Symbicort® Turbuhaler® (Symbicort® Turbuhaler®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceBudesonide + FormoterolBudesonide + Formoterol
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  • Symbicort® Turbuhaler®
    powder d / inhal. 
    AstraZeneca AB     Sweden
  • Symbicort® Turbuhaler®
    powder d / inhal. 
    AstraZeneca AB     Sweden
  • Foradil Combi
    capsules d / inhal. 
    Novartis Pharma AG     Switzerland
  • Formisonide®-native
    powder d / inhal. 
    NATIVA, LLC     Russia
    • Dosage form: & nbsppowder for inhalation dosed
    Composition:Each delivered dose (dose exiting from the mouthpiece) contains as active substances: budesonide micronized 80 μg and formoterol fumarate dihydrate 4.5 μg; or budesonide micronized 160 μg and formoterol fumarate dihydrate 4.5 μg.
    Excipients: lactose monohydrate 810 μg or 730 μg
    Description:Inhaler: a rotating dispenser of red color, on which the Braille code is pressed. The cover is white. On the inside of the lid there are 5 ribbed thickenings in the form of longitudinal strips. In the dosing indicator window, the figure "60" or "120" for the inhaler is shown for 60 doses or 120 doses, respectively. The mouthpiece has four longitudinal ribs and can rotate. Content: granules from white to almost white, mostly round in shape.
    Pharmacotherapeutic group:bronchodilating agent combined (beta2-adrenomimetic selective + glucocorticosteroid local)
    ATX: & nbsp

    R.03.A.K.07   Formoterol and budesonide

    Pharmacodynamics:

    Symbicort contains formoterol and budesonide, which have different mechanisms of action and show an additive effect in reducing the frequency of exacerbations of bronchial asthma.
    The special properties of budesonide and formoterol make it possible to use their combination at the same time as maintenance therapy and for relief of seizures, or as a supporting therapy for bronchial asthma.
    Budesonide. Budesonide - glucocorticosteroid, which upon inhalation provides rapid (within hours) and dose-dependent antiinflammatory effect on the airways, reducing the frequency and severity of symptoms of asthma exacerbations. With the appointment of inhaled budesonide, there is a lower incidence of serious adverse effects than with systemic glucocorticosteroids. Reduces the severity of the edema of the bronchial mucosa, the production of mucus,sputum formation and airway hyperreactivity.
    The exact mechanism of the anti-inflammatory effect of glucocorticosteroids is unknown.
    Formoterol. Formoterol selective agonist β2-adrenergic receptors, after inhalation of which there is a rapid and prolonged relaxation of the smooth muscles of the bronchi in patients with reversible airway obstruction. The dose-dependent bronchodilator effect occurs within 1 to 3 minutes after inhalation and persists for at least 12 hours after taking a single dose.
    Symbicort Turbuhaler: Budesonide + Formoterol
    Bronchial asthma
    Clinical efficacy of Symbicort as maintenance therapy
    Addition of formoterol to budesonide reduces the severity of symptoms of bronchial asthma, improves lung function and reduces the frequency of exacerbations of the disease.
    The action of Symbicort Turbuhaler on lung function corresponds to the action of a combination of mono preparations of budesonide and formoterol and exceeds the action of one budesonide. In all cases, beta2-adrenostimulator of short action was used to stop seizures.There was no decrease in the anti-asthmatic effect over time. The drug is well tolerated.
    Symbicort Turbuhaler as a maintenance therapy in combination with short-acting beta2-adrenergic stimulant for the relief of seizures was prescribed to patients aged 6 to 11 years for 12 weeks (two inhalations of 80 / 4.5 μg / inhalation twice a day). There was an improvement in pulmonary function and good tolerability of therapy in comparison with the corresponding dose of budesonide Turbuhaler.
    Clinical efficacy of Symbicort as maintenance therapy and for relief of seizures.
    In a follow-up of 4,447 patients treated with Symbicort as maintenance therapy and to relieve seizures for 6 to 12 months, there was a statistically and clinically significant decrease in the number of severe exacerbations, an increase in the time to the onset of the first exacerbation compared to a combination of Symbicort budesonide as maintenance therapy and beta2-adrenostimulyatora for relief of attacks. There was also effective control over the symptoms of the disease, pulmonary function and a reduction in the frequency of administration of inhalations for relief of attacks.There was no development of tolerance to prescribed therapy. In patients who have applied for medical assistance in connection with the development of an acute attack of bronchial asthma, after the inhalation of Symbicort, the relief of symptoms (removal of bronchospasm) occurred as quickly and effectively as after the appointment of salbutamol and formoterol.
    Chronic obstructive pulmonary disease (COPD)
    In patients with severe COPD (FEV1 = 36% before the commencement of Symbicort therapy), compared with patients receiving therapy alone, a significant decrease in the frequency of exacerbations of the disease was observed with the use of Symbicort turbuhaler formoterol or placebo (mean frequency of exacerbations 1.4 compared with 1.8 to 1.9 in the placebo / formoterol group). There was no difference between the intake of Symbicort and formoterol in the index of forced expiratory volume in the first second (FEV1).

