Instructions for use SYMBICORT® TURBUHALER® (SYMBICORT TURBUHALER)
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) 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.
If therapy is insufficiently effective or the maximum recommended doses of Symbicort Turbuhaler are exceeded, it is necessary to reconsider treatment tactics. 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 always carry emergency medications with them, 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 only for maintenance therapy) .
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.
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 may also be at this risk. It is necessary to provide additional administration of GCS during periods of stress or surgery.
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.
For acute bronchial obstruction, taking formoterol at a dose of 90 mcg for 3 hours is safe. 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 problems in patients with lactose intolerance.
Use in pediatrics
Symbicort Turbuhaler is not recommended for use in children under 6 years of age.
Symbicort Turbuhaler is not recommended as maintenance therapy or for the relief of seizures
in children and adolescents under the age of 18 years
.
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® Turbuhaler®
Bronchial asthma
Symbicort Turbuhaler is not intended for the initial treatment of intermittent and mild persistent bronchial asthma. The dose of the drugs included in Symbicort is selected 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 maintenance dose of the drug. In the event that individual patients require a different combination of doses of active components than in Symbicort Turbuhaler, β2-adrenergic agonists and/or glucocorticosteroids should be prescribed in separate inhalers.
Patients should visit their doctor regularly to monitor the optimal dose of Symbicort Turbuhaler. The dose should be reduced to the lowest dose that maintains optimal control of asthma symptoms. Once optimal control of asthma is achieved with twice daily dosing, it is recommended to titrate the dose to the lowest effective dose, up to once daily dosing, in cases where, in the opinion of the physician, the patient requires maintenance therapy in combination with a long-acting bronchodilator . Adults (18 years and older): Symbicort Turbuhaler 320/9 mcg/dose: 1 inhalation twice daily. If necessary, the dose can be increased to 2 inhalations twice a day. After achieving optimal control of asthma symptoms while taking the drug twice a day, it is possible to reduce the dose to the lowest effective dose, up to once a day. Adolescents (12-17 years): Symbicort Turbuhaler 320/9 mcg/dose: 1 inhalation twice daily. Children under 12 years of age: Symbicort Turbuhaler 320/9 mcg/dose is not recommended for children under 12 years of age due to the lack of clinical data. Symbicort Turbuhaler 320/9 mcg/dose is intended for maintenance therapy only. COPD Adults: 1 inhalation of Symbicort Turbuhaler 320/9 mcg/dose twice a day. Special groups of patients: there is no need for special selection of the drug dose for elderly patients. There is no data on the use of Symbicort Turbuhaler 320/9 mcg/dose in patients with renal or hepatic impairment. Since budesonide and formoterol are eliminated primarily by the kidneys, with the participation of hepatic metabolism, a slower rate of elimination of the drug can be expected in patients with severe cirrhosis.
Instructions for correct use of Turbuhaler:
The mechanism of action of Turbuhaler: when inhaled by the patient through the mouthpiece, the drug enters the respiratory tract. The patient must be instructed:
- carefully study the instructions for use of Turbuhaler
-inhale strongly 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 inhaling maintenance doses to reduce the risk of developing candidiasis of the oral mucosa and pharynx. It is also necessary to rinse your mouth with water after inhalation to relieve symptoms in case of candidiasis of the oral mucosa and pharynx.
The patient may not taste or feel the drug after using Turbuhaler, which is 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 (Fig. 1).
When you inhale, Turbuhaler powder is delivered to your lungs. Therefore, it is important that you take a strong and deep breath
through the mouthpiece.
Preparing Turbuhaler for first use:
Before the first
using Turbuhaler, it must be prepared for work.
Unscrew and remove the cover.
Hold the inhaler vertically with the red dispenser facing down (Fig. 2). Do not hold the inhaler by the mouthpiece when turning the dispenser.
Turn the dispenser all the way in one direction
(no matter clockwise or counterclockwise),
and then also all the way in the opposite direction.
