Efficacy and safety of Symbicort 80/4.5 mcg, used in a flexible dosing regimen in children aged 6 to 12 years suffering from bronchial asthma

Symbicort turbuhaler

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

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

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

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

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

Symbicort® Turbuhaler® 320/9 mcg/dose

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

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

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

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

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

There is no data on the use of Symbicort Turbuhaler in patients with renal or hepatic impairment. Because As 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 turbuhaler;
• inhale forcefully 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 fungal infections 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, so it is important that the patient inhales forcefully and deeply through the mouthpiece.

Before using the turbohaler for the first time, you must prepare it for use:

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.

To take one dose, the patient must complete 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. A clicking sound will be heard during this procedure.

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.

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.

SYMBICORT TURBUHALER por. d/inhal. 80+4.5 mcg/dose 60 doses

Directions for use and doses

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, 2-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 reaching the optimal

control of symptoms of bronchial asthma while taking the drug twice a day, it is possible to reduce the dose to the lowest effective dose, up to taking the drug 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 a single 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.