    Pharmacokinetics:

    Suction. Symbicort Turbuhaler is bioequivalent to the corresponding mono preparations with respect to the systemic action of budesonide and formoterol. Despite this, there was a slight increase in suppression of cortisol after taking Symbicort Turbuhaler compared with mono preparations.This difference does not affect clinical safety. There is no evidence of pharmacokinetic interaction between budesonide and formoterol.

    Pharmacokinetic parameters for the relevant substances are comparable after the appointment of budesonide and formoterol in the form of monopreparations and as part of Symbicort Turbuhaler. For budesonide, when administered in a combination preparation, the area under the concentration-time curve (AUC) is somewhat larger, the absorption of the drug is faster and the maximum concentration in the blood plasma is higher. For formoterol, when administered as a combination, the maximum concentration in the blood plasma coincides with that for a mono drug.
    Inhalable budesonide quickly absorbed and reaches the maximum concentration in the plasma 30 minutes after the inhalation. The average dose of budesonide, which fell into the lung after inhalation through 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,got into the lungs after the inhalation through Turbuhaler, does not differ from the indices in adult patients (the final concentration of the drug in the blood plasma was not determined). Inhalable formoterol quickly absorbed and reaches the maximum concentration in the blood plasma 10 minutes after the inhalation. The average dose of formoterol, which fell into the lung after inhalation through Turbuhaler, is 28-49% of the delivered dose. Systemic bioavailability is about 61% of the delivered dose.

    Distribution and metabolism. About 50% of formoterol and 90% of budesonide bind to plasma proteins. The distribution volume for formoterol is about 4 l / kg and for budesonide is 3 l / kg. Formoterol is inactivated by conjugation (active O-demethylated metabolites are formed mainly in the form of inactivated conjugates). Budesonide is subjected to intensive biotransformation (about 90%) during the first passage through the liver with the formation of metabolites with low glucocorticosteroid activity. Glucocorticosteroid activity of the main metabolites - 6-β-hydroxybudesonide and - 16α-hydroxy-prednisolone - does not exceed 1% of the analogous activity of budesonide.There is no evidence for the interaction of metabolites 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. Formoterol has a high system clearance (approximately 1.4 l / min); the half-life of the drug is an average of 17 hours.

    Budesonide is metabolized predominantly with the participation of the enzyme CYP3A4. Metabolites of budesonide are excreted by the kidneys in unmodified form or in the form of conjugates. In urine, only a small amount of unmodified budesonide is found. Budesonide has a high system clearance (approximately 1.2 l / min).

    The pharmacokinetics of formoterol and budesonide in patients with renal insufficiency have not been studied. The concentration of budesonide and formoterol in blood plasma can be increased in patients with liver disease.

    Indications:

    Bronchial asthma, as maintenance therapy and for relief of seizures (insufficiently controlled by the intake of inhaled glucocorticosteroids and beta2-adrenergic stimulants of short action as therapy on demand, or adequately controlled by inhaled GCS and long-acting beta2-adrenostimulants).

    COPD (Symptomatic therapy in patients with severe chronic obstructive pulmonary disease (FEV)1 <50% of the estimated calculated level) and with repeated exacerbations in the anamnesis, which have severe symptoms of the disease, despite long-acting bronchodilator therapy).

