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
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).
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 _
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).
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.
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 guide 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.
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.
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.
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.
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.
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.
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.
