Symbicort Rapichaler aerosol 80 / 4.5 ?g / dose, 120 dose
Expiration Date: 05/2027
Russian Pharmacy name:
Симбикорт Рапихалер аэрозоль 80/4,5мкг/доза, 120доз
For inhalation use.
The drug SymbicortЃ Rapichaler enters the lungs directly after inhalation, therefore, the patient must be trained in the correct use of the inhaler (see subsection УInstructions for using the drug SymbicortЃ RapichalerФ). The patient should be informed about the need to regularly use SymbicortЃ Rapichaler, i.e. continue taking it even in the absence of symptoms of the disease in order to achieve the greatest therapeutic effect. Bronchial asthma The dose of SymbicortЃ Rapichaler should be regularly monitored by the attending physician, who corrects it individually, depending on the severity of the disease in accordance with the current recommendations. The initial dose is adjusted to achieve effective symptom control. After achieving the desired clinical effect, the dose should be gradually reduced to the minimum dose,allowing optimal control of the symptoms of bronchial asthma. Thus, subsequently, it is possible to switch to therapy with only inhaled glucocorticosteroids. When stopping treatment with SymbicortЃ Rapichaler, it is recommended to gradually reduce the dose. In the case of severe bronchial asthma, regular medical supervision is necessary, since life-threatening situations may arise. In patients with severe bronchial asthma, persistent symptoms of the disease, frequent exacerbations are noted, and the values ??of the maximum expiratory flow rate are less than 60% of the normal value, vary within more than 30% and do not normalize, despite taking bronchodilators. These patients are prescribed high-dose inhaled glucocorticosteroids or oral glucocorticosteroids.With a sudden worsening of symptoms, it is possible to increase the dose of the glucocorticosteroid under the supervision of a physician. At the same time, an increase in the dose of an inhaled glucocorticosteroid should not be achieved due to the more frequent use of the combined drug. With an unstable course of bronchial asthma, it is possible to switch to therapy with monopreparations. Recommendations for the use of SymbicortЃ Rapichaler in patients receiving oral glucocorticosteroids are given in the 'Special instructions' section.receiving oral glucocorticosteroids are given in the section 'Special instructions'.receiving oral glucocorticosteroids are given in the section 'Special instructions'.
Doses
Bronchial asthma
Patients take a maintenance daily dose of Symbicort Rapichaler and, if necessary, a fast-acting bronchodilator to relieve symptoms.
Children aged 6 to 11
SymbicortЃ Rapichaler 80 mcg + 4.5 mcg / dose: 2 inhalations 2 times a day. The maximum daily dose is 4 inhalations of 80 mcg + 4.5 mcg / dose. Children aged 12 to 17 years SymbicortЃ Rapichaler 80 mcg + 4.5 mcg / dose: 2 inhalations 1-2 times a day. In case of increased symptoms, you can temporarily increase the dose (no more than 1 week) to 4 inhalations 2 times a day. SymbicortЃ Rapichaler 160 mcg + 4.5 mcg / dose: 2 inhalations 1-2 times a day. In case of intensification of symptoms, you can temporarily increase the dose (no more than 1 week) to 4 inhalations 2 times a day. Adults over the age of 18 SymbicortЃ Rapichaler 80 mcg + 4.5 mcg / dose: 2 inhalations 1-2 times a day. In case of increased symptoms, you can increase the dose to 4 inhalations 2 times a day temporarily or as a maintenance dose. SymbicortЃ Rapichaler 160 mcg + 4.5 mcg / dose: 2 inhalations 1-2 times a day.In case of intensification of symptoms, you can temporarily increase the dose to 4 inhalations 2 times a day, temporarily or as a maintenance dose. The equivalence of SymbicortЃ TurbuhalerЃ and SymbicortЃ RapichalerЃ preparations was statistically established when using 2 inhalations 80 ?g + 4.5 ?g / dose or 160 ?g + 4.5 ?g / dose 2 times a day. However, this equivalence has not been confirmed for all dosages. Patients should be informed of the need to carry a fast-acting bronchodilator at all times to relieve seizures. Frequent use of the drug for the relief of attacks indicates a worsening of bronchial asthma and requires correction of therapy.The equivalence of SymbicortЃ TurbuhalerЃ and SymbicortЃ RapichalerЃ preparations was statistically established when using 2 inhalations 80 ?g + 4.5 ?g / dose or 160 ?g + 4.5 ?g / dose 2 times a