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pharmachologic effect

Combined bronchodilator (selective beta2-adrenergic agonist + local glucocorticosteroid).

Salticasone® - nashiv - is a combination drug containing 2 active components: salmeterol xinafoate and fluticasone propionate, which have different mechanisms of action. Salmeterol prevents the occurrence of symptoms of bronchospasm, fluticasone improves pulmonary function and prevents exacerbation. Due to its convenient dosing regimen, Salticasone®-native may be an alternative for patients who simultaneously receive a beta2-adrenergic receptor agonist and an inhaled glucocorticosteroid (GCS) using different inhalers.

Salmeterol is a selective, long-acting (up to 12 hours) beta2-adrenergic receptor agonist, which has a long side chain in its structure that binds to the outer domain of the receptor.

The pharmacological properties of salmeterol provide protection against histamine-induced bronchoconstriction and longer bronchodilation (lasting at least 12 hours) than short-acting beta2-adrenergic receptor agonists.

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

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. 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 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 does not cause adverse effects that are observed with systemic administration of glucocorticosteroids.

With long-term use of inhaled fluticasone, the daily secretion of adrenal hormones remains within normal limits in both adults and children, even when using the maximum recommended doses. After switching patients receiving other inhaled corticosteroids to fluticasone, 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 fluticasone use. With long-term use of fluticasone, 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).

Saltikazon-native

Trade name: Saltikazon-native

International name: Salmeterol+Fluticasone&, (Salmeterol+Fluticasone)

Pharmacological group: combined bronchodilator (selective beta2-adrenergic agonist + local glucocorticosteroid)

Pharmacological group for ATC: R03AK06. Salmeterol in combination with other drugs for the treatment of obstructive airway diseases

Pharmacodynamics:

Combined bronchodilator (contains salmeterol and fluticasone).

Salmeterol is a selective long-acting beta2-adrenergic receptor agonist (12 hours). The salmeterol molecule has a long side chain that binds to the external site of the receptor. Due to these pharmacological properties, salmeterol is more effective in preventing histamine-induced bronchospasm and causes longer-lasting bronchodilation compared to conventional short-acting beta2-agonists. Effectively and for a long time inhibits the release of mast cell mediators such as histamine, leukotrienes and PgD2 in lung tissues. Suppresses the early and late stages of an allergic reaction; after administration of a single dose, bronchial hyperreactivity decreases; suppression of the late stage lasts 30 hours, when the bronchodilator effect is no longer present.

Fluticasone is a local GCS. When administered by inhalation, it has a pronounced anti-inflammatory effect, which leads to a decrease in the severity of symptoms and a decrease in the frequency of exacerbations of diseases accompanied by airway obstruction.

With long-term use of inhaled fluticasone in maximum doses, the daily and reserve secretion of adrenal hormones remains within normal limits in adults and children. Residual decrease in adrenal reserve function may persist for a long time after therapy.

Pharmacokinetics:

Simultaneous inhalation administration of salmeterol and fluticasone does not affect the pharmacokinetics of each of these substances.

Salmeterol: after inhalation administration in therapeutic doses, very low concentrations of the drug in plasma are created (200 pg/ml or less). With regular use of inhaled salmeterol, hydroxynaphthoic acid is detected in the systemic circulation in concentrations of up to 100 ng/ml.

Fluticasone: after inhalation administration, the relative bioavailability is 10-30% depending on the drug delivery system. Systemic absorption occurs primarily in the lungs. Part of the inhaled dose can be swallowed, but its systemic effect is minimal due to the drug’s poor solubility in water and intensive metabolism during the “first pass” through the liver. The bioavailability of fluticasone when swallowed is less than 1%. There is a direct relationship between the size of the inhaled dose and the systemic effect of fluticasone; the volume of distribution is about 300 liters. Metabolized in the liver to an inactive metabolite with the participation of CYP3A4 of the cytochrome P450 system. Less than 5% of the metabolite is excreted in the urine. Plasma clearance - 1.15 l/min. T1/2 - 8 hours.

Indications for use:

Bronchial asthma in patients with insufficient disease control during constant monotherapy with inhaled GCS with periodic use of a short-acting beta2-adrenergic agonist, in 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.

Maintenance therapy for COPD and FEV1 less than 60% of predicted values and a history of repeated exacerbations in which severe symptoms of the disease persist despite regular use of bronchodilators.

Contraindications:

Hypersensitivity, children's age (up to 4 years).

Carefully:

Pulmonary tuberculosis, fungal, viral or bacterial infections of the respiratory system, thyrotoxicosis, pheochromocytoma, diabetes mellitus, uncontrolled hypokalemia, IGSS, uncontrolled arterial hypertension, arrhythmia, prolongation of the QT interval on the ECG, hypoxia of various origins, cataracts, glaucoma, hypothyroidism, osteoporosis, pregnancy, lactation period.

Dosage regimen:

Inhalation. The initial dose of the drug is determined based on the dose of fluticasone that is recommended for the treatment of the disease of this severity.

The initial dose should then be gradually reduced to the minimum effective dose.

Adults and adolescents 12 years of age and older: 2 inhalations (25 mcg salmeterol and 50 mcg fluticasone) 2 times a day, or 2 inhalations (25 mcg salmeterol and 125 mcg fluticasone) 2 times a day, or 2 inhalations (25 mcg salmeterol and 250 mcg of fluticasone) 2 times a day, or 1 inhalation (50 mcg of salmeterol and 100 mcg of fluticasone) 2 times a day, or 1 inhalation of 50 mcg of salmeterol and 250 mcg of fluticasone) 2 times a day, or 1 inhalation (50 mcg of salmeterol and 500 mcg of fluticasone) 2 times a day.

