SYMBICORT TURBUHALER POR D/ING 160+4.5 MCG/DOSE 120 DOSES

pharmachologic effect

Combined drug for the treatment of bronchial asthma. Contains formoterol and budesonide, which have different mechanisms of action and exhibit an additive effect in reducing the frequency of exacerbations of bronchial asthma.

Budesonide - GCS, after inhalation in recommended doses, has an anti-inflammatory effect on the bronchi, reducing the severity of symptoms and the frequency of exacerbations of bronchial asthma. When budesonide is prescribed in the form of inhalations, there is a lower incidence of serious adverse effects than when using systemic corticosteroids. Reduces the severity of edema of the bronchial mucosa, mucus production, sputum formation and airway hyperreactivity.

Formoterol is a selective β2-adrenergic receptor agonist. Causes relaxation of bronchial smooth muscles in patients with reversible airway obstruction. The bronchodilator effect is dose-dependent, occurs within 1-3 minutes after inhalation and persists for at least 12 hours after taking a single dose.

With the combined use of formoterol and budesonide, the severity of symptoms of bronchial asthma decreases, pulmonary function improves and the frequency of exacerbations of the disease decreases.

The effect of Symbicort Turbuhaler on lung function corresponds to the effect of the combination of budesonide and formoterol monotherapy and exceeds the effect of budesonide alone. The drug is well tolerated.

While taking Symbicort Turbuhaler as maintenance therapy for 12 weeks in children aged 6 to 11 years (two inhalations of 80/4.5 mcg/inhalation 2 times a day), pulmonary function improved and the drug was well tolerated, compared with an appropriate dose of budesonide turbuhaler.

In patients with severe chronic obstructive pulmonary disease, while taking Symbicort Turbuhaler, a significant reduction in the frequency of exacerbations of the disease was observed compared with patients receiving formoterol or placebo alone as therapy (average frequency of exacerbations of 1.4 compared with 1.8-1.9 in the placebo/formoterol group).

There were no differences noted between taking Symbicort Turbuhaler and formoterol in terms of FEV1 values.

Buy Symbicort Turbuhaler powder for inhalation 320mcg+9mcg/dose 60doses in pharmacies

Symbicort Turbuhaler Buy Symbicort Turbuhaler in pharmacies Symbicort Turbuhaler in the medicine directory DOSAGE FORMS powder for inhalation 320mcg/9mcg 60dz

MANUFACTURERS AstraZeneca AB (Sweden)

GROUP Combined products containing glucocorticosteroids

COMPOSITION Budesonide + Formoterol.

INTERNATIONAL NON-PROPENTED NAME Budesonide + Formoterol

SYNONYMS Foradil Combi

PHARMACOLOGICAL ACTION The drug contains formoterol and budesonide, which have different mechanisms of action and exhibit an additive effect in reducing the frequency of exacerbations of bronchial asthma. Budesonide is an inhaled glucocorticosteroid. When used in recommended doses, it has an anti-inflammatory effect in the bronchi, reducing the severity of symptoms and the frequency of exacerbations of bronchial asthma with a lower frequency of side effects than when using systemic glucocorticosteroids. Reduces the severity of swelling of the bronchial mucosa, mucus production, sputum formation and airway hyperactivity. Formoterol is a selective b2-adrenergic receptor agonist. Causes relaxation of bronchial smooth muscles in patients with reversible airway obstruction. The bronchodilator effect occurs quickly, within 1-3 minutes after inhalation, and persists for 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.

INDICATIONS FOR USE Bronchial asthma is insufficiently controlled by taking inhaled glucocorticosteroids and short-acting beta-adrenergic stimulants or adequately controlled by inhaled glucocorticosteroids and long-acting beta-adrenergic stimulants. Symptomatic therapy in patients with severe chronic obstructive pulmonary disease (COPD) and a history of repeated exacerbations who have severe symptoms of the disease despite therapy with long-acting bronchodilators.

CONTRAINDICATIONS Hypersensitivity to budesonide, formoterol or inhaled lactose; children under 6 years of age. Carefully. Pulmonary tuberculosis (active or inactive form; fungal, viral or bacterial infections of the respiratory system, thyrotoxicosis, pheochromocytoma, diabetes mellitus, uncontrolled hypokalemia, idiopathic hypertrophic subaortic stenosis, severe arterial hypertension, aneurysm of any location or other severe cardiovascular diseases (ischemic heart disease, tachyarrhythmia or severe heart failure), prolongation of the QT interval (taking formoterol may cause prolongation of the QTc interval

SIDE EFFECTS Since the drug contains budesonide and formoterol, you can expect the same side effects that are noted when these drugs are used separately. There was no increase in the incidence of adverse reactions observed during the concomitant administration of the two drugs. The most common adverse reactions associated with taking the drug are such pharmacologically expected undesirable side effects for b2-agonists, such as tremor and rapid heartbeat. These symptoms are usually of moderate severity and disappear after a few days.

INTERACTION No data available.

OVERDOSE No data available.

SPECIAL INSTRUCTIONS It is recommended to instruct the patient on the need to rinse the mouth with water after inhalation in order to prevent the development of candidiasis of the oral mucosa. During pregnancy, Symbicort Turbuhaler should be prescribed only in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus. Symbicort Turbuhaler can be prescribed to nursing women if the expected benefit of therapy for the mother outweighs the potential risk for the child. Symbicort Turbuhaler does not affect the ability to drive vehicles or operate machinery.

STORAGE CONDITIONS Store at a temperature below 30 degrees C out of the reach of children.

Pharmacokinetics

Suction

Symbicort® Turbuhaler® is bioequivalent to the corresponding monotherapy drugs (budesonide and formoterol) in terms of their systemic action. Despite this, a slight increase in cortisol suppression was noted after taking Symbicort Turbuhaler compared to monotherapy. This difference does not affect clinical safety. There is no evidence of a pharmacokinetic interaction between budesonide and formoterol. The pharmacokinetic parameters of budesonide and formoterol were comparable after they were taken as single drugs and as part of Symbicort Turbuhaler.

When using the combination drug, the AUC of budesonide was slightly higher, the absorption of the drug was faster and the Cmax value was higher; The Cmax of formoterol coincided with that for the single drug. Inhaled budesonide is rapidly absorbed and reaches Cmax after 30 minutes. The average dose of budesonide that enters the lungs after inhalation through a turbuhaler is 32-44% of the delivered dose. Systemic bioavailability is approximately 49% of the delivered dose. In children aged 6 to 16 years, the average dose of budesonide entering the lungs after inhalation through a turbuhaler does not differ from those in adult patients (the final concentration of the drug in the blood plasma was not determined).

Inhaled formoterol is rapidly absorbed and reaches Cmax 10 minutes after inhalation. Studies have shown that the average dose of formoterol delivered to the lungs after inhalation through a turbuhaler is 28-49% of the delivered dose. Systemic bioavailability is about 61% of the delivered dose.

Distribution

Plasma protein binding of budesonide is approximately 90%, formoterol - 50%.

Vd of budesonide is about 3 l/kg, formoterol - 4 l/kg.

Metabolism

Budesonide undergoes intense biotransformation (about 90%) during the “first pass” through the liver with the formation of metabolites with low glucocorticoid activity. Budesonide is metabolized predominantly by the enzyme CYP3A4. The glucocorticoid activity of the main metabolites - 6-β-hydroxybudesonide and 16-α-hydroxyprednisolone - does not exceed 1% of the similar activity of budesonide.

Formoterol is metabolized primarily in the liver by conjugation to form active O-demethylated metabolites, mainly in the form of inactivated conjugates.

There is no evidence of metabolite interactions or substitution reactions between budesonide and formoterol.

Removal

Budesonide is excreted in the urine in the form of metabolites or in the form of conjugates and only in small quantities unchanged. Budesonide has a high systemic clearance (approximately 1.2 l/min).

After inhalation, 8-13% of the delivered dose of formoterol is excreted unchanged in the urine. Formoterol has a high systemic clearance (approximately 1.4 l/min); T1/2 averages 17 hours.

Pharmacokinetics in special clinical situations

The pharmacokinetics of formoterol in children and in patients with renal failure have not been studied.

Plasma concentrations of budesonide and formoterol may be increased in patients with liver disease.

Symbicort Turbuhaler

Pharmacological action Combined drug for the treatment of bronchial asthma. Contains formoterol and budesonide, which have different mechanisms of action and exhibit an additive effect in reducing the frequency of exacerbations of bronchial asthma. Budesonide is a corticosteroid for inhalation use. When used in recommended doses, it has an anti-inflammatory effect in the lungs, reducing the severity of symptoms and the frequency of exacerbations of bronchial asthma with a lower incidence of side effects than when using systemic corticosteroids. The exact mechanism responsible for the anti-inflammatory effect of the drug is unknown. Formoterol is a selective b2-adrenergic receptor agonist. Causes relaxation of bronchial smooth muscles in patients with reversible airway obstruction. The bronchodilator effect occurs quickly, within 1-3 minutes after inhalation, and persists for 12 hours after taking a single dose. Clinical studies have found that the combined use of formoterol and budesonide reduces the severity of symptoms of bronchial asthma, improves lung function and reduces the frequency of exacerbations of the disease. The effect of Symbicort Turbuhaler on lung function corresponds to the effect of the combination of budesonide and formoterol monotherapy and exceeds the effect of budesonide alone. The drug is well tolerated. When taking Symbicort Turbuhaler for 12 weeks (two inhalations of 80/4.5 mcg/inhalation twice a day), children aged 6 to 11 years improved pulmonary function and were well tolerated. In patients with severe COPD, a significant reduction in the incidence of exacerbations of the disease was observed while taking Symbicort Turbuhaler compared with patients receiving formoterol or placebo alone as therapy (mean exacerbation frequency 1.4 compared with 1.8–1.9 in the placebo/formoterol group). There were no differences observed between Symbicort and formoterol on forced expiratory volume (FEV1).

