Foradil combi capsules 12mcg/400 mcg №120

A set of capsules with powder for inhalation.

Capsules with powder for inhalation transparent colorless.

Composition: formoterol fumarate dihydrate 12 mcg

Excipients: lactose monohydrate.

The composition of the shell of the capsule: gelatin.

Capsules with powder for inhalation hard gelatin.

Composition: Budesonide 400 mcg

Excipients: lactose monohydrate.

The composition of the shell of the capsule: iron oxide red (E172), iron oxide black (E172), dye crimson (Ponso 4R), titanium dioxide (E171), gelatin, water.

Pharmacology

A drug with anti-inflammatory and bronchodilatory effects.

Formoterol

Selective β2-adrenoreceptor agonist. It has a bronchodilator effect in patients with both reversible and irreversible airway obstruction. The action of the drug occurs quickly (within 1-3 minutes) and lasts for 12 hours after inhalation. When using the drug in therapeutic doses, the effect on the cardiovascular system is minimal and is noted only in rare cases.

Slows down the release of histamine and leukotrienes from mast cells. In animal experiments, some of the anti-inflammatory properties of formoterol were shown, such as the ability to inhibit the development of edema and the accumulation of inflammatory cells.

In studies conducted in humans, it was shown that Foradil Combi effectively prevents bronchospasm caused by inhaled allergens, exercise, cold air, histamine or methacholine. Since the bronchodilator effect of Foradil Kombi remains pronounced for 12 hours after inhalation, supportive therapy, in which Foradil Kombi is prescribed 2 times / day, makes it possible in most cases to provide the necessary control of bronchospasm in chronic lung diseases both during the day and at night.

In patients with chronic obstructive pulmonary disease (COPD) of a stable course, formoterol causes a rapid onset of a bronchodilator effect and an improvement in quality of life parameters.

Budesonide

Budesonide is a glucocorticosteroid (GCS) for inhalation use, with virtually no systemic effect. Budesonide has anti-inflammatory, anti-allergic and immunosuppressive effects. Increases the production of lipocortin, which is an inhibitor of phospholipase A2, inhibits the release of arachidonic acid, inhibits the synthesis of metabolites of arachidonic acid metabolism - cyclic endoperexia and prostaglandins. Warns neutrophil marginal accumulation, reduces inflammatory exudation and cytokine production, inhibits macrophage migration, reduces the severity of infiltration and granulation processes, the formation of chemotaxis substance (which explains the effectiveness in "late" allergy reactions); inhibits the release of inflammatory mediators from mast cells (immediate allergic reaction).Increases the number of "active" β-adrenergic receptors, restores the patient's response to bronchodilators, allowing them to reduce the frequency of their use, reduces swelling of the bronchial mucosa, mucus production, sputum formation and reduces respiratory tract hyperreactivity. Increases mucociliary transport.

The therapeutic effect of the drug in patients requiring treatment of GCS, develops on average within 10 days after the start of therapy. With regular use in patients with bronchial asthma, budesonide reduces the severity of chronic inflammation in the lungs, and thus improves pulmonary function, the course of bronchial asthma, reduces bronchial hyperreactivity and prevents exacerbations of the disease.

Pharmacokinetics

Formoterol

Suction

After a single inhalation of formoterol fumarate at a dose of 120 mcg to healthy volunteers, formoterol was rapidly absorbed into the plasma, Cmax of formoterol in the plasma was 266 pmol / l and was reached within 5 min after inhalation. In patients with COPD who received formoterol at a dose of 12 μg or 24 μg 2 times / day for 12 weeks, plasma formoterol concentrations, measured 10 minutes, 2 hours and 6 hours after inhalation, were in the ranges of 11.5–25.7 pmol / L and 23.3-50.3 pmol, respectively.

In studies that examined the total excretion of formoterol and its (R, R) - and (S, S) -enantiomers with urine, it was shown that the amount of formoterol in the systemic circulation increases in proportion to the dose of the inhalation dose (12-96 μg).

After inhalation use of formoterol at a dose of 12 mcg or 24 mcg 2 times / day for 12 weeks, the excretion of unchanged formoterol in the urine in patients with asthma increased by 63-73%, and in patients with COPD by 19-38%. This indicates some cumulation of formoterol in the plasma after repeated inhalations. However, there was no greater cumulation of one of the enantiomers of formoterol compared with the others after repeated inhalations.

