Salmecort, 1 piece, 25 mcg+250 mcg/dose, dosed aerosol for inhalation
Salmecort 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 advised to always have medication available to relieve acute symptoms.
The combination of salmeterol and fluticasone propionate can be used for initial maintenance therapy in patients with persistent bronchial asthma (daily occurrence of symptoms or daily use of drugs to relieve attacks) if there are indications for the use of corticosteroids and their approximate dosage has been determined.
More frequent use of short-acting bronchodilators to relieve symptoms indicates worsening disease control, and in such situations the patient should consult a doctor.
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 a higher dose of GCS. If the dose of Salmecort used does not provide adequate control of the disease, the patient should also consult a doctor.
Patients with asthma should not sharply reduce treatment with Salmecort 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. In patients with COPD receiving Salmecort, the incidence of pneumonia may increase (see "Side effects"). Clinicians should be aware of the possibility of pneumonia in patients with COPD, since the clinical presentation of exacerbation of COPD and pneumonia 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 (see “Overdose”). Possible systemic reactions include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, and glaucoma. Therefore, when treating asthma, it is important to reduce the dose to the lowest dose that provides effective control of the disease.
In emergency and planned situations that can cause stress, you must always remember the possibility of suppressing adrenal function and be prepared to use GCS (see “Overdose”).
When carrying out resuscitation measures or surgical interventions, it is necessary to determine the degree of adrenal insufficiency.
It is recommended to regularly measure the height of children who receive long-term therapy with inhaled corticosteroids.
Patients transferred from oral corticosteroids to inhaled fluticasone propionate therapy, due to the possibility of adrenal suppression, should be treated with extreme caution and their adrenal function should be regularly monitored. 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, incl. GCS for local use.
After starting treatment with inhaled fluticasone propionate, systemic corticosteroids should be withdrawn gradually, and such patients should have a special patient card containing an indication of the possible need for additional administration of corticosteroids in stressful situations.
In patients with exacerbation of bronchial asthma, hypoxia, it is necessary to control the concentration of potassium ions (K+) in plasma.
There are very rare reports of increased blood glucose levels, and this should be remembered when prescribing a combination of salmeterol with fluticasone propionate to patients with diabetes mellitus (see “Side effects”).
Due to the potential for systemic effects of GCS, including Cushing's syndrome and adrenal suppression, the combined use of fluticasone propionate and ritonavir should be avoided unless the potential benefit to the patient outweighs the risk associated with the systemic effects of GCS (see Interactions). .
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. The effect of concomitant use of inhaled corticosteroids on the risk of death in patients with asthma has not been studied.
Like other inhaled drugs, Salmecort 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 Salmecort and, if necessary, begin alternative therapy (see “Side effects”).
Adverse reactions associated with the pharmacological action of beta2-agonists, such as tremor, subjective palpitations and headache, may occur. However, these reactions are short-term in nature, and their severity decreases with regular therapy (see “Side effects”).
Impact on the ability to drive vehicles and operate machinery.
Clinical studies have not provided data on the effect of the drug on the ability to drive vehicles and other mechanisms, but the side effects that the drug may cause should be taken into account.
Salmecort air. d/inhal. dosage 25 mcg+125 mcg/dose 120 doses No. 1
Salmecort is not intended for the relief of acute symptoms, since in such cases a rapid and short-acting inhaled bronchodilator (for example, salbutamol) should be used. Patients should be advised to always have medication available to relieve acute symptoms. The combination of salmeterol and fluticasone propionate can be used for initial maintenance therapy in patients with persistent bronchial asthma (daily occurrence of symptoms or daily use of drugs to relieve attacks) if there are indications for the use of corticosteroids and their approximate dosage has been determined.
More frequent use of short-acting bronchodilators to relieve symptoms indicates worsening disease control, and in such situations the patient should consult a doctor.
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 a higher dose of GCS. If the dose of Salmecort used does not provide adequate control of the disease, the patient should also consult a doctor.
Patients with asthma should not sharply reduce treatment with Salmecort 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.
In patients with COPD receiving Salmecort, the incidence of pneumonia may increase (see section "Side effects"). Clinicians should be aware of the possibility of pneumonia in patients with COPD, since the clinical presentation of exacerbation of COPD and pneumonia 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 (see section “Overdose”). Possible systemic reactions include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, and glaucoma.
Therefore, when treating asthma, it is important to reduce the dose to the lowest dose that provides effective control of the disease.
In emergency and planned situations that can cause stress, you must always remember the possibility of suppressing adrenal function and be prepared to use GCS (see section “Overdose”).