Children from 4 to 12 years: 2 inhalations (25 mcg salmeterol and 50 mcg fluticasone) 2 times a day or 1 inhalation (50 mcg salmeterol and 100 mcg fluticasone) 2 times a day.

In case of impaired liver and kidney function, as well as in elderly patients, there is no need to reduce doses.

Side effects:

Salmeterol: paradoxical bronchospasm, irritation of the mucous membranes of the mouth or throat, changes in taste (dysgeusia), hypokalemia, nervousness, abdominal pain, nausea, vomiting, hyperglycemia, tremor, palpitations, headache, arrhythmias (including atrial fibrillation , supraventricular tachycardia and extrasystole), arthralgia, allergic reactions (skin rash, angioedema), skeletal muscle spasms.

Fluticasone: hoarseness, dysphonia, irritation of the pharyngeal mucosa, candidiasis of the oral cavity and pharynx, paradoxical bronchospasm, allergic skin reactions.

With long-term use in high doses, systemic effects of fluticasone may be observed: decreased function of the adrenal cortex, osteoporosis, growth retardation in children, cataracts, glaucoma.

Overdose:

Symptoms: tremor, headache, tachycardia, suppression of adrenal function.

Treatment: selective beta-blockers, discontinuation of the drug (after a few days, adrenal function is restored on its own).

Interaction:

Beta blockers reduce effectiveness.

Inhibitors of the CYP3A4 enzyme (including ketoconazole, ritonavir) increase the concentration of fluticasone in the blood plasma.

Special instructions:

The drug is intended for long-term treatment and prevention of exacerbations of the disease, and not for stopping attacks (short-acting inhaled bronchodilators should be used).

The drug should be taken regularly, even in the absence of symptoms of the disease.

An increased need for the use of short-acting bronchodilators indicates a worsening of the disease.

It is not recommended to abruptly stop treatment with the drug.

With long-term use of any inhaled corticosteroids, especially in high doses, systemic effects may be observed. It is important that when a therapeutic effect is achieved, the dose of inhaled corticosteroids is reduced to the minimum effective dose that controls the course of the disease in order to avoid the development of systemic side effects.

It is recommended to regularly monitor the growth dynamics of children receiving inhaled corticosteroids for a long time.

Due to possible adrenal insufficiency, caution should be exercised and regular monitoring of adrenal cortex function indicators when transferring patients who have taken oral corticosteroids to treatment with inhaled fluticasone. Cancellation of systemic corticosteroids against the background of inhaled fluticasone should be carried out gradually. During periods of stress, you may need to take additional corticosteroids.

If the drug has to be discontinued due to an overdose of salmeterol, the patient must be prescribed appropriate corticosteroid replacement therapy.

In rare cases, when transferring patients from taking systemic corticosteroids to inhaled therapy, conditions accompanied by hypereosinophilia (including Charge-Strauss syndrome) may occur. As a rule, this occurs during dose reduction or withdrawal of systemic corticosteroids, but a cause-and-effect relationship has not been established.

When transferring patients from taking systemic corticosteroids to inhalation therapy, allergic reactions (including allergic rhinitis, eczema), which were previously suppressed by systemic drugs, may also occur.

Description connected via INN

Update date 04/03/2015

Manufacturer: Nativa LLC, Russia

Registration certificate holder: Nativa LLC, Russia

Release form: dosed powder for inhalation, 50 mcg + 100 mcg, 50 mcg + 250 mcg, 50 mcg + 500 mcg, 10 capsules each in a blister pack made of multilayer aluminum foil and printed aluminum foil

Belongs to VED

Dispensing conditions: by prescription

To provide social assistance

Registration data: LP-003400 dated 12/31/2015

Status of the registration certificate: expiration date 12/31/2020

Indications for use

Saltikazon® - native is intended for the regular treatment of bronchial asthma, if combination therapy with a long-acting beta2-adrenergic agonist and an inhaled glucocorticosteroid is indicated:

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

Salticasone® - native is intended for maintenance therapy for COPD in patients with a forced expiratory volume (FEV1) value <60% of the expected values (before inhalation of a bronchodilator) and a history of repeated exacerbations, in whom severe symptoms of the disease persist despite regular bronchodilator therapy.

Directions for use and doses

Salticasone® - native 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 Salticazon® - native should be reduced to the lowest dose that provides effective control of symptoms.

If taking Saltikazon® - native 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 per day.

The patient should be prescribed a form of the drug Salticazon® - native, which contains a dose of fluticasone corresponding to the severity of his disease.

If therapy with inhaled corticosteroids does not provide adequate control of the disease, then replacing them with Salticasone® - native at a dose therapeutically equivalent to the dose of administered corticosteroids can 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 Saltikasone® - native may allow reducing the dose of corticosteroids required to control the course of the disease. If the patient does not receive appropriate therapy, taking only inhaled corticosteroids, then replacing them with the drug Saltikazon® - native at a dose therapeutically equivalent to the dose of administered corticosteroids can improve control of bronchial asthma.

Recommended doses:

One inhalation (50 mcg salmeterol and 100 mcg fluticasone propionate) 2 times a day, or
one inhalation (50 mcg salmeterol and 250 mcg fluticasone propionate) 2 times a day, or
one inhalation (50 mcg of salmeterol and 500 mcg of fluticasone propionate) 2 times a day.

In adults, when doubling the dose while using any form of release of the drug Salticazon® - native for 14 days, the same safety and tolerability is maintained as with regular use of the drug, one inhalation twice a day. The dose may be doubled in cases where patients require additional short-term (up to 14 days) therapy with inhaled corticosteroids.

Chronic obstructive pulmonary disease (COPD)

For adult patients, the maximum recommended dose is 1 inhalation (50 mcg of salmeterol and 500 mcg of fluticasone) 2 times a day.