Pharmacokinetics

Absorption Symbicort Turbuhaler is bioequivalent to the corresponding monotherapy drugs (budesonide and formoterol) in terms of their systemic action. Despite this, a slight increase in cortisol suppression was noted after taking Symbicort Turbuhaler compared to monotherapy. This difference does not affect the clinical safety of Symbicort Turbuhaler. There is no evidence of a pharmacokinetic interaction between budesonide and formoterol. The pharmacokinetic parameters of budesonide and formoterol were comparable after they were taken as single drugs and as part of Symbicort Turbuhaler. When using a combination drug, the AUC of budesonide was slightly higher, the absorption of the drug was faster and the Cmax value was higher, the Cmax of formoterol coincided with that for the single drug. Inhaled budesonide is rapidly absorbed and reaches Cmax within 30 minutes. The average dose of budesonide that enters the lungs after inhalation through a turbuhaler is 32-44% of the delivered dose. Systemic bioavailability is approximately 49% of the delivered dose. In children aged 6 to 16 years, the average dose of budesonide that enters the lungs after inhalation through Turbuhaler does not differ from those in adult patients (the final concentration of the drug in the blood plasma was not determined). Inhaled formoterol is rapidly absorbed and reaches Cmax 10 minutes after inhalation. Studies have shown that the average dose of formoterol delivered to the lungs after inhalation through a turbuhaler is 28-49% of the delivered dose. Systemic bioavailability is about 61% of the delivered dose. Distribution and metabolism Approximately 50% of formoterol and 90% of budesonide are bound to plasma proteins. Vd of formoterol is about 4 l/kg, budesonide - 3 l/kg. Formoterol is metabolized in the liver by conjugation to form active O-demethylated and deformylated metabolites, but mainly inactivated conjugates. Budesonide undergoes intense biotransformation (about 90%) during the “first pass” through the liver with the formation of metabolites with low glucocorticoid activity. The glucocorticoid activity of the main metabolites - 6-b-hydroxybudesonide and 16-a-hydroxyprednisolone - does not exceed 1% of the similar activity of budesonide. There is no evidence of metabolite interactions or substitution reactions between budesonide and formoterol. Formoterol is metabolized in the liver. Budesonide is metabolized primarily by the enzyme CYP3A4. Excretion After inhalation, 8-13% of the delivered dose of formoterol is excreted unchanged in the urine. Formoterol has a high systemic clearance (approximately 1.4 l/min), T1/2 averages 17 hours. Budesonide is excreted in the urine in the form of metabolites (conjugates) and only in small quantities unchanged. Budesonide has a high systemic clearance (approximately 1.2 l/min), T1/2 after intravenous administration averages 4 hours. Pharmacokinetics in special clinical cases The pharmacokinetics of formoterol in children and in patients with renal failure has not been studied. Plasma concentrations of budesonide and formoterol may be increased in patients with liver disease.

Indications

- maintenance therapy of bronchial asthma in cases where the use of a combination of inhaled corticosteroids and long-acting beta2-agonists is clinically justified: in patients whose condition is not sufficiently controlled by taking inhaled corticosteroids and short-acting inhaled beta2-agonists used as emergency medications “as needed” "or in patients whose condition is already adequately controlled with inhaled corticosteroids and long-acting beta2-agonists. Symbicort Turbuhaler containing 80 mcg budesonide and 4.5 mcg formoterol in 1 dose is not indicated for patients with severe bronchial asthma. – symptomatic therapy in patients with severe chronic obstructive pulmonary disease (COPD) (FEV1 Dosage regimen

Symbicort Turbuhaler is not intended for initial selection of therapy in the first stages of treatment of bronchial asthma. The dose selection of the drugs included in Symbicort Turbuhaler is carried out individually and depending on the severity of the disease. This must be taken into account when starting treatment with combination drugs. In the event that individual patients require a dosage beyond the recommended treatment regimen, β2-adrenergic agonists and/or glucocorticoids should be prescribed separately in the appropriate dosage. For bronchial asthma, adults and adolescents (12 years and older) are prescribed Symbicort Turbuhaler 80/4.5 mcg/dose, 1-2 inhalations 2 times a day, Symbicort Turbuhaler 160/4.5 mcg/dose, 1-2 inhalations 2 times a day. After achieving optimal control of the symptoms of bronchial asthma while taking the drug 2 times a day, it is possible to reduce the dose to the lowest effective dose, up to 1 time a day. Children aged 6 to 12 years are prescribed Symbicort Turbuhaler 80/4.5 mcg/dose, 1-2 inhalations 2 times a day. For COPD, adults are prescribed Symbicort Turbuhaler 160/4.5 mcg/dose, 2 inhalations 2 times a day. There is no need for special selection of the drug dose for elderly patients. There is no data on the use of Symbicort Turbuhaler in patients with renal or hepatic impairment. Since budesonide and formoterol are eliminated primarily by the kidneys via hepatic metabolism, a slower rate of drug elimination can be expected in patients with severe cirrhosis. Instructions for the correct use of turbuhaler The mechanism of action of turbuhaler is such that when the patient inhales through the mouthpiece, air currents carry the medicinal substance into the respiratory tract. The following instructions must be given to the patient: carefully read the “Instructions for Use”, which is included in the packaging along with each turbulence tube, inhale strongly and deeply through the mouthpiece to ensure that the optimal dose of the drug reaches the lungs, never exhale through the mouthpiece in order to minimize the possibility of developing a fungal infection of the oropharynx, the patient should rinse his mouth with water after each inhalation. The patient may not taste or feel the drug after using Turbuhaler, due to the small amount of the substance delivered.

Side effect

Since Symbicort Turbuhaler contains budesonide and formoterol, the same side effects that are observed when these drugs are used separately can be expected. There was no increase in the incidence of adverse reactions observed during the concomitant administration of the two drugs. The most common adverse reactions associated with taking the drug are such pharmacologically expected undesirable side effects for beta2-agonists, such as tremor and tachycardia, which are usually of moderate severity and disappear within a few days after the start of treatment. Side effects that are associated with budesonide or formoterol are listed below. From the side of the central nervous system: often (1/100) - headache, possible - agitation, anxiety, nausea, dizziness, sleep disturbances. From the cardiovascular system: often (1/100) - tachycardia, more pronounced tachycardia is possible. From the musculoskeletal system: often (1/100) - tremor, muscle cramps are possible. From the respiratory system: often (1/100) - candidiasis of the oral mucosa, mild irritation in the throat, cough, hoarseness, pneumonia, rarely (1/1000) - bronchospasm, in isolated cases - paradoxical bronchospasm. Dermatological reactions: often (1/100) - hemorrhages in the subcutaneous fat, rarely (1/1000) - exanthema, urticaria, itching. Symptoms of systemic action of budesonide: in isolated cases - depression, behavioral disturbances (mainly in children), adrenal hypofunction, immediate or delayed allergic reactions (including dermatitis, Quincke's edema and bronchospasm). Symptoms associated with the action of formoterol: in isolated cases - angina pectoris, hyperglycemia, changes in taste, blood pressure fluctuations. For other beta2-agonists, cardiac arrhythmias such as atrial fibrillation, supraventricular tachycardia and extrasystole have been reported.

Contraindications

– children under 6 years of age, – hypersensitivity to budesonide, formoterol or inhaled lactose.

Pregnancy and lactation

There are no clinical data on the use of Symbicort Turbuhaler or the combined use of formoterol and budesonide during pregnancy. During pregnancy, Symbicort Turbuhaler should be prescribed only in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus. Budesonide should be used at the lowest effective dose necessary to maintain adequate control of asthma symptoms. It is unknown whether formoterol and budesonide pass into breast milk. Symbicort Turbuhaler can be prescribed to nursing women if the expected benefit of therapy for the mother outweighs the potential risk for the child.