    Contraindications:- Hypersensitivity to budesonide, formoterol or inhaled lactose.
    - Children under 6 years old.
    - Lactose intolerance, lactase deficiency or glucose-galactose malabsorption (see section "Special instructions").
    Carefully:Tuberculosis of the lungs (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 site or other severe cardiovascular diseases (coronary heart disease, tachyarrhythmia or severe heart failure) , prolongation of QT interval (reception of formoterol may cause prolongation of QTc-interval).
    Pregnancy and lactation:There are no clinical data on the use of Symbicort or the sharing of formoterol and budesonide during pregnancy. During pregnancy, Symbicort should be used only when the benefits of using the drug exceed the potential risk to the fetus. The lowest effective dose of budesonide needed to maintain adequate control of asthma symptoms should be used. Inhalable budesonide is excreted in breast milk, however, when applied in therapeutic doses, no effect on the child was noted. It is not known whether the formoterol in the breast milk of women. Symbicort can be prescribed to lactating women only if the expected benefit to the mother is greater than any possible risk to the child.
    Dosing and Administration:

    Bronchial asthma

    Symbicort Turbuhaler is not intended for the initial treatment of bronchial asthma of intermittent and easy persistent flow. Selection of the dose of drugs that make up Symbicort occurs individually and depending on the severity of the disease. This need to be taken into account not only at the beginning of treatment with combined preparations, but also with a change in the maintenance dose of the drug.In the event that individual patients require a different combination of doses of active components than in Symbicort Turbuhaler, β2adrenomimetics and / or glucocorticosteroids in separate inhalers. The dose should be reduced to the lowest, against which the optimal control of symptoms of bronchial asthma remains. Patients should be under the constant supervision of a physician for adequate selection of a dose of Symbicort Turbuhaler. When full control over the symptoms of bronchial asthma is achieved against the background of the minimum recommended dose of the drug, the next step is to try to administer monotherapy with inhaled glucocorticosteroids.

    There are two approaches to the appointment of Symbicort Turbuhaler therapy:

    A. Symbicort Turbuhaler as maintenance therapy: Symbicort Turbuhaler is assigned to the constant maintenance therapy in combination with a separate short-acting beta2- agonists for cupping.

    B. Symbicort Turbuhaler as maintenance therapy and cupping: Symbicort Turbuhaler assigned for constant maintenance therapy as well as on-demand with the appearance of symptoms.

    A. Symbicort Turbuhaler as maintenance therapy

    The patient should always have a separate inhaler with a beta2-adrenergic stimulant of short action for relief of attacks.

    Adults (18 years and over): Symbicort Turbuhaler 80 / 4.5 mcg / dose and 160 / 4.5 mcg / dose: 1 - 2 inhalations twice a day. If necessary, it is possible to increase the dose to 4 inhalations twice a day.

    Adolescents (12-17 years): Symbicort Turbuhaler 80 / 4.5 mcg / dose and 160 / 4.5 mcg / dose: 1 - 2 inhalations twice a day.

    Children older than 6 years: Symbicort Turbuhaler 80 / 4.5 mcg / dose: 1 - 2 inhalations twice a day.

    After achieving optimal control over the symptoms of bronchial asthma when taking the drug twice a day, it is recommended to titrate the dose to the minimum effective, up to taking the drug once a day in those cases when, according to the doctor, the patient needs supportive therapy in combination with a long-acting bronchodilator actions.

    An increase in the frequency of use of beta2-adrenergic stimulants of short action is an indicator of worsening of general control over the disease and requires revision of antiasthmatic therapy.

    V. Symbicort Turbuhaler as maintenance therapy and for relief of attacks

    Symbicort Turbuhaler can be appointed as a permanent maintenance therapy, and as a therapy on demand in case of seizures. The patient must always have Symbicort for relief of attacks.

    Symbicort as a supportive therapy and for relief of seizures is especially indicated in patients with:

    -Inadequate control of bronchial asthma and the need for frequent use of drugs to stop seizures;

    -the presence of an anamnesis of exacerbations of bronchial asthma requiring medical intervention.

    It requires careful monitoring of dose-dependent side effects in patients who use a large number of inhalations to stop seizures.

