Pulmicort Turbuhaler powder for inhalation dosed 100 mcg/dose, 200 doses

Pharmacological properties of the drug Pulmicort turbuhaler

Pharmacodynamics . Budesonide (INN - budesonidum - budesonide) is a GCS with a pronounced local anti-inflammatory effect. The exact mechanism of action of GCS in the treatment of asthma has not been fully elucidated. Anti-inflammatory effects such as inhibition of the release of inflammatory mediators and inhibition of the cytokine-mediated immune response are of primary importance. The affinity of budesonide for GCS receptors is approximately 15 times higher than that of prednisolone. The anti-inflammatory effect causes a decrease in bronchial obstruction both at the early and late stages of the allergic reaction. Budesonide reduces the activity of histamine and methacholine in the airways in patients with hyperresponsiveness. Studies have demonstrated that the sooner budesonide is started after the onset of an asthma attack, the greater the improvement in lung function that can be expected. A study of the use of Pulmicort Turbuhaler in healthy volunteers showed a dose-dependent effect on the content of cortisol in blood plasma and urine. When used in recommended doses, Pulmicort Turbuhaler has a significantly less effect on adrenal function than prednisone at a dose of 10 mg, which was shown in ACTH tests. In children over 5 years of age, no systemic effects were observed when using doses up to 400 mcg per day. Biochemical signs of systemic action of the drug may occur when taking the drug at a dose of 400 to 800 mcg per day; When using a dose of 800 mcg per day, such signs are common. Asthma, as well as the use of inhaled corticosteroids, can cause growth retardation. Observations of children and adolescents receiving budesonide for a long period (up to 13 years) showed that the growth of patients reached the expected levels for adults. Inhaled budesonide therapy has been shown to be effective in preventing exercise-induced asthma. Pharmacokinetics . Absorption. After inhaled administration, budesonide is rapidly absorbed. Cmax in blood plasma is achieved within 30 minutes after inhalation. In studies, the average accumulation of budesonide in the lungs after inhalation through Turbuhaler was 25–35% of the administered dose. Systemic bioavailability is about 38%. Distribution and metabolism. Plasma protein binding is approximately 90%. The volume of distribution is approximately 3 l/kg. Budesonide undergoes significant (about 90%) first-pass metabolism in the liver to metabolites with low glucocorticosteroid activity. The GCS activity of the main metabolites, 6β-hydroxybudesonide and 16α-hydroxyprednisolone, is less than 1% of the activity of budesonide. Removal . Budesonide is eliminated by metabolism catalyzed primarily by the CYP3A4 enzyme. Metabolites are excreted in the urine in unchanged or conjugated form. Only a small amount of unchanged budesonide is detected in the urine. Budesonide has a high systemic clearance (approximately 1.2 l/min), its T1/2 from blood plasma after intravenous administration averages 4 hours. The pharmacokinetic parameters of budesonide are proportional to the dose at clinically significant doses. The pharmacokinetics of budesonide in patients with impaired renal function is unknown. The effect of budesonide may be increased in patients with liver disease.

Pulmicort 0.25 mg/ml 2 ml 20 pcs. dosed suspension for inhalation

pharmachologic effect

Antiallergic, anti-inflammatory, glucocorticoid.

Composition and release form Pulmicort 0.25 mg/ml 2 ml 20 pcs. dosed suspension for inhalation

Dosed suspension for inhalation - 1 ml:

• active substance: budesonide (micronized) - 0.25/0.5 mg;
• excipients: sodium chloride - 8.5 mg; sodium citrate - 0.5 mg; disodium edetate (sodium salt of ethylenediaminetetraacetic acid disubstituted, disodium salt EDTA) - 0.1 mg; polysorbate 80 - 0.2 mg; citric acid (anhydrous) - 0.28 mg; purified water - up to 1 ml.

Suspension for inhalation dosed, 0.25 mg/ml and 0.5 mg/ml. 2 ml of the drug in a LDPE container. 5 containers are connected into 1 sheet. A sheet of 5 containers is packaged in a laminated foil envelope. 4 envelopes in a cardboard box.

Description of the dosage form

An easily resuspended, white or off-white, sterile suspension in LDPE containers containing a single dose.

Directions for use and doses

Inhalation. The dose of the drug is selected individually. If the recommended dose does not exceed 1 mg/day, the entire dose of the drug can be taken at one time (at a time). If you take a higher dose, it is recommended to divide it into 2 doses.

Recommended starting dose

Children from 6 months and older - 0.25–0.5 mg/day. If necessary, the dose can be increased to 1 mg/day.

Adults/elderly patients - 1-2 mg/day.

Maintenance dose

Children from 6 months and older - 0.25–2 mg/day.

Adults - 0.5–4 mg/day. In case of severe exacerbations, the dose may be increased.

* Should be diluted with 0.9% sodium chloride solution to a volume of 2 ml.