You will hear a click as you turn the dispenser. Follow the described procedure twice.
The inhaler is now ready for use and you do not have to repeat this procedure
preparing Turbuhaler for work before each use. To take the drug, follow the instructions below.
How to use SYMBICORT® TURBUHALER®
To take one dose, follow the procedure described below.
1. Unscrew and remove the cover.
2. Hold the inhaler vertically with the red dispenser facing down (Fig. 2). Do not hold the inhaler by the mouthpiece when turning the dispenser. In order to measure the dose, turn the dispenser all the way in one direction (no matter clockwise or counterclockwise), and then also all the way in the opposite direction. You will hear a click as you turn the dispenser.
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 (Figure 3). 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, repeat steps 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.
IMPORTANT!
Do not attempt to remove the mouthpiece as it is attached to the inhaler and cannot be removed.
The Turbuhaler's mouthpiece rotates, but do not turn it unless necessary.
Because the amount of powder inhaled 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 required dose of the drug.
If you mistakenly repeat the procedure for loading the inhaler more than once before taking the drug, you will still receive one dose of the drug when inhaling. While the dose indicator will show the total number of doses measured.
The sound you hear when you shake the inhaler is made by the drying agent, not the medicine.
How do you know when your inhaler needs to be changed?
The dose indicator (Fig. 4) shows the approximate number of doses remaining in the inhaler; the count of doses of filled Turbuhaler begins with the 60th or 120th dose (depending on the total number of doses of Turbuhaler you purchased).
The indicator shows an interval of 10 doses, so it does not show every dispensed (loaded) dose. You can be sure that Turbuhaler delivers the required dose of the drug, even if you do not notice a change 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 Turbuhaler. When the number 0 appears on a red background in the middle of the dose indicator window (Fig. 5), the inhaler must be replaced with a new one.
Note that even when the dose indicator window shows 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
Clean the outside of the mouthpiece regularly (once a week) with a dry cloth.
Do not use water or other liquids to clean the mouthpiece.
Disposal
Be careful with the used inhaler and remember that some medication may remain inside the inhaler.
Buy Symbicort Turbuhaler powder for inhalation 160mcg+4.5mcg/dose 60doses in pharmacies
Composition 1 dose contains:
Active ingredients:
budesonide 160 mcg,
frommoterol fumarate dihydrate 4.5 mcg;
Excipient:
lactose monohydrate. Pharmacological action Pharmacodynamics
Symbicort Turbuhaler 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. Budesonide, an inhaled glucocorticosteroid, in recommended doses has an anti-inflammatory effect in the bronchi, reducing the severity of symptoms and the frequency of exacerbations of bronchial asthma with a lower incidence of side effects than when using systemic glucocorticosteroids. Reduces the severity of edema of the bronchial mucosa, mucus production, sputum formation and airway hyperreactivity.
Formoterol. Formoterol is a selective β2-adrenergic receptor agonist that causes relaxation of bronchial smooth muscle 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.
Budesonide + Formoterol. Bronchial asthma 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 Symbicort Turbuhaler on bronchial 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.
Symbicort Turbuhaler improves bronchial function and is well tolerated in children aged 6 to 11 years when taken for 12 weeks (two inhalations of 80/4.5 mcg/inhalation twice a day).
Chronic obstructive pulmonary disease (COPD) In patients with severe COPD, 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 exacerbation frequency 1.4 but compared with 1.8-1.9 in the placebo group /formoterol). There were no differences between the use of Symbicort and formoterol on the forced expiratory volume in the first minute (FEV).
Pharmacokinetics
Suction. Symbicort Turbuhaler is bioequivalent to the corresponding monotherapy drugs in terms of the systemic action of budesonide and formoterol. Despite this, a slight increase in cortisol suppression was noted after taking Symbicort Turbuhaler compared to monotherapy. This difference does not have an impact on clinical safety. There is no evidence of a pharmacokinetic interaction between budesonide and formoterol.