In experimental studies, the toxic effect of a combination of drugs on reproductive function in animals has not been studied. When studying the effect of formoterol on reproductive function in animals, it was found that side effects were observed at very high concentrations of the drug in the body.

special instructions

Caution should be exercised when using Symbicort Turbuhaler in patients with active or inactive forms of pulmonary tuberculosis, fungal, viral or bacterial respiratory infections. Symbicort Turbuhaler should be administered with caution to patients with thyrotoxicosis, pheochromocytoma, diabetes mellitus, uncontrolled hypokalemia, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other serious cardiovascular diseases (coronary artery disease, tachyarrhythmia or severe heart failure). Caution should be exercised when treating patients with a prolonged QTc interval. Taking formoterol may cause a prolongation of the QTc interval. The drug should be used with extreme caution during exacerbation of severe bronchial asthma, since the risk of developing hypokalemia increases against the background of hypoxia. During the treatment of exacerbation of severe bronchial asthma, it is recommended to monitor serum potassium levels. When using the drug in patients with diabetes mellitus, the concentration of glucose in the blood should be additionally monitored. It is recommended to gradually reduce the dose of the drug before stopping treatment. An increase in the frequency of taking bronchodilators as emergency medications indicates a worsening of the underlying disease and serves as a basis for revising the treatment tactics for bronchial asthma. Sudden and progressive deterioration in control of symptoms of asthma or COPD is a potentially life-threatening condition and requires urgent medical attention. In this situation, you should consider increasing the dose of GCS or adding systemic anti-inflammatory therapy, for example, a course of oral GCS or antibiotic treatment, in case of infection. Patients are advised to carry emergency medications with them at all times (b2 - short-acting adrenergic agonists). Treatment with Symbicort Turbuhaler should not be started during an exacerbation of bronchial asthma. As with any other inhaled therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after taking a dose of the drug. If a severe reaction develops, treatment tactics should be reconsidered and, if necessary, alternative therapy should be prescribed. Systemic effects may occur when taking any inhaled corticosteroids, especially when taking high doses of drugs over a long period of time. Systemic effects are less likely to occur with inhalation therapy than with oral corticosteroids. Possible systemic effects include adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, and glaucoma. Particular attention should be paid to older COPD patients with reduced bone mineral density due to possible effects on bone tissue. Therefore, it is very important to use the lowest effective dose of inhaled corticosteroids that provides optimal control of asthma symptoms. It is necessary to carefully monitor the growth of children and adolescents who take GCS for a long time in any dosage form, and evaluate the ratio of the benefits of GCS therapy to the possible risk of growth retardation. If there is reason to believe that adrenal function has been impaired due to previous systemic GCS therapy, precautions should be taken when transferring patients to treatment with Symbicort Turbuhaler. The benefits of inhaled budesonide therapy generally minimize the need for oral corticosteroids, but patients who discontinue oral corticosteroids may experience long-term adrenal insufficiency. Patients who in the past required urgent use of high doses of corticosteroids may also be at this risk. In extreme cases and in any situation that may cause stress, the possibility of residual adrenal dysfunction in such patients must always be kept in mind. In such situations, it is necessary to provide adequate treatment for GCS. Depending on the degree of adrenal dysfunction, it may be necessary to consult a specialist before undergoing recommended procedures. Symbicort Turbuhaler contains lactose (less than 1 mg/dose). Typically this amount does not cause problems in patients with lactose intolerance. Use in pediatrics In children under 6 years of age, the effectiveness and safety of the drug have not been fully studied. Symbicort Turbuhaler is not recommended for use in this category of patients. Effect on the ability to drive vehicles and operate machines Symbicort Turbuhaler does not affect the ability to drive vehicles and operate machines.

It is recommended to gradually reduce the dose of the drug before stopping treatment. An increase in the frequency of taking bronchodilators as emergency medications indicates a worsening of the underlying disease and serves as a basis for revising the treatment tactics for bronchial asthma. Sudden and progressive deterioration in control of symptoms of asthma or COPD is a potentially life-threatening condition and requires urgent medical attention. In this situation, you should consider increasing the dose of glucocorticosteroids or adding systemic anti-inflammatory therapy, for example, a course of oral glucocorticosteroids or antibiotic treatment, in case of infection. Patients are advised to carry emergency medications (short-acting β2-adrenergic agonists) with them at all times. Treatment with Symbicort Turbuhaler should not be started during an exacerbation 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 drug. If a severe reaction develops, treatment tactics should be reconsidered and, if necessary, alternative therapy should be prescribed. Systemic effects may occur when taking any inhaled glucocorticosteroids, especially when taking high doses of drugs over a long period of time. Systemic effects are less likely to occur with inhaled therapy than with oral corticosteroids. Possible systemic effects include adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, and glaucoma. Particular attention should be paid to older COPD patients with reduced bone mineral density due to possible effects on bone tissue. Therefore, it is very important to use the lowest effective dose of inhaled corticosteroids that provides optimal control of asthma symptoms. Clinicians should carefully monitor the growth of children and adolescents who take long-term glucocorticosteroids in any dosage form and evaluate the ratio of the benefits of glucocorticosteroid therapy to the possible risk of growth retardation. If there is reason to believe that adrenal function has been impaired due to previous systemic steroid therapy, precautions should be taken when transferring patients to treatment with Symbicort Turbuhaler. The benefits of inhaled budesonide therapy generally minimize the need for oral steroids, but patients who discontinue oral steroid therapy may experience long-term adrenal insufficiency. Patients who have previously required acute high-dose corticosteroids may also be at risk. In extreme cases and in any situation that may cause stress, the possibility of residual adrenal dysfunction in such patients must always be kept in mind. In such situations, it is necessary to provide adequate treatment with glucocorticosteroids. Depending on the degree of adrenal dysfunction, it may be necessary to consult a specialist before undergoing recommended procedures.

Overdose

Symptoms: with an overdose of formoterol, reactions typical of b2-adrenergic receptor agonists are most likely to occur: tremor, headache, tachycardia. Hypotension, metabolic acidosis, hypokalemia, and hyperglycemia may also occur. In case of acute overdose of budesonide, even in significant doses, no clinically significant symptoms are expected. With chronic use of budesonide in excessive doses, the systemic effect of GCS may occur. In acute bronchial obstruction, taking formoterol at a dose of 90 mcg for 3 hours was safe. Treatment: supportive and symptomatic treatment is indicated.

Drug interactions

With simultaneous oral administration of ketoconazole at a dose of 200 mg 1 time / day and budesonide at a dose of 3 mg, the concentration of budesonide in plasma increases on average 6 times. When taking ketoconazole 12 hours after taking budesonide, the concentration of the latter in plasma increases on average by 3 times. There is no information on such an interaction with budesonide during inhalation administration, however, a noticeable increase in the concentration of the drug in the blood plasma should be expected. Since there are currently no data to make dosage recommendations, this combination of drugs should be avoided. If this is not possible, then the intervals between doses of ketoconazole and budesonide should be increased as much as possible. A dose reduction of budesonide should also be considered. Other strong CYP3A4 inhibitors are also likely to significantly increase budesonide plasma levels. β-adrenergic blockers may weaken or inhibit the effect of formoterol. Symbicort Turbuhaler should not be co-administered with beta blockers (including eye drops) unless absolutely necessary. With the simultaneous use of Symbicort Turbuhaler and quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), MAO inhibitors and tricyclic antidepressants, the QT interval may be prolonged and the risk of ventricular arrhythmias may increase. L-dopa, L-thyroxine, oxytocin and alcohol can reduce the tolerance of the heart muscle to beta2-sympathomimetics. With the simultaneous administration of MAO inhibitors, as well as drugs with similar properties (furazolidone, procarbazine), the development of hypertensive reactions is possible. When performing anesthesia with halogenated hydrocarbon drugs while using Symbicort Turbuhaler, there is an increased risk of developing arrhythmias in patients. With simultaneous administration of other beta-adrenergic agonists, additive effects are possible. The hypokalemic effect can be enhanced by the simultaneous administration of xanthine derivatives, steroids and diuretics. Hypokalemia increases the susceptibility to the development of arrhythmias in patients taking digitalis glycosides. There is no interaction of budesonide with other drugs used to treat bronchial asthma.

Storage conditions and periods

Store at temperatures below 30°C out of the reach of children. Shelf life: 2 years. Do not use after the expiration date stated on the package. Conditions for dispensing from pharmacies The drug is dispensed with a prescription.

Indications for use of the drug

- bronchial asthma (insufficiently controlled by the use of inhaled corticosteroids and short-acting beta2-agonists as on-demand therapy, or adequately controlled by inhaled corticosteroids and long-acting beta2-agonists). Symbicort® Turbuhaler® 80/4.5 mcg/dose and 160/4.5 mcg/dose can be used as maintenance therapy and to relieve attacks;

— COPD (symptomatic therapy in patients with severe chronic obstructive pulmonary disease (FEV<50% of the estimated calculated level) and with a history of repeated exacerbations, in the presence of severe symptoms of the disease, despite therapy with long-acting bronchodilators).

Dosage regimen

Symbicort® Turbuhaler® is not intended for the initial treatment of intermittent and mild persistent bronchial asthma.

The dose selection of the drugs included in Symbicort Turbuhaler is carried out individually and depending on the severity of the disease. This must be taken into account not only when starting treatment with combination drugs, but also when changing the dose of the drug.

If individual patients require a different combination of doses of active substances than in Symbicort® Turbuhaler®, beta2-adrenergic agonists and/or corticosteroids should be prescribed separately in separate inhalers.

Bronchial asthma

Symbicort® Turbuhaler® 80/4.5 mcg/dose and 160/4.5 mcg/dose

Patients should be under constant medical supervision to ensure adequate dosage adjustment of Symbicort Turbuhaler. The dose should be reduced to the lowest dose that maintains optimal control of asthma symptoms. Once complete control over the symptoms of bronchial asthma is achieved against the background of the minimum recommended dose of the drug, at the next stage you can try prescribing monotherapy with inhaled corticosteroids.

There are two approaches to prescribing therapy with Symbicort Turbuhaler:

— as maintenance therapy, Symbicort® Turbuhaler® is prescribed for continuous maintenance therapy in combination with a separate short-acting beta2-adrenergic agonist to relieve attacks;

— as maintenance therapy and for the relief of attacks, Symbicort® Turbuhaler® is prescribed both for continuous maintenance therapy and on demand when symptoms appear.

As maintenance therapy

The patient must always have with him a separate inhaler with a short-acting beta2-adrenergic agonist to relieve attacks.

Adults (18 years and older)

Symbicort® Turbuhaler® is prescribed 80/4.5 mcg/dose and 160/4.5 mcg/dose, 1-2 inhalations 2 times a day. If necessary, the dose can be increased to 4 inhalations 2 times a day.

