

Children 4 years and older:

two inhalations (25 mcg of salmeterol and 50 mcg of fluticasone propionate) 2 times a day.

There is currently no data on the use of Seretide® in children under 4 years of age

Chronic obstructive pulmonary disease (COPD)

For adult patients

the maximum recommended dose is two inhalations (25 mcg salmeterol and 250 mcg fluticasone propionate) 2 times a day.

Special patient groups

There is no need to reduce the dose of Seretide in elderly patients, or in patients with impaired renal or hepatic function.

Instructions for use of the inhaler (for patients)

Checking the inhaler

Before using the inhaler for the first time, or if the inhaler has not been used for a week or more, remove the cap from the mouthpiece by slightly squeezing the cap on the sides, hold the inhaler between the thumb and fingers of one hand, so that the thumb is on the base under the mouthpiece, Shake the inhaler well and release two streams into the air to make sure that the inhaler is working.

Using an inhaler

Remove the cap from the mouthpiece by lightly squeezing the sides of the cap.
Inspect the inhaler inside and out, including the mouthpiece, for foreign objects.
Shake the inhaler well to ensure that any foreign objects are removed and that the contents of the inhaler are evenly mixed.
Hold the inhaler between the thumb and fingers of one hand in a vertical position, bottom up, with the thumb resting on the base under the mouthpiece.
Exhale as deeply as possible, then place the mouthpiece in your mouth between your teeth, closing your lips around it, but without biting down on the mouthpiece.
Immediately after you start inhaling through your mouth, press the top of the inhaler to spray Seretide® while continuing to inhale deeply and slowly.
While holding your breath, remove the inhaler from your mouth and remove your finger from the top of the inhaler. Continue holding your breath for as long as possible.
To carry out the second spray, hold the inhaler vertically and after about 30 seconds repeat steps 3-7.
After using the inhaler, rinse your mouth with water and then spit it out.
Immediately close the mouthpiece cap by pressing and clicking into position. If latching does not occur, turn the mouthpiece cap and try closing the mouthpiece again. Do not press the cap with force.

The drug can also be used through a spacer. Attention! When following steps 5, 6 and 7, you should not rush.

You should begin inhaling as slowly as possible, just before pressing the inhaler valve.

It is recommended to practice in front of a mirror the first few times.

If you see "fog" coming from the top of the inhaler or from the corners of your mouth, then you should start all over again, starting from step 2.

If your doctor gives you other instructions for using your inhaler, follow them strictly. Contact your doctor if you have difficulty using your inhaler.

Children

Young children may need help using the inhaler and should be assisted by an adult. Wait for the child to exhale and activate the inhaler as the child begins to inhale. Practice using the inhaler with your child. Older children and adults with weak hands should hold the inhaler with both hands. In this case, both index fingers should be located on the top of the inhaler, and both thumbs should be on the base below the mouthpiece.

Cleaning the inhaler

The inhaler must be cleaned at least once a week.

Remove the protective cap from the mouthpiece.
Do not remove the metal can from the plastic casing.
Use a dry cloth or cotton swab to wipe the inside and outside of the mouthpiece and plastic casing.
Close the mouthpiece with the protective cap.

Do not immerse the metal can in water.

Overdose

It is not recommended to prescribe the drug in doses exceeding those specified in the “Dosage regimen” section. It is important to regularly review the patient's dosage regimen and reduce the dose to the lowest recommended dose that provides effective disease control.

Symptoms

Expected symptoms and signs of salmeterol overdose are typical of excessive beta2-adrenergic stimulation and include tremor, headache, tachycardia, increased systolic blood pressure and hypokalemia.

Acute overdose of fluticasone propionate by inhalation can provoke temporary suppression of the hypothalamic-pituitary-adrenal axis. This usually does not require any emergency measures, since normal adrenal function is restored within a few days.

Treatment

There is no specific treatment for overdose of salmeterol and fluticasone propionate. In case of overdose, maintenance therapy should be carried out and the patient's condition should be monitored. In case of chronic overdose, it is recommended to monitor the reserve function of the adrenal cortex.

Contraindications for use

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

Carefully _

Like all other inhaled drugs containing corticosteroids, Seretide® should be used with caution in patients with acute or latent pulmonary tuberculosis.

The drug Seretide® should be prescribed with caution in case of thyrotoxicosis.

Seretide® should be used with caution in case of fungal, viral or bacterial infections of the respiratory system.

When taking any drugs from the sympathomimetic group, especially when therapeutic doses are exceeded, the development of cardiovascular phenomena such as an increase in systolic blood pressure and heart rate is possible. For this reason, Seretide® should be prescribed with caution to patients with cardiovascular diseases, incl. arrhythmias, such as supraventricular tachycardia and extrasystole, ventricular extrasystole, atrial fibrillation.

All sympathomimetic drugs in dosages exceeding therapeutic doses can cause a transient decrease in serum potassium levels. Therefore, Seretide® should be administered with caution to patients with hypokalemia.

Any inhaled GCS can cause systemic effects, especially with long-term use in high doses. Therefore, the drug should be used with caution in case of glaucoma, cataracts, osteoporosis (see section “Special instructions and precautions for use”).

There are very rare reports of increased blood glucose levels, so patients with diabetes should use Seretide® with caution (see section "Side effects").

Use in children

The use of the drug is contraindicated in children under 4 years of age.

Restrictions for children

Use with caution

Use in elderly patients

In elderly patients

no dose reduction is required.

Restrictions for elderly patients

Use with caution

Use for liver dysfunction

In patients with liver dysfunction

no dose reduction is required.

Restrictions for liver dysfunction

Possible use

Use during pregnancy and breastfeeding

Fertility

There are no data on the effect on fertility in humans. In animal studies, there was no effect of fluticasone propionate or salmeterol xinafoate on male or female fertility.

Pregnancy

Data on the use of the drug in pregnant women are limited. Use during pregnancy is permissible only if the potential benefit to the mother outweighs the possible risk to the fetus.

A retrospective study found no increased risk of major congenital malformations (SCDCs) following exposure to fluticasone propionate during the first trimester of pregnancy compared with other inhaled corticosteroids.

When conducting reproductive toxicity studies in animals with the administration of each component of the drug separately or in combination, the effect on the fetus of excessive systemic concentrations of the active beta2-adrenergic agonist and GCS was revealed.

Extensive experience in the clinical use of drugs of this class indicates that when using therapeutic doses, the described effects are not clinically significant.

Breastfeeding period

The concentration of salmeterol and fluticasone propionate in the blood plasma after inhalation of the drug in therapeutic doses is extremely low, so their concentration in breast milk should be equally low. This is confirmed by studies on animals, in whose milk low concentrations of the drug were determined. There are no related data regarding women's breast milk.

The use of the drug during breastfeeding is permissible only if the potential benefit to the mother outweighs the possible risk to the child.

Restrictions when breastfeeding

Contraindicated

Restrictions during pregnancy

Contraindicated

Use for renal impairment

In patients with impaired renal function

no dose reduction is required.

Restrictions for impaired renal function

Possible use

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C; do not freeze, do not expose to direct sunlight.

Terms of sale

The drug is available with a prescription.