Special patient groups

There is no need to reduce the dose of Salticazon® - native in elderly patients, as well as in patients with impaired renal or liver function.

Saltikazon-native 50 µg/250 µg 30 pcs. dosed powder for inhalation

pharmachologic effect

Bronchodilator, glucocorticoid, beta-adrenomimetic.

Composition and release form Saltikazon-native 50 µg/250 µg 30 pcs. dosed powder for inhalation

Dosed powder - 1 capsule:

active ingredients: salmeterol xinafoate - 72.5/72.5/72.5 mcg (in terms of salmeterol - 50/50/50 mcg); fluticasone propionate - 100/250/500 mcg;
excipients: sodium benzoate - 2/2/2 mg; lactose monohydrate - up to 12/12/12 mg;
capsule body: indigotine - -/0.3/-%; iron oxide yellow - -/1.7143/-%; azorubine - -/-/0.0016%; brilliant black - -/-/0.0958%; patented blue - -/-/0.1643%; quinoline yellow - -/-/1.1496%; titanium dioxide - 2/2/1.3333%; gelatin - up to 100/up to 100/up to 100%;
capsule cap: azorubine - -/-/0.0016%; brilliant black - -/-/0.0958%; patented blue - -/-0.1642%; quinoline yellow - -/-/1.1496%; titanium dioxide - 2/1/1.3333%; gelatin - up to 100/up to 100/up to 100%.

10 caps. in contour blister packaging made of polymer film and printed aluminum foil or multilayer aluminum foil and printed aluminum foil.

3 or 6 blister packs with or without an inhalation device are placed in a cardboard box.

Description of the dosage form

Hard gelatin capsules No. 3, body - white, cap - green.

The contents of the capsules are white or almost white powder.

Directions for use and doses

Inhalation.

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

The course of treatment and dose changes are prescribed by the doctor on an individual basis.

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

Bronchial asthma. If the patient does not receive appropriate therapy, taking only inhaled corticosteroids, then replacing them with the drug Saltikazon®-native at a dose therapeutically equivalent to the dose of administered corticosteroids may improve asthma control. In patients in whom the course of asthma can be controlled exclusively with the help of inhaled corticosteroids, replacing them with the drug Salticazon®-native may allow reducing the dose of corticosteroids required to control the course of asthma.

Adults (18 years and older). 1 inhalation (50 mcg salmeterol and 100 mcg fluticasone propionate) 2 times a day or 1 inhalation (50 mcg salmeterol and 250 mcg fluticasone propionate) 2 times a day or 1 inhalation (50 mcg salmeterol and 500 mcg fluticasone propionate) 2 times a day .

In adults over 18 years of age, doubling the dose of Salticazon®-native maintains the same safety and tolerability as with regular use of this combination 2 times a day. The dose may be doubled in cases where patients require additional short-term (up to 14 days) inhaled corticosteroid therapy, as described in the treatment guidelines for asthma.

Currently, there is no data on the use of Saltikazon®-native in patients under the age of 18 years.

The dose of Saltikazon®-native should be reduced to the lowest dose that provides effective control of symptoms.

If symptom control is ensured by taking Saltikazon®-native 2 times a day, reducing the dose to the minimum effective may include a single dose of the drug per day.

COPD The maximum recommended dose for adults is: one inhalation (50 mcg of salmeterol and 500 mcg of fluticasone propionate) 2 times a day.

Special patient groups

There is no need to reduce the dose of Saltikazon®-native in elderly patients, as well as in patients with impaired renal or liver function.

Pharmacodynamics

Salticasone®-native is a combination drug containing salmeterol and fluticasone propionate, which have different mechanisms of action. Salmeterol prevents the occurrence of bronchospasm, fluticasone propionate improves pulmonary function and prevents exacerbation. The drug Salticasone®-native 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 that has a long side chain that binds to the outer domain of the receptor.

The pharmacological properties of salmeterol provide protection against histamine-induced bronchoconstriction and longer-lasting bronchodilation (lasting at least 12 hours) than short-acting β2-adrenergic receptor agonists. The onset of the bronchodilator effect is within 10–20 minutes.

Salmeterol is a strong and long-acting inhibitor of the release of mast cell mediators such as histamine, LT and PGD2 from human lung tissue. Salmeterol inhibits the early and late phases of the response to inhaled allergens; the effect lasts more than 30 hours after one dose, when the bronchodilator effect is no longer present.

A 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 fully established.

Fluticasone propionate is a synthetic corticosteroid for topical use that improves pulmonary function and prevents exacerbations.

Fluticasone propionate inhibits the influx of mast cells, eosinophils, lymphocytes, macrophages, neutrophils, reduces the production and release of inflammatory mediators and other biologically active substances (including histamine, PG, LT and cytokines) involved in the formation of allergen-specific sensitization. As a result, capillary permeability decreases, exudation disappears, mucus secretion by mucous glands decreases, and the patency of the bronchial tree is restored.

When inhaled in recommended doses, fluticasone propionate exhibits 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 diseases accompanied by airway obstruction. Restores the patient's response to bronchodilators, allowing to reduce the frequency of their use.

With long-term use of inhaled fluticasone propionate in the maximum recommended doses, the daily secretion of adrenal hormones remains within normal limits. After transferring patients receiving other inhaled corticosteroids to fluticasone propionate, the daily secretion of adrenal hormones gradually normalizes, despite previous and current periodic use of oral corticosteroids. 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).

Pharmacokinetics

Simultaneous inhalation administration of salmeterol and fluticasone propionate does not affect the pharmacokinetics of each of these substances. Even despite the very low concentration of the drug Saltikazon®-native in plasma, its interaction with other substrates and inhibitors of the CYP3A4 isoenzyme cannot be excluded.