When carrying out resuscitation measures or surgical interventions, it is necessary to determine the degree of adrenal insufficiency. It is recommended to regularly measure the height of children who receive long-term therapy with inhaled corticosteroids.
Due to the possibility of adrenal suppression, patients switched from oral corticosteroids to inhaled fluticasone propionate therapy should be treated with extreme caution and their adrenal function regularly monitored. 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.
After starting treatment with inhaled fluticasone propionate, systemic corticosteroids should be withdrawn gradually, and such patients should have a special patient card containing an indication of the possible need for additional administration of corticosteroids in stressful situations.
In patients with exacerbation of bronchial asthma, hypoxia, it is necessary to control the concentration of potassium ions K+ in plasma.
There are very rare reports of increased blood glucose levels, and this should be remembered when prescribing a combination of salmeterol with fluticasone propionate to patients with diabetes mellitus (see section "Side effects").
Due to the potential for systemic effects of GCS, including Cushing's syndrome and adrenal suppression, the combined use of fluticasone propionate and ritonavir should be avoided unless the potential benefit to the patient outweighs the risk associated with the systemic effects of GCS (see section "Interaction with other drugs").
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. The effect of concomitant use of inhaled corticosteroids on the risk of death in patients with asthma has not been studied.
Like other inhaled drugs, Salmecort 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 Salmecort and, if necessary, begin alternative therapy (see section “Side Effects”).
Adverse reactions associated with the pharmacological action of beta2 antagonists, such as tremor, subjective palpitations and headache, may occur. However, these reactions are short-term in nature, and their severity decreases with regular therapy (see section “Side effects”).
Salmecort 25mcg+125mcg/dose 120 doses aerosol for inhalation dosed
pharmachologic effect
Salmecort is a combined bronchodilator (contains salmoterol and fluticasone propionate).
Salmeterol is a selective long-acting β2-adrenergic receptor agonist (at least 12 hours). The salmeterol molecule has a long side chain that binds to the outer domain 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 β2-receptor 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; late-stage inhibition persists for more than 30 hours after administration of a single dose, when the bronchodilator effect is no longer present.
Fluticasone propionate; - topical corticosteroids. When inhaled in recommended doses, it has a pronounced anti-inflammatory and antiallergic 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 propionate 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.
Composition and release form Salmecort 25mcg+125mcg/dose 120 doses aerosol for inhalation dosed
Aerosol – 1 dose:
- Active substances: salmeterol xinafoate 36.3 mcg, which corresponds to the content of salmeterol 25 mcg, fluticasone propionate 125 mcg.
- Excipients: 1,1,1,2-tetrafluoroethane (HFA-134a) - 73.024 mg, polyethylene glycol 1000 - 0.01464 mg.
120 doses - aluminum aerosol cans (1) with a dosing valve and mouthpiece - cardboard packs.
Description of the dosage form
Aerosol for inhalation, dosed; in the form of a suspension of white or almost white color.
Directions for use and doses
Inhalation. For inhalation use 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.
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. During treatment, the patient should be regularly monitored by a doctor in order to select the optimal dose. The patient should not independently change the dose of the drug prescribed by the doctor.
Bronchial asthma
If taking Salmecort 2 times a day ensures control of symptoms, as part of reducing the dose to the minimum effective, it is possible to reduce the frequency of taking the drug to 1 time a day.
The patient should be prescribed a form of Salmecort that contains a dose of fluticasone propionate appropriate to the severity of his disease.
If therapy with inhaled corticosteroids does not provide adequate control of the disease, then replacing them with Salmecort at a dose therapeutically equivalent to the dose of administered corticosteroids may improve asthma control. In patients whose asthma can be controlled exclusively with inhaled corticosteroids, replacing them with Salmecort may reduce the dose of corticosteroids required to control the course of asthma.
Recommended Doses
Adults and children aged 12 years and older:
- 2 inhalations (25 mcg salmeterol and 50 mcg fluticasone propionate) 2 times a day, or
- 2 inhalations (25 mcg salmeterol and 125 mcg fluticasone propionate) 2 times a day, or
- 2 inhalations (25 mcg salmeterol and 250 mcg fluticasone pronionate) 2 times a day.
Children aged 4 years and older:
- 2 inhalations (25 mcg salmeterol and 50 mcg fluticasone propionate) 2 times a day.
All patients taking the drug as maintenance therapy should consult a physician 6-12 weeks after the initial dose.
Chronic obstructive pulmonary disease
For adult patients, the maximum recommended dose is 2 inhalations (25 mcg salmeterol and 250 mcg fluticasone propionate) 2 times a day.
Special patient groups
There is no need to reduce the dose of Salmecort in elderly patients, as well as in patients with impaired renal or liver function.