RU/SFC/0040/16 12/23/2016

special instructions

Seretide® is not intended for the relief of acute symptoms, since in such cases a rapid and short-acting inhaled bronchodilator (for example, salbutamol) should be used. Patients should be advised to always have medication available to relieve acute symptoms.

The combination of salmeterol and fluticasone propionate can be used for initial maintenance therapy in patients with persistent bronchial asthma (daily occurrence of symptoms or daily use of drugs to relieve attacks) if there are indications for the use of corticosteroids and their approximate dosage has been determined.

More frequent use of short-acting bronchodilators to relieve symptoms indicates worsening disease control, and in such situations the patient should consult a doctor.

Sudden and increasing deterioration in control of bronchospastic syndrome poses a potential threat to life, and in such situations the patient should also consult a doctor. The physician should consider prescribing a higher dose of GCS. If the dose of Seretide® used does not provide adequate control of the disease, the patient should also consult a doctor.

Patients with asthma should not abruptly stop treatment with Seretide due to the risk of exacerbation; the dose of the drug should be reduced gradually under the supervision of a physician. In patients with COPD, drug withdrawal may be accompanied by symptoms of decompensation and requires medical supervision.

Clinical studies have provided evidence of an increased incidence of pneumonia in patients with COPD receiving Seretide® (see section “Side Effects”). Clinicians should be aware of the possibility of developing pneumonia in COPD, since the clinical presentation of pneumonia and exacerbation of COPD are often similar.

Any inhaled GCS can cause systemic effects, especially with long-term use in high doses; however, the likelihood of such symptoms occurring is much lower than with treatment with oral corticosteroids (see section “Overdose”). Possible systemic reactions include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, and glaucoma. Therefore, when treating asthma, it is important to reduce the dose to the lowest dose that provides effective control of the disease.

In emergency and planned situations that can cause stress, it is always necessary to remember the possibility of adrenal suppression and be prepared to use GCS (see section “Overdose”).

When carrying out resuscitation measures or surgical interventions, it is necessary to determine the degree of adrenal insufficiency.

It is recommended to regularly measure the height of children who receive long-term therapy with inhaled corticosteroids.

Due to the possibility of adrenal suppression, patients switched from oral corticosteroids to inhaled fluticasone propionate therapy should be treated with extreme caution and their adrenal function regularly monitored.

After starting treatment with inhaled fluticasone propionate, systemic corticosteroids should be withdrawn gradually, and such patients should have a special patient card containing an indication of the possible need for additional administration of corticosteroids in stressful situations.

In patients with exacerbation of bronchial asthma, hypoxia, it is necessary to control the concentration of K+ ions in the plasma.

There are very rare reports of increased blood glucose levels, and this should be kept in mind when prescribing a combination of salmeterol and fluticasone propionate to patients with diabetes mellitus (see section "Side effects").

During the post-marketing period, there have been reports of clinically significant drug interactions between fluticasone propionate and ritonavir, leading to systemic effects of GCS, including Cushing's syndrome and adrenal suppression. Therefore, it is recommended to avoid the combined use of fluticasone propionate and ritonavir, unless the potential benefit to the patient outweighs the risk associated with the systemic effects of GCS (see section “Drug Interactions”).

Data from a clinical study of the safety of salmeterol added to the treatment of bronchial asthma compared with placebo showed that the incidence of deaths due to bronchial asthma was significantly higher in the salmeterol group. When taking salmeterol compared with placebo, the risk of serious respiratory adverse reactions or death in African-American patients appears to be greater than in other patients. The significance of pharmacogenetic factors or other causes is unknown. The effect associated with the use of GCS on the risk of death in patients with asthma was not studied in this study.

Like other inhaled drugs, Seretide® can cause paradoxical bronchospasm, manifested by an increase in shortness of breath immediately after use. In this case, you should immediately use a fast- and short-acting inhaled bronchodilator, discontinue Seretide®, examine the patient and, if necessary, begin alternative therapy (see section “Side Effects”).

Impact on the ability to drive vehicles and machinery

In clinical studies, no data were obtained on the effect of the drug on the ability to drive vehicles and other mechanisms, however, the side effects that the drug may cause should be taken into account.

Side effect

All undesirable reactions presented below are characteristic of the active ingredients - salmeterol and fluticasone propionate separately. The profile of adverse reactions of the drug Seretide® does not differ from the profile of adverse reactions of its active substances.

Clinical trial data

Frequency of occurrence of adverse reactions

Infectious and parasitic diseases:

often - candidiasis of the oral cavity and pharynx, pneumonia (in patients with COPD); rarely - esophageal candidiasis.

From the immune system:

hypersensitivity reactions: uncommon - skin hypersensitivity reactions, shortness of breath; rarely - anaphylactic reactions.

From the endocrine system:

possible systemic effects (see section "Special Instructions"): infrequently - cataracts; rarely - glaucoma.

Metabolism and nutrition:

uncommon - hyperglycemia; very rarely - hypokalemia.

Mental disorders:

infrequently - anxiety, sleep disturbances; rarely - changes in behavior, incl. hyperactivity and irritability (especially in children).

From the nervous system:

very often - headache (see section "Special instructions"); infrequently - tremor (see section "Special instructions").

From the heart:

infrequently - rapid heartbeat (see sections “With caution” and “Special instructions”), tachycardia, atrial fibrillation; rarely - arrhythmia, including ventricular extrasystole, supraventricular tachycardia and extrasystole.

From the respiratory system, chest and mediastinal organs:

often - hoarseness and/or dysphonia; infrequently - pharyngeal irritation.

For the skin and subcutaneous tissues:

infrequently - bruising.

From the musculoskeletal system and connective tissue:

often - muscle spasms, arthralgia.

Post-registration observation data

Frequency of occurrence of adverse reactions

From the immune system:

hypersensitivity reactions: rarely - angioedema (mainly swelling of the face and oropharynx), bronchospasm.

From the endocrine system:

possible systemic effects (see section "Special Instructions") rarely - Cushing's syndrome, Cushingoid symptoms, suppression of adrenal function, growth retardation in children and adolescents, decreased bone mineral density.

From the respiratory system, chest and mediastinal organs:

rarely - paradoxical bronchospasm (see section "Special instructions").

Possible product names

Seretide aeros. d/inhal. doses 25 mcg+250 mcg/dose 120 doses.
SERETIDE 25 µG/250 µG AEROSOL 120 DOSES
SERETIDE 25MCG+250MCG/DOSE 120 DOSES AEROSOL
SERETED AEROS. D/INGAL. 120 DOZES (25MCG+250MCG) X1
SERETYD AIR. D/ING. DOSER. 25MCG+250MCG/DOSE (INHALER) 120 DOSES No. 1
SERETIDE 25MCG+250MCG/DOSE AEROSOL D/INHALATION DOSAGE. 120DOZ (R)
(Seretide) Seretide aerosol. d/inhal. doses 25 mcg+250 mcg/dose 120 doses.

Indications for use of the drug Seretide™

Reversible obstructive diseases of the respiratory tract Systematic treatment of reversible broncho-obstructive diseases of the respiratory tract, including asthma in children and adults if it is necessary to prescribe a bronchodilator in combination with inhaled corticosteroids. The drug is intended for the treatment of:

patients receiving effective maintenance doses of selective long-acting β2-adrenergic receptor agonists and inhaled corticosteroids;
patients who experience symptoms of the disease during treatment with inhaled corticosteroids;
patients regularly receiving bronchodilators and requiring the use of inhaled corticosteroids.