Salmeterol

Salmeterol acts locally in the lung tissue, and therefore its plasma levels do not correlate with the therapeutic effect. 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). The plasma concentration of salmeterol correlates with the dose of the inhaled drug. With regular use of inhaled salmeterol, hydroxynaphthoic acid is determined in the blood, the Css value of which is about 10 pg/ml. These concentrations are 1000 times lower than equilibrium levels observed in toxicity studies.

Fluticasone propionate

Absorption and distribution. After inhalation administration, the absolute bioavailability of fluticasone propionate in healthy people is 10–30% of the nominal dose. In patients with COPD and bronchial asthma, lower plasma concentrations of fluticasone propionate are observed. Systemic absorption occurs predominantly in the lungs, and is initially more intense, but then slows down.

Part of the inhaled dose may be swallowed, but due to the poor solubility of fluticasone propionate in water and intensive metabolism during the first passage through the liver, the systemic effect is minimal. The bioavailability of fluticasone propionate when absorbed from the gastrointestinal tract is less than 1%.

There is a direct relationship between increasing the inhalation dose and the plasma concentration of fluticasone propionate.

Vss of fluticasone propionate is about 300 l.

The degree of binding to plasma proteins is approximately 91%.

Metabolism and excretion. With the participation of the CYP3A4 isoenzyme, fluticasone propionate is quickly eliminated from the blood to form an inactive carboxyl metabolite.

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

The final T1/2 is approximately 8 hours.

The renal clearance of unchanged fluticasone propionate is negligible (

Indications for use Saltikazon-native 50 µg/250 µg 30 pcs. dosed powder for inhalation

Treatment of bronchial asthma in patients who are indicated for combination therapy with a long-acting β2-adrenergic agonist and inhaled corticosteroids:

patients with insufficient disease control on the background of constant monotherapy with inhaled GCS with periodic use of a short-acting β2-adrenergic agonist;
patients with adequate disease control during therapy with inhaled GCS and a long-acting β2-adrenergic agonist;
as initial maintenance therapy in patients with persistent bronchial asthma (daily occurrence of symptoms, daily use of drugs for rapid relief of symptoms) if there are indications for prescribing GCS to achieve disease control.

Maintenance therapy for COPD in patients with forced expiratory volume (FEV1) values

Contraindications

hypersensitivity to the components of the drug;
age up to 18 years.

With caution: for pulmonary tuberculosis (acute and latent), fungal, viral or bacterial infections of the respiratory system, thyrotoxicosis, pheochromocytoma, diabetes mellitus, hypokalemia, cardiovascular diseases (including idiopathic hypertrophic subaortic stenosis, uncontrolled arterial hypertension, prolongation of the QT interval on ECG, coronary artery disease), arrhythmias (supraventricular tachycardia and extrasystoles, ventricular extrasystoles, atrial fibrillation), cataracts, glaucoma, hypothyroidism, osteoporosis, pregnancy, lactation, allergic reactions to lactose and milk protein in history.

Application of Saltikazon-native 50 µg/250 µg 30 pcs. powder for inhalation, dosed during pregnancy and breastfeeding

During pregnancy and lactation (breastfeeding), Saltikazon®-native can be prescribed only if the expected benefit to the mother outweighs any possible risk to the fetus or child.

special instructions

Salticasone®-native is not intended for the relief of attacks. In case of attacks, patients should use short-acting inhaled bronchodilators (for example, salbutamol), which patients are advised to always have with them.

If paradoxical bronchospasm develops, you should immediately use a short-acting inhaled bronchodilator, discontinue Salticasone®-native and begin, if indicated, alternative therapy.

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

Salticasone®-native 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 GCS and when their approximate dosage is determined.

You should rinse your mouth with water after inhaling Saltikazon®-native to reduce the severity and frequency of deepening of the voice and candidiasis. For candidiasis, antifungal drugs are prescribed for topical use, while therapy with Saltikazon®-native is continued.

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

Sudden and progressive deterioration in control of bronchospastic syndrome is potentially life-threatening. In such situations, medical supervision is necessary. If the used dose of Saltikazon®-native does not provide adequate control of the disease, then additional administration of GCS may be required. If the exacerbation is caused by an infection, then antibiotics are prescribed.

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

Some patients may have individual high sensitivity to inhaled corticosteroids. Any inhaled GCS can cause systemic effects, especially with long-term use in high doses; It should be noted, however, that the likelihood of such symptoms occurring is much lower than with treatment with oral corticosteroids. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, decreased bone mineral density, cataracts, and glaucoma.

Particular caution should be exercised and regular monitoring of adrenal function indicators when transferring patients taking oral corticosteroids to treatment with fluticasone propionate for inhalation, due to possible adrenal insufficiency. When transferring patients from taking systemic corticosteroids to inhalation therapy, allergic reactions (for example, allergic rhinitis, eczema), which were previously suppressed by systemic corticosteroids, may occur. In such situations, it is recommended to carry out symptomatic treatment with antihistamines and/or topical drugs (including corticosteroids for topical use).

Patients should carry a card with them indicating that they may need to take additional corticosteroids in various stressful situations.

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

When treating patients with COPD with Saltikazon®-native, one should be aware of the increased incidence of pneumonia. Clinical signs of developed pneumonia often resemble an exacerbation of the underlying disease.

When salmeterol is used compared with placebo, the risk of serious respiratory adverse events or death appears to be greater in African-American patients than in other patients.

Currently, there is no data on the use of Saltikazon®-native in patients under the age of 18 years.

Control of laboratory parameters

In patients with exacerbation of bronchial asthma, hypoxia, it is necessary to monitor the concentration of potassium in the blood plasma.

