Clinical and pharmacological group: & nbsp

Beta-adrenomimetics

Glucocorticosteroids

Included in the formulation
  • 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
  • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    ONLS

    АТХ:

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

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

    Pharmacodynamics:

    Salmeterol stimulates β2-adrenoreceptors, which are found in membranes of smooth muscle cells of the bronchi, uterus, gastrointestinal tract, detrusor of the bladder, blood vessels (vessels of skeletal muscles, lungs, coronary vessels). In this case, the smooth muscles of the bronchi relax, the tonus and contractile activity of the myometrium, bladder, gallbladder and bile ducts decrease, motor and stomach and intestine tone, blood vessels expand.

    Salmeterol is lipophilic, due to which it not only penetrates well into the membranes of smooth muscle cells of the bronchi, but also lingers in the lipid layer of the membranes, creating a distinctive depot in the immediate vicinity of the receptor. This delays the activation of β2-adrenergic receptors (apparently, a small diffusion rate through the lipid layers of the membrane determines the delayed onset of action of the substance on the receptor and is the cause of the slow development of the drug effect).

    Relaxation of smooth muscles with stimulation of β2-adrenoreceptors, conjugated with Gs-proteins stimulating adenylate cyclase, is associated with an increase in the level of cAMP and activation of cAMP-dependent protein kinase in smooth muscle cells. cAMP-dependent protein kinase A inhibits the kinase of light chains of myosin, as a result, phosphorylation of light chains of myosin is disrupted and its interaction with actin does not occur. cAMP-dependent protein kinase A inhibits phospholampane (an inhibitor of Ca2 + -ATPase), as a result in the smooth muscle cells the activity of Ca2 + -ATPase transporting Ca2 + from the cytoplasm to the sarcoplasmic reticulum increases and the concentration of cytoplasmic Ca2 + decreases.All this leads to a decrease in the tone and contractile activity of smooth muscles. It is possible to increase blood glucose levels, since β2-adrenoreceptors control the glycogenolysis process in the liver and skeletal muscles and insulin secretion in the pancreas, and when stimulated they activate phosphorylase and increase the breakdown of glycogen, resulting in increased blood glucose levels.

    The secretion of insulin with stimulation of β2-adrenergic receptors is increasing.

    The anti-inflammatory effect of fluticasone is due to the interaction with intracellular glucocorticoid receptors-the formation of dimers of the glucocorticoid-glucocorticoid receptor complex (release of the receptor from the bonds with heat shock proteins 70 and 90 and immunophilin). After that, the activated receptor penetrates into the nucleus, binding to glucocorticoid-sensitive regulatory elements of DNA - a specific effect on gene expression (activation and suppression). And interaction with other protein transcription factors, including NFκB and AP-1, which regulate the expression of many proteins of the immune system, leads to suppression of gene expression encoding some cytokines, collagenase and stromelysins.

    Pharmacokinetics:

    After inhalation, 10-20% of the dose of salmeterol reaches the lower respiratory tract. The rest of the dose remains in the inhaler, settles on the mucous membrane of the oropharynx and then is swallowed. Fraction, settled on the mucosa of the respiratory tract, is absorbed into the lung tissue and blood, but not metabolized in the lungs.

    The degree of binding to plasma proteins is about 10%.

    Metabolised in the liver and excreted mainly with urine in unchanged form and in the form of phenolic sulfate. The swallowed portion of the inhalation dose is absorbed from the gastrointestinal tract and is subjected to active metabolism during "first passage" through the liver, turning into phenolic sulfate. The half-life period is more than 5 hours. It is excreted with feces mainly in the form of metabolites.

    Bioavailability of fluticasone 30% (with aerosol inhalation) and 13.5% (with powder inhalation). The connection with proteins is 91%, with transcortin insignificant. Biotransformation in the liver (CYP3A4), one low-active metabolite is known. The half-life is 7-8 hours after intravenous administration; elimination with feces and urine (<5% in the form of metabolites).

    Indications:

    Broncho-obstructive diseases:

    patients receiving maintenance therapy with long-acting β2-adrenergic agonists and inhaled GCS;

    with persisting symptoms of the disease on the background of inhaled glucocorticosteroids;

    regularly using bronchodilators, which shows the therapy GCS).