COPD Basic therapy for COPD, including chronic bronchitis and emphysema.

Use of the drug Seretide™

The drug is intended for inhalation use only. Patients should understand that the drug should be used regularly, even in the absence of attacks of bronchial obstruction, since it is prescribed to prevent the disease. Patients should be under regular medical supervision, they need to select the optimal dose of Seretide, which can only be changed as directed by a doctor. Reversible obstructive airway diseases. Seretide is prescribed in the minimum effective dose to ensure control of the symptoms of the disease. When control is achieved by using the drug 2 times a day, you can try to reduce the dose to the minimum effective, the frequency of use is 1 time a day. The amount of fluticasone propionate in the chosen form should correspond to the severity of the disease. If asthma symptoms are not sufficiently controlled using inhaled corticosteroids alone, such control can be improved by replacing inhaled corticosteroid therapy with Seretide at a therapeutically equivalent dose of corticosteroids. For patients whose asthma symptoms are sufficiently controlled by the use of corticosteroids alone, replacing them with Seretide may allow a reduction in the dose of corticosteroids while maintaining control of asthma symptoms. Seretide Discus is for inhalation use only. Recommended doses Adults and adolescents over 12 years of age: 1 inhalation (50 mcg salmeterol/100 mcg fluticasone propionate) 2 times a day; or 1 inhalation (50 mcg salmeterol/250 mcg fluticasone propionate) 2 times a day; or 1 inhalation (50 mcg salmeterol/500 mcg fluticasone propionate) 2 times a day. Adults aged 18 years and older: If an adult patient aged 18 years or older requires short-term (up to 14 days) additional therapy with inhaled corticosteroids, he can be prescribed a double dose of any form of Seretide, comparable in safety and tolerability profile to the usual dose of Seretide 2 times. per day. Children aged 4 to 12 years : 1 inhalation (50 mcg salmeterol/100 mcg fluticasone propionate) 2 times a day. There are no data on the use of the drug in children under 4 years of age, so use is not recommended. COPD . For adult patients, the maximum recommended dose is 1 inhalation (50 mcg salmeterol/500 mcg fluticasone propionate) 2 times a day. Selected groups of patients: There is no need for dose adjustment in elderly patients and in patients with liver or kidney pathology. Discus is a device designed to release powder and then inhale it. Before use, open and charge the device by sliding the lever. Then place the mouthpiece in your mouth and wrap your lips around it, then inhale the dose and close the device. The indicator shows the number of doses remaining in the Discus. Rules for using the Discus inhaler The new Discus inhaler must be closed. Contains 60 doses of the drug in powder form. The dose indicator at the top shows how many doses are left. In this way, every dose is precisely measured and hygienically protected. There is no need for special care of the inhaler and refilling doses. Numbers 5 to 0 appear in red to indicate remaining doses. Usage:

open the inhaler;
move the lever;
inhale;
close the inhaler.

How the Discus inhaler works: when you press the lever in the inhaler, a small hole in the mouthpiece opens slightly and a dose is unpacked for inhalation. When closing the inhaler, the lever automatically rotates to its original position and the inhaler is ready to prepare the next dose if necessary. The case protects the inhaler when not in use. Caring for your Discus inhaler: wipe the mouthpiece of the inhaler with a dry cloth. Need to remember:

the inhaler is stored in a dry place;
the inhaler must be closed when not in use;
never exhale into a Discus inhaler;
press the lever only when you are ready to take a dose;
never exceed the recommended dose.

Seretide Evohaler is for inhalation use only. Recommended doses Adults and adolescents 12 years of age and older: 2 inhalations of 25 mcg salmeterol/50 mcg fluticasone propionate 2 times daily; or 2 inhalations of 25 mcg salmeterol/125 mcg fluticasone propionate 2 times a day; or 2 inhalations of 25 mcg salmeterol/250 mcg fluticasone propionate 2 times a day. Adults 18 years of age and older: If an adult requires short-term (up to 14 days) adjunctive therapy with an inhaled corticosteroid, a double dose of any form of Seretide Evohaler can be administered, which will have a safety and tolerability profile comparable to the usual dose of Seretide Evohaler twice daily. day. Children aged 4 years and older : 2 inhalations of 25 mcg salmeterol/50 mcg fluticasone propionate 2 times a day. There are no data regarding the use of Seretide Evohaler in children under 4 years of age. COPD For adult patients, the maximum recommended dose is 2 inhalations (25 mcg salmeterol/250 mcg fluticasone propionate) 2 times a day. Selected patient groups: There is no need to adjust the dose in elderly patients or in patients with insufficient renal or hepatic function. For patients who find it difficult to coordinate inhalation with nebulization of the inhaler, it is recommended to use a spacer (a device for facilitating the administration of inhaled drugs AeroChamber Plus - see below). Use of a device for administering metered inhalation aerosols AeroChamber Plus To avoid deterioration of disease control due to improper use of metered inhalation aerosols, it is recommended to use an additional device - a Spencer with an AeroChamber Plus mask. This is a volumetric chamber through which the aerosol from the inhaler enters the patient's respiratory tract. The AeroChamber Plus spacer can be used in children under the age of 4 years, and the spacer with a face mask can be used from the first days of life (0-18 months - orange mask, 1 year-5 years - yellow mask). The use of AeroChamber Plus allows you to reduce the oropharyngeal disposition of the drug: fewer aerosol particles are retained in the oropharynx, larynx and trachea, and more reach the lower respiratory tract (due to the presence of a valve and diaphragm in this spacer). In addition, it slows down the speed of the aerosol jet, due to which its large non-respirable particles (4.7 microns) are eliminated. AeroChamber Plus has a universal adapter. Rules for using the AeroChamber Plus spacer :

carefully check the spacer for damage or foreign objects;
remove the cap from the inhaler mouthpiece;
shake the inhaler;
insert the inhaler mouthpiece into the adapter;
carefully and tightly press the mask to your face;
press the inhaler once and inhale slowly;
keep the mask pressed to your face for 6 breaths after pressing the inhaler;
Carefully remove the mask from your face.

Rules for caring for the AeroChamber Plus spacer:

it is necessary to wash the spacer before the first use, after which the spacer is washed once a week;
disconnect the adapter for the inhaler, do not disconnect the mask and valves;
immerse the spacer with the disconnected adapter in warm water with detergent for 15 minutes;
rinse the spacer thoroughly with warm water;
shake off any remaining water from the spacer, do not wipe it dry;
leave the spacer at room temperature in a vertical position until completely dry, then reattach the adapter;
After 24 months with constant use, the spacer should be replaced.

Seretide air for ing 25mcg+125mcg/dose 120doses

Active substances

fluticasone,
salmeterol

Release form and composition of the drug Seretide®

Aerosol for inhalation dosed in the form of a suspension of white or almost white color.

1 dose

salmeterol xinafoate* 36.3 mcg,

which corresponds to a salmeterol content of 25 mcg

fluticasone propionate* 125 mcg

Excipients: 1,1,1,2-tetrafluoroethane - up to 75 mg.

pharmachologic effect

Mechanism of action

Salmeterol is a selective, long-acting (up to 12 hours) β2-adrenergic receptor agonist that has a long side chain that binds to the outer domain of the receptor.