Instructions for using the inhaler
The inhaler must be shaken before each use.
Checking the inhaler
1. Before the first use or if the inhaler has not been used for 2 days or more, it is necessary to check the inhaler. To do this, perform 4 presses (inhalations) into the air.
Using an inhaler
2. Remove the protective cover from the mouthpiece. In this case, the mouthpiece must remain tightly attached to the bottle (inhaler); If the inhaler has been stored without a protective cap, the mouthpiece must be checked for contamination.
3. Hold the inhaler in your hands with the mouthpiece down so that one finger is at the bottom of the inhaler and another finger or two is at the top end of the inhaler. Exhale and place the mouthpiece between your teeth.
4. Cover the mouthpiece tightly with your lips and slightly tilt your head back. Slowly begin inhaling and at the same time press the bottom of the can. Continue inhaling until the end.
5. Remove the inhaler from the mouth and hold your breath for 10 seconds or as long as is comfortable. Exhale slowly.
Note:
After each inhalation, you must rinse your mouth and/or throat with water. This will help reduce the dryness associated with taking the drug. The break between inhalations should be at least 1 minute. When performing repeated inhalation, repeat steps 2-5. After use, you must close the mouthpiece with a protective cap.
It is recommended to carry out the first few inhalations while monitoring yourself in front of a mirror. If you see the drug “leakage” through the mouth or from the hole between the mouthpiece and the body of the inhaler, this indicates incorrect inhalation technique.
Inhalations for young children should be carried out under the supervision of an adult.
Older children and adults with weak hands should hold the inhaler with both hands. In this case, both index fingers should be located on the top of the inhaler, and both thumbs should be on the base below the mouthpiece.
Cleaning the inhaler
The inhaler must be cleaned at least once a day.
1. Remove the metal canister with the drug from the body of the inhaler. Remove the spray tip.
2. Rinse the mouthpiece and body of the inhaler under warm running water.
3. Wipe thoroughly with a dry cloth or cotton swab. Overheating should be avoided.
4. Assemble the inhaler.
After using all the doses indicated on the package, the metal can should be thrown away.
Pharmacokinetics
There is no data indicating that co-administration of inhaled salmeterol and fluticasone propionate affects the pharmacokinetics of either substance.
Salmeterol
After inhalation administration in therapeutic doses, very low concentrations of the drug are created in the blood plasma (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 propionate
After inhalation administration, the relative bioavailability ranges from 10% to 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 inhaled dose and the systemic effect of fluticasone, Vd is about 300 l.
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 is 1.15 l/min. T1/2; about 8 hours.
Indications for use Salmecort 25mcg+125mcg/dose 120 doses aerosol for inhalation dosed
The drug Salmecort is intended for the regular treatment of bronchial asthma in patients who are indicated for combination therapy with a long-acting beta2-adrenergic agonist and corticosteroids for inhalation use:
- in patients with insufficient disease control on the background of constant monotherapy with GCS for inhalation with periodic use of a short-acting beta2-adrenergic agonist;
- in patients with adequate disease control during therapy with GCS for inhalation and a long-acting beta2-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 in patients with COPD whose forced expiratory volume (FEV1) value
Contraindications
- Hypersensitivity to one or more components of the drug;
- children's age (up to 4 years).
Carefully
Like all other inhaled drugs containing corticosteroids, Salmecort should be used with caution in patients with acute or latent pulmonary tuberculosis, fungal, viral or bacterial infections of the respiratory system, and thyrotoxicosis.
When taking any drugs from the sympathomimetic group, especially when therapeutic doses are exceeded, the development of cardiovascular phenomena such as an increase in systolic blood pressure and heart rate is possible. For this reason, Salmecort should be prescribed with caution to patients suffering from cardiovascular diseases, incl. with arrhythmias, such as supraventricular tachycardia and extrasystole, ventricular extrasystole, atrial fibrillation.
All sympathomimetic drugs in doses exceeding therapeutic doses can cause a transient decrease in serum potassium levels, so Salmecort should be prescribed with caution to patients with hypokalemia.
Any inhaled GCS can cause systemic effects, especially with long-term use in high doses, so the drug should be used with caution in case of glaucoma, cataracts, osteoporosis (see section “Special instructions and precautions for use”).
There are very rare reports of increased blood glucose levels, so patients with diabetes should use Salmecort with caution (see section "Side effects").
Application of Salmecort 25mcg+125mcg/dose 120 doses aerosol for inhalation dosed during pregnancy and lactation
Pregnant and lactating women should be prescribed the drug only if the expected benefit to the mother outweighs any possible risk to the fetus or child.