Just as it was reported for other medicines used in the form of inhalations, most of the formoterol used with the inhaler will be swallowed and then absorbed from the gastrointestinal tract. When prescribing 80 mcg of 3H-labeled formoterol, two healthy volunteers were absorbed at least 65% of formoterol by two healthy volunteers.

Distribution

Binding of formoterol to plasma proteins is 61-64% (with albumin - 34%).

In the range of concentrations noted after the use of the drug in therapeutic doses, the saturation of the binding sites is not achieved.

Metabolism

The main route of metabolism of formoterol is direct glucuronization. Another metabolic pathway is O-demethylation followed by glucuronization.

Unimportant metabolic pathways include conjugation of formoterol with sulfate, followed by deformation. Many isoenzymes are involved in the process of glucuronization (UGT1A1, 1A3, 1A6, 1A7, 1A8, 1A9, 1A10, 2B7 and 2B15) and O-demethylation (CYP2D6, CYP2C19, CYP2C9, CYP2A6) of formoterol, which is supposed to be in the same line, it is in the way to put the line, it is a line, it is a line that it is in the face of the line, and it is in the process of formathromol, but it is in the process of going into the line, or an isoenzyme involved in the metabolism of formoterol.At therapeutic concentrations, formoterol does not inhibit cytochrome P450 system isoenzymes.

Removal

In patients with bronchial asthma and COPD who received formoterol fumarate at a dose of 12 mcg or 24 mcg 2 times / day for 12 weeks, approximately 10% or 7%, respectively, was determined in the urine as unchanged formoterol. The calculated proportions of (R, R) - and (S, S) -enantiomers of unchanged formoterol in urine are 40% and 60%, respectively, after a single dose of formoterol (12-120 mcg) in healthy volunteers and after single and repeated doses of formoterol in patients with bronchial asthma.

The active substance and its metabolites are completely eliminated from the body; about 2/3 of the oral dose is excreted in the urine, and 1/3 from the feces. Renal clearance of formoterol is 150 ml / min.

In healthy volunteers, the final T1 / 2 of formoterol from plasma after a single inhalation at a dose of 120 μg is 10 hours; the final T1 / 2 (R, R) - and (S, S) -enantiomers, calculated by excretion with urine, were 13.9 h and 12.3 h, respectively.

Pharmacokinetics in special clinical situations

After correction for body weight, the pharmacokinetic parameters of formoterol in men and women do not have significant differences.

The pharmacokinetics of formoterol in elderly patients aged 65 years and older has not been studied.

In a clinical study in children aged 5–12 years with bronchial asthma who received formoterol fumarate at a dose of 12 μg or 24 μg 2 times / day for 12 weeks, the excretion of unchanged formoterol in the urine increased by 18–84% compared with the corresponding indicator measured after the first dose.

In clinical studies in children in the urine was determined about 6% of unchanged formoterol.

The pharmacokinetics of formoterol in patients with impaired liver and / or kidney function has not been studied.

Budesonide

Suction

Budesonide is rapidly and completely absorbed after inhalation, while Cmax in the blood plasma is achieved immediately after administration. After inhalation of budesonide, taking into account the sedimentation of the drug on the mucous membrane of the oropharynx, the absolute bioavailability is 73%. Absolute bioavailability when taking the drug inside is ± 10%.

Distribution

Vd is 3 L / kg. Plasma protein binding - 88%. In experimental studies, budesonide accumulated in the spleen, lymph nodes, thymus, adrenal cortex, reproductive organs and bronchi, and also penetrated the placental barrier. Systemic clearance of inhalation drug - 0.5 l / min.

Metabolism

Budesonide is not metabolized in the lungs. After absorption, the drug is almost completely (about 90%) metabolized in the liver with the formation of several inactive metabolites (biological activity is 100 times less compared to budesonide), including 6β-hydroxybudesonide and 16α-hydroxyprednisolone (systemic clearance - 1.4 l / min). Budesonide has a high systemic clearance of 84 l / h and a short T1 / 2 of 2.8 h. The main metabolic pathway of budesonide in the liver using the CYP3A4 isoenzyme of the P450 system can be altered by the action of inhibitors or inducers of CYP3A4.

Removal

T1 / 2 - 2-2.8 h. Excreted through the intestine in the form of metabolites - 10%, kidneys - 70%.

Pharmacokinetics in special clinical situations

Plasma budesonide concentration increases in patients with liver disease.

Bronchial asthma:

- insufficiently controlled intake of inhaled corticosteroids and short-acting beta2-agonists as an on-demand therapy;

- adequately controlled by inhaled corticosteroids and long-acting beta2-agonists.