It is advisable to determine the minimum effective maintenance dose for all patients.

If it is necessary to achieve an additional therapeutic effect, it is possible to recommend increasing the daily dose of Pulmicort® (up to 1 mg/day) instead of combining the drug with oral corticosteroids, due to the lower risk of developing systemic effects.

Patients receiving oral corticosteroids

Cancellation of oral corticosteroids should begin against the background of a stable health condition of the patient. For 10 days, it is necessary to take a high dose of Pulmicort® while taking oral corticosteroids at the usual dose. Subsequently, over 1 month, the dose of oral corticosteroids (for example, 2.5 mg of prednisolone or its analogue) should be gradually reduced to the minimum effective dose. In many cases, it is possible to completely stop taking oral corticosteroids.

Since Pulmicort®, administered as a suspension through a nebulizer, enters the lungs when inhaled, it is important to instruct the patient to inhale the drug through the nebulizer mouthpiece calmly and evenly.

There are no data on the use of budesonide in patients with renal failure or impaired liver function. Taking into account the fact that budesonide is eliminated by biotransformation in the liver, an increase in the duration of action of the drug can be expected in patients with severe liver cirrhosis.

Stenosing laryngotracheitis (false croup)

Children from 6 months and older - 2 mg/day. The dose of the drug can be taken at one time (at a time) or divided into 2 doses of 1 mg each with an interval of 30 minutes.

Using Pulmicort® using a nebulizer

Pulmicort® is used for inhalation using an appropriate nebulizer equipped with a mouthpiece and a special mask. The nebulizer is connected to a compressor to create the required air flow (5–8 l/min); the filling volume of the nebulizer should be 2–4 ml.

It is important to inform the patient about the following:

• you must carefully read the instructions for use of the drug;
• Ultrasonic nebulizers are not suitable for the use of Pulmicort® suspension;
• Pulmicort® suspension is mixed with 0.9% sodium chloride solution or with solutions of terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglycate and ipratropium bromide; the diluted suspension is used within 30 minutes;
• after inhalation, you should rinse your mouth with water to reduce the development of oropharyngeal candidiasis;
• to prevent skin irritation, after using the mask, rinse your face with water;
• It is recommended to regularly clean the nebulizer in accordance with the manufacturer's instructions.

In cases where a child cannot independently inhale through a nebulizer, a special mask is used.

How to use Pulmicort® using a nebulizer

1. Before use, gently shake the container with a gentle swirling motion.
2. Hold the container straight upright and open it by turning and tearing off the “wing”.
3. Carefully place the open end of the container into the nebulizer and slowly squeeze out the contents of the container.

The container containing a single dose is marked with a line. If the container is turned upside down, this line will show a volume of 1 ml.

If only 1 ml of suspension is to be used, squeeze out the contents of the container until the surface of the liquid reaches the level indicated by the line.

Store the opened container in a place protected from light. An opened container must be used within 12 hours.

Before using the remaining liquid, carefully shake the contents of the container with a rotational motion.

Note

1. After each inhalation, rinse your mouth with water.
2. If the patient uses a mask, make sure that the mask fits tightly to the face when inhaling. Wash your face after inhalation.

Cleaning

The nebulizer chamber, mouthpiece or mask should be cleaned after each use.

Wash the nebulizer chamber, mouthpiece or mask with warm water using a mild detergent or in accordance with the manufacturer's instructions. Rinse and dry the nebulizer well by connecting the chamber to the compressor or air inlet valve.

Pharmacodynamics

Budesonide, an inhaled corticosteroid, 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 corticosteroids. Reduces the severity of edema of the bronchial mucosa, mucus production, sputum formation and airway hyperreactivity. It is well tolerated during long-term treatment and does not have mineralocorticosteroid activity.

The time for the onset of the therapeutic effect after inhalation of one dose of the drug is several hours. The maximum therapeutic effect is achieved 1–2 weeks after treatment. Budesonide has a preventive effect on the course of bronchial asthma and does not affect the acute manifestations of the disease.

A dose-dependent effect on the content of cortisol in plasma and urine while taking Pulmicort® was shown. At recommended doses, the drug has significantly less effect on adrenal function than prednisone at a dose of 10 mg, as shown in ACTH tests.

Pharmacokinetics

Absorption. Inhaled budesonide is rapidly absorbed. In adults, the systemic bioavailability of budesonide after inhalation of Pulmicort® suspension through a nebulizer is approximately 15% of the total prescribed dose and about 40–70% of the delivered dose. Cmax in blood plasma is achieved 30 minutes after the start of inhalation.

Metabolism and distribution. Plasma protein binding averages 90%. Vd of budesonide is approximately 3 l/kg. After absorption, budesonide undergoes intense biotransformation (more than 90%) in the liver with the formation of metabolites with low glucocorticosteroid activity. The glucocorticosteroid activity of the main metabolites 6β-hydroxy-budesonide and 16α-hydroxyprednisolone is less than 1% of the glucocorticosteroid activity of budesonide.