    Adults (18 years and over): Symbicort Turbuhaler 80 / 4.5 μg / dose and 160 / 4.5 μg / dose: the recommended dose for maintenance therapy is 2 inhalations per day, 1 inhalation is taken in the morning and evening, or 2 inhalations only once in the morning or only in the evening. For some patients, a maintenance dose of Symbicort Turbuhaler 160 / 4.5 mcg / dose 2 inhalations can be given twice a day. If symptoms occur, the appointment of 1 additional inhalation is necessary.With a further increase in symptoms within a few minutes, another 1 additional inhalation is prescribed, but no more than 6 inhalations for stopping 1 attack. Usually no more than 8 appointments are required inhalations per day, but you can increase the number of inhalations to 12 per day for a short time. Patients who receive more than 8 inhalations per day are advised to seek medical help for a review of therapy.

    Children and adolescents under 18 years of age: Symbicort Turbuhaler as a supportive therapy and for relieving seizures is not recommended for children and adolescents.

    COPD

    Adults: 2 inhalations Symbicort Turbuhaler 160 / 4.5 mcg / dose twice a day.

    Special patient groups: there is no need for a special dose selection for elderly patients. There is no data on the use of Symbicort in patients with renal or hepatic insufficiency. As budesonide and formoterol, mainly, are deduced with the participation of hepatic metabolism, then in patients with severe cirrhosis of the liver, a slowing down of the drug release rate can be expected.

    Children under 6 years: Symbicort Turbuhaler is not recommended for children under 6 years.

    Instructions for proper use of Turbuhaler:

    The mechanism of action of the turbuhaler: when inhaled by the patient through the mouthpiece, the drug enters the respiratory tract. It is necessary to instruct the patient:

    -read carefully the instructions for using Turbuhaler

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

    never exhale through the mouthpiece

    - Rinse your mouth with water after inhalation of maintenance doses to reduce the risk of developing candidiasis of the mucous membrane of the mouth and throat. It is also necessary to rinse the mouth with water after the inhalation for relief of symptoms in the case of candidiasis of the mucous membrane of the oral cavity and pharynx.

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

    INSTRUCTION FOR USE OF TURBUCHALER

    Turbuhaler - multi-dose inhaler, which allows you to dose and inhale the drug in very small doses (Figure 1).

    When you inhale, the powder from Turbuhaler is delivered to the lungs. It is therefore important that you breathed deeply and deeply through the mouthpiece.

    Preparing the Turbuhaler for first use:

    Before first Using Turbuhaler it must be prepared for work.

    Unscrew and remove the lid.

    Hold the inhaler vertically with the red dispenser down (Fig. 2). Do not hold the inhaler for mouthpiece when you turn the dispenser.

    Turn the dispenser all the way in one direction (no matter, clockwise or counterclockwise), and then also against the stop in the opposite direction. During the rotation of the dispenser, you will hear a click. Follow the procedure twice.

    The inhaler is now ready for use, and You must not repeat this procedure training of Turbuhaler to work before each use. In order to take the drug, follow the instructions below.

    How to use SIMBIKORT® TURBUCHALER®

    To take one dose, follow the procedure described below.

    1. Unscrew and remove the cover.

    2. Hold the inhaler vertically with the red dispenser downward (Figure 2). Do not hold the inhaler for the mouthpiece when you turn the dispenser. To measure the dose, turn the dispenser all the way in one direction (no matter clockwise or counterclockwise), and then as far as it will go in the opposite direction. During the rotation of the dispenser, you will hear a click.

    3. Exhale. Do not exhale through the mouthpiece.

    4. Carefully place the mouthpiece between the teeth, compress the lips and inhale deeply and deeply through the mouth (Figure 3). The mouthpiece should not be chewed or compressed with teeth.

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

    6. If more than one dose is required, repeat steps 2-5.

    7. Close the inhaler cover, check that the cover of the inhaler has been carefully screwed.

    8. Rinse your mouth with water without swallowing.

    IMPORTANT!

    Do not attempt to remove the mouthpiece, since it is attached to the inhaler and is not removed.

    The Turbuhaler's mouthpiece rotates, but do not turn it unnecessarily.

    Since the amount of inhaled powder is very small, you may not feel the taste of the powder after inhalation. However, if you followed the instructions, you can be sure that you inhaled (inhaled) the necessary dose of the drug.

    If you mistakenly repeated the procedure for loading the inhaler more than once before taking the drug, with inhalation, you still get one dose of the drug. While the dose indicator will show the total number of measured doses.