Chronic obstructive pulmonary disease (COPD) (with proven efficacy of GCS).

Formoterol and budesonide are intended for inhalation use. Preparations are capsules with powder for inhalation, which should be used only with the help of a special device - an arolizer, which is included in the package.

Formoterol and budesonide should be administered individually, in the minimum effective dose.

When controlling the symptoms of bronchial asthma during therapy with formoterol, it is necessary to consider the possibility of gradually reducing the dose of the drug. Reducing the dose of formoterol is carried out under regular medical supervision of the patient. Against the background of exacerbation of asthma should not begin treatment with formoterol or change the dosage of the drug. Formoterol should not be used for relief of acute attacks of bronchial asthma.

When prescribing therapy to a patient using an inhalation device, one should gradually select (titrate) the dose of the drug to doses sufficient to maintain the therapeutic effect.

Foradil is intended for inhalation use in adults and children aged 6 years and older. The drug is a powder for inhalation, used with a special device - airliner, which is included in the package.

Budesonide + formoterol

Adults

Pre-inhalation of beta-adrenostimulyatorov expands the bronchi, improves the flow of budesonide into the respiratory tract and enhances its therapeutic effect. Therefore, for maintenance therapy of bronchial asthma and COPD, inhalation of formoterol is first carried out, then inhalation of budesonide.

1. The dose of formoterol for regular maintenance therapy is 12-24 μg (contents of 1-2 capsules) 2 times / day. Do not exceed the maximum recommended dose of the drug for adults (48 mg / day).

Given that the maximum daily dose of formoterol is 48 μg, if necessary, you can additionally use 12-24 μg / day to relieve symptoms of bronchial asthma. If the need to use additional doses of the drug ceases to be episodic (for example, it becomes more often than 2 days a week), the patient should be advised to consult with a doctor about the revision of therapy, as this may indicate a worsening course of the disease.

2The maintenance dose of budesonide for adult patients is 400-800 mcg / day in 2 doses (200-400 mcg, 2 times / day).

With exacerbation of asthma during the transfer from oral GCS to inhaled or with a decrease in the dose of oral GCS, budesonide can be administered in a dose of 1600 mcg / day in 2-4 doses.

If the dose of budesonide (divided into several doses) is less than 400 mg / day, there is no need to use the drug.

Children ≥6 years old

Pre-inhalation of beta-adrenostimulyatorov expands the bronchi, improves the flow of budesonide into the respiratory tract and enhances its therapeutic effect. Therefore, for the maintenance treatment of bronchial asthma, first inhalation of formoterol is carried out, then inhalation of budesonide.

1. The dose of formoterol for regular maintenance therapy is 12 mcg 2 times / day. The maximum recommended dose of the drug is 24 mg / day.

2. The dose of budesonide for regular maintenance therapy is 100-200 mcg 2 times / day. If necessary, the dose of budesonide can be increased to the maximum - 800 mg / day.

Inhalation rules

In order to ensure the correct use of drugs, a doctor or other medical professional must show the patient how to use the inhaler; explain to the patient that it is necessary to use capsules with powder for inhalation only with the help of an airliser; warn the patient that the capsules are intended for inhalation use only and are not intended for ingestion. In children and adolescents, inhaled budesonide and formoterol should be supervised by adults. It is necessary to make sure that the child correctly performs the inhalation technique. It is important for the patient to understand that, due to the destruction of the gelatin capsule, small pieces of gelatin can be inhaled through the mouth or throat as a result of inhalation. In order to minimize this phenomenon, one should not pierce the capsule more than 1 time.

Remove the capsule from the blister pack immediately before use.

Rinsing the mouth with water after inhalation of budesonide can prevent irritation of the mucous membranes of the mouth and pharynx, as well as reduce the risk of developing systemic adverse events.

Instructions for the use of aerolizer

1. Remove the cap from the aeolizer.

2. Hold the aerolizer firmly by the base and turn the mouthpiece in the direction of the arrow.

3. Place the capsule in the cell located at the base of the aerolizer (it has the shape of a capsule). It should be remembered that removing the capsule from a blister pack should be immediately prior to inhalation.

4. Turning the mouthpiece, close the aeolizer.

5. Holding the aerolizer in a strictly upright position, push the blue buttons on the sides of the aerolizer once to the end. Then let them go.

