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

    Active substance:

    25 + 50 μg

    25 + 125 μg

    25 + 250 μg

    Salmeterol xinafoate

    36.3 μg

    36.3 μg

    36.3 μg

    (in terms of salmeterol)

    (25 μg)

    (25 μg)

    (25 μg)

    Fluticasone propionate

    50 μg

    125 μg

    250 mcg

    Excipients:




    Perfluorodecalin

    40 μg

    40 μg

    40 μg

    Propellant R 134a of pharmacopoeial quality (1,1,1,2-tetrafluoroethane) Note

    up to 75 mg

    up to 75 mg

    up to 75 mg

    The target dose is salmeterol

    21 mcg / dose

    21 mcg / dose

    21 mcg / dose

    The target dose is fluticasone

    44 mcg / dose

    110 μg / dose

    220 μg / dose

    Description:

    A suspension of white or almost white color, under pressure in an aluminum container with a dosing valve equipped with a spray nozzle; The drug is sprayed out of the balloon as an aerosol cloud.

    Pharmacotherapeutic group:Bronchodilator combined (beta2-adrenomimetic selective + glucocorticosteroid local)
    ATX: & nbsp

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

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

    Pharmacodynamics:

    Mechanism of action

    Salticasone® aeronaut - a combined preparation containing two active components: salmeterol and fluticasone, possessing different mechanisms of action. Salmeterol prevents the appearance of symptoms of bronchospasm, fluticasone propionate improves pulmonary function and prevents the exacerbation of the disease. A drug Salticasone® aeronaut due to the convenient dosing regimen can be an alternative for patients who simultaneously receive β2-adrenomimetic and inhaled glucocorticosteroid (GCS) from different inhalers.

    Salmeterol is a selective long-acting (up to 12 hours) β2-adrenomimetic, having in its structure a long side chain that binds to the outer domain of the receptor.

    Pharmacological properties salmeterol provide more effective protection against histamine-induced bronchoconstriction and prolonged bronchodilation more (not less than 12 hours) than β2-adrenomimetiki short-acting.

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

    Salmeterol depresses the early and late phases of the response to inhaled allergens. The inhibition of the late phase of the response persists for more than 30 hours after taking a single dose, while the bronchodilator effect is no longer present. Single administration of salmeterol weakens the hyperreactivity of the bronchial tree. This indicates that salmeterol in addition to bronchodilating activity has an additional effect, not associated with the expansion of bronchi, the clinical significance of which has not been finally established. This mechanism of action is different from the anti-inflammatory effect of GCS.

    Fluticasone propionate belongs to the SCS group for topical application and, when inhaled at recommended doses, it has a pronounced anti-inflammatory and anti-allergic effect in the lungs, which leads to a decrease in clinical symptoms, a decrease in the frequency of exacerbations of bronchial asthma.Fluticasone propionate does not cause undesirable phenomena, which are observed when taking SCS systemic action.

    With prolonged use of inhalation fluticasone propionate, the daily secretion of hormones in the adrenal cortex remains within normal limits in both adults and children, even when using the maximum recommended doses. After transferring patients receiving other inhaled glucocorticosteroids to the administration of fluticasone propionate, the daily secretion of adrenal cortex hormones gradually improves, despite the previous and current recurrent use of oral GCS. This indicates the restoration of the adrenal function against the background of the inhalation application of fluticasone propionate. With prolonged use of fluticasone propionate, the reserve function of the adrenal cortex also remains within normal limits, as evidenced by a normal increase in cortisol production in response to appropriate stimulation (it should be borne in mind that the residual decrease in adrenal reserve caused by previous therapy may persist for a long time).

    Pharmacokinetics:

    There is no evidence that when combined inhalation salmeterol and fluticasone propionate affect the pharmacokinetics of each other, and therefore the pharmacokinetic characteristics of each component of the drug Salticasone® aeronaut can be considered separately.

    Suction

    Salmeterol acts locally in the lung tissue, so its concentration in the blood plasma is not an indicator of therapeutic effects. Data on its pharmacokinetics are very limited due to technical problems in determining its concentration: when inhaled in therapeutic doses, its maximum concentration in the blood plasma is extremely low (about 200 pg / ml and below). After regular inhalation of salmeterol in the blood, it is possible to detect hydroxynaphthoic acid, the equilibrium concentrations of which are about 100 ng / ml.