Fluticasone propionate belongs to the group of corticosteroids for topical use and, when administered by inhalation in recommended doses, has a pronounced anti-inflammatory and antiallergic effect in the lungs, which leads to a decrease in clinical symptoms and a decrease in the frequency of exacerbations of bronchial asthma. Fluticasone propionate does not cause the adverse effects that are observed with systemic administration of corticosteroids.

Indications of the drug Seretide®

The drug Seretide® is intended for the regular treatment of bronchial asthma if combination therapy with a long-acting beta2-adrenergic agonist and inhaled corticosteroids is indicated:

patients with insufficient disease control on the background of constant monotherapy with inhaled corticosteroids with periodic use of a short-acting beta2-adrenergic agonist;
patients with adequate disease control during therapy with inhaled GCS and a long-acting beta2-adrenergic agonist;
as initial maintenance therapy in patients with persistent bronchial asthma if there are indications for prescribing GCS to achieve disease control.
The drug Seretide® is intended for maintenance therapy in patients with COPD with an FEV1 value <60% of the predicted value (before inhalation of a bronchodilator) and a history of repeated exacerbations, in whom severe symptoms of the disease persist despite regular bronchodilator therapy.

Dosage regimen

Seretide® is intended for inhalation only.

The patient should be informed that to obtain 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 recommendation of a doctor.

Bronchial asthma

The dose of Seretide should be reduced to the lowest dose that provides effective control of symptoms.

If taking Seretide® 2 times a day provides control over symptoms, as part of reducing the dose to the minimum effective, it is possible to reduce the frequency of taking the drug to 1 time a day.

The patient should be prescribed a form of Seretide that contains a dose of fluticasone propionate appropriate to the severity of his disease.

Recommended Doses

Adults and children 12 years of age and older: two inhalations (25 mcg salmeterol and 50 mcg fluticasone propionate) 2 times / day, or two inhalations (25 mcg salmeterol and 125 mcg fluticasone propionate) 2 times / day, or two inhalations (25 mcg salmeterol and 250 mcg of fluticasone propionate) 2 times a day.

Children 4 years of age and older: two inhalations (25 mcg of salmeterol and 50 mcg of fluticasone propionate) 2 times a day.

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

Chronic obstructive pulmonary disease (COPD)

For adult patients, the maximum recommended dose is two inhalations (25 mcg salmeterol and 250 mcg fluticasone propionate) 2 times a day.

Special patient groups

There is no need to reduce the dose of Seretide in elderly patients, or in patients with impaired renal or hepatic function.

Before use, consultation with a specialist is required.

Storage regimen, contraindications and side effects are indicated in the instructions.

Side effects of Seretide™

Since Seretide contains salmeterol and fluticasone propionate, adverse reactions of the type and severity that are characteristic of each component can be expected. No additional side effects were noted with the simultaneous use of 2 components of the drug. As with other inhaled drugs, paradoxical bronchospasm may occur with an immediate increase in the severity of shortness of breath after inhalation. If such a condition develops, a rapid and short-acting inhaled bronchodilator should be immediately used. Seretide should be discontinued immediately, the patient examined and, if necessary, alternative therapy prescribed. Data from clinical studies Salmeterol-fluticasone propionate Isolated cases of hematomas have been reported. Commonly reported side effects included hoarseness/dysphonia, throat irritation, headache, oral and throat candidiasis, and palpitations. Patients with COPD may develop pneumonia. Post-licensing data Salmeterol-fluticasone propionate Infrequent skin hypersensitivity reactions have been described. There are isolated reports of hypersensitivity reactions that manifest as angioedema (mainly swelling of the face and oropharynx), respiratory symptoms (shortness of breath and/or bronchospasm) and very rarely anaphylactic reactions. There have been isolated cases of anxiety, sleep disturbances and behavioral changes, including hyperactivity and agitation (mainly in children), as well as isolated cases of hyperglycemia. Salmeterol There are reports of pharmacological side effects of treatment with β2-agonists, such as tremor, palpitations, headache (usually transient, the severity of which decreases with regular use of the drug). In patients with higher sensitivity, cardiac arrhythmia (including atrial fibrillation, supraventricular tachycardia and extrasystole) is noted. Rarely - arthralgia and very rarely - hypersensitivity reactions and anaphylaxis, including edema and angioedema, bronchospasm and anaphylactic shock. There are reports of irritation of the mucous membranes of the mouth and throat. Uncommon: rash; common: muscle spasm. There are isolated reports of the development of hyperglycemia. Fluticasone propionate Some patients experienced hoarseness and candidiasis of the mucous membrane of the mouth and throat. Skin hypersensitivity reactions have been described, in isolated cases - angioedema of the face and oropharynx, the development of respiratory symptoms - shortness of breath and bronchospasm, and extremely rarely - anaphylactic reactions. Rinsing the mouth and throat with water after inhaling the drug can help reduce the incidence of dysphonia and candidiasis. Symptomatic candidiasis can be treated with topical antifungals while continuing to take Seretide. Possible systemic effects include adrenal suppression, Cushing's syndrome, Cushingoid signs, growth retardation in children and adolescents, decreased bone mineralization, cataracts and glaucoma. There are isolated reports of the development of hyperglycemia. There are anecdotal reports of anxiety, sleep disturbances and behavioral disturbances, including hyperactivity and agitation (mainly in children).