At this stage, when the capsule is punctured, it may collapse, as a result of which small pieces of gelatin can get into the mouth or throat. Since gelatin is edible, it causes no harm. In order for the capsule not to collapse completely, the following requirements should be fulfilled: do not pierce the capsule more than once; follow the rules of storage; remove the capsule from the blister only immediately prior to inhalation.

6. Make a full exhalation.

7Take the mouthpiece in your mouth and slightly tilt your head back. Grip the mouthpiece tightly with your lips and take a quick, even, deep breath. In this case, the patient should hear the characteristic rattling sound created by rotating the capsule and spraying the powder. If there was no characteristic sound, then you need to open the airliner and see what happened to the capsule. Perhaps she was stuck in a cell. In this case, you need to carefully remove the capsule. In no case do not try to release the capsule by repeated pressing the buttons on the sides of the airliser.

8. If a characteristic sound is heard during inhalation, you should hold your breath as long as possible. At the same time, remove the mouthpiece from the mouth. Then exhale. Open the aeroliser and see if there is any powder remaining in the capsule. If powder remains in the capsule, repeat the steps described in paragraphs 6–8.

9. After the end of the inhalation procedure, open the airliner, take out the empty capsule, close the mouthpiece and close the aerializer with a cap.

To remove powder residues, wipe the mouthpiece and the cell with a dry cloth. You can also use a soft brush.

The adverse reactions reported in clinical trials are distributed according to the frequency of occurrence. The following criteria were used to estimate the frequency: very often (≥ 1/10); often (from ≥ 1/100, <1/10); sometimes (≥ 1/1000, <1/100); rarely (≥ 1/10 000, <1/1000); very rarely (<1/10 000), including individual messages.Within each group, adverse events are distributed in order of decreasing significance.

Formoterol

Allergic reactions: very rarely - hypersensitivity reactions, such as arterial hypotension, urticaria, angioedema, pruritus, exanthema.

From the side of the central nervous system: often - headache, tremor; sometimes - agitation, anxiety, irritability, insomnia, dizziness.

Since the cardiovascular system: often - a feeling of heartbeat; sometimes - tachycardia; very rarely - peripheral edema.

On the part of the respiratory system: sometimes - bronchospasm, including paradoxical, irritation of the mucous membrane of the pharynx and larynx.

On the part of the digestive system: very rarely - nausea, taste disturbances.

From the musculoskeletal system: sometimes - muscle cramps, myalgia.

The following side effects were found when using other dosage forms, which include formoterol: cough and rash.

When using formoterol in clinical practice, the following changes in the results of laboratory tests were noted: hypokalemia, hyperglycemia, lengthening of the QT interval (when conducting an ECG).

Budesonide

On the part of the endocrine system: rarely - suppression of the function of the adrenal cortex, Cushing's syndrome, hypercorticism, growth retardation in children and adolescents.

On the part of the organ of vision: rarely - cataract, glaucoma.

Allergic reactions: rarely - hypersensitivity reactions, rash, urticaria, angioedema, pruritus.

From the side of the central nervous system: rarely - unusual behavior, including depression (described in children).

From the musculoskeletal system: decrease in bone mineral density.

On the part of the respiratory system: often - cough; rarely - paradoxical bronchospasm, candidiasis of the mucous membrane of the oral cavity and larynx, pharynx irritation, dysphonia, disappearing after cessation of budesonide therapy or lowering the dose of the drug.

In a three-year clinical study with budesonide in patients with COPD, there was an increase in the incidence of subcutaneous hematomas (10%) and pneumonia (6%) compared with the placebo group (4% and 3%, with p <0.001 and p <0.01, respectively) .

 Contraindications

• lactation period (breastfeeding);
• active pulmonary tuberculosis;
• hereditary intolerance to galactose, severe lactase deficiency and glucose-galactose impaired absorption syndrome;
• children up to 6 years;
• Hypersensitivity to formoterol, budesonide, or any other component of the drug.

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Formoterol

Observance of special care at application of formoterol (especially from the point of view of a dose reduction) and careful observation of patients is required in the presence of the following associated diseases: IHD; heart rhythm and conduction disturbances, especially AV degree III blockade; severe chronic heart failure ; idiopathic subvalvular aortic stenosis; hypertrophic obstructive cardiomyopathy, aortic aneurysm; thyrotoxicosis; known or suspected lengthening of the QT interval (QT corrected> 0.44 sec), hypokalemia, hypocalcemia and pheochromocytoma.