Excretion. Budesonide is metabolized mainly by the enzyme CYP3A4. Metabolites are excreted unchanged in the urine or in conjugated form. Budesonide has a high systemic clearance (about 1.2 l/min). The pharmacokinetics of budesonide is proportional to the administered dose of the drug.

The pharmacokinetics of budesonide in children and patients with impaired renal function have not been studied. In patients with liver disease, the residence time of budesonide in the body may increase.

Indications for use Pulmicort 0.25 mg/ml 2 ml 20 pcs. dosed suspension for inhalation

• bronchial asthma requiring maintenance therapy with corticosteroids;
• chronic obstructive pulmonary disease (COPD);
• stenosing laryngotracheitis (false croup).

Contraindications

• hypersensitivity to budesonide;
• children's age up to 6 months.

With caution (more careful monitoring of patients is required): in patients with active pulmonary tuberculosis; fungal, viral, bacterial infections of the respiratory system, cirrhosis of the liver; When prescribing, the possible manifestation of the systemic effect of GCS should be taken into account.

Application Pulmicort 0.25 mg/ml 2 ml 20 pcs. suspension for inhalation, dosed during pregnancy and breastfeeding

Observation of pregnant women taking budesonide did not reveal developmental abnormalities in the fetus; however, the risk of their development cannot be completely excluded, therefore, during pregnancy, due to the possibility of worsening the course of bronchial asthma, the minimum effective dose of budesonide should be used.

Budesonide passes into breast milk, however, when using Pulmicort® in therapeutic doses, no effect on the child was noted. Pulmicort® can be used during breastfeeding.

special instructions

To minimize the risk of fungal infection of the oropharynx, the patient should be instructed to thoroughly rinse the mouth with water after each inhalation of the drug.

Co-administration of budesonide with ketoconazole, itraconazole or other potential CYP3A4 inhibitors should be avoided. If budesonide and ketoconazole or other potential CYP3A4 inhibitors have been prescribed, the time between doses should be increased to the maximum possible.

Due to the possible risk of weakening adrenal function, special attention should be paid to patients who are switching from oral corticosteroids to taking Pulmicort®. Also, special attention should be paid to patients who have taken high doses of corticosteroids or who have been receiving the highest recommended doses of inhaled corticosteroids for a long time. In stressful situations, these patients may exhibit signs and symptoms of adrenal insufficiency. In case of stress or in cases of surgical intervention, it is recommended to carry out additional therapy with systemic corticosteroids.

Particular attention should be paid to patients who are transferred from systemic to inhaled GCS (Pulmicort®), or in cases where a violation of the pituitary-adrenal function can be expected. In such patients, the dose of systemic corticosteroids should be reduced with extreme caution and the hypothalamic-pituitary-adrenal function should be monitored. Patients may also require the addition of oral corticosteroids during stressful situations, such as trauma or surgery.

When switching from oral corticosteroids to Pulmicort®, patients may experience previously observed symptoms, such as muscle pain or joint pain. In such cases, a temporary increase in the dose of oral corticosteroids may be necessary. In rare cases, symptoms such as fatigue, headache, nausea and vomiting may occur, indicating systemic insufficiency of GCS.

Replacing oral corticosteroids with inhaled ones sometimes leads to the manifestation of concomitant allergies (for example, rhinitis and eczema), which were previously treated with systemic drugs.

In children and adolescents receiving treatment with corticosteroids (regardless of the method of delivery) for an extended period, it is recommended to regularly monitor growth parameters. When prescribing GCS, the balance between the benefits of using the drug and the possible risk of growth retardation should be taken into account.

The use of budesonide at a dose of up to 400 mcg/day in children over 3 years of age did not lead to systemic effects. Biochemical signs of a systemic effect of the drug may occur when taking the drug at a dose of 400 to 800 mcg/day. When the dose exceeds 800 mcg/day, systemic effects of the drug are common.

The use of corticosteroids for the treatment of bronchial asthma may cause growth impairment. The results of observations of children and adolescents receiving budesonide for a long period (up to 11 years) showed that the growth of patients reaches the expected normative indicators for adults.

Therapy with inhaled budesonide 1 or 2 times a day has shown effectiveness for the prevention of bronchial asthma due to physical exertion.

Impact on the ability to drive a car or use other machinery. Pulmicort® does not affect the ability to drive a car or use other machinery.

Overdose

Symptoms: in case of acute overdose, no clinical manifestations occur. With prolonged use of the drug in doses significantly higher than recommended, a systemic glucocorticosteroid effect may develop in the form of hypercortisolism and suppression of adrenal function.