Special instructions for the use of Seretide™

Treatment of reversible obstructive airway diseases should be carried out according to a sequential program, the patient's condition must be regularly monitored both clinically and by determining indicators of pulmonary function. Seretide is not a drug for the relief of acute symptoms when the use of fast- and short-acting bronchodilators (for example, salbutamol) is necessary. The patient should be advised to always carry an appropriate medication to relieve symptoms. An increase in the frequency of use of short-acting bronchodilators to relieve asthma attacks indicates a deterioration in disease control, in which case the patient should consult a doctor. The rapid and progressive deterioration of asthma control poses a potential threat to life, which requires a revision of treatment tactics, and it may be necessary to increase the dose of GCS. The patient should also be examined if the prescribed dose of Seretide does not provide adequate control of asthma symptoms. The need for additional administration of GCS, as well as antibiotic therapy in case of infection, should be assessed. Given the risk of exacerbation of asthma or COPD, treatment with Seretide should not be abruptly stopped; the dose should be reduced gradually under medical supervision. Like other inhaled drugs containing corticosteroids, Seretide should be prescribed with caution to patients with active or latent pulmonary tuberculosis or thyrotoxicosis. In clinical studies of patients with COPD who received Seretide, an increased incidence of pneumonia was demonstrated. Doctors should be careful about the possible development of pneumonia in this category of patients, since the clinical symptoms of pneumonia and exacerbation of COPD often coincide. Cardiovascular effects, such as increases in systolic blood pressure and heart rate, can sometimes occur with all symatomimetics, especially in doses that exceed therapeutic doses. Therefore, Seretide should be used with caution in the treatment of patients with existing cardiovascular disease. The use of all sympathomimetics in doses that exceed therapeutic doses may lead to a transient increase in plasma potassium levels. Therefore, Seretide should be used with caution in patients predisposed to hypokalemia. Systemic effects can occur when using any inhaled GCS, especially in high doses over a long period of time; these effects are much less likely than with oral administration of corticosteroids (see OVERDOSE ). Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children, decreased bone mineralization, cataracts, and glaucoma. Therefore, it is important to titrate the dose of inhaled corticosteroids to the minimum effective, ensuring the ability to control asthma symptoms. You should always keep in mind the possibility of adrenal dysfunction in extreme situations, which may require the use of corticosteroids. It is recommended to regularly monitor growth dynamics in children receiving inhaled GCS for a long period. Some patients may be more sensitive to the effects of inhaled corticosteroids than most patients. Given the possibility of dysfunction of the adrenal cortex, it is necessary to transfer patients from oral corticosteroid therapy to inhaled fluticasone propionate with extreme caution, while regularly monitoring the function of the adrenal cortex. After administration of inhaled fluticasone propionate, systemic therapy should be discontinued gradually. Patients should have a special card with them indicating the need for additional administration of GCS in stressful situations. There are isolated reports of the development of hyperglycemia, which should be taken into account when prescribing Seretide to patients with diabetes mellitus. According to post-marketing data from the use of the drug, clinically significant drug interactions were reported in patients using fluticasone propionate and ritanavir, which was the cause of the systemic effects of GCS, including Cushing's syndrome and adrenal suppression. Therefore, the combined use of fluticasone propionate and ritanavir should be avoided, unless the benefit of this use is greater than the risk of systemic effects of GCS. A large clinical trial conducted in the United States ( SMART ), which compared the safety of Serevent (a component of Seretide Evohaler) or placebo as an addition to conventional therapy, showed an increase in asthma-related deaths in patients treated with Serevent. These studies suggest that African-American patients are at higher risk of severe respiratory complications or death when treated with Serevent compared to placebo. It is not known whether this is due to pharmacogenetic or other factors. SMART study did not determine whether concomitant use of inhaled corticosteroids would alter the risk of asthma-related deaths. According to a drug interaction study, combined use with systemic ketoconazole increases the effect of salmeterol. This may lead to prolongation of the QT . Therefore, caution should be exercised when concomitantly using salmeterol and strong CYP3A4 inhibitors (for example, ketoconazole). During pregnancy and breastfeeding. Prescribing medications during pregnancy and lactation is permissible only if the expected benefit to the mother outweighs the potential risk to the fetus or child. There is insufficient experience with the use of salmeterol xinafoate and fluticasone propionate during pregnancy and lactation. Reproductive toxicity studies in animals, conducted both with individual components of the drug and with their combination, revealed the effects on the fetus that can be expected when using a strong β2-agonist and corticosteroids in high doses. Experience in the clinical use of drugs of these classes indicates the absence of such effects in therapeutic doses. Salmeterol xinafoate and fluticasone propionate do not have genotoxic potential. The plasma concentrations of salmeterol xinafoate and fluticasone propionate after inhalation at therapeutic doses are very low, and therefore their concentrations in breast milk can be expected to be correspondingly low. There are no data on the concentration of drugs in human breast milk. Children. There are no data regarding the use of Seretide in children under 4 years of age, therefore the use of the drug is not recommended. Impact on the ability to drive vehicles and operate other machinery. No specific studies were carried out; Based on the pharmacology of both drugs, it can be assumed that there is no effect.

Seretide aerosol for inhalation 25 mcg+250 mcg/dose 120 doses

Registration Certificate Holder

GlaxoSmithKline Trading (Russia)

Dosage form

Medicine - Seretide®

Description

Aerosol for inhalation dosed

in the form of a white or almost white suspension.

1 dose

salmeterol xinafoate* 36.3 mcg, which corresponds to the content of salmeterol 25 mcg fluticasone propionate* 250 mcg

Excipients

: 1,1,1,2-tetrafluoroethane - up to 75 mg.

120 doses - aluminum inhalers (1) with a plastic spray - cardboard packs.

* the composition includes an excess of up to 10% salmeterol xinafoate and up to 15% fluticasone propionate to compensate for losses during production and in the dosing device inside the inhaler (excess is not taken into account in the given composition).

Indications

The drug Seretide® is intended for the regular treatment of bronchial asthma if combination therapy with a long-acting beta2-adrenergic agonist and inhaled corticosteroids is indicated:

patients with insufficient disease control on the background of constant monotherapy with inhaled corticosteroids with periodic use of a short-acting beta2-adrenergic agonist;
patients with adequate disease control during therapy with inhaled GCS and a long-acting beta2-adrenergic agonist;
as initial maintenance therapy in patients with persistent bronchial asthma if there are indications for prescribing GCS to achieve disease control.

The drug Seretide® is intended for maintenance therapy in patients with COPD with an FEV1 value <60% of the predicted value (before inhalation of a bronchodilator) and a history of repeated exacerbations, in whom severe symptoms of the disease persist despite regular bronchodilator therapy.

Contraindications for use

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

Carefully _

Like all other inhaled drugs containing corticosteroids, Seretide® should be used with caution in patients with acute or latent pulmonary tuberculosis.

The drug Seretide® should be prescribed with caution in case of thyrotoxicosis.

Seretide® should be used with caution in case of fungal, viral or bacterial infections of the respiratory system.

There are very rare reports of increased blood glucose levels, so patients with diabetes should use Seretide® with caution (see section "Side effects").

pharmachologic effect

Mechanism of action

Salmeterol

is a selective long-acting (up to 12 hours) β2-adrenergic receptor agonist, which has a long side chain that binds to the outer domain of the receptor.

A single administration of salmeterol weakens the hyperreactivity of the bronchial tree.
This indicates that salmeterol, in addition to bronchodilator activity, has an additional effect not associated with bronchial dilation, the clinical significance of which has not been fully established. This mechanism of action differs from the anti-inflammatory effect of GCS. Fluticasone propionate
belongs to the group of corticosteroids for topical use and, when administered by inhalation in recommended doses, has a pronounced anti-inflammatory and antiallergic effect in the lungs, which leads to a decrease in clinical symptoms and a decrease in the frequency of exacerbations of bronchial asthma. Fluticasone propionate does not cause the adverse effects that are observed with systemic administration of corticosteroids.

Drug interactions

Due to the risk of developing bronchospasm, the use of selective and non-selective beta-blockers should be avoided, unless they are absolutely necessary for the patient.

Xanthine derivatives, corticosteroids and diuretics increase the risk of developing hypokalemia (especially in patients with exacerbation of bronchial asthma, during hypoxia).

MAO inhibitors and tricyclic antidepressants increase the risk of side effects from the cardiovascular system.

Seretide® is compatible with cromoglycic acid.

Dosage regimen

Seretide® is intended for inhalation only.

The patient should be informed that to obtain 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 recommendation of a doctor.

Bronchial asthma

The dose of Seretide should be reduced to the lowest dose that provides effective control of symptoms.

If taking Seretide® 2 times a day provides control over symptoms, as part of reducing the dose to the minimum effective, it is possible to reduce the frequency of taking the drug to 1 time a day.

The patient should be prescribed a form of Seretide that contains a dose of fluticasone propionate appropriate to the severity of his disease.

Recommended Doses

Adults and children 12 years and older:

Children 4 years and older:

two inhalations (25 mcg of salmeterol and 50 mcg of fluticasone propionate) 2 times a day.