Given the hyperglycemic effect characteristic of beta-adrenomimetics, including formoterol, in patients with diabetes mellitus, additional regular monitoring of blood glucose concentrations is recommended.

Budesonide

Since budesonide is not effective for the relief of acute bronchospasm, the drug should not be prescribed as the main therapy for asthmatic status or other acute asthmatic conditions.

Caution should be exercised when using budesonide in patients with inactive pulmonary tuberculosis, with fungal, bacterial and viral infections of the respiratory tract, cirrhosis of the liver, glaucoma. Also, given the possibility of the development of fungal infections, it is necessary to prescribe the drug with caution in bronchiectasis and pneumoconiosis.

Capsules formoterol and budesonide contain lactose.

Formoterol

The safety of using Foradil Kombi during pregnancy and lactation has not yet been established.

Use during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus. Formoterol, as well as other beta2-adrenomimetics, can slow down the process of childbirth due to tocolytic action (a relaxing effect on the smooth muscles of the uterus).

It is not known whether formoterol is excreted in human breast milk. When taking Foradil Kombi, breastfeeding should be stopped.

Budesonide

In experimental studies on animals revealed the possible teratogenic effect of GCS on the fetus. There are no data on the teratogenic effect of budesonide or on the presence of reproductive toxicity of a drug when used in humans.

Use during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus. If necessary, the treatment of GCS during pregnancy, they are preferably prescribed in the form of inhalation, because GCS for inhalation use have a smaller systemic effect compared with oral GCS.

It is not known whether budesonide is excreted in human breast milk.

Formoterol

It is shown that the use of formoterol improves the quality of life of patients with COPD.

Formoterol belongs to the class of long-acting beta2-adrenergic mimetics. Against the background of the use of another beta2-adrenergic long-acting, salmeterol, there was an increase in the frequency of deaths associated with bronchial asthma (13 of 13,176 patients) compared with placebo (3 of 13,179 patients). Clinical studies to assess the incidence of deaths associated with bronchial asthma, against the background of the use of formoterol was not conducted.

Anti-inflammatory therapy

Foradil Combi should not be used together with other long-acting β2-adrenoreceptor agonists.

For patients with bronchial asthma, formoterol should be used only as an additional treatment with insufficient effectiveness of other drugs controlling the course of the disease, for example,inhaled GCS (in medium and low doses) or in severe form of the disease, requiring the use of two supporting therapies, including formoterol. When prescribing the drug to patients who do not receive anti-inflammatory therapy, it should be started simultaneously with the use of formoterol. When prescribing formoterol, it is necessary to assess the condition of the patients in relation to the adequacy of the anti-inflammatory therapy they receive. After initiation of treatment with formoterol, patients should be advised to continue the anti-inflammatory therapy unchanged, even if improvement is noted.

For the relief of an acute attack of bronchial asthma, short-acting β2-adrenoreceptor agonists should be used. With a sudden deterioration, patients should immediately seek medical attention.

Severe exacerbations of bronchial asthma

In clinical studies with the use of formoterol, there was a slight increase in the incidence of severe exacerbations of bronchial asthma compared with placebo, incl. for children 5-12 years old.

In placebo-controlled clinical studies in patients receiving formoterol for 4 weeks, there was an increase in the incidence of severe exacerbations of bronchial asthma (0.9% with a dosage regimen of 10-12 μg 2 times / day, 1.9% - with 24 μg 2 times / days) compared with the placebo group (0.3%).

In two large controlled clinical trials,including 1095 adult patients and adolescents 12 years and older, severe exacerbations of bronchial asthma, requiring hospitalization, were more often observed in patients who received formoterol at a dose of 24 μg 2 times / day (9/271, 3.3%), compared with the formoterol groups in a dose of 12 mg 2 times / day (1/275, 0.4%), placebo (2/277, 0.7%) and albuterol (2/272, 0.7%).

When using formoterol for 16 weeks in another large clinical study, which included 2085 adult patients and adolescents, there was no increase in the incidence of severe exacerbations of bronchial asthma, depending on the increase in the dose of formoterol. However, in this study, the incidence of severe exacerbations was higher in the formoterol group (with a dosing regimen of 24 mcg 2 times / day - 2/527, 0.4%, with 12 mcg 2 times / day - 3/527, 0.6%) compared with placebo (1/517, 0.2%). In the open phase of this study with the use of formoterol in a dose of 12 μg 2 times / day (if necessary, patients could use up to two additional doses of the drug), the frequency of severe exacerbations of bronchial asthma was 1/517, 0.2%.