Features of the action of the drug upon its withdrawal

Due to the risk of exacerbation, sudden discontinuation of the drug Salticazon®-native should be avoided. 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.

Use for liver dysfunction. In patients with impaired liver function, no dose reduction is required.

Use for renal dysfunction. In patients with impaired renal function, no dose reduction is required.

Influence on the ability to drive a car and other vehicles, to work with moving mechanisms. Salticasone®-native does not affect the ability to drive vehicles or operate machinery. May affect the ability to drive vehicles and operate machinery with the development of side effects.

Overdose

Symptoms

Salmeterol. Objective and subjective symptoms of salmeterol overdose include: tremor, headache, tachycardia, increased blood pressure and hypokalemia.

Treatment: antidotes are cardioselective β-blockers. In cases where it is necessary to discontinue the drug Saltikazon®-native due to an overdose of its constituent salmeterol, the patient should be prescribed an appropriate replacement adrenergic agonist.

Fluticasone propionate. Inhalation of doses of fluticasone propionate exceeding the recommended ones may cause temporary depression of the hypothalamic-pituitary-adrenal system. This usually does not require any emergency measures, since in most cases normal adrenal function is restored within a few days.

Saltikazon®-native. With prolonged inhalation of excessively large doses of the drug Saltikazon®-native, significant suppression of the adrenal glands may occur.

Patients should be aware that they should not use the drug Saltikazon®-native in doses exceeding the recommended ones.

It is important to regularly assess the effectiveness of therapy and reduce the dose of Saltikazon®-native to the minimum effective, i.e. to one that provides effective control of disease symptoms. In case of chronic overdose, it is recommended to monitor the reserve function of the adrenal cortex.

Side effects Saltikazon-native 50mcg/250mcg 30 pcs. dosed powder for inhalation

Since the drug Salticasone®-native contains salmeterol and fluticasone propionate, the development of adverse reactions characteristic of each component separately should be expected. No additional side effects were noted with the simultaneous use of two components of the drug.

Frequency determination: very often (≥1/10); often (from 1/100 to 1/10); uncommon (from 1/1000 to 1/100); rare (from 1/10000 to 1/1000); very rarely (

Infectious and parasitic diseases: often - candidiasis of the oral and pharyngeal mucosa, pneumonia (in patients with COPD).

From the immune system: rarely - hypersensitivity reactions, such as exanthema, urticaria, itching, rash, dermatitis, angioedema, anaphylactic reaction, bronchospasm.

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

From the endocrine system: rarely - hypercortisolism; very rarely - symptoms of systemic effects of GCS (including adrenal hypofunction, Cushing's syndrome), decreased bone mineral density.

From the side of the central nervous system: very often - headache; uncommon - nausea, dizziness, psychomotor agitation, anxiety, sleep disturbances; rarely - behavioral disorders; very rarely - depression, taste disturbances.

From the cardiovascular system: infrequently - palpitations, tachycardia, atrial fibrillation; rarely - arrhythmia, including ventricular extrasystole, supraventricular tachycardia and extrasystole; very rarely - angina pectoris, blood pressure fluctuations, peripheral edema.

From the respiratory system: often - cough, hoarseness and/or dysphonia, which disappears after stopping therapy or reducing the dose of the drug; uncommon - pharyngeal irritation; rarely - bronchospasm, including paradoxical.

From the skin: infrequently - bruising.

From the musculoskeletal system: often - tremor, muscle cramps, arthralgia; infrequently - myalgia; rarely - a decrease in bone mineral density.

Other: infrequently - cataracts; rarely - glaucoma.

To reduce the risk of candidiasis after inhalation of Saltikazon®-native, it is recommended to rinse your mouth and throat with water.

The systemic effect of inhaled corticosteroids can be observed when taking the drug in high doses for a long time.

Drug interactions

The use of selective and non-selective β-blockers should be avoided unless it is really necessary and justified, due to the risk of developing bronchospasm.

Fluticasone propionate undergoes extensive metabolism during the first passage through the liver under the influence of the CYP3A4 isoenzyme. Due to this factor, as well as high systemic clearance, when fluticasone propionate is used in the form of inhalations, its concentration in the blood plasma is low. This makes a clinically significant interaction involving fluticasone propionate unlikely.

With the simultaneous use of known CYP3A4 inhibitors and fluticasone propionate, caution should be exercised, since in such situations it is possible to increase the level of the latter in plasma.

Ritonavir (a highly active inhibitor of the CYP3A4 isoenzyme) can cause a significant increase in the concentration of fluticasone propionate in the blood 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, which was manifested by the development of Cushing's syndrome and suppression of adrenal function. Given this, the simultaneous use of fluticasone propionate and ritonavir should be avoided, unless the potential benefit of combination therapy for the patient outweighs the risk of developing systemic side effects of GCS.

Other inhibitors of the CYP3A4 isoenzyme cause a negligible (erythromycin) and insignificant (ketoconazole) increase in plasma fluticasone propionate levels, with virtually no decrease in serum cortisol concentrations. Despite this, caution is recommended when using fluticasone propionate concomitantly with 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.

In a drug interaction study, it was found that the use of ketoconazole as concomitant systemic therapy enhances the effect of salmeterol. This may lead to prolongation of the QT interval.

Caution should be exercised when co-prescribing 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) when used simultaneously with the drug Saltikazon®-native.

MAO inhibitors and tricyclic antidepressants increase the risk of side effects from the cardiovascular system when used simultaneously with the drug Saltikazon®-native.