day. However, this equivalence has not been confirmed for all dosages. Patients should be informed of the need to carry a fast-acting bronchodilator at all times to relieve seizures. Frequent use of the drug for the relief of attacks indicates a worsening of bronchial asthma and requires correction of therapy.The equivalence of SymbicortЃ TurbuhalerЃ and SymbicortЃ RapichalerЃ preparations was statistically established when using 2 inhalations 80 ?g + 4.5 ?g / dose or 160 ?g + 4.5 ?g / dose 2 times a day. However, this equivalence has not been confirmed for all dosages. Patients should be informed of the need to carry a fast-acting bronchodilator at all times to relieve seizures. Frequent use of the drug to relieve attacks indicates a worsening of bronchial asthma and requires correction of therapy.Patients should be informed of the need to carry a fast-acting bronchodilator at all times to relieve seizures. Frequent use of the drug for the relief of attacks indicates a worsening of bronchial asthma and requires correction of therapy.Patients should be informed of the need to carry a fast-acting bronchodilator at all times to relieve seizures. Frequent use of the drug for the relief of attacks indicates a worsening of bronchial asthma and requires correction of therapy.
COPD
SymbicortЃ Rapichaler 160 mcg + 4.5 mcg / dose: 2 inhalations 2 times a day. Maximum daily dose: 4 inhalations. SymbicortЃ Rapichaler 80 mcg + 4.5 mcg / dose is not used (registered) for the treatment of COPD.
Application in special patient groups
There are no data on the use of the drug Symbicort Rapichaler in patients with impaired liver and kidney function. Excretion of budesonide and formoterol occurs mainly by metabolism in the liver, therefore, an increase in exposure is possible in patients with severe liver disease. Such patients should be closely monitored. No dose adjustment is required in elderly patients.
Instructions for using the drug Symbicort Rapichaler
Read this section carefully before using this medicine.
Inhaler
The inhaler is delivered assembled. Do not disassemble the inhaler into its component parts. If the connection of the parts of the inhaler is loosened, it is necessary to secure them and continue to use the inhaler in accordance with the doctor's prescription. Preparing the inhaler for use Before using the inhaler for the first time, remove the inhaler from the laminated aluminum foil bag. The bag can be thrown away. Before using the inhaler for the first time, and also if the inhaler has not been used for a week or more, or if the inhaler has been dropped, it is necessary to prepare it for use: shake gently and make 2 releases of the drug into the air.
Using an inhaler
1. Shake the inhaler gently before each use.
2. Remove the protective cap from the mouthpiece by pressing on both sides and pulling.
3. Hold the inhaler upright in front of your mouth with your thumb (or thumbs of both hands) on the base of the inhaler and your index finger (s) on the top of the inhaler, as shown in the illustrations. Then, exhale as deeply as possible, place the mouthpiece of the inhaler between your teeth and wrap your lips tightly around it.
4. Then you need to take a slow deep breath through the mouth. At the beginning of inhalation, press the dispenser of the inhaler to release the drug.
5. After taking a deep breath, hold your breath for about 10 seconds, or as long as you feel comfortable. Then remove the inhaler from the mouth and your finger from the top of the inhaler.
6. Following the doctor's instructions, do another inhalation - gently shake the inhaler and repeat steps 3-5.
7. Put the protective cap on the mouthpiece and close it to prevent the ingress of dust and other contaminants; you will hear a soft click.
8. Rinse the mouth with water to remove any residual drug.
Cleaning the inhaler You should regularly, at least once a week, clean the mouthpiece of the inhaler as follows:
1. Remove the protective cap from the mouthpiece.
2. Wipe the inside and outside of the mouthpiece with a clean dry cloth.
3. Close the mouthpiece with the protective cap.
4. Do not immerse the inhaler in water.
5. Do not disassemble the inhaler into its component parts.
active substance: micronized budesonide, micronized formoterol fumarate dihydrate
Children and adolescents up to 18 years old; hypersensitivity to budesonide, formoterol, or inhaled lactose.