Pharmacokinetic parameters for the corresponding substances are comparable after the administration of budesonide and formoterol in the form of single drugs and as part of Symbicort Turbuhaler. For budesonide, when administered as part of a combination drug, the area under the concentration-time curve (AUC) is slightly larger, the drug is absorbed faster and the maximum plasma concentration is higher.
For formoterol, when administered as part of a combination drug, the maximum concentration in blood plasma coincides with that for the single drug.
Inhaled budesonide is rapidly absorbed and reaches maximum plasma concentration 30 minutes after inhalation. The average dose of budesonide that enters the lungs 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 that entered 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 maximum concentration in blood plasma 10 minutes after inhalation. The average dose of formoterol that enters the lungs after inhalation through Turbuhaler is 28-49% of the delivered dose. Systemic bioavailability is approximately 61% of the delivered dose.
Distribution and metabolism. Approximately 50% of formoterol and 90% of budesonide are bound to plasma proteins. The volume of distribution for formoterol is about 4 l/kg and for 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 passage through the liver with the formation of metabolites with low glucocorticosteroid activity. The glucocorticosteroid activity of the main metabolites 6-beta-hydroxybudesonide and 16-alpha-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.); The half-life 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).
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. Indications Bronchial asthma (insufficiently controlled by taking inhaled corticosteroids and short-acting beta 2-adrenergic stimulants or adequately controlled by inhaled corticosteroids and long-acting beta 2-adrenergic stimulants). COPD (Symptomatic treatment in patients with severe chronic obstructive pulmonary disease (FEV < 50% predicted) and with a history of recurrent exacerbations who have severe symptoms of the disease despite therapy with long-acting bronchodilators). Use during 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 used only in cases where the benefits of the drug outweigh the potential risk to the fetus.
The lowest effective dose of budesonide needed to maintain adequate control of asthma symptoms should be used. It is not known whether formoterol or budesonide passes into women's breast milk. Symbicort Turbuhaler can be prescribed to breastfeeding women only if the expected benefit to the mother is greater than any possible risk to the baby. Contraindications Children under 6 years of age.
With caution: Pulmonary tuberculosis (active or inactive form); fungal, viral or bacterial infections of the respiratory system, thyrotoxicosis, pheochromocytoma, diabetes mellitus, uncontrolled hypokalismia, idiomatic hypertrophic subaortic stenosis, severe arterial hypertension, aneurysm of any location or other severe cardiovascular diseases (coronary heart disease, tachyarrhythmia or severe heart failure) , prolongation of the QT interval (taking formoterol may cause prolongation of the QTc interval). Side effects From the central nervous system: headache; psychomotor agitation, anxiety, nausea, dizziness, sleep disturbances; depression, behavioral disorders (mainly in children), taste disorders.
From the cardiovascular system: palpitations; tachycardia; atrial fibrillation, supraventricular tachycardia, extrasystole; angina pectoris, blood pressure fluctuations.
From the musculoskeletal system: tremor; muscle cramps.
From the respiratory system: candidiasis of the mucous membrane of the mouth and pharynx, mild irritation in the throat, cough, hoarseness; bronchospasm.
Dermatological reactions: bruising; exanthema, itching, dermatitis.
Allergic reactions: urticaria, angioedema, anaphylactic reactions.
Metabolic disorders: hypokalemia; hyperglycemia, symptoms of systemic action of GCS (including adrenal hypofunction). Interaction Taking 200 mg of ketoconazole once a day increases the plasma concentration of orally administered budesonide at a dose of 3 mg by an average of 6 times. When ketoconazole is prescribed 12 hours after taking budesonide, the concentration of the latter in plasma increases 3 times. There is no information about such an interaction with inhaled budesonide, however, a noticeable increase in the concentration of the drug in plasma should be expected (if such a combination cannot be excluded, the interval between the administration of ketoconazole and budesonide should be maximized or the dose of budesonide reduced). Dr. CYP3A4 inhibitors are also likely to significantly increase budesonide plasma concentrations.