Teenagers (12-17 years old)

Symbicort® Turbuhaler® is prescribed 80/4.5 mcg/dose and 160/4.5 mcg/dose, 1-2 inhalations 2 times a day.

Children over 6 years of age

Symbicort® Turbuhaler® 80/4.5 mcg/dose is prescribed, 1-2 inhalations 2 times a day.

After achieving optimal control of symptoms of bronchial asthma while taking the drug 2 times a day, it is recommended to titrate the dose to the lowest effective dose, up to 1 time a day, in cases where, in the opinion of the doctor, the patient requires maintenance therapy in combination with long-acting bronchodilators.

An increase in the frequency of use of short-acting beta2-agonists is an indicator of deterioration in overall disease control and requires a review of anti-asthma therapy.

As maintenance therapy and to relieve attacks

The patient must always have Symbicort® Turbuhaler® with him to relieve attacks.

In this case, the drug is especially indicated for patients with insufficient control of bronchial asthma and the need for frequent use of drugs to relieve attacks; if there is a history of exacerbations of bronchial asthma that required medical intervention.

It is necessary to carefully monitor the occurrence of dose-dependent side effects in patients using a large number of inhalations to relieve attacks.

Adults (18 years and older)

Symbicort® Turbuhaler® 80/4.5 mcg/dose and 160/4.5 mcg/dose are prescribed; The recommended dose is 2 inhalations per day: 1 inhalation in the morning and evening, or 2 inhalations 1 time per day only in the morning or only in the evening. Some patients may be prescribed a maintenance dose of Symbicort® Turbuhaler® 160/4.5 mcg/dose 2 inhalations 2 times a day. If symptoms occur, 1 additional inhalation is necessary. With a further increase in symptoms within a few minutes, 1 additional inhalation is prescribed, but no more than 6 inhalations to relieve 1 attack.

Usually it is not necessary to prescribe more than 8 inhalations per day, but you can increase the number of inhalations to 12 per day for a short time. In patients who use more than 8 inhalations per day, a review of therapy is recommended.

Symbicort® Turbuhaler® 80/4.5 mcg/dose and 160/4.5 mcg/dose as maintenance therapy and for the relief of attacks

not recommended
for children and adolescents under 18 years of age
.

Symbicort® Turbuhaler® 320/9 mcg/dose

Adults (18 years and older)

the drug is prescribed 1 inhalation 2 times a day. If necessary, the dose can be increased to 2 inhalations 2 times a day. After achieving optimal control of bronchial asthma symptoms while taking the drug 2 times a day, it is recommended to titrate the dose to the lowest effective dose, up to 1 time a day.

Teenagers aged 12-17 years

Prescribe 1 inhalation 2 times a day.

Symbicort® Turbuhaler® 320/9 mcg/dose is not recommended for children under 12 years of age

due to lack of clinical data.

Patients should visit their doctor regularly to monitor the optimal dose of the drug. The dose should be reduced to the lowest dose that maintains optimal control of asthma symptoms. After achieving optimal control of symptoms of bronchial asthma while taking the drug 2 times a day, it is recommended to titrate the dose to the lowest effective dose, up to 1 time a day, in cases where, in the opinion of the doctor, the patient requires maintenance therapy in combination with long-acting bronchodilators.

COPD

For adults

Symbicort® Turbuhaler® 160/4.5 mcg/dose, 2 inhalations 2 times a day or Symbicort® Turbuhaler® 320/9 mcg/dose, 1 inhalation 2 times a day, are prescribed.

There is no need for special selection of the drug dose for elderly patients

There is no data on the use of Symbicort Turbuhaler in patients with renal or hepatic impairment

. Since budesonide and formoterol are eliminated primarily through hepatic metabolism, a slower rate of elimination of the drug can be expected in patients with severe cirrhosis.

Rules for using the turbohaler

The mechanism of action of the turbuhaler is such that when the patient inhales through the mouthpiece, air currents carry the drug into the respiratory tract.

The patient must be instructed:

— carefully study the “Instructions for Use” of the turbohaler;

- inhale strongly and deeply through the mouthpiece to ensure that the optimal dose of the drug reaches the lungs;

- never exhale through the mouthpiece;

- in order to minimize the possibility of developing a fungal infection of the oropharynx, rinse your mouth with water after each inhalation. It is also necessary to rinse your mouth with water after inhalation to relieve symptoms and in case of development of candidiasis of the oral mucosa and pharynx.

The patient may not taste or feel the drug after using Turbuhaler, due to the small amount of the substance delivered.

Instructions for use of turbuhaler

Turbuhaler is a multi-dose inhaler that allows you to dose and inhale the drug in very small doses. When inhaled, the powder from the turbuhaler is delivered to the lungs. therefore, it is important that the patient inhales forcefully and deeply through the mouthpiece.

Before first use

The turbohaler must be prepared for operation:

1. Unscrew and remove the cap.

2. Hold the inhaler vertically with the red dispenser facing down. Do not hold the inhaler by the mouthpiece while turning the dispenser. Turn the dispenser all the way in one direction, and then also all the way in the opposite direction. Perform the described procedure twice.

Now the inhaler is ready for use; it is not necessary to repeat this procedure for preparing the turbuhaler for use before each use.

For one dose

The patient must perform the following procedure:

1. Unscrew and remove the cap.

2. Hold the inhaler vertically with the red dispenser facing down. Do not hold the inhaler by the mouthpiece while turning the dispenser. In order to measure the dose, turn the dispenser all the way in one direction, and then also all the way in the opposite direction.

3. Exhale. Do not exhale through the mouthpiece.

4. Gently place the mouthpiece between your teeth, purse your lips and inhale forcefully and deeply through your mouth. Do not chew or squeeze the mouthpiece with your teeth.

5. Before exhaling, remove the inhaler from your mouth.

6. If inhalation of more than one dose is required, paragraphs should be repeated. 2-5.

7. Close the inhaler with the cap and check that the inhaler cap is screwed on tightly.

8. Rinse your mouth with water without swallowing.

You cannot remove the mouthpiece, because it is attached to the inhaler and cannot be removed. The turbhaler mouthpiece rotates, but should not be turned unless necessary.

Because the amount of powder inhaled is very small, you may not be able to taste the powder after inhalation.

However, absolutely strict adherence to the instructions ensures inhalation (inhalation) of the required dose of the drug.

If the procedure for loading the inhaler was mistakenly repeated more than once before taking the drug, patients will still receive one dose of the drug when inhaled. In this case, the dose indicator will show the total number of measured doses.

The sound heard when the inhaler is shaken is produced by the drying agent, not the drug substance.

The need to replace the inhaler

The dose indicator shows the approximate number of doses remaining in the inhaler; dose counting upon filling the turbohaler begins with the 60th or 120th dose (depending on the total number of doses of the purchased turbohaler). The indicator shows an interval of 10 doses, so it does not show every dispensed (loaded) dose.

Turbuhaler delivers the required dose of the drug, even if no changes are noticeable in the dose indicator window.

The appearance of a red background in the dose indicator window means that there are 10 doses of the drug left in the turbuhaler. When the number 0 appears on a red background in the middle of the dose window, the inhaler should be thrown away.

Please note that even when the indicator window shows the number 0, the dispenser continues to rotate. However, the dose indicator stops recording the number of doses (stops moving) and the number 0 remains in the dose window of the inhaler.

Cleaning

Regularly (once a week) you should clean the outside of the mouthpiece with a dry cloth. Do not use water or other liquids to clean the mouthpiece.

Disposal

You should be careful when handling a used inhaler and be aware that some medication may remain inside the inhaler.

Symbicort turbuhaler powder for inhalation 160 mcg plus 4.5 mcg 60 doses

Indications for use of the drug SYMBICORT® TURBUHALER® - bronchial asthma (insufficiently controlled by the use of inhaled corticosteroids and short-acting beta2-adrenergic agonists as on-demand therapy, or adequately controlled by inhaled corticosteroids and long-acting beta2-adrenergic agonists). Symbicort® Turbuhaler® 80/4.5 mcg/dose and 160/4.5 mcg/dose can be used as maintenance therapy and to relieve attacks;

- symptomatic therapy in patients with severe chronic obstructive pulmonary disease (FEV<50% of the estimated calculated level) and with a history of repeated exacerbations, in the presence of severe symptoms of the disease, despite therapy with long-acting bronchodilators.

pharmachologic effect

With the combined use of formoterol and budesonide, the severity of symptoms of bronchial asthma decreases, pulmonary function improves and the frequency of exacerbations of the disease decreases.

The effect of Symbicort® Turbuhaler® on lung function corresponds to the effect of the combination of budesonide and formoterol monotherapy and exceeds the effect of budesonide alone. The drug is well tolerated.

While taking Symbicort® Turbuhaler® as maintenance therapy for 12 weeks in children aged 6 to 11 years (two inhalations of 80/4.5 mcg/inhalation 2 times a day), pulmonary function improved and the drug was well tolerated, compared with the corresponding dose of budesonide turbuhaler.

In patients with severe chronic obstructive pulmonary disease, while taking Symbicort® Turbuhaler®, there was a significant reduction in the frequency of exacerbations of the disease compared with patients receiving formoterol or placebo alone as therapy (mean frequency of exacerbations 1.4 compared with 1.8-1.9 in the placebo/formoterol group ).

There were no differences observed between Symbicort® Turbuhaler® and formoterol in terms of FEV1 values.