    Fluticasone propionate: the absolute bioavailability of inhalation fluticasone propionate in healthy people varies depending on the inhaler used, when a combination of salmeterol and fluticasone is administered with a metered aerosol for inhalation, it is 5.3%.In patients with bronchial asthma and chronic obstructive pulmonary disease (COPD), lower concentrations of fluticasone propionate in blood plasma are observed. Systemic absorption occurs mainly through the lungs. At first it is faster, but then its speed slows down.

    Part of the inhalation dose can be swallowed, but this part contributes minimal to systemic absorption due to the low solubility of fluticasone propionate in water and due to its pre-systemic metabolism; bioavailability from the gastrointestinal tract the path is less than 1%. As the inhalation dose increases, a linear increase in the concentration of fluticasone propionate in the blood plasma is observed.

    Distribution

    There is no data on the distribution of salmeterol.

    Fluticasone propionate has a large volume of distribution in the equilibrium state (about 300 liters) and has a relatively high degree of binding to plasma proteins (91%).

    Metabolism

    Research results in vitro showed that salmeterol Extensively metabolized by isoenzyme CYP3A4 cytochrome P450 systems to α-hydroxysalmeterol by aliphatic oxidation.

    Fluticasone propionate is rapidly eliminated from the blood plasma, mainly as a result of metabolism under the action of the isoenzyme CYP3A4 the cytochrome P450 system to the inactive carboxyl metabolite. Caution should be exercised while using known inhibitors CYP3A4 and fluticasone, because in such situations it is possible to increase the concentration of the latter in blood plasma.

    Excretion

    There is no data on salmeterol excretion.

    The elimination of fluticasone propionate is characterized by rapid clearance from the blood plasma (1150 ml / min) and a final half-life of about 8 hours. The renal clearance of unchanged fluticasone propionate is negligible (<0.2%), in the form of a metabolite with urine, less than 5% dose.

    Pharmacokinetic interactions

    With the simultaneous use of 15 healthy volunteers salmeterol (inhalation 50 μg twice a day) and inhibitor isoenzyme CYP3A4 - ketoconazole (oral 400 mg once a day) for 7 days, there was a significant increase in salmeterol concentration in the blood plasma (an increase in CmOh in 1,4 times and AUC in 15 times).There was no increase in salmeterol accumulation when taking repeated doses.

    Indications:

    A drug Salticasone® aeronaut It is intended for regular treatment of bronchial asthma if combined therapy of β2-adrenomimetikom long-acting and inhaled glucocorticosteroid:

    - patients with insufficient disease control against continuous monotherapy with inhaled glucocorticosteroids with periodic use of β2- short-acting adrenomimetics, or

    - patients with adequate disease control on the background of inhaled glucocorticosteroid therapy and β2long-acting adenomimetic, or

    - as a starting supportive therapy for patients with persistent asthma in the presence of indications for the appointment of glucocorticosteroids to achieve control of the disease.

    A drug Salticasone® aeronaut is intended for maintenance therapy in COPD in patients with a forced exhalation volume (FEV1) <60% of the proper values ​​(before the inhalation of the bronchodilator) and with repeated exacerbations in the history, in which the expressed symptoms of the disease persist,despite regular therapy with bronchodilators.

    Contraindications:

    - Hypersensitivity to the components of the drug;

    - children under 4 years.

    Carefully:

    Like all other inhaled preparations containing GCS, the drug Salticasone® aeronaut should be used with caution in patients with acute or latent pulmonary tuberculosis.

    A drug Salticasone® aeronaut should be administered with caution in thyrotoxicosis.

    A drug Salticasone® aeronaut should be used with caution in fungal, viral or bacterial infections of the respiratory system.

    When you take any drugs group of sympathomimetics, especially if you exceed the therapeutic dose, it is possible to develop cardiovascular effects such as an increase in systolic blood pressure and heart rate. For this reason, the drug Salticasone® aeronaut should be administered with caution to patients with cardiovascular disease, including with arrhythmias, such as supraventricular tachycardia and extrasystole, ventricular extrasystole, atrial fibrillation.

    Salticasone® aeronaut should be administered with caution to patients with hypokalemia, since all sympathomimetic drugs in dosages exceeding therapeutic ones can cause a transient decrease in potassium concentration (K+) in the blood plasma.