There is currently no data on the use of Seretide® in children under 4 years of age

Chronic obstructive pulmonary disease (COPD)

For adult patients

the maximum recommended dose is two inhalations (25 mcg salmeterol and 250 mcg fluticasone propionate) 2 times a day.

Special patient groups

There is no need to reduce the dose of Seretide in elderly patients, or in patients with impaired renal or hepatic function.

Instructions for use of the inhaler (for patients)

Checking the inhaler

Using an inhaler

1. Remove the cap from the mouthpiece by lightly squeezing the cap from the sides.

2. Inspect the inhaler from the outside and inside, including the mouthpiece, for foreign objects.

3. Shake the inhaler well to ensure that any foreign objects are removed and that the contents of the inhaler are evenly mixed.

4. Hold the inhaler between the thumb and fingers of one hand in a vertical position, bottom up, with the thumb resting on the base under the mouthpiece.

5. Exhale as deeply as possible, then place the mouthpiece in your mouth between your teeth, closing your lips around it, but without biting down on the mouthpiece.

6. Immediately after you start inhaling through your mouth, press the top of the inhaler to spray Seretide® while continuing to inhale deeply and slowly.

7. While holding your breath, remove the inhaler from your mouth and remove your finger from the top of the inhaler. Continue holding your breath for as long as possible.

8. To carry out the second spray, hold the inhaler vertically and after about 30 seconds repeat steps 3-7.

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

10. Immediately close the mouthpiece cap by pressing and clicking into position. If latching does not occur, turn the mouthpiece cap and try closing the mouthpiece again. Do not press the cap with force.

The drug can also be used through a spacer. Attention! When following steps 5, 6 and 7, you should not rush.

You should begin inhaling as slowly as possible, just before pressing the inhaler valve.

It is recommended to practice in front of a mirror the first few times.

If you see "fog" coming from the top of the inhaler or from the corners of your mouth, then you should start all over again, starting from step 2.

If your doctor gives you other instructions for using your inhaler, follow them strictly. Contact your doctor if you have difficulty using your inhaler.

Children

Cleaning the inhaler

The inhaler must be cleaned at least once a week.

1. Remove the protective cap from the mouthpiece.

2. Do not remove the metal can from the plastic casing.

3. Use a dry cloth or cotton swab to wipe the inside and outside of the mouthpiece and plastic housing.

4. Close the mouthpiece with the protective cap.

Do not immerse the metal can in water.

Overdose

Symptoms

Expected symptoms and signs of salmeterol overdose are typical of excessive beta2-adrenergic stimulation and include tremor, headache, tachycardia, increased systolic blood pressure and hypokalemia.

When taking the drug in doses higher than recommended for a long period of time, significant suppression of the function of the adrenal cortex is possible.
Rare cases of acute adrenal crisis have been described, which occurred mainly in children who received doses of the drug higher than recommended for a long time (several months or years). Acute adrenal crisis is characterized by hypoglycemia, accompanied by confusion and/or convulsions. Situations that may trigger an acute adrenal crisis include trauma, surgery, infection, or any rapid reduction in the dose of inhaled fluticasone propionate in Seretide. Treatment
There is no specific treatment for overdose of salmeterol and fluticasone propionate. In case of overdose, maintenance therapy should be carried out and the patient's condition should be monitored. In case of chronic overdose, it is recommended to monitor the reserve function of the adrenal cortex.

Side effect

The adverse reactions presented below are listed according to the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is defined as follows: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and < 1/1000), very rare (<1/10,000, including isolated cases). Frequency categories were formed based on data from clinical trials of the drug and post-registration surveillance.

Clinical trial data

Frequency of occurrence of adverse reactions

Infectious and parasitic diseases:

often - candidiasis of the oral cavity and pharynx, pneumonia (in patients with COPD); rarely - esophageal candidiasis.

From the immune system:

hypersensitivity reactions: uncommon - skin hypersensitivity reactions, shortness of breath; rarely - anaphylactic reactions.

From the endocrine system:

possible systemic effects (see section "Special Instructions"): infrequently - cataracts; rarely - glaucoma.

Metabolism and nutrition:

uncommon - hyperglycemia; very rarely - hypokalemia.

Mental disorders:

infrequently - anxiety, sleep disturbances; rarely - changes in behavior, incl. hyperactivity and irritability (especially in children).

From the nervous system:

very often - headache (see section "Special instructions"); infrequently - tremor (see section "Special instructions").

From the heart:

From the respiratory system, chest and mediastinal organs:

often - hoarseness and/or dysphonia; infrequently - pharyngeal irritation.

For the skin and subcutaneous tissues:

infrequently - bruising.

From the musculoskeletal system and connective tissue:

often - muscle spasms, arthralgia.

Post-registration observation data

Frequency of occurrence of adverse reactions

From the immune system:

hypersensitivity reactions: rarely - angioedema (mainly swelling of the face and oropharynx), bronchospasm.
From the endocrine system:
possible systemic effects (see section "Special Instructions") rarely - Cushing's syndrome, Cushingoid symptoms, suppression of adrenal function, growth retardation in children and adolescents, decreased bone mineral density.

From the respiratory system, chest and mediastinal organs:

rarely - paradoxical bronchospasm (see section "Special instructions").

special instructions

More frequent use of short-acting bronchodilators to relieve symptoms indicates worsening disease control, and in such situations the patient should consult a doctor.

In emergency and planned situations that can cause stress, it is always necessary to remember the possibility of adrenal suppression and be prepared to use GCS (see section “Overdose”).

When carrying out resuscitation measures or surgical interventions, it is necessary to determine the degree of adrenal insufficiency.

It is recommended to regularly measure the height of children who receive long-term therapy with inhaled corticosteroids.

In patients with exacerbation of bronchial asthma, hypoxia, it is necessary to control the concentration of K+ ions in the plasma.

There are reports of adverse reactions associated with the pharmacological action of beta2-antagonists, such as tremor, subjective palpitations and headache.
However, these reactions are short-term in nature, and their severity decreases with regular therapy (see section “Side effects”). Effect on the ability to drive vehicles and operate machinery.
Clinical studies have not provided data on the effect of the drug on the ability to drive vehicles and operate machinery; however, side effects that the drug may cause should be taken into account.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C; do not freeze, do not expose to direct sunlight.

Best before date

Shelf life: 2 years.

Do not use after expiration date.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - Contraindicated. Restrictions when breastfeeding - Contraindicated.

Fertility

There are no data on the effect on fertility in humans. In animal studies, there was no effect of fluticasone propionate or salmeterol xinafoate on male or female fertility.

Pregnancy

Data on the use of the drug in pregnant women are limited. Use during pregnancy is permissible only if the potential benefit to the mother outweighs the possible risk to the fetus.

Extensive experience in the clinical use of drugs of this class indicates that when using therapeutic doses, the described effects are not clinically significant.

Breastfeeding period

The use of the drug during breastfeeding is permissible only if the potential benefit to the mother outweighs the possible risk to the child.

Use for renal impairment

Restrictions for impaired renal function - No restrictions.

In patients with impaired renal function

no dose reduction is required.

Use for liver dysfunction

Restrictions for liver dysfunction - No restrictions.

In patients with liver dysfunction

no dose reduction is required.