Pharmacokinetics

Suction

Symbicort® Turbuhaler® is bioequivalent to the corresponding monotherapy drugs (budesonide and formoterol) in terms of their systemic action. Despite this, a slight increase in cortisol suppression was noted after taking Symbicort® Turbuhaler® compared to monotherapy. This difference does not affect the clinical safety of Symbicort® Turbuhaler®. There is no evidence of a pharmacokinetic interaction between budesonide and formoterol. The pharmacokinetic parameters of budesonide and formoterol were comparable after they were taken as single drugs and as part of Symbicort® Turbuhaler®.

Distribution

Plasma protein binding of budesonide is approximately 90%, formoterol - 50%.

Vd of budesonide is about 3 l/kg formoterol - 4 l/kg.

Metabolism

Formoterol is metabolized mainly in the liver by conjugation to form active O-demethylated metabolites, mainly inactivated conjugates.

There is no evidence of metabolite interactions or substitution reactions between budesonide and formoterol.

Removal

Budesonide is excreted in the urine in the form of metabolites or in the form of conjugates and only in small quantities unchanged. Budesonide has a high systemic clearance (approximately 1.2 l/min).

After inhalation, 8-13% of the delivered dose of formoterol is excreted unchanged in the urine. Formoterol has a high systemic clearance (approximately 1.4 l/min); T1/2 averages 17 hours.

Pharmacokinetics in special clinical situations

The pharmacokinetics of formoterol in children and in patients with renal failure have not been studied.

Plasma concentrations of budesonide and formoterol may be increased in patients with liver disease.

Instructions for use / dosage

Symbicort® Turbuhaler® is not intended for the initial treatment of intermittent and mild persistent bronchial asthma.

The dose selection of the drugs included in Symbicort® Turbuhaler® is carried out individually and depending on the severity of the disease. This must be taken into account not only when starting treatment with combination drugs, but also when changing the dose of the drug.

Bronchial asthma

Patients should be under constant medical supervision to ensure adequate dosage adjustment of Symbicort® Turbuhaler®. The dose should be reduced to the lowest dose that maintains optimal control of asthma symptoms.

Symbicort® Turbuhaler® 80/4.5 mcg/dose and 160/4.5 mcg/dose

Once complete control over the symptoms of bronchial asthma is achieved against the background of the minimum recommended dose of the drug, at the next stage you can try prescribing monotherapy with inhaled corticosteroids.

As maintenance therapy

the drug is prescribed in combination with a separate short-acting beta2-adrenergic agonist to relieve attacks. The patient must always have with him a separate inhaler with a short-acting beta2-adrenergic agonist to relieve attacks.

Adults (18 years and older) are prescribed Symbicort® Turbuhaler® 80/4.5 mcg/dose and 160/4.5 mcg/dose, 1-2 inhalations 2 times a day. If necessary, the dose can be increased to 4 inhalations 2 times a day.

Adolescents (12-17 years old) are prescribed Symbicort® Turbuhaler® 80/4.5 mcg/dose and 160/4.5 mcg/dose, 1-2 inhalations 2 times a day.

Children over 6 years of age are prescribed Symbicort® Turbuhaler® 80/4.5 mcg/dose, 1-2 inhalations 2 times a day.

After achieving optimal control of bronchial asthma symptoms while taking the drug 2 times a day. It is recommended to titrate the dose to the lowest effective dose, up to 1 time per day, in cases where, in the opinion of the doctor, the patient requires maintenance therapy in combination with long-acting bronchodilators.

An increase in the frequency of use of short-acting beta2-agonists is an indicator of deterioration in overall disease control and requires a review of anti-asthma therapy.

As maintenance therapy and to relieve attacks

the drug is especially indicated for patients with insufficient control of bronchial asthma and the need for frequent use of drugs to relieve attacks; if there is a history of exacerbations of bronchial asthma that required medical intervention. The patient must always have Symbicort® Turbuhaler® with him to relieve attacks.

It is necessary to carefully monitor the occurrence of dose-dependent side effects in patients using a large number of inhalations to relieve attacks.

Adults (18 years and older) are prescribed Symbicort® Turbuhaler® 80/4.5 mcg/dose and 160/4.5 mcg/dose; The recommended dose is 2 inhalations per day: 1 inhalation in the morning and evening, or 2 inhalations 1 time per day. only in the morning or only in the evening. Some patients may be prescribed a maintenance dose of Symbicort® Turbuhaler® 160/4.5 mcg/dose 2 inhalations 2 times a day. If symptoms occur, 1 additional inhalation is necessary. With a further increase in symptoms within a few minutes, 1 additional inhalation is prescribed, but no more than 6 inhalations to relieve 1 attack.

Symbicort® Turbuhaler® 320/9 mcg/dose

For adults (18 years and older), the drug is prescribed 1 inhalation 2 times a day. If necessary, the dose can be increased to 2 inhalations 2 times a day. After achieving optimal control of bronchial asthma symptoms while taking the drug 2 times a day. It is recommended to titrate the dose to the lowest effective dose, up to 1 time per day.

Adolescents aged 12-17 years are prescribed 1 inhalation 2 times a day.

COPD

Adults are prescribed Symbicort® Turbuhaler® 160/4.5 mcg/dose, 2 inhalations 2 times a day. or Symbicort® Turbuhaler® 320/9 mcg/dose, 1 inhalation 2 times a day.

There is no need for special selection of the drug dose for elderly patients .

There is no data on the use of Symbicort® Turbuhaler® in patients with renal or hepatic insufficiency . Since budesonide and formoterol are eliminated primarily through hepatic metabolism, a slower rate of elimination of the drug can be expected in patients with severe cirrhosis.

Rules for using the turbohaler

The mechanism of action of the turbuhaler is such that when the patient inhales through the mouthpiece, air currents carry the drug into the respiratory tract.

The patient must be instructed:

— carefully study the “Instructions for Use” of the turbohaler;

- inhale strongly and deeply through the mouthpiece to ensure that the optimal dose of the drug reaches the lungs;

- never exhale through the mouthpiece;

The patient may not taste or feel the drug after using Turbuhaler, due to the small amount of the substance delivered.

Instructions for use of turbuhaler

Before first use

The turbohaler must be prepared for operation:

1. Unscrew and remove the cap.

Now the inhaler is ready for use; it is not necessary to repeat this procedure for preparing the turbuhaler for use before each use.

For one dose

The patient must perform the following procedure:

1. Unscrew and remove the cap.

3. Exhale. Do not exhale through the mouthpiece.

4. Gently place the mouthpiece between your teeth, purse your lips and inhale forcefully and deeply through your mouth. Do not chew or squeeze the mouthpiece with your teeth.

5. Before exhaling, remove the inhaler from your mouth.

6. If inhalation of more than one dose is required, paragraphs should be repeated. 2-5.

7. Close the inhaler with the cap and check that the inhaler cap is screwed on tightly.

8. Rinse your mouth with water without swallowing.

You cannot remove the mouthpiece, because it is attached to the inhaler and cannot be removed. The turbhaler mouthpiece rotates, but should not be turned unless necessary.

Because the amount of powder inhaled is very small, you may not be able to taste the powder after inhalation.

However, absolutely strict adherence to the instructions ensures inhalation (inhalation) of the required dose of the drug.

The sound heard when the inhaler is shaken is produced by the drying agent, not the drug substance.

The need to replace the inhaler

Turbuhaler delivers the required dose of the drug, even if no changes are noticeable in the dose indicator window.

Cleaning

Regularly (once a week) you should clean the outside of the mouthpiece with a dry cloth. Do not use water or other liquids to clean the mouthpiece.

Disposal

You should be careful when handling a used inhaler and be aware that some medication may remain inside the inhaler.

Side effect

There was no increase in the incidence of adverse reactions observed during the concomitant administration of the two drugs.

The most common adverse reactions associated with taking the drug are such pharmacologically expected undesirable side effects for beta2-agonists, such as tremor and tachycardia, which are usually of moderate severity and disappear within a few days after the start of treatment.

During the use of budesonide for COPD, bruising and pneumonia occurred at an incidence of 10% and 6%, respectively, compared with 4% and 3% in the placebo group (p>0.001 and p>0.01, respectively).

From the side of the central 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, behavioral disorders (mainly in children), taste disturbances.

From the cardiovascular system:

often (>1/100, <1/10) - tachycardia; 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, mild 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, urticaria, itching, dermatitis, angioedema.

Metabolic disorders:

rarely (>1/10,000, <1/1000) - hypokalemia; very rarely (<1/10,000) - hyperglycemia, symptoms of systemic action of GCS (including adrenal hypofunction).

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 the blood levels of insulin, free fatty acids, glycerol, and ketone derivatives.

Contraindications to the use of the drug SYMBICORT® TURBUHALER®

- children under 6 years of age (for all dosage forms);

- children under 12 years of age (for a dosage form containing budesonide 320 mcg + formoterol 9 mcg);

- hypersensitivity to budesonide, formoterol or inhaled lactose.

Carefully _

Symbicort® Turbuhaler® should be used in patients with pulmonary tuberculosis (active or inactive form), with fungal, viral or bacterial infections of the respiratory system, in patients with thyrotoxicosis, pheochromocytoma, diabetes mellitus, uncontrolled hypokalemia, idiopathic hypertrophic subaortic stenosis, severe arterial hypertension, aneurysm of any location or other severe cardiovascular diseases (coronary artery disease, tachyarrhythmia or severe heart failure), with prolongation of the QT interval (formoterol may cause prolongation of the QTc interval).
Use of the drug SYMBICORT® TURBUHALER® during pregnancy and lactation
There are no clinical data on the use of Symbicort® Turbuhaler® or the combined use of budesonide and formoterol during pregnancy.