    Any inhaled GCS can cause systemic effects, especially with prolonged use in high doses. Therefore, the drug should be used with caution in glaucoma, cataracts, osteoporosis (see section "Special instructions").

    There are very rare reports of an increase in the concentration of glucose in the blood plasma, so patients with diabetes should use the drug Salticasone® aeronaut with caution (see section "Side effects").

    Pregnancy and lactation:

    Impact on fertility

    There is no data on the effect on fertility in humans. In animal studies, the effects of fluticasone propionate or salmeterol xinafonate on the fertility of males and females have not been demonstrated.

    Pregnancy

    Data on the use of salmeterol and fluticasone in pregnancy are limited. Use during pregnancy is only permissible if the potential benefit to the mother exceeds the possible risk to the fetus.

    According to the results of a retrospective epidemiological study, there was no increased risk of serious congenital malformations after exposure to fluticasone propionate during the first trimester of pregnancy compared to other inhaled glucocorticosteroids.

    When carrying out reproductive toxicity studies in animals with the administration of salmeterol and fluticasone, either individually or in combination, the effects on the fetus of excessive systemic concentrations of the active beta2-adrenomimetics and GCS.

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

    Breastfeeding period

    The concentration of salmeterol and fluticasone propionate in blood plasma after inhaling in therapeutic doses is extremely low, so their concentration in breast milk should also be low. This is confirmed by studies in animals in the milk of which low concentrations of salmeterol and fluticasone propionate were detected. There is no corresponding data on breast milk.

    The use of the drug in the period of breastfeeding is permissible only if the potential benefit to the mother exceeds the possible risk for the child.

    Dosing and Administration:

    A drug Salticasone® aeronaut is only for inhalation use.

    The patient should be informed that to obtain the optimal effect the drug should be used regularly, even in the absence of clinical symptoms of bronchial asthma and COPD.

    The physician should regularly evaluate the effectiveness of the patient's treatment.

    Determining the duration of the course of therapy and changing the dose of the drug is possible only on the advice of a doctor.

    Bronchial asthma

    Dose of the drug Salticasone® aeronaut should be reduced to the lowest dose, which provides effective control of symptoms.

    If the drug is taken Salticasone® aeronaut 2 times a day provides control over the symptoms, within the dose reduction to minimally effective, it is possible to reduce the frequency of taking the drug up to 1 time per day.

    The patient should be given a dosage of the drug Salticasone® aeronaut, which contains a dose of fluticasone propionate,corresponding to the severity of his disease.

    If inhaled GCS therapy does not provide adequate control over the disease, then their replacement by Salticasone® aeronaut in a dose therapeutically equivalent to the dose administered by GCS, can improve the control of the course of bronchial asthma.

    In patients who can monitor the course of bronchial asthma exclusively with the help of inhaled GCS, their replacement by the drug Salticasone® aeronaut may allow to reduce the dose of GCS necessary for the control of the course of bronchial asthma.

    Recommended doses

    Adults and children 12 years and older

    - Two inhalations (25 μg salmeterol and 50 μg fluticasone propionate) 2 times a day, or

    - two inhalations (25 mcg salmeterol and 125 mcg fluticasone propionate) 2 times a day, or

    - two inhalations (25 μg salmeterol and 250 μg fluticasone propionate) 2 times a day.

    Children 4 years and over

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

    Chronic obstructive pulmonary disease (COPD)

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

    Individual patient groups

    There is no need to reduce the dose of the drug Salticasone® aeronaut in elderly and older patients, as well as in patients with impaired renal or hepatic function.

    Instructions for inhalation

    Checking the inhaler

    Before using the inhaler for the first time, or if the inhaler has not been used for a week or more, check its operation. To do this, remove the protective cap from the mouthpiece of the inhaler, shake the inhaler well and press the balloon, releasing one jet of the drug into the air.

    Carrying out inhalations

    Step 1. Remove the protective cap from the inhaler mouthpiece, as shown in figure 1.

    Step 2. Vigorously shake the inhaler to evenly mix the contents of the inhaler.

    Step 3. Make a slow, full exhalation. Do not exhale into the inhaler!

    Step 4. Holding the balloon, as shown in Figure 2, tightly grasp the mouthpiece with your lips, without squeezing it with your teeth.