    The sound that you hear when you shake the inhaler is produced by a dehumidifying agent, not a medicine.

    How do I know when the inhaler needs to be replaced?

    The dose indicator (Fig.4) shows the approximate number of doses remaining in the inhaler, the count of doses filled Turbuhaler starts with the 60th or 120th dose (depending on the total number of doses purchased by you Turbuhaler).

    The indicator shows an interval of 10 doses, so it does not show every metered (loaded) dose. You can be sure that Turbuhaler delivers the necessary dose of the drug, even if you do not notice the changes in the dose indicator window.

    The appearance of a red background in the dose indicator window means that there are 10 doses remaining in the Turbuhaler. When the figure 0 appears on a red background in the middle of the dose indicator window (Figure 5), the inhaler should be replaced with a new one.


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

    Cleaning

    Regularly (once a week), clean the mouthpiece from the outside with a dry cloth.

    Do not use water or other liquids to clean the mouthpiece.

    Recycling

    Be careful with the inhaler used, remember that some amount of the drug may remain inside the inhaler.
    Side effects:Against the background of the joint appointment of two drugs, there was no increase in the incidence of adverse reactions.
    The most common adverse reactions associated with taking the drug are pharmacologically expected adverse effects for p2-adrenomimetics, such as tremor and heart palpitations; symptoms usually have a moderate degree of severity and go through a few days after the start of treatment. AT
    the use of budesonide in COPD, bruising and pneumonia occurred at a frequency of 10% and 6%, respectively, compared with 4% and 3% in the placebo group (p <0.001 and p <0.01, respectively).
    Frequent (> 1/100, <1/10)
    Central Nervous System: Headache
    Cardiovascular system: Palpitation
    Musculoskeletal system: Tremor
    Respiratory tract: Candidiasis of the oral and pharyngeal mucosa, cough, hoarseness, slight irritation in the throat
    Infrequent (> 1/1000, <1/100)
    Cardiovascular system: Tachycardia
    Musculoskeletal system: Muscle cramps
    Central nervous system: Psychomotor agitation, anxiety, nausea, dizziness, sleep disturbances
    Skin: Bleeding
    Rare (> 1/10000, <1/1000)
    Skin: Immediate and delayed hypersensitivity reactions (eg, dermatitis, exanthema, urticaria, pruritus, angioedema, anaphylactic reaction
    Respiratory tract: Bronchospasm
    Metabolic disorders: hypokalemia
    Cardiovascular system: Arrhythmia (eg, atrial fibrillation, supraventricular tachycardia, extrasystole)
    Very rare (<1/10000)
    Metabolic disorders: Hyperglycemia, signs or symptoms of systemic glucocorticosteroid effects (including adrenal hypofunction)
    Psychiatric symptoms: Depression, behavioral disorders (mainly in children)
    Central Nervous System: Taste Disorders
    Cardiovascular system: Angina pectoris, fluctuations in blood pressure
    The systemic effect of inhaled glucocorticosteroids can occur when taking high doses for a long time.
    The use of β2-adrenomimetikov can lead to an increase in the blood levels of insulin, free fatty acids, glycerol and ketone derivatives.
    Overdose:Symptoms of an overdose of formoterol: tremor, headache, heart palpitations.In some cases, the development of tachycardia, hyperglycaemia, hypokalemia, lengthening of the QTc interval, arrhythmia, nausea and vomiting has been reported. Supportive and symptomatic treatment may be prescribed.
    If it is necessary to cancel Symbicort Turbuhaler due to an overdose of formoterol, which is part of the combined preparation, consideration should be given to the appointment of an appropriate glucocorticosteroid.
    In acute overdose of budesonide, even in significant doses, no clinically significant effects are expected. When chronic intake of excessive doses, the systemic action of glucocorticosteroids, such as hypercorticism and suppression of adrenal function, may manifest itself.
    Interaction:The administration of 200 mg of ketoconazole once a day raises the concentration in the plasma of oral budesonide (a single dose of 3 mg) when administered jointly, on average, 6-fold. With the appointment of ketoconazole 12 hours after the administration of budesonide, the concentration in the plasma of the latter increased, on average, 3-fold.
    There is no information about such interaction with inhaled budesonide, however, we should expect a significant increase in the concentration of the drug in the blood plasma.Since there is no data for recommendations for dose selection, the above combination of drugs should be avoided. If this is not possible, the time interval between administration of ketoconazole and budesonide should be maximized. You should also consider the possibility of reducing the dose of budesonide. Other potent inhibitors of CYP3A4 are also likely to significantly increase the concentration of budesonide in plasma. It is not recommended to use Symbicort as maintenance therapy and to relieve seizures for patients receiving potent CYP3A4 inhibitors.