Use in elderly patients

Restrictions for elderly patients - Use with caution.

In elderly patients

no dose reduction is required.

Use in children

Restrictions for children - With caution.

The use of the drug is contraindicated in children under 4 years of age.

Terms of sale

The drug is available with a prescription.

RU/SFC/0040/16 12/23/2016

Contacts for inquiries

GlaxoSmithKline Trading JSC (Russia)

125167 Moscow Leningradsky Prospekt, 37a, bldg. 4 BC "Arcus III" Tel. Fax

Drug interactions Seretide™

Non-selective and selective β2-adrenergic blockers should be avoided in patients with reversible bronchial obstruction, unless absolutely necessary. Under normal conditions, after inhaled use of the drug, low plasma concentrations of fluticasone are achieved due to extensive first-pass metabolism and high systemic clearance of the drug mediated by cytochrome P450 3A4 in the liver and intestines. Therefore, clinically significant interactions due to fluticasone propionate are unlikely. Based on drug interaction studies in healthy volunteers, it has been shown that rinatavir (a strong inhibitor of cytochrome P450 3A4) can significantly increase plasma concentrations of fluticasone propionate, which can lead to a significant decrease in plasma cortisol concentrations. According to post-marketing data from the use of the drug, clinically significant drug interactions were reported in patients who were treated with inhaled or intranasal administration of fluticasone propionate and ritanavir, which was the cause of the systemic effects of GCS, including Cuschiig's syndrome and suppression of adrenal function. Therefore, the simultaneous use of fluticasone propionate and ritanavir should be avoided, unless the benefit of use will outweigh the risk of systemic effects of GCS. Based on studies of other cytochrome P450 3A4 inhibitors, it has been proven that other cytochrome P450 3A4 inhibitors have a very minor (erythromycin) or small (ketoconazole) effect on increasing the systemic concentration of fluticasone propionate in the blood plasma, without leading to a significant decrease in cortisol concentrations. However, strong inhibitors of cytochrome P450 3A4 (for example, ketoconazole) should be used with caution, given the possibility of systemic effects of fluticasone propionate. The combined use of ketoconazole and salmeterol causes a significant increase in the concentration of salmeterol in the blood plasma (maximum plasma concentration 1.4 times and 15 times the AUC), which may cause a prolongation of the QT (see SPECIAL INSTRUCTIONS ).

Seretide™ overdose, symptoms and treatment

Symptoms of salmeterol overdose that can be expected are typical of excessive β2-adrenergic receptor stimulation and include tremor, headache, tachycardia, increased systolic blood pressure and hypokalemia. Cardioselective beta-adrenergic blockers are used as optimal antidotes, which should be used with caution when treating patients with a history of bronchospasm. If treatment with Seretide must be discontinued due to an overdose of the β2-agonist included in the drug, the patient should be prescribed appropriate corticosteroid replacement therapy. Inhalation of fluticasone propionate in doses higher than recommended may lead to temporary depression of the hypothalamic-pituitary-adrenal axis. This condition does not require immediate attention as adrenal function returns within a few days. However, when doses higher than recommended are used over a long period of time, significant suppression of adrenal function is possible. Cases of acute adrenal crises have been reported rarely, mainly in children receiving higher than recommended doses of the drug over a long period (several months or years). Hypoglycemia may occur, accompanied by impaired consciousness and/or convulsions. Factors that trigger acute adrenal crisis include trauma, surgery, infection, or a sharp reduction in the dose of inhaled fluticasone propionate. Therefore, Seretide should not be used in doses higher than recommended. The dosage regimen should be regularly reviewed and the dose reduced to the minimum level sufficient to effectively control the disease.

Seretide 25mcg/250mcg 120 doses aerosol for inhalation dosed

pharmachologic effect

Bronchodilator (selective beta2-adrenergic agonist + local glucocorticosteroid)

Composition and release form Seretide 25 µg/250 µg 120 doses aerosol for inhalation metered

Aerosol for inhalation dosed - 1 dose:

Active ingredients: salmeterol xinafoate* - 36.3 mcg, which corresponds to the content of salmeterol - 25 mcg; fluticasone propionate* - 50/125/200 mcg;
Excipients: 1,1,1,2-tetrafluoroethane - up to 75 mg.

120 doses - aluminum inhalers (1) with a plastic spray - cardboard packs.

Description of the dosage form

Aerosol for inhalation dosed in the form of a suspension of white or almost white color.

Characteristic

Combined drug.

Directions for use and doses

Seretide® is intended for inhalation only.

The patient should be informed that to obtain 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 recommendation of a doctor.

Bronchial asthma

The dose of Seretide should be reduced to the lowest dose that provides effective control of symptoms.

If taking Seretide® 2 times a day provides control over symptoms, as part of reducing the dose to the minimum effective, it is possible to reduce the frequency of taking the drug to 1 time a day.

The patient should be prescribed a form of Seretide that contains a dose of fluticasone propionate appropriate to the severity of his disease.

Recommended Doses

Children 4 years of age and older: two inhalations (25 mcg of salmeterol and 50 mcg of fluticasone propionate) 2 times a day.

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

Chronic obstructive pulmonary disease (COPD)

For adult patients, the maximum recommended dose is two inhalations (25 mcg salmeterol and 250 mcg fluticasone propionate) 2 times a day.

Special patient groups

There is no need to reduce the dose of Seretide in elderly patients, or in patients with impaired renal or hepatic function.

Pharmacodynamics

Mechanism of action

Salmeterol is a selective, long-acting (up to 12 hours) β2-adrenergic receptor agonist that has a long side chain that binds to the outer domain of the receptor.

Pharmacokinetics

There is no data indicating that when administered together by inhalation, salmeterol and fluticasone propionate affect each other's pharmacokinetics, and therefore the pharmacokinetic characteristics of each component of Seretide® can be considered separately.

A study conducted in 15 healthy volunteers who simultaneously received salmeterol (inhaled 50 mcg twice daily) and the CYP3A4 inhibitor ketoconazole (oral 400 mg once daily) for 7 days showed a significant increase in salmeterol concentrations in blood plasma (increase in Cmax by 1.4 times and AUC by 15 times). There was no increase in salmeterol accumulation with repeated doses. In three patients, treatment was discontinued due to QTc prolongation or palpitations with sinus tachycardia. In the remaining 12 patients, concomitant use of salmeterol and ketoconazole did not have a clinically significant effect on heart rate, blood potassium levels, or QTc interval duration.

Suction

Salmeterol acts locally in the lung tissues, 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 Cmax in plasma is extremely low (about 200 pg/ml and below). After regular inhalations of salmeterol, hydroxynaphthoic acid can be detected in the blood, the Css of which is about 100 ng/ml. These concentrations are 1000 times lower than the Css observed in toxicity studies. No adverse effects were observed with long-term regular use of the drug (for more than 12 months) in patients with airway obstruction.

Fluticasone propionate: The absolute bioavailability of inhaled fluticasone propionate in healthy subjects varies depending on the inhaler used, but is 5.3% when the combination of salmeterol and fluticasone propionate is administered by metered dose inhalation aerosol. In patients with bronchial asthma and COPD, lower plasma concentrations of fluticasone propionate are observed. Systemic absorption occurs primarily through the lungs. At first she is faster, but then her speed slows down.