    The balloon should be pointed upside down!

    Step 5. Take the deepest breath in through your mouth, at the same time, quickly press at the bottom of the balloon before the release of one inhalation dose.

    Step 6. Hold the breath for a few seconds, then remove the mouthpiece from the mouth and slowly exhale through the nose.

    Step 7. Put the protective cap on the inhaler mouthpiece.

    Repeat steps 2-6 to obtain a second inhalation dose, if necessary. After inhalation of the drug Salticasone® aeronaut it is recommended to rinse the mouth and throat with water. Do not swallow water!

    Cleaning the inhaler

    Regularly (at least once a week), flush the mouthpiece of the inhaler with water, as shown in Figure 3. To do this, remove the metal can from the plastic case, rinse the case and cap with warm water. Do not use hot water and do not immerse the metal can into the water.

    Dry the case and cap carefully, but do not use heating devices. Place the metal can back into the case and put on the cap.

    The balloon is designed for 120 inhalations. After this, the cylinder should be replaced.

    The patient should follow the doctor's advice on the use of the inhaler, if any difficulties arise, consult a doctor.

    WARNING: a plastic mouthpiece designed specifically for the preparation Salticasone® aeronaut and serves for accurate dosing of the drug.The mouthpiece should not be used with other metered aerosols. Also you can not use the drug Salticasone® aeronaut with any other adapters, except the mouthpiece supplied with the drug.

    Children

    Small children can not use the inhaler themselves and adults should help them. Wait for the child to breathe in and bring the inhaler into operation at the time of inspiration. Older children and adults with weak hands should hold the inhaler with both hands.

    Side effects:

    All the undesirable reactions presented below are characteristic for the active substances - salmeterol and fluticasone propionate alone. Profile of adverse drug reactions Salticasone® aeronaut does not differ from the profile of undesirable reactions of its active substances.

    The undesirable reactions presented below are listed in accordance with the damage to organs and organ systems and frequency of occurrence. Frequency of occurrence of undesirable reactions is estimated as follows: "very often" (≥10%); "frequently" (≥1% and <10%), "infrequently" (≥ 0.1% and <1%), "rarely" (≥ 0.01 and <0.1%), "very rare" (< 0.01%, including individual cases).

    Immune system disorders: infrequently - skin reactions hypersensitivity, dyspnea; rarely - anaphylactic reactions, angioedema, mainly edema of the face and oropharynx, bronchospasm.

    Disorders from the endocrine system: rarely - Cushing's syndrome, cushingoid symptoms, suppression of adrenal function, growth retardation in children and adolescents, reduction of bone mineral density.

    Disorders from the metabolism and nutrition: infrequently - hyperglycemia; rarely - hypokalemia.

    Disorders of the psyche: infrequently - anxiety, sleep disturbances; rarely - changes in behavior, including increased activity and irritability (especially in children).

    Disturbances from the nervous system: Often - headache; infrequently - tremor.

    Disturbances on the part of the organ of sight: infrequently - cataract; rarely - glaucoma.

    Heart Disease: infrequently - heart palpitations, tachycardia, atrial fibrillation; rarely - arrhythmia, including ventricular extrasystole, supraventricular tachycardia and extrasystole.

    Disturbances from the respiratory system, chest and mediastinal organs: often - hoarseness of voice and / or dysphonia; infrequently - irritation of pharynx; rarely - paradoxical bronchospasm.

    Disturbances from the skin and subcutaneous tissues: infrequently - bruising.

    Disturbances from musculoskeletal and connective tissue: often - muscle spasms, arthralgia.

    Infectious and parasitic diseases: often - Candidiasis of the mouth and pharynx, pneumonia (in patients with COPD); rarely - candidiasis of the esophagus.

    If any of the unwanted reactions listed in the manual is aggravated, or if you notice any other undesirable reactions not listed in the instructions, inform the doctor about it.

    Overdose:

    It is not recommended to administer the drug at doses exceeding those specified in the section "Method of administration and dose". It is important to review the patient regularly dosing regimen and dose reduction to the lowest of the recommended doses, provide effective control of symptoms (see. The section "Method of administration and dose").