There is insufficient data on the use of salmeterol and fluticasone propionate during pregnancy and lactation.
Pregnancy
Excessive systemic concentrations of active beta2-adrenergic agonists and corticosteroids have an effect on the fetus.
Extensive clinical experience with drugs of this class indicates that when using therapeutic doses, the described effects are not clinically significant. Salmeterol and fluticasone propionate are not genotoxic.
Lactation period
The concentration of salmeterol and fluticasone propionate in the blood plasma after inhalation of the drug in therapeutic doses is extremely low, so their concentration in breast milk should be equally low. There are no data on the concentration of salmeterol and fluticasone propionate in the breast milk of women during lactation.
Use in children
The use of the drug in children under 4 years of age is contraindicated.
special instructions
Salmecort is not intended for the relief of acute symptoms, since in such cases a rapid and short-acting inhaled bronchodilator (for example, salbutamol) should be used. Patients should be informed to always have medication available to relieve acute symptoms.
The combination of salmeterol and fluticasone propionate can be used for initial maintenance therapy in patients with persistent bronchial asthma (daily occurrence of symptoms or daily use of drugs to relieve attacks) if there are indications for the administration of GCS and when determining their approximate dose.
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 increasing deterioration in asthma control poses a potential threat to life, in such situations the patient should also consult a doctor. The physician should consider a higher dose of GCS. If the dose of Salmecort used does not provide adequate control of the disease, the patient should also consult a doctor.
Patients with asthma should not abruptly stop treatment with Salmecort 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.
In patients with COPD receiving Salmecort, the incidence of pneumonia may increase (see section "Side effects"). Clinicians should be aware of the possibility of pneumonia in patients with COPD, since the clinical presentation of exacerbation of COPD and pneumonia 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 (see section "Overdose"). Possible systemic reactions include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts and glaucoma. Therefore, when treating asthma, it is important to reduce the dose to the lowest dose that provides effective control of the disease.
In emergency and planned situations that can cause stress, you must always remember the possibility of suppressing adrenal function and be prepared to use GCS (see section “Overdose”).
When carrying out resuscitation measures or surgical interventions, it is necessary to determine the degree of adrenal insufficiency.
It is recommended to regularly measure the height of children who receive long-term therapy with inhaled corticosteroids.
Due to the potential for adrenal suppression, patients switched from oral corticosteroids to inhaled fluticasone propionate therapy should be treated with extreme caution and adrenal function regularly monitored. 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, incl. GCS for local use.
After starting treatment with inhaled fluticasone propionate, systemic corticosteroids should be withdrawn gradually; such 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. This should be remembered when prescribing a combination of salmeterol with fluticasone propionate to patients with diabetes mellitus (see section “Side effects”).
Due to the potential for systemic effects of GCS, including Cushing's syndrome and adrenal suppression, the combined use of fluticasone propionate and ritonavir should be avoided unless the potential benefit to the patient outweighs the risk associated with the systemic effects of GCS (see section "Interaction with other drugs").
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. The effect of concomitant use of inhaled corticosteroids on the risk of death in patients with asthma has not been studied.
Like other inhaled drugs, Salmecort 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 Salmecort and, if necessary, begin alternative therapy (see section “Side Effects”).
Adverse reactions associated with the pharmacological action of beta2 antagonists, such as tremor, palpitations and headache, may occur. However, these reactions are short-term in nature, and their severity decreases with regular therapy (see section “Side effects”).
Impact on the ability to drive vehicles and operate machinery
In clinical studies, no data were obtained on the effect of the drug on the ability to drive vehicles and other mechanisms, however, the side effects that the drug may cause should be taken into account.
Overdose
It is not recommended to prescribe the drug in doses exceeding those specified in the section “Method of administration and doses”. It is important to regularly review the patient's dosage regimen and reduce the dose to the lowest recommended dose that provides effective disease control (Dosage and Administration).
Symptoms
Expected symptoms and signs of salmeterol overdose are typical of excessive beta2-adrenergic stimulation and include tremor, headache, tachycardia, increased systolic blood pressure and hypokalemia.
An acute overdose of fluticasone propionate by inhalation can provoke temporary suppression of the hypothalamic-pituitary-adrenal axis. This usually does not require any emergency measures, since normal adrenal function is restored within a few days.
When taking the drug in doses higher than recommended for a long period of time, significant suppression of the function of the adrenal cortex is possible. Rare cases of acute adrenal crisis have been described, which occurred mainly in children who received doses of the drug higher than recommended for a long time (several months or years). An acute adrenaline crisis is manifested by hypoglycemia, accompanied by confusion and/or convulsions. Situations that may trigger an acute adrenal crisis include trauma, surgery, infection, or any rapid reduction in the dose of inhaled fluticasone propionate, which is part of the drug Salmecort.