    X.J40-J47.J43.9   Emphysema (lung) (pulmonary)

    X.J40-J47.J43.2   Centrilobular emphysema

    X.J40-J47.J43.1   Pancreatic emphysema

    X.J40-J47.J43   Emphysema

    X.J40-J47.J45.9   Asthma, unspecified

    X.J40-J47.J45.8   Mixed asthma

    X.J40-J47.J45.1   Non-allergic asthma

    X.J40-J47.J45.0   Asthma with predominance of an allergic component

    X.J40-J47.J45   Asthma

    X.J40-J47.J44.9   Chronic obstructive pulmonary disease, unspecified

    X.J40-J47.J44.8   Other specified chronic obstructive pulmonary disease

    X.J40-J47.J44.1   Chronic obstructive pulmonary disease with exacerbation, unspecified

    X.J40-J47.J44   Other chronic obstructive pulmonary disease

    Contraindications:

    Hypersensitivity, children under 4 years.

    Carefully:

    Tuberculosis of the lungs, 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 genesis, cataract, glaucoma, hypothyroidism, osteoporosis, pregnancy, lactation.

    Pregnancy and lactation:

    Action category for the fetus by FDA - C.

    In studies on Dutch rabbits, the use of salmeterol was associated with fetal development of the cleft of the upper palate, curvature of the limbs, and delayed ossification of the frontal bones. In studies on New Zealand rabbits, the use of salmeterol inside at a dose 1600 times higher than the recommended dose for treating humans (per 1 m2 of body surface area) only delayed the ossification of the frontal bones. The use of salmeterol in rats at a dose 160 times higher than the recommended dose for treating humans (per 1 m2 of body surface area) was not accompanied by a significant adverse effect on the fetus.

    There is no information on the penetration into breast milk. It is found in the milk of lactating rats at a concentration comparable to that in blood plasma.

    Dosing and Administration:

    Inhalation. The initial dose of the drug is determined based on the dose of fluticasone, which is recommended for the treatment of a disease of a given severity.Then the initial dose should be gradually reduced to the lowest effective dose.

    Adults and adolescents aged 12 years and older: 2 inhalations (25 μg salmeterol and 50 μg fluticasone) 2 times a day, or 2 inhalations (25 μg salmeterol and 125 μg fluticasone) 2 times a day, or 2 inhalations (25 μg salmeterol and 250 μg fluticasone) twice daily or 1 inhalation (50 μg salmeterol and 100 μg fluticasone) twice daily, or 1 inhalation 50 μg salmeterol and 250 μg fluticasone) twice daily or 1 inhalation (50 μg salmeterol and 500 μg fluticasone) 2 times a day.

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

    If there is a violation of the liver and kidneys, as well as elderly patients, there is no need to reduce the dose.

    Side effects:

    Salmeterol: paradoxical bronchospasm, irritation of the mucous membranes of the mouth or throat, changes in taste sensations (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), spasms of skeletal muscles.

    Fluticasone: hoarseness of voice, dysphonia, irritation of the mucous membrane of the pharynx, candidiasis of the oral cavity and pharynx, paradoxical bronchospasm, skin allergic reactions.

    With prolonged use in high doses, systemic effects of fluticasone can be noted: a decrease in the 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, withdrawal of the drug, (after a few days, the function of the adrenal glands is restored independently).

    Interaction:

    Beta-adrenoblockers reduce the effectiveness of inhibitors of the enzyme CYP3A4 (incl. ketoconazole, ritonavir), increase the concentration of fluticasone in the blood plasma.

    Special instructions:

    Composition - calmeterol - 25-50 mcg; fluticasone 100-500 μg.

    Not suitable for relief of acute attacks of bronchial asthma. To be used as a basic therapy if monotherapy is ineffective.

    Compared to increasing the dose of inhaled glucocorticoids, the combination does not improve the safety profile and the clinical course of asthma, but the FVD values ​​improve.

    Compared with monotherapy β2-adrenomimetics long-acting reduce the incidence of COPD attacks, but increase the risk of pneumonia.

    Compared with monotherapy with inhaled glucocorticoids, the frequency of COPD attacks is reduced by 9.

    Compared with placebo, they improve the quality of life in COPD.

    Adding β2-adrenomimetics long-acting reduces the need for inhaled glucocorticoids with the same level of control of bronchial asthma.

    Monitoring: growth and development in children; techniques of inhalation, lung function; densitometry of bones, ophthalmic status for more than 6 weeks (cataracts, glaucoma, infectious diseases), tonometry.

    The effectiveness is comparable with the combination formoterol + budesonide.

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