Carefully
Pulmonary tuberculosis (active or inactive form), fungal, viral or bacterial respiratory infections, thyrotoxicosis, pheochromocytoma, diabetes mellitus, uncontrolled hypokalemia, idiopathic hypertrophic subaortic stenosis, severe arterial hypertension, aneurysm of any localization or other severe cardiovascular diseases ( tachyarrhythmia or severe heart failure), prolongation of the QT interval.
pharmachologic effect
Combined bronchodilator. Budesonide and formoterol have different mechanisms of action and exhibit an additive effect in reducing the frequency of exacerbations of bronchial asthma and COPD. The special properties of budesonide and formoterol make it possible to use their combination simultaneously as supportive therapy and to relieve attacks, or as a supportive therapy for bronchial asthma. Budesonide - GCS, which after inhalation has a quick (within several hours) and dose-dependent anti-inflammatory effect on the respiratory tract, reducing the severity of symptoms and the frequency of exacerbations of bronchial asthma. With the appointment of inhaled budesonide, there is a lower incidence of serious adverse effects than with the use of systemic corticosteroids. Reduces the severity of edema of the bronchial mucosa, mucus production,sputum formation and airway hyperresponsiveness. The exact mechanism of the anti-inflammatory action of GCS is unknown. Formoterol is a selective ?2-adrenergic receptor agonist that, after inhalation, causes rapid and prolonged relaxation of bronchial smooth muscles in patients with reversible airway obstruction. Bronchodilator dose-dependent effect occurs quickly, within 1-3 minutes after inhalation and persists for at least 12 hours after taking a single dose. The addition of formoterol to budesonide reduces the severity of symptoms of bronchial asthma, improves bronchial function and reduces the frequency of exacerbations of the disease. The effect of this fixed combination on bronchial function corresponds to the action of a combination of monopreparations of budesonide and formoterol and exceeds the effect of budesonide alone.In all cases, a short-acting beta2-adrenostimulant was used to relieve seizures. There was no decrease in anti-asthmatic action over time. The combination is well tolerated.
Side effect
From the nervous system: often (> 1/100, <1/10) - headache; less often (> 1/1000, <1/100) - psychomotor agitation, anxiety, nausea, dizziness, sleep disturbances; very rarely (<1/10 000) - depression, behavior disorders (mainly in children), taste disturbances. From the side of the cardiovascular system: often (> 1/100, <1/10) - palpitations; less often (> 1/1000, <1/100) - tachycardia; rarely (> 1/10 000, <1/1000) - atrial fibrillation, supraventricular tachycardia, extrasystole; very rarely (<1/10 000) - angina pectoris, blood pressure fluctuations. From the musculoskeletal system: often (> 1/100, <1/10) - tremor; less often (> 1/1000, <1/100) - muscle cramps. From the respiratory system: often (> 1/100, <1/10) - candidiasis of the oral mucosa and pharynx,slight irritation in the throat, cough, hoarseness; rarely (> 1/10 000, <1/1000) - bronchospasm. Dermatological reactions: less often (> 1/1000, <1/100) - bruising; rarely (> 1/10 000, <1/1000) - exanthema, itching, dermatitis. Allergic reactions: rarely (> 1/10 000, <1/1000) - urticaria, angioedema, anaphylactic reactions. Metabolic disorders: rarely (> 1/10 000, <1/1000) - hypokalemia; very rarely (<1/10 000) - hyperglycemia, symptoms of systemic action of GCS (including hypofunction of the adrenal glands). The systemic effect of inhaled corticosteroids can be observed when taking the drug in high doses for a long time. The use of beta2-adrenergic agonists can lead to an increase in blood levels of insulin, free fatty acids, glycerol, ketone derivatives.rarely (> 1/10 000, <1/1000) - bronchospasm. Dermatological reactions: less often (> 1/1000, <1/100) - bruising; rarely (> 1/10 000, <1/1000) - exanthema, itching, dermatitis. Allergic reactions: rarely (> 1/10 000, <1/1000) - urticaria, angioedema, anaphylactic reactions. Metabolic disorders: rarely (> 1/10 000, <1/1000) - hypokalemia; very rarely (<1/10 000) - hyperglycemia, symptoms of systemic action of GCS (including hypofunction of the adrenal glands). The systemic effect of inhaled corticosteroids can be observed when taking