Side effects Pulmicort 0.25 mg/ml 2 ml 20 pcs. dosed suspension for inhalation

The incidence of undesirable effects is presented as follows: often (>1/100.1/1000.1/10000,

From the respiratory tract: often - oropharyngeal candidiasis, irritation of the mucous membrane of the throat, cough, hoarseness, dry mouth; rarely - bronchospasm.

General: rarely - angioedema, headache.

On the skin: rarely - bruising of the skin, rash, contact dermatitis, urticaria.

From the side of the central nervous system: rarely - nervousness, excitability, depression, behavioral disorders.

Taking into account the risk of developing oropharyngeal candidiasis, the patient should thoroughly rinse his mouth with water after each inhalation of the drug.

In rare cases, symptoms caused by the systemic effect of corticosteroids, including adrenal hypofunction, may occur.

There have been cases of facial skin irritation when using a nebulizer with a mask. To prevent irritation, your face should be washed with water after using the mask.

Drug interactions

There was no interaction of budesonide with other drugs used in the treatment of bronchial asthma.

Ketoconazole (200 mg once daily) increases plasma concentrations of oral budesonide (3 mg once daily) by an average of 6-fold when administered together. When taking ketoconazole 12 hours after taking budesonide, the concentration of the latter in the blood plasma increased by an average of 3 times. There is no information on such an interaction when taking budesonide in the form of inhalation, but it is assumed that in this case an increase in the concentration of budesonide in the blood plasma should be expected. If it is necessary to take ketoconazole and budesonide, the time between doses of the drugs should be increased to the maximum possible. A dose reduction of budesonide should also be considered. Another potential inhibitor of CYP3A4 (eg itraconazole) also significantly increases plasma concentrations of budesonide.

Pre-inhalation of beta-agonists dilates the bronchi, improves the entry of budesonide into the respiratory tract and enhances its therapeutic effect.

Phenobarbital, phenytoin, rifampicin reduce the effectiveness (induction of microsomal oxidation enzymes) of budesonide.

Methandrostenolone and estrogens enhance the effect of budesonide.

Use of the drug Pulmicort turbuhaler

Dosing is individual. Recommended doses of the drug in case of initiation of inhaled glucocorticosteroid therapy, during exacerbations of severe asthma, as well as when reducing the dose or discontinuing oral corticosteroids, are as follows: children aged 5–7 years : 100–400 mcg per day (total daily dose of the drug can be divided into 2–4 inhalations). The daily dose of the drug can be taken at one time (one time). Children aged 7 years and older : 100–800 mcg per day (the total daily dose of the drug can be divided into 2–4 inhalations). If the recommended dose is ≤400 mcg, then the entire dose can be taken at one time. Adults : Usual doses are 200–800 mcg per day (the total daily dose of the drug can be divided into 2–4 inhalations). In the most severe cases, the daily dose can be increased to 1600 mcg. If the recommended dose does not exceed 400 mcg/day, the entire dose of the drug can be taken at one time (one time). The maintenance dose should be as low as possible. It is possible that when using Pulmicort Turbuhaler the patient will not feel the taste of the medicine; this is due to the small particle size of the substance that is released during its use. The time for the onset of the therapeutic effect after inhalation of one dose of the drug is several hours. The full therapeutic effect is achieved several weeks after treatment. Treatment with Pulmicort Turbuhaler is preventive and has no proven effect on acute symptoms of the disease. If a patient in a stable condition is transferred from Pulmicort in the form of a metered dose inhaler to Pulmicort Turbuhaler, the possibility of reducing the daily dose of budesonide should be considered. To enhance the therapeutic effect, it is possible to recommend increasing the daily dose of Pulmicort Turbuhaler instead of combining the drug with oral corticosteroids, due to the lower risk of developing systemic effects. Patients using oral steroids When replacing therapy with oral steroids, the patient should be in a relatively stable condition. For 10 days, a high dose of Pulmicort Turbuhaler is used in combination with the dose of an oral steroid that was used previously. Thereafter, the oral dose should be gradually reduced to the lowest possible level, for example, 2.5 mg of prednisolone or equivalent per month. Often, the use of an oral steroid can be stopped completely. There is no experience in treating patients with impaired hepatic and renal function. Since budesonide is eliminated primarily by hepatic metabolism, caution is required when used in patients with severe liver cirrhosis. Instructions for the correct use of Pulmicort Turbuhaler . The active substance enters the patient's respiratory tract along with the air flow during active inhalation through the Turbuhaler. It is important to instruct the patient to:

• compliance with the instructions for use;
• inhale forcefully and deeply through the nozzle to ensure that the optimal dose reaches the lungs;
• never exhale through the nozzle;
• after use, close Pulmicort Turbuhaler with a cap;
• Rinse your mouth with water after inhaling a maintenance dose to minimize the risk of oral candidiasis.

Pulmicort turbuhaler 200mcg/dose 100doses dosed powder for inhalation

Latin name

Pulmicort Turbuhaler

Release form

Powder for inhalation.