During pregnancy, Symbicort® Turbuhaler® should be prescribed only in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus. Budesonide should be used at the lowest effective dose necessary to maintain adequate control of asthma symptoms.

It is unknown whether budesonide and formoterol are excreted in human breast milk. Symbicort® Turbuhaler® can be prescribed to nursing women if the expected benefit of therapy for the mother outweighs the potential risk for the child.

Use for liver dysfunction

There are no data on the use of Symbicort® Turbuhaler® in patients with liver failure . Since budesonide and formoterol are eliminated primarily by the kidneys via hepatic metabolism, a slower rate of elimination of the drug can be expected in patients with severe cirrhosis.

Use for renal impairment

There are no data on the use of Symbicort® Turbuhaler® in patients with renal failure .

special instructions

It is recommended to gradually reduce the dose of the drug before stopping treatment and it is not recommended to abruptly stop therapy.

Symbicort® Turbuhaler® 80/4.5 mcg/dose and 320/9 mcg/dose is not intended for the treatment of patients with severe bronchial asthma.

Symbicort® Turbuhaler® is not intended for initial selection of therapy in the first stages of treatment of bronchial asthma.

Formoterol may cause QT prolongation, so the drug should be used with caution in patients with a prolonged QT interval.

An increase in the frequency of taking bronchodilators as emergency medications indicates a worsening of the course of the underlying disease and is the basis for revising the treatment tactics for bronchial asthma. Sudden and progressive deterioration in control of symptoms of asthma or COPD is a potentially life-threatening condition and requires urgent medical attention. In this situation, the possibility of increasing the dose of GCS should be considered, i.e. prescribing a course of oral corticosteroids or antibiotic treatment in case of infection.

Patients are advised to carry emergency medications with them at all times, or Symbicort® Turbuhaler® (for patients with bronchial asthma using Symbicort® Turbuhaler® for maintenance therapy and for the relief of attacks), short-acting beta2-agonists (for all patients using Symbicort® Turbuhaler® ® for maintenance therapy only).

The patient's attention should be drawn to the need to regularly take a maintenance dose of Symbicort® Turbuhaler® in accordance with the selected therapy, even in cases where there are no symptoms of the disease. Inhalation of Symbicort® Turbuhaler® to relieve attacks should be carried out only when symptoms occur, but the use of the drug is not indicated for regular preventive use, i.e. before physical activity. In such cases, the use of a separate short-acting bronchodilator is indicated.

Treatment with Symbicort® Turbuhaler® should not be started during an exacerbation of bronchial asthma.

As with any other inhaled therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after taking a dose of the drug. In this regard, therapy with Symbicort® Turbuhaler® should be discontinued, treatment tactics should be reconsidered and, if necessary, alternative therapy should be prescribed.

Systemic effects may occur when taking any inhaled corticosteroids, especially when taking high doses of drugs over a long period of time. Systemic effects are less likely to occur with inhalation therapy than with oral corticosteroids. Possible systemic effects include adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, and glaucoma.

It is recommended to regularly monitor the growth of children receiving inhaled corticosteroids for a long time. In case of established growth retardation, therapy should be reconsidered in order to reduce the dose of inhaled GCS. It is necessary to carefully evaluate the ratio of the benefits of GCS therapy to the possible risk of growth retardation. When choosing therapy, consultation with a pediatric pulmonologist is recommended.

Based on the limited data from studies of long-term corticosteroid use, it can be assumed that most children and adolescents receiving inhaled budesonide therapy will eventually achieve normal adult growth rates. However, slight (about 1 cm), short-term growth retardation has been reported, mainly in the first year of treatment.

Due to the potential effect of inhaled corticosteroids on bone mineral density, special attention should be paid to patients taking the drug in high doses for a long time and with risk factors for osteoporosis. Studies of long-term use of inhaled budesonide in children at an average daily dose of 400 mcg or in adults at an average daily dose of 800 mcg did not show a significant effect on bone mineral density. There is no data regarding the effect of high doses of the drug on bone mineral density.

If there is reason to believe that adrenal function has been impaired due to previous systemic GCS therapy, precautions should be taken when transferring patients to treatment with Symbicort® Turbuhaler®.

The benefits of inhaled budesonide therapy generally minimize the need for oral corticosteroids, but patients who discontinue oral corticosteroids may experience long-term adrenal insufficiency. Patients who in the past required urgent use of high doses of corticosteroids or received long-term treatment with inhaled corticosteroids at a high dose may also be at this risk. In extreme cases and in any situation that may cause stress (including surgery), the possibility of residual adrenal dysfunction in such patients must always be kept in mind. In such situations, it is necessary to provide adequate treatment for GCS. Depending on the degree of adrenal dysfunction, it may be necessary to consult a specialist before undergoing recommended procedures.

The need for the use and dose of inhaled GCS should be reconsidered in patients with active or inactive forms of pulmonary tuberculosis, fungal, viral or bacterial infections of the respiratory system.

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 developing symptoms of hypokalemic action increases. In such cases, it is recommended to monitor serum potassium levels.

Formoterol at a dose of 90 mcg over 3 hours is safe for patients with acute bronchial obstruction. During treatment, blood glucose concentrations should be monitored in patients with diabetes mellitus.

Symbicort® Turbuhaler® contains lactose (less than 1 mg/dose). Typically, this amount does not cause adverse reactions in patients with lactose intolerance.

Use in pediatrics

Symbicort® Turbuhaler® 80/4.5 mcg/dose and 160/4.5 mcg/dose are contraindicated in children under 6 years of age.

Symbicort® Turbuhaler® 80/4.5 mcg/dose and 160/4.5 mcg/dose are not recommended as maintenance therapy or for the relief of attacks
in children and adolescents under 18 years of age .
Symbicort® Turbuhaler® 320/9 mcg/dose is contraindicated in children under 12 years of age due to the lack of clinical data.

Impact on the ability to drive vehicles and operate machinery

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

Overdose

Symptoms:

In case of acute overdose of budesonide, even in significant doses, no clinically significant symptoms are expected. With chronic use of budesonide in excessive doses, systemic effects of GCS, such as hypercortisolism and suppression of adrenal function, may occur.

In case of formoterol overdose - tremor, headache, tachycardia, in some cases - hyperglycemia, hypokalemia, prolongation of the QTc interval, arrhythmias, nausea, vomiting.

In acute bronchial obstruction, taking formoterol at a dose of 90 mcg for 3 hours was safe.

Treatment:

Supportive and symptomatic treatment is indicated.

If it is necessary to discontinue Symbicort® Turbuhaler® due to an overdose of formoterol, which is part of the combination drug, you should consider prescribing an appropriate GCS.

Drug interactions

With simultaneous oral administration of ketoconazole at a dose of 200 mg 1 time / day. and budesonide at a dose of 3 mg, the concentration of budesonide in plasma increases on average 6 times. When taking ketoconazole 12 hours after taking budesonide, the concentration of the latter in plasma increases on average by 3 times. There is no information on such an interaction with budesonide during inhalation administration, however, a noticeable increase in the concentration of the drug in the blood plasma should be expected. Since there are currently no data to make dosage recommendations, this combination of drugs should be avoided. If this is not possible, then the intervals between doses of ketoconazole and budesonide should be increased as much as possible. A dose reduction of budesonide should also be considered. Other strong CYP3A4 inhibitors are also likely to significantly increase budesonide plasma levels. It is not recommended to prescribe Symbicort® Turbuhaler® as maintenance therapy and for the relief of attacks in patients receiving potent CYP3A4 inhibitors.

β-adrenergic blockers may weaken or inhibit the effect of formoterol. Symbicort® Turbuhaler® should not be co-administered with beta-blockers (including eye drops) unless absolutely necessary.

With the simultaneous use of Symbicort® Turbuhaler® and quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), MAO inhibitors and tricyclic antidepressants, the QT interval may be prolonged and the risk of ventricular arrhythmias may increase.

In addition, levodopa, levothyroxine, oxytocin and ethanol may reduce the tolerance of the heart muscle to beta2-agonists.

With the simultaneous administration of MAO inhibitors, as well as drugs with similar properties (furazolidone, procarbazine), an increase in blood pressure is possible.

When performing anesthesia with halogenated hydrocarbon drugs while using Symbicort® Turbuhaler®, there is an increased risk of developing arrhythmias in patients.

When taking Symbicort® Turbuhaler® and other β-adrenergic receptor agonists simultaneously, the side effects of formoterol may increase.

The hypokalemic effect of beta2-adrenergic agonists can be enhanced by the simultaneous administration of xanthine derivatives, mineral derivatives of corticosteroids and diuretics. Hypokalemia increases the susceptibility to the development of arrhythmias in patients taking cardiac glycosides.

There is no interaction of budesonide with other drugs used to treat bronchial asthma.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

The drug should be stored at a temperature not exceeding 30°C out of the reach of children. Shelf life: 2 years.

Side effect

There was no increase in the incidence of adverse reactions observed during the concomitant administration of the two drugs.

During the use of budesonide for COPD, bruising and pneumonia occurred at an incidence of 10% and 6%, respectively, compared with 4% and 3% in the placebo group (p>0.001 and p>0.01, respectively).

From the side of the central nervous system:

From the cardiovascular system:

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, mild 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, urticaria, itching, dermatitis, angioedema.