Part of the inhalation dose may be swallowed, but this part makes a minimal contribution to systemic absorption due to the low solubility of fluticasone propionate in water and due to its first-pass 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 are no data on the distribution of salmeterol.

Fluticasone propionate has a large Vd at steady state (about 300 L) and has a relatively high degree of binding to plasma proteins (91%).

Metabolism

The results of an in vitro study showed that salmeterol is extensively metabolized by the CYP3A4 isoenzyme of the cytochrome P450 system to α-hydroxysalmeterol by aliphatic oxidation. In a repeated-dose study of salmeterol and erythromycin in healthy volunteers, there were no clinically significant changes in the pharmacodynamic effects when taking 500 mg of erythromycin 3 times a day. However, an interaction study between salmeterol and ketoconazole showed a significant increase in plasma concentrations of salmeterol.

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 an inactive carboxyl metabolite. Caution must be exercised when using known CYP3A4 inhibitors and fluticasone propionate simultaneously, since in such situations the plasma levels of the latter may increase.

Removal

There are no data regarding the elimination of salmeterol.

The distribution of fluticasone propionate is characterized by rapid plasma clearance (1150 ml/min) and a final half-life of approximately 8 hours. The renal clearance of unchanged fluticasone propionate is negligible (

Indications for use Seretide 25mcg/250mcg 120 doses aerosol for inhalation dosed

The drug Seretide® is intended for the regular treatment of bronchial asthma if combination therapy with a long-acting beta2-adrenergic agonist and inhaled corticosteroids is indicated:

patients with insufficient disease control on the background of constant monotherapy with inhaled corticosteroids with periodic use of a short-acting beta2-adrenergic agonist;
patients with adequate disease control during therapy with inhaled GCS and a long-acting beta2-adrenergic agonist;
as initial maintenance therapy in patients with persistent bronchial asthma if there are indications for prescribing GCS to achieve disease control.

The drug Seretide® is intended for maintenance therapy in patients with COPD with an FEV1 value

Contraindications

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

Carefully

Like all other inhaled drugs containing corticosteroids, Seretide® should be used with caution in patients with acute or latent pulmonary tuberculosis.

The drug Seretide® should be prescribed with caution in case of thyrotoxicosis.

Seretide® should be used with caution in case of fungal, viral or bacterial infections of the respiratory system.

Any inhaled GCS can cause systemic effects, especially with long-term use in high doses. Therefore, the drug should be used with caution for glaucoma, cataracts, and osteoporosis.

There are very rare reports of increased blood glucose levels, so patients with diabetes should use Seretide with caution.

Application of Seretide 25mcg/250mcg 120 doses aerosol for inhalation dosed during pregnancy and breastfeeding

Fertility

There are no data on the effect on fertility in humans. In animal studies, there was no effect of fluticasone propionate or salmeterol xinafoate on male or female fertility.

Pregnancy

Data on the use of the drug in pregnant women are limited. Use during pregnancy is permissible only if the potential benefit to the mother outweighs the possible risk to the fetus.

Extensive experience in the clinical use of drugs of this class indicates that when using therapeutic doses, the described effects are not clinically significant.

Breastfeeding period

The use of the drug during breastfeeding is permissible only if the potential benefit to the mother outweighs the possible risk to the child.

The use of the drug is contraindicated in children under 4 years of age.

special instructions

More frequent use of short-acting bronchodilators to relieve symptoms indicates worsening disease control, and in such situations the patient should consult a doctor.

Clinical studies have provided evidence of an increase in the incidence of pneumonia in patients with COPD receiving Seretide®. Clinicians should be aware of the possibility of developing pneumonia in COPD, since the clinical presentation of pneumonia and exacerbation of COPD are often similar.

Any inhaled GCS can cause systemic effects, especially with long-term use in high doses; however, the likelihood of such symptoms occurring is much lower than with treatment with oral corticosteroids. Possible systemic reactions include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, and glaucoma. Therefore, when treating asthma, it is important to reduce the dose to the lowest dose that provides effective control of the disease.

In emergency and planned situations that can cause stress, it is always necessary to remember the possibility of adrenal suppression and be prepared to use GCS.

When carrying out resuscitation measures or surgical interventions, it is necessary to determine the degree of adrenal insufficiency.

It is recommended to regularly measure the height of children who receive long-term therapy with inhaled corticosteroids.

In patients with exacerbation of bronchial asthma, hypoxia, it is necessary to control the concentration of K+ ions in the plasma.

There are very rare reports of increased blood glucose levels, and this should be kept in mind when prescribing the combination of salmeterol and fluticasone propionate to patients with diabetes mellitus.

Impact on the ability to drive vehicles and operate machinery

Overdose

It is not recommended to prescribe the drug in doses exceeding those specified in the instructions section. It is important to regularly review the patient's dosage regimen and reduce the dose to the lowest recommended dose that provides effective disease control.

Symptoms

Expected symptoms and signs of salmeterol overdose are typical of excessive beta2-adrenergic stimulation and include tremor, headache, tachycardia, increased systolic blood pressure and hypokalemia.

Treatment

Side effects Seretide 25mcg/250mcg 120 doses aerosol for inhalation dosed

Clinical trial data

Frequency of occurrence of adverse reactions

Infectious and parasitic diseases: often - candidiasis of the oral cavity and pharynx, pneumonia (in patients with COPD); rarely - esophageal candidiasis.

From the immune system: hypersensitivity reactions: infrequently - skin hypersensitivity reactions, shortness of breath; rarely - anaphylactic reactions.

From the endocrine system: possible systemic effects: infrequently - cataracts; rarely - glaucoma.

From the side of metabolism and nutrition: infrequently - hyperglycemia; very rarely - hypokalemia.

Mental disorders: infrequently - anxiety, sleep disorders; rarely - changes in behavior, incl. hyperactivity and irritability (especially in children).

From the nervous system: very often - headache; infrequently - tremor.

From the heart: infrequently - rapid heartbeat, tachycardia, atrial fibrillation; rarely - arrhythmia, including ventricular extrasystole, supraventricular tachycardia and extrasystole.

From the respiratory system, chest and mediastinal organs: often - hoarseness and/or dysphonia; infrequently - pharyngeal irritation.

From the skin and subcutaneous tissues: infrequently - bruising.

From the musculoskeletal system and connective tissue: often - muscle spasms, arthralgia.

Post-registration observation data

Frequency of occurrence of adverse reactions

From the immune system: hypersensitivity reactions: rarely - angioedema (mainly swelling of the face and oropharynx), bronchospasm.

From the endocrine system: possible systemic effects rarely - Cushing's syndrome, Cushingoid symptoms, suppression of adrenal function, growth retardation in children and adolescents, decreased bone mineral density.

From the respiratory system, chest and mediastinal organs: rarely - paradoxical bronchospasm.

Drug interactions

Due to the risk of developing bronchospasm, the use of selective and non-selective beta-blockers should be avoided, unless they are absolutely necessary for the patient.

Xanthine derivatives, corticosteroids and diuretics increase the risk of developing hypokalemia (especially in patients with exacerbation of bronchial asthma, during hypoxia).

MAO inhibitors and tricyclic antidepressants increase the risk of side effects from the cardiovascular system.

Seretide® is compatible with cromoglycic acid.