the drug in high doses for a long time. The use of beta2-adrenergic agonists can lead to an increase in blood levels of insulin, free fatty acids, glycerol, ketone derivatives.rarely (> 1/10 000, <1/1000) - bronchospasm. Dermatological reactions: less often (> 1/1000, <1/100) - bruising; rarely (> 1/10 000, <1/1000) - exanthema, itching, dermatitis. Allergic reactions: rarely (> 1/10 000, <1/1000) - urticaria, angioedema, anaphylactic reactions. Metabolic disorders: rarely (> 1/10 000, <1/1000) - hypokalemia; very rarely (<1/10 000) - hyperglycemia, symptoms of systemic action of GCS (including hypofunction of the adrenal glands). The systemic effect of inhaled corticosteroids can be observed when taking the drug in high doses for a long time. The use of beta2-adrenergic agonists can lead to an increase in blood levels of insulin, free fatty acids, glycerol, ketone derivatives.less often (> 1/1000, <1/100) - bruising; rarely (> 1/10 000, <1/1000) - exanthema, itching, dermatitis. Allergic reactions: rarely (> 1/10 000, <1/1000) - urticaria, angioedema, anaphylactic reactions. Metabolic disorders: rarely (> 1/10 000, <1/1000) - hypokalemia; very rarely (<1/10 000) - hyperglycemia, symptoms of systemic action of GCS (including hypofunction of the adrenal glands). The systemic effect of inhaled corticosteroids can be observed when taking the drug in high doses for a long time. The use of beta2-adrenergic agonists can lead to an increase in blood levels of insulin, free fatty acids, glycerol, ketone derivatives.less often (> 1/1000, <1/100) - bruising; rarely (> 1/10 000, <1/1000) - exanthema, itching, dermatitis. Allergic reactions: rarely (> 1/10 000, <1/1000) - urticaria, angioedema, anaphylactic reactions. Metabolic disorders: rarely (> 1/10 000, <1/1000) - hypokalemia; very rarely (<1/10 000) - hyperglycemia, symptoms of systemic action of GCS (including hypofunction of the adrenal glands). The systemic effect of inhaled corticosteroids can be observed when taking the drug in high doses for a long time. The use of beta2-adrenergic agonists can lead to an increase in blood levels of insulin, free fatty acids, glycerol, ketone derivatives.1/1000) - urticaria, angioedema, anaphylactic reactions. Metabolic disorders: rarely (> 1/10 000, <1/1000) - hypokalemia; very rarely (<1/10 000) - hyperglycemia, symptoms of systemic action of GCS (including hypofunction of the adrenal glands). The systemic effect of inhaled corticosteroids can be observed when taking the drug in high doses for a long time. The use of beta2-adrenergic agonists can lead to an increase in blood levels of insulin, free fatty acids, glycerol, ketone derivatives.1/1000) - urticaria, angioedema, anaphylactic reactions. Metabolic disorders: rarely (> 1/10 000, <1/1000) - hypokalemia; very rarely (<1/10 000) - hyperglycemia, symptoms of systemic action of GCS (including hypofunction of the adrenal glands). The systemic effect of inhaled corticosteroids can be observed when taking the drug in high doses for a long time. The use of beta2-adrenergic agonists can lead to an increase in blood levels of insulin, free fatty acids, glycerol, ketone derivatives.The systemic effect of inhaled corticosteroids can be observed when taking the drug in high doses for a long time. The use of beta2-adrenergic agonists can lead to an increase in blood levels of insulin, free fatty acids, glycerol, ketone derivatives.The systemic effect of inhaled corticosteroids can be observed when taking the drug in high doses for a long time. The use of beta2-adrenergic agonists can lead to an increase in blood levels of insulin, free fatty acids, glycerol, ketone derivatives.Application during pregnancy and lactation
During pregnancy, the budesonide / formoterol combination should be used only in cases where the expected benefit of therapy to the mother outweighs the potential risk to the fetus. Budesonide should be used in the minimum effective dose necessary to maintain adequate control of bronchial asthma symptoms. Inhaled budesonide is excreted in breast milk, however, when used in therapeutic doses, no effect on the child has been noted. It is not known whether formoterol is excreted in breast milk in women. The budesonide / formoterol combination should be given to nursing women only if the expected benefit to the mother outweighs any potential risk to the baby.