    Blockers (beta-adrenergic receptors can weaken the action of formoterol.) Symbicort should not be given concomitantly with beta-blockers (including eye drops), except for forced cases.
    The joint administration of Symbicort Turbuhaler and quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), monoamine oxidase (MAO) inhibitors and tricyclic antidepressants can prolong the QTc interval and increase the risk of ventricular arrhythmias. Besides, levodopa, levothyroxine, oxytocin and alcohol can reduce heart muscle tolerance to β2-adrenomimetics.
    Co-administration of MAO inhibitors, as well as drugs with similar properties, such as furazolidone and procarbazine, can cause an increase in blood pressure.
    There is an increased risk of arrhythmia in patients with general anesthesia with preparations of halogenated hydrocarbons.
    With the joint administration of Symbicort turbuhaler and other β-adrenergic drugs, the side effect of formoterol may be increased. As a result of the application of β2-adrenomimetics hypokalemia may occur, which can be intensified by concomitant treatment with xanthine derivatives, mineral derivatives of glucocorticosteroids or diuretics. Hypokalemia may increase predisposition to the development of arrhythmias in patients taking cardiac glycosides.
    No interaction of budesonide and formoterol with other medications used to treat bronchial asthma was noted.
    Special instructions:It is recommended to gradually reduce the dose of the drug before cessation of treatment and is not recommended abruptlyto cancel treatment.
    Symbicort (80 / 4.5 mcg / dose) Turbuhaler is not intended for patients with severe bronchial asthma.
    Symbicort Turbuhaler is not intended for initial selection of therapy at the first stages of treatment of bronchial asthma.
    If the effectiveness of therapy is insufficient or if the maximum recommended dose of Symbicort is exceeded, it is necessary to revise the treatment tactics. An unexpected and progressive deterioration in the management of symptoms of bronchial asthma or COPD is potentially life threatening and requires urgent medical intervention. In this situation, the possibility of increasing the dose of glucocorticosteroids should be considered; appointment of a course of oral glucocorticosteroids or treatment with antibiotics in case of infection.
    Patients are advised to always carry emergency medications, or Symbicort Symbicort (for asthma patients using Symbicort Symbicort maintenance therapy and cupping), or beta2- agonists short-acting (for all patients using Symbicort Turbuhaler only for maintenance therapy ).
    It is necessary to draw the patient's attention to the need for regular maintenance of a maintenance dose of Symbicort Turbuhaler in accordance with the selected therapy, even in cases of absence of symptoms of the disease. Inhalation Symbicort Turbuhaler for relief of seizures should be carried out only in the event of symptoms, but not shown for regular preventive use, i.e. before exercise. In such cases, the use of a single short-acting bronchodilator is indicated.
    If the symptoms of bronchial asthma are amenable to control, you can gradually reduce the dose of Symbicort Turbuhaler, while it is important to constantly monitor the condition of patients. The lowest effective dose of Symbicort turbuhaler should be given (see section "Dosage and Administration").
    Treatment with Symbicort Turbuhaler should not be started during an exacerbation or a significant deterioration in the course of bronchial asthma.
    During the treatment with Symbicort Turbuhalerom can mark exacerbations and the development of serious undesirable phenomena associated with bronchial asthma. Patients should continue treatment,but seek medical help if there is no control over the symptoms of bronchial asthma or if the condition worsens after the start of therapy.
    As with any other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after taking a dose of the drug. In this connection, it is necessary to stop the therapy with Symbicort, to reconsider the tactics of treatment and, if necessary, to prescribe alternative therapy. Systemic action may occur when taking any inhaled glucocorticosteroids, especially when taking high doses of drugs for a long period of time. The manifestation of systemic action is less likely in inhalation therapy than with oral glucocorticosteroids. Possible systemic effects include suppression of adrenal function, growth retardation in children and adolescents, decreased bone mineral density, cataracts and glaucoma.