Treatment
There is no specific treatment for overdose of salmeterol and fluticasone propionate. In case of overdose, maintenance therapy should be carried out and the patient's condition should be monitored.
When using the drug in doses exceeding those indicated in the instructions for a long time, suppression of the function of the adrenal cortex may be observed.
Side effects Salmecort 25mcg+125mcg/dose 120 doses aerosol for inhalation dosed
All undesirable reactions presented below are characteristic of the active ingredients - salmeterol and fluticasone propionate separately. The safety profile of the drug Salmecort does not differ from the profile of adverse reactions of its active substances.
The adverse reactions presented below are listed according to the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is defined as follows: very often (≥1/10), often (≥1/100 and
Infections and infestations: often - candidiasis of the oral cavity and pharynx, pneumonia (in patients with COPD).
On the part of the immune system: rarely - skin hypersensitivity reactions; rarely - anaphylactic reactions, angioedema (mainly swelling of the face and oropharynx), bronchospasm.
From the endocrine system: ;possible systemic effects include (see sections “With caution” and “Special instructions”); rarely - Cushing's syndrome, Cushingoid symptoms, suppression of adrenal function, growth retardation in children and adolescents, decreased bone mineral density.
From the organs of vision: ;uncommon - cataract; rarely - glaucoma.
From the side of metabolism and nutrition: ;uncommon - hyperglycemia; very rarely - hypokalemia.
Mental disorders: ;uncommon - anxiety, sleep disorders; rarely - changes in behavior, incl. increased activity and irritability (especially in children).
From the nervous system: very often - headache (see section "Special instructions"); infrequently - tremor (see section "Special instructions").
From the cardiovascular system: ;uncommon - rapid heartbeat (see section “With caution” and “Special instructions”), tachycardia, atrial fibrillation; rarely - arrhythmia, including ventricular extrasystole, supraventricular tachycardia, extrasystole.
From the respiratory system: often - hoarseness and/or dysphonia; uncommon - pharyngeal irritation; rarely - paradoxical bronchospasm (see section "Special instructions").
From the skin and subcutaneous tissues: rarely - bruising.
From the musculoskeletal system: often - muscle spasms, arthralgia.
From the digestive system: very rarely - dyspepsia, nausea.
Children and teenagers
Theoretically, it is possible to develop systemic reactions, including Cushing's syndrome, Cushingoid symptoms, suppression of adrenal function, and growth retardation in children and adolescents. Very rarely, anxiety, sleep disturbances and behavioral disorders, including hyperactivity and irritability, may occur.
Drug interactions
Due to the risk of developing bronchospasm, the use of selective and non-selective beta-blockers should be avoided unless they are absolutely necessary for the patient.
Salmeterol
Concomitant use with ketoconazole should be avoided unless the benefit of use outweighs the potential risk of systemic adverse reactions during treatment with salmeterol. There is a similar risk of interaction with other strong CYP3A4 inhibitors (itraconazole, telithromycin, ritonavir).
Fluticasone propionate
In normal situations, inhalation of fluticasone propionate is accompanied by low plasma concentrations due to intensive first-pass metabolism and high systemic clearance under the influence of the CYP3A4 isoenzyme of the cytochrome P450 system in the intestine and liver. This makes clinically significant interactions involving fluticasone propionate unlikely.
Ritonavir, as a highly active inhibitor of the CYP3A4 enzyme, can cause a sharp increase in plasma fluticasone propionate concentrations, resulting in a significant decrease in serum cortisol concentrations. Concomitant use with ritanovir causes side effects such as Cushing's syndrome and adrenal suppression. Given the above, the simultaneous use of fluticasone propionate and ritanovir should be avoided, unless the potential benefit to the patient outweighs the risk of systemic side effects of GCS.
Other inhibitors of the CYP3A4 isoenzyme cause a negligible (erythromycin) and insignificant (ketoconazole) increase in plasma fluticasone propionate levels, with virtually no decrease in serum cortisol concentrations. Despite this, caution is recommended during concomitant use of strong CYP3A4 inhibitors (e.g. ketoconazole), since such combinations may increase plasma concentrations of fluticasone propionate.
Xanthine derivatives, corticosteroids and diuretics increase the risk of developing hypokalemia (especially in patients with exacerbation of bronchial asthma, during hypoxia).
MAO inhibitors and tricyclic antidepressants increase the risk of side effects from the cardiovascular system.
Compatible with cromoglycic acid.