Application in children
The drug is contraindicated for use in children and adolescents under the age of 18 years.
Use in elderly patients
There is no need for a special selection of the dose of the drug for elderly patients.
special instructions
Before stopping treatment, it is recommended to gradually reduce the dose. It is not recommended to abruptly cancel treatment. The combination of budesonide / formoterol is not used for the initial selection of therapy in the early stages of bronchial asthma treatment. Taking formoterol can cause prolongation of the QT interval. An increase in the frequency of taking bronchodilators as emergency drugs indicates a deterioration in the course of the underlying disease and serves as the basis for revising the tactics of treating bronchial asthma. An unexpected and progressive deterioration in the control of symptoms of bronchial asthma or COPD is a potentially life-threatening condition and requires urgent medical attention. In this situation, the possibility of increasing the dose of corticosteroids or adding systemic anti-inflammatory therapy should be considered, for example,a course of oral corticosteroids or antibiotic treatment in case of infection. Patients are advised to carry emergency medications with them at all times (short-acting beta2-adrenergic agonists). The patient's attention should be drawn to the need for regular intake of a drug containing a combination of budesonide / formoterol in accordance with the selected dose, even in cases where there are no symptoms of the disease. Treatment should not be started during an exacerbation or significant deterioration in the course of bronchial asthma. As with any other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after taking a dose of the combined drug. In this connection, therapy should be discontinued, treatment tactics should be reviewed and, if necessary, alternative therapy should be prescribed.The systemic effect can manifest itself when taking any inhaled corticosteroids, especially when taking drugs in high doses for a long period of time. The manifestation of a systemic effect is less likely with inhalation therapy than with the use of oral corticosteroids. Possible systemic effects include suppression of adrenal function, decreased bone mineral density, cataracts, and glaucoma. Due to the potential effect of inhaled corticosteroids on bone mineral density, special attention should be paid to patients taking high doses of the drug for a long period with the presence of risk factors for osteoporosis.Studies of long-term use of inhaled budesonide in children at an average daily dose of 400 mcg (metered dose) or adults at a daily dose of 800 mcg (metered dose) have not shown a noticeable effect on bone mineral density. If there is reason to believe that adrenal function was impaired against the background of previous systemic GCS therapy, precautions should be taken when transferring patients to treatment with a budesonide / formoterol combination. The advantages of inhaled budesonide therapy, as a rule, minimize the need for taking oral steroids, however, in patients who discontinue therapy with oral corticosteroids, adrenal insufficiency may persist for a long time. The patients,who in the past needed urgent high doses of corticosteroids or received long-term treatment with inhaled corticosteroids in a high dose may also be in this risk group. It is necessary to provide for the additional appointment of GCS during periods of stress or surgery. The need for the use and dose of inhaled corticosteroids should be reviewed in patients with active or inactive forms of pulmonary tuberculosis, fungal, viral or bacterial respiratory infections. With the joint appointment of beta2-adrenergic agonists with drugs that can cause or enhance the hypokalemic effect, for example, xanthine derivatives, steroids or diuretics, the hypokalemic effect of beta2-adrenergic agonists may be enhanced. Special precautions should be taken in patients with unstable bronchial asthma,using short-acting bronchodilators to relieve attacks during exacerbation of severe bronchial asthma, because the risk of developing hypokalemia increases against the background of hypoxia and in other conditions, when the likelihood of the development of a hypokalemic effect increases. In such cases, it is recommended to monitor serum potassium. During the period of treatment, the concentration of glucose in the blood should be monitored in patients with diabetes mellitus. Influence on the ability to drive vehicles and mechanisms The combination of budesonide / formoterol may have a negligible effect if side effects occur. Care must be taken when driving vehicles and mechanisms during the treatment period.the risk of developing hypokalemia increases against the background of hypoxia and in other conditions, when the likelihood of developing a hypokalemic effect increases. In such cases, it is recommended