    Symptoms

    Expected symptoms and signs of a salmeterol overdose are typical for excessive β2-adrenergic stimulation and include tremor, headache, tachycardia, increased systolic blood pressure, and hypokalemia.

    Acute overdose of fluticasone propionate with inhalation can provoke a temporary suppression of the hypothalamic-pituitary-adrenal system. Usually this does not require taking any emergency measures, since the normal function of the adrenal glands is restored within a few days.

    When taking the drug in doses above the recommended for a long period of time, a significant suppression of the function of the adrenal cortex is possible. There are rare cases of acute adrenal crisis, which occurred mainly in children who received doses of a combination of salmeterol and fluticasone propionate above those recommended for a long time (several months or years). Acute adrenal crisis is manifested by hypoglycemia, accompanied by confusion and / or convulsions. Situations that can serve as triggers for an acute adrenal crisis include trauma, surgery, infection, or any rapid reduction in the dose of fluticasone propionate, which is part of the drug Salticasone® aeronaut.

    Treatment

    Specific treatment of an overdose of salmeterol and fluticasone is absent.In case of an overdose, supportive therapy should be followed and the patient's condition monitored. In chronic overdose, it is recommended to monitor the reserve function of the adrenal cortex.

    Interaction:

    Because of the danger of developing bronchospasm, the use of selective and nonselective βadrenoblockers, except when they are extremely necessary for the patient.

    In normal situations, inhalations of fluticasone propionate are accompanied by low concentrations of it in the blood plasma due to intensive metabolism during "first passage" and high systemic clearance under the influence of isoenzyme CYP3A4 systems of cytochrome P450 in the intestine and liver. Due to this, clinically significant interactions involving fluticasone propionate are unlikely.

    The study of drug interactions in healthy volunteers showed that ritonavir - highly active inhibitor of isoenzyme CYP3A4 - can cause a sharp increase in the concentration of fluticasone propionate in the blood plasma, resulting in a significant decrease in serum cortisol concentrations.There have been reports of clinically significant drug interactions in patients who simultaneously received fluticasone propionate (intranasally or by inhalation) and ritonavir. These interactions caused systemic side effects peculiar to SCS, such as Cushing's syndrome and suppression of adrenal function. Given this fact, the simultaneous use of fluticasone propionate and ritonavir should be avoided, unless the potential benefit to the patient exceeds the risk of systemic side effects of GCS.

    Studies have shown that other isoenzyme inhibitors CYP3A4 cause negligible (erythromycin) and insignificant (ketoconazole) an increase in the level of fluticasone propionate in blood plasma, at which the concentrations of serum cortisol are practically not reduced. Despite this, it is advisable to use caution while using fluticasone propionate and strong inhibitors CYP3A4 (eg, ketoconazole), since such combinations do not exclude the possibility of increasing the concentration of fluticasone propionate in the blood plasma, which can potentially increase the systemic effects of fluticasone propionate.When studying the interaction of drugs, it was found that the use of ketoconazole as a concomitant systemic therapy significantly increases the concentration of salmeterol in the blood plasma (an increase in CmOh in 1,4 times and AUC in 15 times). it can lead to lengthening of the interval QTc. Caution should be exercised when co-administration of strong inhibitors CYP3A4 (e.g., ketoconazole) and salmeterol.

    The derivatives of xanthine, GCS and diuretics increase the risk of hypokalemia (especially in patients with exacerbation of bronchial asthma, hypoxia). Monoamine oxidase inhibitors and tricyclic antidepressants increase the risk of developing unwanted reactions from the cardiovascular system.

    A drug Salticasone® aeronaut compatible with cromoglycic acid drugs.

    Special instructions:

    A drug Salticasone® aeronaut It is not intended to alleviate the acute symptoms of the disease, since in such cases rapid and short-acting inhaled bronchodilator (for example, salbutamol). Patients should be informed that they always have at hand a drug to stop acute symptoms.

    The combination of salmeterol with fluticasone propionate can be used for initial maintenance therapy in patients with persistent asthma (daily occurrence of symptoms or daily use of medications to stop seizures), if there is evidence of SCS administration and when determining their approximate dosage.

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

    The sudden and increasing deterioration in the control of bronchial asthma poses a potential threat to life, and in such situations, the patient should also consult a doctor. The doctor should consider the possibility of prescribing a higher dose of GCS. If the dose used is Salticasone® aeropativ does not provide adequate control over the disease, the patient should also consult a doctor.