Saltikazon®-native is compatible with cromoglycic acid.

special instructions

Salticasone® - native is not intended for the relief of acute symptoms, since in such cases a fast- and short-acting inhaled bronchodilator (for example, salbutamol) should be used. Patients should be informed to always have medication available to relieve acute symptoms. The combination of salmeterol with fluticasone can be used for initial maintenance therapy in patients with persistent bronchial asthma (daily onset of symptoms or daily use of drugs to relieve attacks) if there are indications for the use of glucocorticosteroids and when determining their approximate dosage.

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

A sudden and increasing deterioration in asthma control is potentially life-threatening, 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 Saltikazon® - native used does not provide adequate control of the disease, the patient should also consult a doctor.

Patients with bronchial asthma should not abruptly stop treatment with Saltikazon® - native 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. There is evidence of an increased incidence of pneumonia in patients with COPD receiving a combination of salmeterol and fluticasone. 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 reactions, 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, 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 suppressing adrenal function and be prepared to use GCS.

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

Due to the possibility of adrenal suppression, patients switched from oral corticosteroids to inhaled fluticasone therapy should be treated with extreme caution and their adrenal function regularly monitored. When transferring patients from taking systemic corticosteroids to inhalation therapy, allergic reactions (for example, allergic rhinitis, eczema) may occur, which were suppressed by systemic corticosteroids. In such situations, it is recommended to carry out symptomatic treatment with antihistamines and/or topical drugs, including corticosteroids for topical use.

After starting treatment with inhaled fluticasone, systemic corticosteroids should be withdrawn gradually; patients should have a special patient card with them indicating the possible need for additional administration of corticosteroids 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 increased blood glucose concentrations, and this should be kept in mind when prescribing the combination of salmeterol with fluticasone to patients with diabetes mellitus.

There is evidence of a clinically significant drug interaction between fluticasone and ritonavir, leading to systemic effects of GCS, including Cushing's syndrome and suppression of adrenal function. Therefore, it is recommended to avoid the combined use of fluticasone and ritonavir, unless the potential benefit to the patient outweighs the risk associated with the systemic effects of GCS.

When taking salmeterol, the risk of serious respiratory adverse reactions or death in African-American patients is believed to be higher than in other patients. The significance of pharmacogenetic factors or other causes is unknown.

Like other inhaled drugs, Saltikazon® - native 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 Salticazon® - native, examine the patient and, if necessary, begin alternative therapy.

There are reports of adverse reactions associated with the pharmacological action of beta2 antagonists, such as subjective palpitations. However, these reactions are short-term in nature, and their severity decreases with regular therapy.

There is no data on the effect of the drug on the ability to drive vehicles and other mechanisms. When taking the drug Saltikazon® - native, adverse reactions such as headache, tremors and muscle spasms may develop, so care must be taken when driving vehicles and operating machinery, as well as when engaging in other potentially hazardous activities that require increased concentration and speed. psychomotor reactions.

Saltikazon-Nativ, por d/ing 50 mcg/500 mcg/dose 60 doses + device d/ing (Nativa LLC, RUSSIA)

Compound.


active substances:
salmeterol xinafoate	72.5/72.5/72.5 mcg
(in terms of salmeterol - 50/50/50 mcg)
fluticasone propionate	100/250/500 mcg
excipients: sodium benzoate - 2/2/2 mg; lactose monohydrate - up to 12/12/12 mg
gelatin capsules
capsule body: indigotine - -/0.3/-%; iron oxide yellow - -/1.7143/-%; azorubine - -/-/0.0016%; brilliant black - -/-/0.0958%; patented blue - -/-/0.1643%; quinoline yellow - -/-/1.1496%; titanium dioxide - 2/2/1.3333%; gelatin - up to 100/up to 100/up to 100%
capsule cap: azorubine - -/-/0.0016%; brilliant black - -/-/0.0958%; patented blue - -/-0.1642%; quinoline yellow - -/-/1.1496%; titanium dioxide - 2/1/1.3333%; gelatin - up to 100/up to 100/up to 100%

Description of the dosage form.

Dosage 50 mcg+100 mcg:

hard gelatin capsules No. 3, body - white, cap - white.

Dosage 50 mcg+250 mcg:

hard gelatin capsules No. 3, body - white, cap - green.

Dosage 50 mcg+500 mcg:

hard gelatin capsules No. 3, body - green, cap - green.

With possessed capsules

- white or almost white powder.
Pharmachologic effect. Bronchodilator, glucocorticoid, beta-adrenomimetic.

Pharmacodynamics.

Fluticasone propionate is a synthetic corticosteroid for topical use that improves pulmonary function and prevents exacerbations.

Pharmacokinetics.

Salmeterol

Fluticasone propionate

Absorption and distribution.

After inhalation administration, the absolute bioavailability of fluticasone propionate in healthy people is 10–30% of the nominal dose. In patients with COPD and bronchial asthma, lower plasma concentrations of fluticasone propionate are observed. Systemic absorption occurs predominantly in the lungs, and is initially more intense, but then slows down.

There is a direct relationship between increasing the inhalation dose and the plasma concentration of fluticasone propionate.

Vss of fluticasone propionate is about 300 l.

The degree of binding to plasma proteins is approximately 91%.

Metabolism and excretion.

With the participation of the CYP3A4 isoenzyme, fluticasone propionate is quickly eliminated from the blood to form an inactive carboxyl metabolite.

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

The final T1/2 is approximately 8 hours.

Renal clearance of unchanged fluticasone propionate is insignificant (<0.2%), less than 5% of the dose is excreted in the urine as a metabolite. Caution must be exercised during the simultaneous use of known CYP3A4 inhibitors and fluticasone propionate, since in such situations it is possible to increase the level of the latter in plasma. It is excreted through the gastrointestinal tract mainly in the form of a hydroxylated metabolite.

Indications.