Metabolic disorders:

rarely (>1/10,000, <1/1000) - hypokalemia; very rarely (<1/10,000) - hyperglycemia, symptoms of systemic action of GCS (including adrenal hypofunction).

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 the blood levels of insulin, free fatty acids, glycerol, and ketone derivatives.

Contraindications to the use of the drug

- children under 6 years of age (for all dosage forms);

- children under 12 years of age (for a dosage form containing budesonide 320 mcg + formoterol 9 mcg);

- hypersensitivity to budesonide, formoterol or inhaled lactose.

Carefully _

Use of the drug during pregnancy and lactation

There are no clinical data on the use of Symbicort Turbuhaler or the combined use of budesonide and formoterol during pregnancy.

special instructions

It is recommended to gradually reduce the dose of the drug before stopping treatment and it is not recommended to abruptly stop therapy.

Symbicort® Turbuhaler® 80/4.5 mcg/dose and 320/9 mcg/dose is not intended for the treatment of patients with severe bronchial asthma.

Symbicort® Turbuhaler® is not intended for initial selection of therapy in the first stages of treatment of bronchial asthma.

The patient's attention should be drawn to the need to regularly take a maintenance dose of Symbicort Turbuhaler in accordance with the selected therapy, even in cases where there are no symptoms of the disease. Inhalation of Symbicort Turbuhaler to relieve attacks should be carried out only when symptoms occur, but the use of the drug is not indicated for regular preventive use, i.e. before physical activity. In such cases, the use of a separate short-acting bronchodilator is indicated.

Treatment with Symbicort Turbuhaler should not be started during an exacerbation of bronchial asthma.

As with any other inhaled therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after taking a dose of the drug. In this regard, treatment with Symbicort Turbuhaler should be discontinued, treatment tactics should be reconsidered and, if necessary, alternative therapy should be prescribed.

The benefits of inhaled budesonide therapy generally minimize the need for oral corticosteroids, but patients who discontinue oral corticosteroids may experience long-term adrenal insufficiency. Patients who in the past required urgent use of high doses of corticosteroids or received long-term treatment with high-dose inhaled corticosteroids may also be at risk. It is necessary to provide additional administration of GCS during periods of stress or surgery. It is recommended to instruct the patient to rinse the mouth with water after inhalation in order to prevent the development of candidiasis of the oral mucosa.

Formoterol may cause QT prolongation, so the drug should be used with caution in patients with a prolonged QT interval.

During treatment, blood glucose concentrations should be monitored in patients with diabetes mellitus.

Symbicort® Turbuhaler® contains lactose (less than 1 mg/dose). Typically, this amount does not cause adverse reactions in patients with lactose intolerance.

Use in pediatrics

Symbicort® Turbuhaler® 80/4.5 mcg/dose and 160/4.5 mcg/dose are contraindicated in children under 6 years of age.

Impact on the ability to drive vehicles and operate machinery

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

Symbicort Rapihaler aerosol for ing 80mcg+4.5mcg/dose 120 doses

ATX Code:

R03AK07 (Formoterol and budesonide)

Active substances

budesonide Rec.INN registered by WHO
formoterol Rec.INN registered by WHO

Release form, packaging and composition of the drug

Aerosol for inhalation dosed in the form of a balloon located inside a red spray device with a white mouthpiece and a gray dose counter; a gray protective cap is attached to the spray device by means of a clamp; There is no corrosion or obvious defects on the outer and inner surfaces of the cylinder and valve.

Contents of the container: a white solid residue, free of visible inclusions, formed after the evaporation of the propellant.

1 dose:

micronized budesonide – 80 mcg

formoterol fumarate dihydrate micronized - 4.5 mcg

Excipients: povidone K25 - 0.75 mcg, macrogol 1000 - 223.8 mcg, apaflurane 227 - up to 74.6 mg.

Clinical and pharmacological group:

GCS for inhalation

Pharmacotherapeutic group:

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

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 maintenance therapy and for the relief of attacks, or as maintenance therapy for bronchial asthma.

Budesonide is a corticosteroid that, after inhalation, has a rapid (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. When prescribing inhaled budesonide, there is a lower incidence of serious adverse effects than when using systemic corticosteroids. Reduces the severity of edema of the bronchial mucosa, mucus production, sputum formation and airway hyperreactivity. The exact mechanism of the anti-inflammatory effect of GCS is unknown.

Formoterol is a selective β2-adrenergic agonist that, following inhalation, causes rapid and long-lasting relaxation of bronchial smooth muscle in patients with reversible airway obstruction. The 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 effect of the combination of budesonide and formoterol monotherapy and exceeds the effect of budesonide alone. In all cases, a short-acting beta2-agonist agonist was used to relieve attacks. There was no decrease in anti-asthmatic effect over time. The combination is well tolerated.

Pharmacokinetics

There is no evidence of a pharmacokinetic interaction between budesonide and formoterol.

The pharmacokinetic parameters for the corresponding substances are comparable after the administration of budesonide and formoterol as single agents and as part of this combination. When administered as part of a combination, the AUC of budesonide is slightly higher, absorption is faster and the Cmax value in the blood plasma is higher. Cmax in blood plasma of formoterol when administered as part of a combination coincides with that for a single drug.

Inhaled budesonide is rapidly absorbed and reaches Cmax in plasma 30 minutes after inhalation. The average dose of budesonide that enters the lungs after inhalation is 32-44% of the delivered dose. Systemic bioavailability is approximately 49% of the delivered dose.

Inhaled formoterol is rapidly absorbed and reaches Cmax in blood plasma 10 minutes after inhalation. The average dose of formoterol that enters the lungs after inhalation is 28-49% of the delivered dose. Systemic bioavailability is approximately 61% of the delivered dose.

Plasma protein binding of formoterol is 50%, budesonide - 90%. Vd of formoterol is about 4 l/kg, budesonide - 3 l/kg.

Formoterol is inactivated by conjugation (active O-demethylated metabolites are formed, mainly in the form of inactivated conjugates). Budesonide undergoes intense biotransformation (about 90%) during the “first pass” through the liver with the formation of metabolites with low glucocorticoid activity. The glucocorticoid activity of the main metabolites 6-β-hydroxybudesonide and 16-α-hydroxyprednisolone does not exceed 1% of the similar activity of budesonide. There is no evidence of metabolite interactions or substitution reactions between budesonide and formoterol.

The bulk of the dose of formoterol is metabolized in the liver and then excreted by the kidneys. After inhalation, 8-13% of the delivered dose of formoterol is excreted unchanged in the urine. Formoterol has a high systemic clearance (approximately 1.4 l/min); T1/2 of the drug averages 17 hours.

Budesonide is metabolized primarily by the enzyme CYP3A4. Budesonide metabolites are excreted in the urine unchanged or in the form of conjugates. Only a small amount of unchanged budesonide is found in the urine. Budesonide has a high systemic clearance (approximately 1.2 l/min).

Indications of active substances

Bronchial asthma, insufficiently controlled by taking inhaled corticosteroids and short-acting beta2-agonists or adequately controlled by inhaled corticosteroids and long-acting beta2-agonists.

Symptomatic treatment of patients with severe COPD (FEV1 <50% predicted level) and with a history of recurrent exacerbations who have severe symptoms of the disease despite therapy with long-acting bronchodilators.

Dosage regimen

The method of administration and dosage regimen of a particular drug depend on its release form and other factors. The optimal dosage regimen is determined by the doctor. The compliance of the dosage form of a particular drug with the indications for use and dosage regimen should be strictly observed.

The dose and frequency of use are set individually, depending on the indications, clinical situation, age of the patient, and dosage form used.

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, behavioral disorders (mainly in children), taste disturbances.

From 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, mild 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 adrenal hypofunction).

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 the blood levels of insulin, free fatty acids, glycerol, and ketone derivatives.

Contraindications for use

Children and adolescents up to 18 years of age; hypersensitivity to budesonide, formoterol or inhaled lactose.

Carefully

Pulmonary tuberculosis (active or inactive form), fungal, viral or bacterial infections of the respiratory system, thyrotoxicosis, pheochromocytoma, diabetes mellitus, uncontrolled hypokalemia, idiopathic hypertrophic subaortic stenosis, severe arterial hypertension, aneurysm of any location or other severe cardiovascular diseases (CHD, tachyarrhythmia or severe heart failure), prolongation of the QT interval.

Use during pregnancy and breastfeeding

During pregnancy, the budesonide/formoterol combination should be used only in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus. Budesonide should be used at the minimum effective dose necessary to maintain adequate control of asthma symptoms.

Inhaled budesonide is excreted in breast milk, however, when used in therapeutic doses, no effects on the child were noted. It is not known whether formoterol is excreted into breast milk in women. The budesonide/formoterol combination should only be prescribed to breastfeeding women if the expected benefit to the mother outweighs any possible risk to the baby.

Use in children

The drug is contraindicated for use in children and adolescents under 18 years of age

Use in elderly patients

There is no need for special selection of the drug dose for elderly patients.

special instructions

It is recommended to gradually reduce the dose before stopping treatment. It is not recommended to abruptly cancel treatment.

The combination of budesonide/formoterol is not used for the initial selection of therapy in the first stages of treatment of bronchial asthma.

Taking formoterol may cause QT prolongation.