Package

A plastic inhaler contains 100 doses of the drug. There is 1 inhaler in a cardboard box.

pharmachologic effect

Budesonide is a glucocorticosteroid with strong local anti-inflammatory effects.

The exact mechanism of action of glucocorticosteroids in the treatment of bronchial asthma is not completely clear.

The anti-inflammatory effects of Pulmicort Turbuhaler, such as inhibition of the release of inflammatory mediators and cytokine-mediated immune responses, are perhaps most important.

The affinity of budesonide for glucocorticosteroid receptors is 15 times higher than that of prednisolone.

The anti-inflammatory effect of budesonide is mediated by a decrease in the degree of airway obstruction during the early and late allergic response.

Budesonide reduces airway reactivity in response to inhaled histamine and methacholine.

The sooner treatment with budesonide is started after the diagnosis of persistent bronchial asthma is made, the greater the improvement in lung function should be expected.

A dose-dependent effect on the content of cortisol in plasma and urine while taking Pulmicort Turbuhaler was shown.

At recommended doses, the drug has significantly less effect on adrenal function than prednisone at a dose of 10 mg, as shown in ACTH tests.

The use of budesonide at a dose of up to 400 mcg per day in children over 3 years of age did not lead to systemic effects.

Biochemical signs of a systemic effect of the drug may occur when taking the drug at a dose of 400 to 800 mcg per day.

When the dose exceeds 800 mcg per day, systemic effects of the drug are common. The use of glucocorticosteroids for the treatment of bronchial asthma may cause growth impairment.

The results of observations of children and adolescents receiving budesonide for a long period (up to 11 years) showed that the growth of patients reaches the expected normative indicators for adults.

Therapy with inhaled budesonide once or twice daily has been shown to be effective in preventing exercise-induced asthma.

Indications

— Bronchial asthma, requiring maintenance therapy with glucocorticosteroids to control the inflammatory process.

— Chronic obstructive pulmonary disease (COPD).

Contraindications

- Hypersensitivity to budesonide.

— Children under 6 years of age.

Use during pregnancy and breastfeeding

When pregnant women take budesonide, no increase in the risk of developmental abnormalities in the fetus has been identified; however, the risk of their development cannot be completely excluded, therefore, during pregnancy, the minimum effective dose of budesonide should be used, not forgetting the possibility of worsening the course of bronchial asthma.

Results from animal studies have shown that corticosteroids may cause abnormalities in fetal development, but these data cannot be extrapolated to humans receiving corticosteroids at recommended doses.

There are no data on the excretion of budesonide into breast milk.

When prescribing the drug, the ratio of the expected benefit to the mother and the potential risk to the child should be taken into account.

special instructions

To minimize the risk of fungal infection of the oropharynx, the patient should be instructed to thoroughly rinse the mouth with water after each inhalation of the drug.

Co-administration of budesonide with ketoconazole, itraconazole or other potential CYP3A4 inhibitors should be avoided.

If budesonide and ketoconazole or itraconazole or other potential CYP3A4 inhibitors have been prescribed, the time between doses should be increased to the maximum possible.

Due to the possible risk of weakening pituitary-adrenal function, special attention should be paid to patients who are transferred from oral glucocorticosteroids to taking Pulmicort.

Also, special attention should be paid to patients taking high doses of glucocorticosteroids, or who have been receiving the highest recommended doses of inhaled glucocorticosteroids for a long time.

In stressful situations, these patients may exhibit signs and symptoms of adrenal insufficiency.

In case of stress or in cases of surgical intervention, additional therapy with systemic glucocorticosteroids is recommended.

Particular attention should be paid to patients who are transferred from systemic to inhaled glucocorticosteroids (Pulmicort Turbuhaler), or in cases where a violation of the pituitary-adrenal function can be expected.

In such patients, the dose of systemic glucocorticosteroids should be reduced with extreme caution and adrenal hormonal function should be monitored.

Patients may also need to be prescribed oral glucocorticosteroids during stressful situations such as trauma, surgery, etc.

When switching from oral glucocorticosteroids to Pulmicort Turbuhaler, patients may experience previously observed symptoms, such as muscle pain or joint pain.

In such cases, a temporary increase in the dose of oral corticosteroids may be necessary.

In rare cases, symptoms such as fatigue, headache, nausea and vomiting may occur, indicating systemic glucocorticosteroid deficiency.

Replacing oral glucocorticosteroids with inhaled ones sometimes leads to the manifestation of existing allergies, rhinitis and eczema, which were previously treated with systemic drugs.

In children and adolescents receiving treatment with glucocorticosteroids (regardless of the method of delivery) for an extended period, it is recommended to regularly monitor growth parameters.