● treatment of bronchial asthma in patients who are indicated for combination therapy with a long-acting β2-adrenergic agonist and inhaled corticosteroids:

- patients with insufficient disease control on the background of constant monotherapy with inhaled GCS with periodic use of a short-acting β2-adrenergic agonist;

— patients with adequate disease control during therapy with inhaled GCS and a long-acting β2-adrenergic agonist;

- as initial maintenance therapy in patients with persistent bronchial asthma (daily occurrence of symptoms, daily use of drugs for rapid relief of symptoms) if there are indications for prescribing GCS to achieve disease control.

● maintenance therapy for COPD in patients with forced expiratory volume (FEV1) <60% of normal values (before bronchodilator inhalation) and a history of repeated exacerbations, in whom severe symptoms of the disease persist despite regular bronchodilator therapy.

Contraindications.

● increased sensitivity to the components of the drug;

● age up to 18 years.

Carefully:

for pulmonary tuberculosis (acute and latent), fungal, viral or bacterial infections of the respiratory system, thyrotoxicosis, pheochromocytoma, diabetes mellitus, hypokalemia, cardiovascular diseases (including idiopathic hypertrophic subaortic stenosis, uncontrolled arterial hypertension, prolongation of the QT interval on the ECG, IHD), arrhythmias (supraventricular tachycardia and extrasystoles, ventricular extrasystoles, atrial fibrillation), cataracts, glaucoma, hypothyroidism, osteoporosis, pregnancy, lactation, a history of allergic reactions to lactose and milk protein.

Use during pregnancy and breastfeeding.

During pregnancy and lactation (breastfeeding), Saltikazon®-native can be prescribed only if the expected benefit to the mother outweighs any possible risk to the fetus or child.

Side effects.

Frequency determination: very often (≥1/10); often (from 1/100 to 1/10); infrequently (from 1/1000 to 1/100); rare (from 1/10000 to 1/1000); very rare (<1/10000).

Infectious and parasitic diseases:

often - candidiasis of the oral mucosa and pharynx, pneumonia (in patients with COPD).

From the immune system:

rarely - hypersensitivity reactions, such as exanthema, urticaria, itching, rash, dermatitis, angioedema, anaphylactic reaction, bronchospasm.

From the side of metabolism:

uncommon - hyperglycemia; very rarely - hypokalemia.

From the endocrine system:

rarely - hypercortisolism; very rarely - symptoms of systemic effects of GCS (including adrenal hypofunction, Cushing's syndrome), decreased bone mineral density.

From the side of the central nervous system:

very often - headache; uncommon - nausea, dizziness, psychomotor agitation, anxiety, sleep disturbances; rarely - behavioral disorders; very rarely - depression, taste disturbances.

From the SSS side:

infrequently - palpitations, tachycardia, atrial fibrillation; rarely - arrhythmia, including ventricular extrasystole, supraventricular tachycardia and extrasystole; very rarely - angina pectoris, blood pressure fluctuations, peripheral edema.

From the respiratory system:

often - cough, hoarseness and/or dysphonia, which disappears after stopping therapy or reducing the dose of the drug; uncommon - pharyngeal irritation; rarely - bronchospasm, including paradoxical.

From the skin:

infrequently - bruising.

From the musculoskeletal system:

often - tremor, muscle cramps, arthralgia; infrequently - myalgia; rarely - a decrease in bone mineral density.

Other:

infrequently - cataracts; rarely - glaucoma.

To reduce the risk of candidiasis after inhalation of Saltikazon®-native, it is recommended to rinse your mouth and throat with water.

The systemic effect of inhaled corticosteroids can be observed when taking the drug in high doses for a long time.

Interaction.

The use of selective and non-selective β-blockers should be avoided unless it is really necessary and justified, due to the risk of developing bronchospasm.

With the simultaneous use of known CYP3A4 inhibitors and fluticasone propionate, caution should be exercised, since in such situations it is possible to increase the level of the latter in plasma.

In a drug interaction study, it was found that the use of ketoconazole as concomitant systemic therapy enhances the effect of salmeterol. This may lead to prolongation of the QT interval.

Caution should be exercised when co-prescribing strong CYP3A4 inhibitors (eg ketoconazole) and salmeterol.

MAO inhibitors and tricyclic antidepressants increase the risk of side effects from the cardiovascular system when used simultaneously with the drug Saltikazon®-native.

Saltikazon®-native is compatible with cromoglycic acid.

Method of administration and dose.

Inhalation.

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

The course of treatment and dose changes are prescribed by the doctor on an individual basis.

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

Bronchial asthma.

If the patient does not receive appropriate therapy, taking only inhaled corticosteroids, then replacing them with the drug Saltikazon®-native at a dose therapeutically equivalent to the dose of administered corticosteroids may improve asthma control. In patients in whom the course of asthma can be controlled exclusively with the help of inhaled corticosteroids, replacing them with the drug Salticazon®-native may allow reducing the dose of corticosteroids required to control the course of asthma.

Currently, there is no data on the use of Saltikazon®-native in patients under the age of 18 years.

The dose of Saltikazon®-native should be reduced to the lowest dose that provides effective control of symptoms.

If symptom control is ensured by taking Saltikazon®-native 2 times a day, reducing the dose to the minimum effective may include a single dose of the drug per day.

COPD

The maximum recommended dose for adults is: one inhalation (50 mcg of salmeterol and 500 mcg of fluticasone propionate) 2 times a day.

Special patient groups

There is no need to reduce the dose of Saltikazon®-native in elderly patients, as well as in patients with impaired renal or liver function.

Instructions for inhalation

The powder inhaler “Inhaler CDM®” is a white plastic device with a movable top part and a retractable compartment for the capsule, about 6 cm high. In order to ensure the correct use of the drug, it should be used only with the help of the “Inhaler CDM®”.