An increase in the frequency of taking bronchodilators as emergency medications indicates a worsening of the underlying disease and serves as a basis for revising the treatment tactics for bronchial asthma. Sudden and progressive deterioration in control of symptoms of asthma or COPD is a potentially life-threatening condition and requires urgent medical attention. In this situation, you should consider increasing the dose of GCS or adding systemic anti-inflammatory therapy, for example, a course of oral GCS or antibiotic treatment in case of infection. Patients are advised to carry emergency medications (short-acting beta2-agonists) with them at all times.

The patient's attention should be drawn to the need to regularly take the drug containing the 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 periods of exacerbation or significant worsening of bronchial asthma.

As with any other inhaled therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after taking a dose of the combination drug. In this regard, therapy should be discontinued, treatment tactics should be reconsidered and, if necessary, alternative therapy should be prescribed.

Systemic effects may occur when taking any inhaled corticosteroids, especially when taking drugs in high doses over a long period of time. Systemic effects are less likely to occur with inhalation therapy than with oral corticosteroids. Possible systemic effects include adrenal suppression, 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) did not show a significant effect on bone mineral density.

The benefits of inhaled budesonide therapy generally minimize the need for oral steroids; however, patients who discontinue oral corticosteroid therapy may experience long-term adrenal insufficiency. Patients who in the past required acute use of high doses of corticosteroids or received long-term treatment with high-dose inhaled corticosteroids may also be at this risk. It is necessary to provide additional administration of GCS during periods of stress or surgery.

When beta2-agonists are co-administered with drugs that can cause or enhance the hypokalemic effect, for example, xanthine derivatives, steroids or diuretics, the hypokalemic effect of beta2-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 developing a hypokalemic effect increases. In such cases, it is recommended to monitor serum potassium levels.

During treatment, blood glucose concentrations should be monitored in patients with diabetes mellitus.

Impact on the ability to drive vehicles and machinery

The budesonide/formoterol combination may have minor effects if side effects occur. Care must be taken when driving vehicles and machinery during the treatment period.

Overdose

Symptoms:

In case of formoterol overdose - tremor, headache, rapid heartbeat; in some cases, the development of tachycardia, hyperglycemia, hypokalemia, prolongation of the QTc interval, arrhythmia, nausea, and vomiting was reported.

In acute bronchial obstruction, taking formoterol at a dose of 90 mcg for 3 hours was safe.

Treatment:

Supportive and symptomatic treatment is indicated.

If it is necessary to discontinue Symbicort Turbuhaler due to an overdose of formoterol, which is part of the combination drug, the issue of prescribing an appropriate GCS should be considered.

Drug interactions

β-adrenergic blockers may weaken or inhibit the effect of formoterol. Symbicort® Turbuhaler® should not be co-administered with beta-blockers (including eye drops) unless absolutely necessary.

With the simultaneous use of Symbicort Turbuhaler and quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), MAO inhibitors and tricyclic antidepressants, the QT interval may be prolonged and the risk of ventricular arrhythmias may increase.

In addition, levodopa, levothyroxine, oxytocin and ethanol may reduce the tolerance of the heart muscle to beta2-agonists.

With the simultaneous administration of MAO inhibitors, as well as drugs with similar properties (furazolidone, procarbazine), an increase in blood pressure is possible.

There is an increased risk of developing arrhythmias in patients undergoing general anesthesia with halogenated hydrocarbon drugs while using Symbicort Turbuhaler.

When taking Symbicort Turbuhaler and other β-adrenergic receptor agonists simultaneously, the side effects of formoterol may increase.

There is no interaction of budesonide with other drugs used to treat bronchial asthma.

Symbicort - a new drug for the treatment of bronchial asthma

About the article

16752

Regular issues of "RMZh" No. 12 dated June 17, 2001 p. 503

Category: General articles

For quotation:

Symbicort is a new drug for the treatment of bronchial asthma. RMJ. 2001;12:503.

Currently, when the inflammatory nature of bronchial asthma (BA) is beyond doubt, inhaled glucocorticoids along with b2-agonists occupy a central place in all guidelines for the treatment of this disease. Inhaled glucocorticoids have an anti-inflammatory effect, and b2-agonists relieve bronchospasm, relieving asthma symptoms. Combining long-acting β2-agonists with inhaled glucocorticoids produces greater improvements in pulmonary function and asthma control than doubling the dose of inhaled glucocorticoids. This publication, based on materials from foreign studies, is devoted to the combination drug Symbicort. In a study by Pauwels et al. [1] showed the benefits of adding the long-acting b2-agonist formoterol (Oxis Turbuhaler) to treatment with the inhaled glucocorticoid budesonide (Pulmicort Turbuhaler). Patients receiving formoterol along with budesonide were less likely to experience both severe and mild exacerbations of asthma. In the group of patients who inhaled budesonide at a dose of 200 mcg per day and formoterol (18 mcg/day), the improvement in respiratory function was more pronounced than in patients who inhaled only budesonide at a dose of 800 mcg/day. The combination of budesonide and formoterol generally made it possible to better control the course of asthma, improve the quality of life of patients and reduce the costs of treating exacerbations. In a study by Kips et al. [2] it was shown that the combination of formoterol and budesonide in small doses is not inferior to large doses of budesonide not only in clinical effectiveness, but also in anti-inflammatory effect. Data from these and other studies served as the basis for the creation of a new drug by the pharmaceutical company AstraZeneca - Symbicort. Symbicort is a combination of the glucocorticoid budesonide and the long-acting b2-agonist formoterol in one inhaler (Turbuhaler). Symbicort has potential advantages over the administration of its components through separate inhalation devices and represents a new approach to the treatment of bronchial asthma. One inhalation dose of Symbicort contains 160 or 80 mcg of budesonide and 4.5 mcg of formoterol. The variability of drug dosing (from 1 to 4 inhalations per day) provides flexibility of therapy depending on the severity of asthma and allows you to titrate the dose to the minimum required using the same inhaler. Symbicort has undergone a number of clinical trials abroad. Compared to inhaled corticosteroids alone, Symbicort has been shown to significantly reduce asthma symptoms, the frequency and duration of exacerbations, and improve pulmonary function. Therapy with Symbicort gives the patient 2 additional months a year without daytime and nighttime asthma symptoms compared to budesonide. When comparing treatment with Symbicort with therapy with budesonide and formoterol through separate inhalers, a trend towards a more rapid increase and stabilization of peak flow measurements in the Symbicort group was revealed [5]. In terms of the speed of onset and severity of the bronchodilator effect, Symbicort is superior to the combination of fluticasone (250 mcg) with salmeterol (50 mcg) [4]. Research shows that many asthma patients do not adhere to their doctor's prescribed treatment regimens. Patients take the recommended dose of inhaled glucocorticosteroid for maintenance therapy only 20–73% of the time [8]. One of the reasons why patients do not comply with doctor’s prescriptions is that when symptoms weaken, many stop taking further maintenance therapy. Many patients do not understand the importance of using maintenance medications that, when inhaled, do not provide immediate relief from asthma symptoms. When treated with Symbicort, patients experience immediate relief after inhalation, since the formoterol contained in Symbicort acts as quickly as traditionally used short-acting bronchodilators. The rapid relief of symptoms experienced by the patient may be more likely to motivate their continued use of Symbicort as prescribed; this should ensure regular inhalation of the corticosteroid included in Symbicort. The latter, in turn, ensures control of the disease, which leads to an improvement in the health of asthma patients using Symbicort [5]. Treatment with Symbicort for asthma in children aged 4-17 years is well tolerated and improves pulmonary function more effectively than budesonide monotherapy [6]. The tolerability of Symbicort when the recommended doses are exceeded was studied in patients with asthma who, against the background of regular treatment with Symbicort at a dose of 160/4.5 mcg, 2 inhalations 2 times a day, received an additional 10 doses of Symbicort within 1 hour (total dose 1600/45 mcg) [7]. Although an increase in heart rate characteristic of b2-agonists was noted (by 5.4 beats/min, etc.), this did not threaten the patients’ condition. The drug Symbicort Turbuhaler was approved for use as a treatment for asthma in Europe in 2000. In Russia, the drug has been submitted for registration and its appearance on the Russian pharmaceutical market is planned for the fall of 2001. Literature:

1. Pauwels RA, et al. Effect of inhaled formoterol and budesonide on exacerbations of asthma. // N Engl J Med, 1997; 337:1405-11.

2. Kips JC, et al. A long-term study of the antiinflammatory effect of low-dose budesonide plus formoterol versus high-dose budesonide in asthma. // Am J Respir Crit Care Med, 2000; 161:996-1001.

3. Ellul-Micallef R., Johansson SA Acute dose-response studies in bronchial asthma with a new corticosteroid, budesonide. // Br J Clin Pharmacol, 1983; 15: 419-22.

4. Palmqvist M., et al. Onset of bronchodilation of budesonide-formoterol vs salmeterol/fluticasone in single inhalers. // Pulmonol Pharmacol Ther, 2001; 14:29-34.

5. Zetterstrom O., et al. Efficacy and safety of a new single inhaler product, containing both budesonide and formoterol, in adult asthma. // Eur Respir J, 2000; 16 (suppl 31): 455s.

6. Tal A., et al. The benefit of a new single inhaler product, containing both budesonide and formoterol, in asthmatic children. // Eur Respir J, 2000; 16 (suppl 31): 384s.

7. Ankerst J., et al. A high-dose of budesonide/formoterol in a single inhaler was well-tolerated by asthmatic patients. // Eur Respir J, 2000; 16 (suppl 31): 33s.

8. Cochrane MG, et al/ Inhaled corticosteroids for asthma therapy – Patient compliance, devices and inhalation technique. // Chest, 2000; 117(2): 542–50

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