Patients should be instructed to contact their physician if the effectiveness of therapy with short-acting bronchodilators decreases, since an independent increase in the frequency of use of the drug may lead to a delay in the initiation of adequate treatment.

In case of sudden deterioration of the condition, it is necessary to consider the possibility of a course of treatment with oral glucocorticosteroids.

Effect on the ability to drive a car or other mechanisms: Pulmicort Turbuhaler does not affect the ability to drive a car or other mechanisms.

Compound

1 dose of powder for inhalation contains: Budesonide 200 mcg.

Directions for use and doses

The dose of Pulmicort Turbuhaler is selected individually.

The recommended doses of the drug in case of initiation of inhaled glucocorticosteroid therapy during severe exacerbations of bronchial asthma, as well as against the background of dose reduction or discontinuation of oral glucocorticosteroids, are as follows:

Children over 8 years old:

100-800 mcg/day (the total daily dose of the drug can be divided into 2-4 inhalations). If the recommended dose does not exceed 400 mcg/day, the entire dose of the drug can be taken at one time (at one time). In children, the transition to a single dose of the drug should be carried out under the supervision of a pediatrician.

Adults:

The usual dose is 200-800 mcg/day (the total daily dose of the drug can be divided into 2-4 inhalations). For the treatment of severe exacerbation of bronchial asthma, the daily dose can be increased to 1600 mcg. If the recommended dose does not exceed 400 mcg/day, the entire dose of the drug can be taken at one time (one time). When selecting a maintenance dose, it is necessary to strive to prescribe the minimum effective dose.

Use in patients receiving oral glucocorticosteroids:

Cancellation of oral glucocorticosteroids should be carried out against the background of a stable health condition of the patient. For 10 days, it is recommended to take a high dose of Pulmicort while taking oral glucocorticosteroids in a selected dose. Subsequently, the dose of oral glucocorticosteroids should be gradually reduced (for example, 2.5 mg of prednisolone or its analogue) to the minimum possible level. In many cases, it is possible to completely stop taking oral glucocorticosteroids.

Use in patients with impaired liver and/or kidney function:

There are no data on the use of budesonide in patients with renal failure or impaired liver function. Taking into account the elimination of budesonide due to biotransformation in the liver, an increase in the duration of action of the drug can be expected in patients with severe liver cirrhosis.

The time for the onset of the therapeutic effect after inhalation of one dose of the drug is several hours.

The maximum therapeutic effect is achieved 1-2 weeks after treatment.

Pulmicort Turbuhaler has a preventive effect on the course of bronchial asthma and does not affect the acute manifestations of the disease.

The effectiveness of budesonide has been demonstrated to be better when using Turbuhaler compared to a similar dose of budesonide in the form of a metered-dose aerosol.

If a patient in stable condition is transferred from Pulmicort aerosol to Pulmicort Turbuhaler, the possibility of reducing the daily dose of budesonide should be considered.

To enhance the therapeutic effect, it is possible to recommend increasing the daily dose of Pulmicort Turbuhaler instead of combining the drug with oral glucocorticosteroids, due to the lower risk of developing systemic effects.

— Instructions for the correct use of Turbuhaler: The drug contained in Turbuhaler enters the patient’s respiratory tract along with air flows when actively inhaling through the Turbuhaler mouthpiece. Attention: It is important to convince the patient to carefully read the instructions for using Pulmicort Turbuhaler.

— To be sure that the optimal dose of the drug reaches the lungs, inhale deeply and forcefully through the Turbuhaler mouthpiece.

- Do not exhale through the mouthpiece under any circumstances.

— After inhaling the required dose of the drug, rinse your mouth with water in order to minimize the risk of fungal infection of the oropharynx.

Side effects

Up to 10% of patients taking the drug may experience the following side effects:

Frequent (>1/100)

From the respiratory tract:

oropharyngeal candidiasis, irritation of the pharyngeal mucosa, cough, hoarseness.

Rare (<1/1000)

Are common:

angioedema.

From the skin:

urticaria, rash, contact dermatitis.

From the respiratory tract:

bronchospasm.

Neuropsychiatric symptoms such as nervousness, excitability, depression, and behavioral disorders may also be observed. Taking into account the risk of developing oropharyngeal candidiasis, the patient should thoroughly rinse his mouth with water after each inhalation of the drug.

In rare cases, symptoms caused by the systemic effect of corticosteroids, including adrenal hypofunction, may occur.

In rare cases, bruising of the skin has been observed.

Drug interactions

There was no interaction of budesonide with other drugs used in the treatment of bronchial asthma.

Ketoconazole (200 mg once daily) increases plasma concentrations of oral budesonide (3 mg once daily) by an average of 6-fold when administered together.

When taking ketoconazole 12 hours after taking budesonide, the concentration of the latter in the blood plasma increased by an average of 3 times.

There is no information about such an interaction when taking inhaled budesonide, but it is assumed that in this case an increase in the concentration of budesonide in the blood plasma should be expected.