Beta-adrenergic receptor blockers (including in the form of eye drops) weaken the effect of formoterol.
Quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), MAO inhibitors and tricyclic antidepressants increase the risk of QT prolongation and ventricular arrhythmias. Dopamine, levothyroxine sodium, oxytocin and ethanol reduce myocardial tolerance of beta2-adrenergic agonists. MAO inhibitors, furazolidone and procarbazine increase the risk of increased blood pressure.
Halogen-containing hydrocarbon drugs for general anesthesia increase the risk of developing arrhythmias. Dr. beta-agonists increase the severity of the side effects of formoterol. Xanthine derivatives, MCS, some diuretics, cardiac glycosides increase the risk of developing hypokalemia. How to take, course of administration and dosage Inhalation.
The dose is selected individually and depends on the severity of the disease.
Adults and children over 12 years of age: when using powder for inhalation containing budesonide and formoterol in a ratio of 80 mcg/4.5 mcg/dose - 1-2 inhalations 2 times a day; 160 mcg/4.5 mcg/dose - 1-2 inhalations 2 times a day.
After achieving optimal control of the symptoms of bronchial asthma while prescribing the drug 2 times a day, it is possible to reduce the dose to the lowest effective one. 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, 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. Special instructions Powder for inhalation containing budesonide and formoterol in a ratio of 80/4.5 mcg/dose is not indicated for patients with severe bronchial asthma. Not intended for initial selection of therapy in the first stages of treatment of bronchial asthma. It is recommended to gradually reduce the dose of the drug before stopping treatment.
An increase in the frequency of taking bronchodilators for emergency care indicates a worsening of the underlying disease and serves as a basis for revising the treatment tactics for bronchial asthma. To minimize the possibility of developing fungal infections of the oropharynx, it is necessary to rinse your mouth with water after each inhalation.
There is no data on the use of the drug to relieve acute attacks of bronchial asthma. Patients should be strictly advised to carry emergency medications with them at all times. Treatment should not be started during an exacerbation of bronchial asthma. As with any other inhalation therapy, paradoxical bronchospasm may occur (in this case, treatment tactics should be reconsidered and, if necessary, alternative therapy should be prescribed).
The occurrence of systemic effects during inhalation therapy is less likely than when using oral corticosteroids. However, it can occur when taking any inhaled corticosteroids, especially when using high doses over a long period of time (it is very important to use the lowest effective dose of inhaled corticosteroids that provides optimal control of asthma symptoms).
Doctors need to carefully monitor the growth of children and adolescents who take GCS for a long time in any dosage form, and evaluate the balance between the benefits of GCS therapy and the possible risk of growth retardation. If adrenal function has been impaired during previous systemic corticosteroid therapy, precautions should be taken when transferring patients to inhaled treatment with the drug (in patients who stop therapy with oral corticosteroids, insufficient adrenal function may persist for a long time).
In stressful situations, it is always necessary to remember the possibility of residual adrenal dysfunction in such patients. There are no clinical data on the use of the drug or the combined use of formoterol and budesonide during pregnancy. In pregnant women, the drug should be used only if the expected benefit to the mother outweighs the potential risk to the fetus, and the lowest effective dose of budesonide needed to maintain adequate control of asthma symptoms should be used.
It is not known whether formoterol or budesonide passes into women's breast milk (the drug should only be prescribed to nursing women if the expected benefit to the mother is greater than any possible risk to the baby). During the treatment period, it is recommended to monitor the concentration of K+ in the blood serum, as well as glucose in patients with diabetes. Contains lactose (less than 1 mg/dose). Typically this amount does not cause problems in patients with lactose intolerance. Release form Powder for inhalation in the form of granules from white to almost white, mostly round in shape. Storage conditions At a temperature not exceeding 30 °C Shelf life 2 years