In a 52-week, multicenter, randomized, double-blind clinical study involving 518 children and adolescents aged 5 to 12 years, the incidence of severe exacerbations of bronchial asthma was higher with formoterol at doses of 24 mcg 2 times / day (11/171, 6.4%), 12 mcg 2 times / day (8/171, 4.7%) compared with placebo (0/176, 0.0%).

However, the results of the above clinical studies do not allow to quantify the frequency
development of severe exacerbations of asthma in various groups.

Hypokalemia

The effect of beta2-adrenomimetic therapy, including formoterol, may be the development of potentially severe hypokalemia. Hypokalemia may increase susceptibility to the development of arrhythmias.

Since this effect of the drug can be enhanced by hypoxia and concomitant treatment, special care should be exercised in patients with severe bronchial asthma. In these cases, it is recommended to regularly monitor the concentration of potassium in the serum.

Paradoxical bronchospasm

As with other inhalation therapy, the possibility of the development of paradoxical bronchospasm should be considered. If it occurs, discontinue the drug immediately and prescribe an alternative treatment.

Impact on the ability to drive vehicles and work with mechanisms

Patients who, with the use of the drug formoterol, experience dizziness or other abnormalities on the part of the central nervous system, should refrain from driving or working with mechanisms during the period of use of the drug.

Budesonide

To ensure that budesonide enters the lungs, it is important to instruct patients to properly inhale the drug in accordance with the instructions for use.

It is necessary to inform patients that the drug is not intended to relieve seizures, but for regular daily prophylactic use even in the absence of symptoms of bronchial asthma.

With the development of paradoxical bronchospasm, you should immediately stop using budesonide, evaluate the patient's condition and, if necessary, prescribe therapy with other drugs. Paradoxical bronchospasm should be stopped immediately with short-acting beta2-adrenergic mimic. Patients should always have a short-acting beta2-adrenergic inhaler available to relieve acute exacerbations of bronchial asthma.

It is necessary to inform patients about the need to go to a doctor when the condition worsens (increasing the need for short-acting bronchodilators, intensifying attacks of shortness of breath). In such cases, it is necessary to conduct an examination of the patient and consider the possibility of increasing the dose of inhaled or oral GCS.

To reduce the risk of developing candidal infections of the mouth and pharynx, the patient must thoroughly rinse his mouth with water after each inhalation of the drug. With the development of candidal infections of the oral cavity and pharynx, it is possible to conduct local antifungal therapy without discontinuing treatment with budesonide.

When exacerbation of asthma should increase the dose of budesonide or, if necessary, conduct a short course of systemic corticosteroids and / or prescribe antibiotic therapy during the development of infection.

It is necessary to regularly monitor the growth dynamics of children and adolescents receiving long-term therapy with inhaled GCS.With growth inhibition should consider the need to reduce the dose of inhaled GCS (prescribed in the minimum effective dose) and refer the child for consultation with an allergist. The long-term effects of growth retardation (the effect on the final growth of an adult) in children receiving therapy with inhaled corticosteroids have not been studied. Adequate research into the possibility of compensating for the arisen growth retardation in children after discontinuation of therapy with oral GCS was not conducted.

Budesonide does not usually affect the adrenal function. However, in some patients with prolonged use in recommended daily doses, systemic effects of budesonide may be noted.

When administering inhaled GCS in high doses or over a long period of time, systemic adverse events may develop (but less frequently than with oral GCS), such as suppressing the function of the adrenal cortex, hypercorticism / Cushing syndrome, growth retardation in children and adolescents, bone mineral density, hypersensitivity reactions, cataracts, glaucoma.

Patients with hormone-independent bronchial asthma

In patients with hormone-independent asthma, the therapeutic effect of budesonide develops on average within 10 days after the start of treatment. At the beginning of budesonide therapy in patients with increased bronchial secretion, oral injections may be added to inhalations of the drug with a short course (lasting about 2 weeks).

Patients with hormone-dependent bronchial asthma

When switching from oral administration of GCS to inhalation use of budesonide, patients should be in a relatively stable state.

During the first 10 days, high doses of budesonide are prescribed in combination with previously used oral corticosteroids. Then the daily dose of oral corticosteroids begins to be gradually reduced (2.5 mg each month in terms of prednisone) to the lowest possible level. Do not abruptly interrupt the treatment of corticosteroids, including budesonide.

In the first months after the transition, the patient’s condition should be carefully monitored.