These drugs should not be coadministered due to lack of data.

If it is necessary to prescribe ketoconazole and budesonide together, the time between taking the drugs should be increased to the maximum possible.

A dose reduction of budesonide should also be considered.

Other potential inhibitors of the CYP3A4 enzyme (eg, itraconazole) also cause a significant increase in plasma concentrations of budesonide.

Overdose

In case of an overdose of Pulmicort Turbuhaler in doses significantly higher than recommended, no clinical manifestations occur.

With prolonged use of the drug in doses significantly higher than recommended, a systemic glucocorticosteroid effect may develop in the form of hypercortisolism and suppression of adrenal function.

Storage conditions

— Store at temperatures below 30°C.

— Store out of the reach of children.

— Do not use after the expiration date.

Best before date

2 years.

Conditions for dispensing from pharmacies

On prescription

Side effects of the drug Pulmicort turbuhaler

The number of local side effects that were observed in patients using the drug is up to 10%.

When using inhaled corticosteroids, in order to minimize the risk of candidal infections of the oropharynx, the patient should rinse his mouth with water after each use of the drug. In isolated cases, signs or symptoms of systemic glucocorticoid effects, including adrenal hypofunction, may appear.

Special instructions for the use of the drug Pulmicort turbuhaler

When using inhaled steroids, patients should rinse their mouths with water after each dose, as there is a risk of infection of the oropharynx by fungal microflora. Concomitant treatment with ketoconazole, itraconazole or other strong CYP3A4 inhibitors should be avoided. If cancellation is not possible, the interval between the use of these drugs should be increased as much as possible. Special monitoring is required in patients who have used oral steroids, since they may remain at risk of developing adrenal insufficiency for a long time. Patients who require acute treatment with high doses of corticosteroids or long-term treatment with the highest recommended doses of inhaled corticosteroids may also be considered at risk. These patients may develop signs and symptoms of adrenal insufficiency when under extreme stress. During periods of stress or planned surgical interventions in this group of patients, the possibility of using additional systemic corticosteroids should be considered. When switching from oral steroid therapy to inhaled corticosteroids, patients may experience a recurrence of symptoms such as muscle and joint pain. In such cases, a temporary increase in the dose of the oral steroid may be possible. In isolated cases, symptoms such as fatigue, headache, nausea, vomiting are noted, indicating systemic insufficiency of GCS. Replacing systemic steroid therapy with inhaled corticosteroids sometimes results in allergic manifestations such as rhinitis and eczema, which were previously controlled by systemic medications. In children and adolescents receiving long-term treatment with corticosteroids, regular growth monitoring is recommended, regardless of the form of the drug used. The benefits of GCS therapy should be considered in comparison with the possible risk of growth inhibition. As with other types of inhaled therapy, paradoxical bronchospasm may occur immediately after dosing. If severe reactions occur, treatment should be reconsidered and alternative therapy initiated if necessary. Patients should be advised to contact their physician if the effect of treatment decreases, as repeated inhalations to control severe asthma attacks should not delay the start of other important therapy. If the patient's condition suddenly worsens, therapy should be supplemented with a short course of oral steroids. Decreased liver function may affect the ability to eliminate budesonide. Use during pregnancy and lactation. Data obtained from a study of approximately 2000 women during pregnancy did not reveal an increased risk of developmental disorders that would result from budesonide therapy. Results from animal studies have demonstrated that corticosteroids may cause developmental disorders, however, these data are not considered significant in humans at recommended doses. Animal studies have also shown the effects of excess prenatal corticosteroids on intrauterine growth retardation, cardiovascular disease in adulthood, and persistent changes in glucocorticoid receptor density, neurotransmitter metabolism, and behavior at doses below teratogenic levels. During pregnancy, it is necessary to use the least effective dose of budesonide, taking into account the risk of worsening the course of asthma. Budesonide is excreted into breast milk. The use of budesonide during breastfeeding should only be considered if the expected benefit to the mother outweighs any likely risk to the baby. Children . Do not use in children under 5 years of age. The drug does not affect the ability to drive vehicles or operate machinery .

Pulmicort Turbuhaler powder for inhalation dosed 200 mcg/dose 100 doses bottle 1 pc. in Moscow

To minimize the risk of fungal infection of the oropharynx, the patient should be instructed to thoroughly rinse the mouth with water after each inhalation of the drug.

Co-administration of budesonide with ketoconazole, itraconazole or other potential CYP3A4 inhibitors should be avoided. If budesonide and ketoconazole or itraconazole or other potential CYP3A4 inhibitors have been prescribed, the time between doses should be increased to the maximum possible.