Capsules are for inhalation use only and are not intended to be swallowed. The capsule should be removed from the blister packaging immediately before use.

Instructions for use of the Inhaler CDM® inhaler

Inhaler CDM® is a single-dose inhaler that allows you to dose and inhale the drug in very small doses. Salticasone®-native enters the patient's respiratory tract along with air flows when active inhalation is performed through the mouthpiece.

Inhaler CDM® is very easy to use. You must follow the step-by-step instructions below:

Step 1. Remove the transparent cap from the Inhaler CDM® device, as shown in Fig. 1.

Step 2. Hold the device firmly with one hand, use the index finger and thumb of the other hand to open the capsule compartment, as shown in Fig. 2. To do this, press PUSH with your index finger on the moving part of the Inhaler CDM®, moving it in the opposite direction.

Step 3. Holding the device with one hand, insert the capsule with the drug into the compartment slot (Fig. 3). Make sure that the capsule is correctly inserted into the slot (Fig. 4).

Step 4. While holding the Inhaler CDM® in a vertical position, close the compartment by pressing the thumb in the opposite direction until it stops until a click is heard (Fig. 5).

Step 5. Holding the Inhaler CDM® device strictly vertically (Fig. 6), bring it into working condition, as shown in Fig. 7. To do this, press firmly on the mouthpiece so that the arrow marked on the body disappears beyond the boundaries of the lower part of the device to the upper line. Then release the mouthpiece to return it to its original position. This will puncture the capsule, allowing the drug to enter the lumen of the mouthpiece.

Step 6. Attention: before inhalation you should exhale (Fig. 8). Do not exhale through the mouthpiece!

Step 7. Gently squeeze the Inhaler CDM® mouthpiece between your teeth, purse your lips and inhale deeply and forcefully through your mouth (Fig. 9). A vibrating sound will be heard inside the capsule compartment as the capsule rotates and disperses. The mouthpiece must not be chewed or squeezed tightly with your teeth!

Step 8. After inhalation, open the capsule compartment, remove the empty capsule, and then close it, as shown in Fig. 5.

Attention: when inhaling, do not close the holes located on the sides of the mouthpiece. This may prevent the free movement of air within the inhaler, thereby reducing the dispersion of the capsule contents.

Do not press on the mouthpiece when inhaling. This may block the movement of the capsule. Hold your breath for about 10 seconds or longer as possible. Remove the inhaler from your mouth. Exhale slowly. Then breathe normally. Repeat steps 5–7 again to ensure the inhaled dose of the drug.

Always close the Inhaler CDM® cap tightly after use, this will keep the mouthpiece clean.

Clean the outside of the mouthpiece regularly (once a week) with a dry cloth.

Overdose.

Symptoms

Salmeterol.

Objective and subjective symptoms of salmeterol overdose include: tremor, headache, tachycardia, increased blood pressure and hypokalemia.

Treatment:

antidotes are cardioselective β-blockers. In cases where it is necessary to discontinue the drug Saltikazon®-native due to an overdose of its constituent salmeterol, the patient should be prescribed an appropriate replacement adrenergic agonist.

Fluticasone propionate.

Inhalation of doses of fluticasone propionate exceeding the recommended ones may cause temporary depression of the hypothalamic-pituitary-adrenal system. This usually does not require any emergency measures, since in most cases normal adrenal function is restored within a few days.

Saltikazon®-native.

With prolonged inhalation of excessively large doses of the drug Saltikazon®-native, significant suppression of the adrenal glands may occur.

Patients should be aware that they should not use the drug Saltikazon®-native in doses exceeding the recommended ones.

Special instructions.

If paradoxical bronchospasm develops, you should immediately use a short-acting inhaled bronchodilator, discontinue Salticasone®-native and begin, if indicated, alternative therapy.

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

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

Patients should carry a card with them indicating that they may need to take additional corticosteroids in various stressful situations.

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

When salmeterol is used compared with placebo, the risk of serious respiratory adverse events or death appears to be greater in African-American patients than in other patients.

Currently, there is no data on the use of Saltikazon®-native in patients under the age of 18 years.

Control of laboratory parameters

In patients with exacerbation of bronchial asthma, hypoxia, it is necessary to monitor the concentration of potassium in the blood plasma.

Features of the action of the drug upon its withdrawal

Due to the risk of exacerbation, sudden discontinuation of the drug Salticazon®-native should be avoided. 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.

Use for liver dysfunction.

In patients with impaired liver function, no dose reduction is required.

Use for renal dysfunction.

In patients with impaired renal function, no dose reduction is required.

Influence on the ability to drive a car and other vehicles, to work with moving mechanisms.

Salticasone®-native does not affect the ability to drive vehicles or operate machinery. May affect the ability to drive vehicles and operate machinery with the development of side effects.

Release form.

Powder for inhalation dosed, 50 mcg + 100 mcg, 50 mcg + 250 mcg, 50 mcg + 500 mcg.

10 caps. in contour blister packaging made of polymer film and printed aluminum foil or multilayer aluminum foil and printed aluminum foil.

3 or 6 blister packs with or without an inhalation device are placed in a cardboard box.

Manufacturer.

LLC Nativa, Russia.

Legal address: 143402, Russia, Moscow region, Krasnogorsk district, Krasnogorsk, st. Oktyabrskaya, 13.

Tel.;.

e-mail; www.nativa.pro

Addresses of production sites: 143422, Moscow region, Krasnogorsk district, village. Petrovo-Dalneye or 142279, Moscow region, Serpukhov district, Obolensk settlement, or 143952, Moscow region, Balashikha, microdistrict. Dzerzhinsky, 40.

Conditions for dispensing from pharmacies.

On prescription.