Bronchial asthma (insufficiently controlled by the intake of inhaled GCS and short-acting β2-adrenostimulants as therapy on demand or adequately controlled by inhaled GCS and long-acting β2-adrenostimulants) as maintenance therapy and to relieve seizures;
Chronic obstructive pulmonary disease (symptomatic therapy in patients with chronic obstructive pulmonary disease with post-bronchodilatory FEV1 <70% of what is expected and a history of exacerbations despite bronchodilator therapy).
Hypersensitivity to budesonide, formoterol, or inhaled lactose;
Lactose intolerance, lactase deficiency or glucose-galactose malabsorption (see "Special instructions");
Children under 6 years of age.
Carefully. Pulmonary tuberculosis (active or inactive form); fungal. Viral or bacterial respiratory infections. Thyrotoxicosis. Pheochromocytoma. Diabetes. Decreased function of the adrenal cortex. Uncontrolled hypokalemia. Hypertrophic obstructive cardiomyopathy. Idiopathic hypertrophic subaortic stenosis. Severe arterial hypertension. Aneurysm of any localization or other severe cardiovascular disease (coronary artery disease. Tachyarrhythmia or severe heart failure). Prolongation of the QT interval (taking formoterol can cause prolongation of the QTc interval).
Application during pregnancy and lactation
There is 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 using the preparation outweigh the potential risk to the fetus. The smallest effective dose of budesonide necessary to maintain adequate control of asthma symptoms should be used.
Inhaled budesonide is excreted in breast milk, however, when used in therapeutic doses, no effect on the child has been noted.
It is not known whether formoterol passes into the breast milk of women. Symbicort Turbuhaler can be prescribed to nursing women only if the expected benefit to the mother is greater than any possible risk to the child.
Against the background of the joint appointment of the two preparation, there was no increase in the frequency of adverse reactions. The most frequent adverse reactions associated with taking the preparation are such undesirable effects pharmacologically expected for β2-adrenergic agonists, such as tremors and palpitations; symptoms are usually mild and resolve within a few days of starting treatment. During the use of budesonide for COPD, bruising and pneumonia occurred with a frequency of 10 and 6%, respectively, compared with 4 and 3% in the placebo group (p <0.001 and p.
Method of administration and dosage
Bronchial asthma.
Symbicort Turbuhaler is not intended for the initial treatment of bronchial asthma of intermittent and mild persistent course. The selection of the dose of the preparations that make up Symbicort Turbuhaler takes place individually and depending on the severity of the disease. This must be taken into account not only when starting treatment with combined preparations, but also when changing the maintenance dose of the preparation.
In the event that individual patients require a different combination of doses of active ingredients than in Symbicort Turbuhaler, β2-adrenomimetics and / or corticosteroids should be prescribed in separate inhalers.
The dose should be reduced to the lowest, against the background of which optimal control of bronchial asthma symptoms is maintained. Patients should be under constant medical supervision for an adequate selection of the dose of Symbicort Turbuhaler. Upon achieving complete control of the symptoms of bronchial asthma against the background of the minimum recommended dose of the preparation, at the next stage, you can try the appointment of monotherapy with inhaled GCS.
There are two approaches to prescribing therapy with Symbicort Turbuhaler:
- as maintenance therapy: the preparation is prescribed for continuous maintenance therapy in combination with a separate short-acting β2-adrenostimulant to relieve seizures;
- as supportive therapy and for relief of seizures: the preparation is prescribed both for continuous maintenance therapy and on demand when symptoms appear.
Symbicort Turbuhaler as supportive therapy. The patient must always carry a separate inhaler with a short-acting β2-adrenostimulant to relieve seizures.
Adults (18 and over). Symbicort Turbuhaler 80 / 4.5 mcg / dose and 160 / 4.5 mcg / dose - 1-2 inhalations 2 times a day. If necessary, it is possible to increase the dose up to 4 inhalations 2 times a day.
Teenagers (12-17 years old). Symbicort Turbuhaler 80 / 4.5 mcg / dose and 160 / 4.5 mcg / dose - 1-2 inhalations 2 times a day.
Children over 6 years old. Symbicort Turbuhaler 80 / 4.5 mcg / dose - 1-2 inhalations, 2 times a day.
Children under 6 years old. Symbicort Turbuhaler is not recommended for children under 6 years old.
After achieving optimal control of the symptoms of bronchial asthma when taking the preparation 2 times a day, it is recommended to titrate the dose to the minimum effective dose, up to taking the preparation once a day in cases where, according to the doctor, the patient needs supportive therapy in combination with a long-acting bronchodilator in combinations with inhaled corticosteroids.
An increase in the use of short-acting β2-adrenostimulants is an indicator of a deterioration in overall disease control and requires a revision of anti-asthma therapy.
Symbicort Turbuhaler as supportive therapy and for relief of seizures. Symbicort Turbuhaler can be prescribed both as continuous maintenance therapy and as on-demand therapy when seizures occur. The patient must always have Symbicort Turbuhaler with him to relieve seizures.
Symbicort Turbuhaler as supportive therapy and for relief of seizures is especially indicated for patients:
- with insufficient control of bronchial asthma and the need for frequent use of preparations to relieve attacks;
- a history of exacerbations of bronchial asthma requiring medical intervention.
Careful monitoring of dose-dependent side effects is required in patients using a large number of inhalations to stop seizures.