Due to the possible risk of weakening pituitary-adrenal function, special attention should be paid to patients who are transferred from oral corticosteroids to taking Pulmicort®. Also, special attention should be paid to patients who have taken high doses of GCS, or who have been receiving the highest recommended doses of inhaled GCS for a long time. In stressful situations, these patients may exhibit signs and symptoms of adrenal insufficiency. In case of stress or in cases of surgical intervention, it is recommended to carry out additional therapy with systemic corticosteroids.

Particular attention should be paid to patients who are transferred from systemic to inhaled GCS (Pulmicort® Turbuhaler®), or in cases where a violation of the pituitary-adrenal function can be expected. In such patients, the dose of systemic corticosteroids should be reduced with extreme caution and the hormonal function of the adrenal glands should be monitored. Patients may also need to be prescribed oral corticosteroids during stressful situations, such as trauma, surgery, etc.

When switching from oral corticosteroids to Pulmicort® Turbuhaler®, patients may experience previously observed symptoms such as muscle pain or joint pain. In such cases, a temporary increase in the dose of oral corticosteroids may be necessary. In rare cases, symptoms such as fatigue, headache, nausea and vomiting may occur, indicating systemic insufficiency of GCS.

Replacing oral corticosteroids with inhaled ones sometimes leads to the manifestation of existing allergies (for example, rhinitis and eczema), which were previously treated with systemic drugs.

In children and adolescents receiving treatment with corticosteroids (regardless of the method of delivery) for an extended period, it is recommended to regularly monitor growth parameters.

Patients should be instructed to contact their physician if the effectiveness of therapy with short-acting bronchodilators decreases, because An independent increase in the frequency of use of the drug may lead to a delay in the prescription of adequate treatment. In case of sudden deterioration of the condition, it is necessary to consider the possibility of a course of treatment with oral corticosteroids.

Impact on the ability to drive a car or use other machinery.

Pulmicort® Turbuhaler® does not affect the ability to drive a car or use other machinery.

Instructions for the correct use of Turbuhaler®

The drug contained in Turbuhaler® enters the patient's respiratory tract along with air flows when active inhalation is performed through the Turbuhaler® mouthpiece.

Attention:

it is important to convince the patient to carefully read the instructions for using Pulmicort® Turbuhaler®.

To be sure that the optimal dose of the drug has reached the lungs, you need to inhale deeply and forcefully through the Turbuhaler® mouthpiece.

Under no circumstances should you exhale through the mouthpiece.

After inhaling the required dose of the drug, rinse your mouth with water in order to minimize the risk of fungal infection of the oropharynx.

How to use Pulmicort® Turbuhaler®

Turbuhaler® is a multi-dose inhaler that allows you to dose and inhale the drug in very small doses. When the patient inhales, Turbuhaler® powder is delivered to the lungs. Therefore, it is important that the patient inhales forcefully and deeply through the mouthpiece.

Turbuhaler® is very easy to use. You just need to follow the instructions given below:

1. Unscrew and remove the cap.

2. Keep the inhaler upright

, dispenser down. Load the dose into the inhaler by turning the dispenser counterclockwise until it stops, and then turn the dispenser to its original position until it clicks.

3. Exhale

.
Do not exhale through
the mouthpiece.
Before exhaling, remove the inhaler from your mouth.
4. Gently squeeze the mouthpiece between your teeth, purse your lips and inhale deeply and forcefully

through the mouth. The mouthpiece should not be chewed or squeezed tightly with your teeth.

If inhalation of more than one dose is required, repeat steps 2–5.

5. Close the inhaler with the cap.

6. Rinse your mouth with water.

IMPORTANT!

Never exhale through the mouthpiece. Always cap the inhaler tightly after use.

Since the amount of powder inhaled is very small, the patient may not be able to taste the powder after inhalation. However, if he followed the instructions, he can be sure that he inhaled the required dose of the drug.

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.

How do you know if your inhaler is empty?

When a red indicator appears in the dose window, it means there are approximately 20 doses left in the inhaler. The inhaler is empty when the red mark reaches the bottom edge of the dose indicator window.

The sound heard when the inhaler is shaken is produced by the drying agent, not the medication.

Interactions of the drug Pulmicort turbuhaler

There are no data on clinically significant cases of interaction of inhaled corticosteroids with drugs used for asthma. Ketoconazole at a dose of 200 mg 1 time per day increases the plasma concentration of oral budesonide (3 mg 1 time per day) by an average of 6 times when taken simultaneously. When ketoconazole was administered 12 hours after budesonide, the concentration of the latter in the blood plasma increased by an average of 3 times. There is no information about such an interaction regarding inhaled budesonide, however, in this case, a significant increase in its level in the blood plasma is expected. Since there are no data to make dosage recommendations, combinations of these drugs should be avoided. If this is not possible, the interval between the use of ketoconazole and budesonide should be increased if possible. The possibility of reducing the dose of budesonide should also be considered. Other potent CYP3A4 inhibitors, such as itraconazole, also lead to significant increases in budesonide plasma levels.