    Patients with bronchial asthma can not abruptly stop treatment with the drug Salticasone® aeronaut because of the danger of developing an exacerbation, the dose of the drug should be reduced gradually under the supervision of a doctor.

    In patients with COPD, the withdrawal of the drug may be accompanied by symptoms of decompensation and requires the supervision of a physician.

    There is evidence of an increase in the incidence of pneumonia in patients with COPD receiving a combination of salmeterol with fluticasone propionate. Doctors should be aware of the possibility of developing pneumonia in COPD, as the clinical picture of pneumonia and exacerbations of COPD are often similar.

    Any inhaled GCS can cause systemic reactions, especially with prolonged use in high doses; but the likelihood of such symptoms is much lower than when treated with oral GCS (see the section "Overdose"). Possible systemic reactions include Cushing's syndrome, cushingoid symptoms, suppression of adrenal function, growth retardation in children and adolescents, reduction of bone mineral density, cataract and glaucoma. Therefore, in the treatment of bronchial asthma, it is important to reduce the dose to the lowest dose, which provides effective control over the disease.

    In emergency and planned situations that can cause stress, it is always necessary to remember the possibility of suppressing the function of the adrenal gland and to be ready for use by the GCS (cf.section "Overdose").

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

    It is recommended to regularly measure the growth of children who receive prolonged therapy with inhaled glucocorticosteroids.

    Due to the possibility of suppression of the adrenal glands of patients transferred from oral GCS to inhalation therapy with fluticasone propionate, it should be treated with extreme caution and regularly monitor the function of the adrenal cortex.

    After initiation of treatment with inhaled fluticasone propionate, systemic GCS should be discontinued gradually, and such patients should carry a special patient card containing an indication of the possible need for additional administration of SCS in stressful situations.

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

    There are very rare reports of an increase in the concentration of glucose in the blood plasma, and this should be borne in mind when appointing a combination of salmeterol with fluticasone propionate in patients with diabetes mellitus.

    There is evidence of a clinically significant drug interaction between fluticasone propionate and ritonavir resulting in systemic effects of GCS, including Cushing's syndrome and suppression of adrenal function. Therefore, it is recommended that joint use of fluticasone and ritonavir should be avoided, unless the potential benefit to the patient exceeds the risk associated with systemic effects of GCS (see "Interactions with Other Drugs").

    A clinical study of the safety of salmeterol added to ongoing asthma therapy compared with placebo showed that the incidence of lethal outcomes due to bronchial asthma was significantly higher in the salmeterol group.

    When using salmeterol compared with placebo, the risk of serious unwanted reactions from the respiratory system or death in patients of African American origin is presumably higher than in other patients. The importance of pharmacogenetic factors or other causes is unknown.

    Like other inhaled drugs, Salticasone® aeronaut can cause a paradoxical bronchospasm, manifested by the increase of dyspnea immediately after application. In this case, rapid and short-acting inhaled bronchodilator should be immediately applied, the drug should be withdrawn Salticasone® aeronaut, to examine the patient and to start, if necessary, alternative therapy (see section "Side effect").

    There are reports of adverse reactions associated with pharmacological action (β2antagonists, such as tremor, subjective palpitation and headache. However, these reactions are of a short-term nature, and their severity decreases with regular therapy (see section "Side effect").

    Effect on the ability to drive transp. cf. and fur:

    No data on the effect of the drug Salticasone® aeronaut on the ability to drive vehicles and mechanisms. However, it is necessary to take into account the side effects that the drug may cause and, if necessary, refrain from managing vehicles and mechanisms, as well as from engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

    Form release / dosage:

    The aerosol for inhalation is dosed, 25 μg / dose + 50 μg / dose, 25 μg / dose + 125 μg / dose, 25 μg / dose + 250 μg / dose.

    Packaging:

    For 120 doses of the drug in an aluminum canister closed by a dosing valve, with a spray nozzle.

    Each cylinder is accompanied with instructions for use in a cardboard bundle.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C, away from heating appliances. Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003744
    Date of registration:20.07.2016
    Expiration Date:20.07.2021
    The owner of the registration certificate:NATIVA, LLC NATIVA, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp01.09.2016
    Illustrated instructions
    Instructions
    Up