to monitor serum potassium. During the period of treatment, the concentration of glucose in the blood should be monitored in patients with diabetes mellitus. Influence on the ability to drive vehicles and mechanisms The combination of budesonide / formoterol may have a negligible effect in the event of side effects. Care must be taken when driving vehicles and mechanisms during the treatment period.the risk of developing hypokalemia increases against the background of hypoxia and in other conditions, when the likelihood of developing a hypokalemic effect increases. In such cases, it is recommended to monitor serum potassium. During the period of treatment, the concentration of glucose in the blood should be monitored in patients with diabetes mellitus. Influence on the ability to drive vehicles and mechanisms The combination of budesonide / formoterol may have a negligible effect if side effects occur. Care must be taken when driving vehicles and mechanisms during the treatment period.During the period of treatment, the concentration of glucose in the blood should be monitored in patients with diabetes mellitus. Influence on the ability to drive vehicles and mechanisms The combination of budesonide / formoterol may have a negligible effect in the event of side effects. Care must be taken when driving vehicles and mechanisms during the treatment period.During the period of treatment, the concentration of glucose in the blood should be monitored in patients with diabetes mellitus. Influence on the ability to drive vehicles and mechanisms The combination of budesonide / formoterol may have a negligible effect if side effects occur. Care must be taken when driving vehicles and mechanisms during the treatment period.
Drug interactions
Taking ketoconazole at a dose of 200 mg 1 time / day increases the plasma concentration of budesonide when administered orally (single dose of 3 mg) when administered together, on average, 6 times. With the appointment of ketoconazole 12 hours after taking budesonide, the plasma concentration of the latter increased, on average, 3 times. There is no information about such an interaction with budesonide with its inhalation use, but a noticeable increase in the concentration of the drug in the blood plasma should be expected. Because there are no data for recommendations on dose selection, the above combination of drugs should be avoided. If possible, the time intervals between the appointment of ketoconazole and budesonide should be maximized. You should also consider reducing the dose of budesonide. Other potent CYP3A4 inhibitors are likelycan also significantly increase the concentration of budesonide in plasma. Blockers of ? 2-adrenergic receptors are able to reduce the intensity of the action of formoterol. The combination of formoterol + budesonide should not be administered concurrently with beta-blockers (including eye drops), except in forced cases. Co-administration of a combination of formoterol + budesonide and quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), MAO inhibitors, tricyclic antidepressants can prolong the QT interval and increase the risk of ventricular arrhythmias. In addition, levodopa, levothyroxine, oxytocin and alcohol can reduce the tolerance of the heart muscle to beta2-adrenergic agonists. The simultaneous use of MAO inhibitors, as well as drugs with similar properties, such as furazolidone and procarbazine,can cause an increase in blood pressure. There is an increased risk of arrhythmias in patients undergoing general anesthesia with halogenated hydrocarbon preparations. With the simultaneous use of a combination of budesonide / formoterol and other beta-adrenergic drugs, the side effects of formoterol may increase. As a result of the use of beta2-adrenergic agonists, hypokalemia may develop, which can be exacerbated by concomitant treatment with xanthine derivatives, corticosteroids or diuretics. Hypokalemia may increase the predisposition to the development of arrhythmias in patients taking cardiac glycosides.With the simultaneous use of a combination of budesonide / formoterol and other beta-adrenergic drugs, the side effects of formoterol may increase. As a result of the use of beta2-adrenergic agonists, hypokalemia may develop, which can be exacerbated by concomitant treatment with xanthine derivatives, corticosteroids or diuretics. Hypokalemia can increase the predisposition to the development of arrhythmias in patients taking cardiac glycosides.With the simultaneous use of a combination of budesonide / formoterol and other beta-adrenergic drugs, the side effects of formoterol may increase. As a result of the use of beta2-adrenergic agonists, hypokalemia may develop, which can be exacerbated by concomitant treatment with xanthine derivatives, corticosteroids or diuretics. Hypokalemia can increase the predisposition to the development of arrhythmias in patients taking cardiac glycosides.
'