Adults and adolescents (12 years and older). The recommended dose for maintenance therapy is 2 inhalations per day, 1 inhalations are taken in the morning and in the evening, or 2 inhalations once, only in the morning or only in the evening. For some patients, a maintenance dose of Symbicort Turbuhaler 160 + 4.5 μg / dose 2 inhalations 2 times a day may be prescribed. If symptoms occur, it is necessary to prescribe 1 additional inhalation. With a further increase in symptoms, 1 additional inhalation is prescribed for several minutes, but no more than 6 inhalations to stop 1 attack.
Usually, the appointment of more than 8 inhalations per day is not required, however, the number of inhalations can be increased to 12 per day for a short time. Patients receiving more than 8 inhalations per day are advised to seek medical attention to review therapy.
Children under 12 years of age: Symbicort Turbuhaler is not recommended for children as supportive therapy and for relief of seizures.
COPD.
Adults: 2 inhalations of Symbicort Turbuhaler 160 + 4.5 mcg / dose 2 times a day.
There is no need for a special selection of the dose of the preparation for elderly patients.
There is no data on the use of Symbicort Turbuhaler in patients with renal or hepatic insufficiency. Since budesonide and formoterol are mainly excreted with the participation of hepatic metabolism, a slowdown in the rate of excretion of the preparation can be expected in patients with severe liver cirrhosis.
Instructions for the correct use of Turbuhaler.
The mechanism of action of Turbuhaler. When inhaled by the patient through the mouthpiece, the preparation enters the respiratory tract.
It is important to instruct the patient about the following:
- it is necessary to carefully study the instructions for use of Turbuhaler;
- inhale strongly and deeply through the mouthpiece to ensure that the optimal dose of the preparation reaches the lungs;
- never exhale through the mouthpiece;
- it is necessary to rinse your mouth with water after inhalation of 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 feel the taste or feel the preparation after using Turbuhaler, which is due to the small amount of the substance being delivered.
Turbuhaler is a multi-dose inhaler that allows you to dose and inhale the preparation in very small doses. When the patient inhales, the Turbuhaler powder is delivered to the lungs. Therefore, it is important that the patient inhales strongly and deeply through the mouthpiece.
Before using Turbuhaler for the first time, it must be prepared for work:
1. Unscrew and remove the cover.
2. Hold the inhaler upright with the red dispenser facing down. Do not hold the inhaler by the mouthpiece when turning the dispenser. Turn the dispenser all the way in one direction (it does not matter, clockwise or counterclockwise), and then also all the way in the opposite direction. A click will be heard as the dispenser rotates. Perform the described procedure twice.
Now the inhaler is ready for use, and the patient does not have to repeat this procedure for preparing Turbuhaler for work before each use. In order to take the preparation, you must follow the instructions below.
How to use Symbicort Turbuhaler.
For a single dose, follow the procedure below.
1. Unscrew and remove the cover.
2. Hold the inhaler upright with the red dispenser facing down. Do not hold the inhaler by the mouthpiece when turning the dispenser. 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. Carefully place the mouthpiece between your teeth, purse your lips and inhale strongly 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, steps 2-5 must be repeated.
7. Close the inhaler with the lid, check that it is tightly screwed on.
8. Rinse mouth with water without swallowing.
Do not try to remove the mouthpiece as it is attached to the inhaler and cannot be removed. The Turbuhaler mouthpiece rotates but should not be turned unnecessarily.
Since the amount of powder inhaled is very small, the patient may not taste the powder after inhalation.
However, if the patient has followed the instructions, then he can be sure that he has inhaled (inhaled) the required dose of the preparation.
If the patient, before taking the preparation, mistakenly repeated the procedure for loading the inhaler more than 1 time, during inhalation he will still receive 1 dose of the preparation. While the dose indicator will show the total number of doses measured.
The sound the patient hears while shaking the inhaler is produced by the desiccant, not the medication.
How to know when an inhaler needs to be replaced.
The dose indicator shows the approximate number of doses remaining in the inhaler, the counting of doses of the filled Turbuhaler starts from the 60th or 120th dose (depending on the total number of doses of the purchased Turbuhaler).
The indicator shows an interval of 10 doses, so it does not show every metered (loaded) dose.
The patient can be sure that Turbuhaler is delivering the required dose of the preparation, even if he does 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 preparation left in Turbuhaler. When the number 0 appears on a red background in the middle of the dose window, the inhaler must be replaced with a new one.
It should be noted 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.
Regularly (once a week) clean the outside of the mouthpiece with a dry cloth.
Do not use water or other liquids to clean the mouthpiece.
Disposal.
It is necessary to be careful with the used inhaler, it should be remembered that a certain amount of the preparation may remain inside the inhaler.
Formoterol.
Symptoms Tremor, headache, heart palpitations. In some cases, the development of tachycardia, hyperglycemia, hypokalemia, lengthening of the QTc interval, arrhythmias, nausea and vomiting were reported.
Treatment. Supportive, symptomatic.
If it is necessary to cancel Symbicort Turbuhaler due to an overdose of formoterol, which is part of the combined preparation, you should consider the appointment of an appropriate GCS.
Budesonide.
Symptoms In acute overdose of budesonide, even in significant doses, clinically significant effects are not expected. With chronic administration of excessive doses, a systemic effect of GCS, such as hypercortisolism and suppression of adrenal function, may occur.
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