    It is recommended to regularly monitor the growth of children receiving long-term glucocorticosteroid therapy in an inhaled form.In the case of an established growth retardation, therapy should be reviewed to reduce the dose of an inhaled glucocorticosteroid. It is necessary to carefully evaluate the ratio of the benefits of glucocorticosteroid therapy to the possible risk of growth retardation. When choosing a therapy, it is recommended to consult a pediatric pulmonologist.
    Based on limited data on long-term glucocorticosteroid intake, it can be assumed that most children and adolescents receiving inhaled budesonide therapy will eventually achieve normal adult growth rates. At the same time, an insignificant short-term growth retardation was reported mainly in the first year of treatment.
    Because of the potential effect of inhaled glucocorticosteroids on the 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 prolonged use of inhaled budesonide in children at an average daily dose of 400 μg (metered dose) or adults at a daily dose of 800 μg (metered dose) did not show a significant effect on bone mineral density.There is no data on the effect of high doses of Symbicort Turbuhaler on the mineral density of bone tissue.
    If there is reason to believe that against the background of previous systemic therapy corticosteroids adrenal function has been compromised, you should take precautions when transferring patients to treatment Symbicort.
    Advantages budesonide inhalation therapy are generally minimize the need for receiving oral corticosteroids, but the patients discontinuing therapy with oral corticosteroids for a long time can be maintained insufficient adrenal function. Patients who in the past needed an urgent intake of high doses of glucocorticosteroids or received long-term treatment with high-dose inhaled glucocorticosteroids may also be at this risk group. It is necessary to provide additional appointment of glucocorticosteroids during the period of stress or surgical intervention. It is recommended that the patient be instructed to rinse the mouth with water after inhalation of maintenance doses in order to prevent the risk of developing candidiasis of the oral and pharyngeal mucosa.It is also necessary to rinse the mouth with water after the inhalation for relief of symptoms in the case of candidiasis of the mucous membrane of the oral cavity and pharynx.
    Precautions should be observed in the treatment of patients with an extended QTc-interval. Taking formoterol can cause an extension of the QTc interval.
    The need and dose of an inhaled glucocorticosteroid in patients with active or inactive forms of pulmonary tuberculosis, fungal, viral or bacterial infections of the respiratory system should be reviewed.
    With the joint appointment of β2- adrenomimetics with drugs that can cause or exacerbate the hypokalemic effect, for example, xanthine derivatives, steroids or diuretics, possibly increasing the hypokalemic effect of β2- adrenomimetics. Special precautions should be taken in patients with unstable bronchial asthma who use short-acting bronchodilators to relieve attacks with exacerbation of severe bronchial asthma, as the risk of hypokalemia increases with hypoxia and other conditions, when the likelihood of developing hypokalemic effects increases. In such cases, it is recommended control the potassium content in the serum.
    Receiving patients with acute bronchial obstruction of formoterol at a dose of 90 mcg in 1 within 3 hours is safe. During the treatment period, the concentration of glucose in the blood should be monitored in patients with diabetes mellitus.
    Symbicort Turbuhaler contains lactose (<1 mg / inhalation). Usually this amount does not cause problems in patients with lactose intolerance.
    Effect on the ability to drive transp. cf. and fur:Symbicort Turbuhaler does not affect the ability to drive a car and operate machinery. It can influence the ability to drive a car and operate machinery in the event of a side effect.
    Form release / dosage:Powder for inhalation dosed 80 / 4.5 μg / dose and 160 / 4.5 μg / dose.
    Packaging:For 60 doses and 120 doses in a plastic inhaler with a first opening control (protective film indicating the location of the opening) consisting of a metering device, a powder storage tank, a desiccant tank, a mouthpiece and a screw cap. Each inhaler is placed in a cardboard box with instructions for use.
    Storage conditions:At temperatures below 30 ° C, in places inaccessible to children.
    Shelf life:2 years.Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:П N013167 / 01
    Date of registration:28.09.2011
    The owner of the registration certificate:AstraZeneca ABAstraZeneca AB Sweden
    Manufacturer: & nbsp
    Representation: & nbspAstraZeneca Pharmaceuticals Ltd.AstraZeneca Pharmaceuticals Ltd.
    Information update date: & nbsp2015-11-27
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