Index of drugs

Treatment of mild, moderate and severe chronic bronchial asthma.

1 dose of inhalation aerosol contains 200 μg of budesonide.

Glucocorticoid with a strong local anti-inflammatory effect. After inhalation of Budesonide, improvement in asthma control may occur within 24 hours of starting treatment, however, the highest treatment efficacy is observed after a few weeks of uninterrupted therapy. Budesonide has a wide range of inhibitory activities on the activity of several cell types (eg eosinophils, macrophages, mast cells, lymphocytes and neutrophils) and mediators (e.g., cytokines, leukotrienes, eicosanoids and histamine) involved in allergic and non-allergic respiratory infections. It reduces excessive secretion, bronchial hyperresponsiveness and bronchial spasms. It is rapidly absorbed through the mucous membrane of the airways. Approx. 20 min after inhaled administration, budesonide forms esters with intracellular fatty acids as a result of reversible coupling, thus extending the local anti-inflammatory action of the drug in the lungs. 10-30% of the dose is excreted into the systemic circulation, after which it is rapidly and extensively metabolised in the liver into less active metabolites. Budesonide is 88% bound to plasma proteins. It is excreted in the urine and faeces in the form of conjugated and unconjugated metabolites. T_0,5 is about 3 hours after inhalation. Budesonide exposure may increase in patients with liver disease. In children, the half-life is much shorter than in adult patients.

Hypersensitivity to the active substance or to any of the excipients.

The drug is not intended to interrupt acute asthma attacks that require the use of short-acting bronchodilators. In patients with peptic ulcer, strict medical supervision is recommended throughout the course of treatment. Changing treatment with oral corticosteroids for inhaled corticosteroids and further treatment requires special care. Patients who have previously taken oral corticosteroids may experience symptoms of adrenocortical dysfunction after switching to an inhaled form. Restoration of normal adrenal function after discontinuation of oral corticosteroids may be long-lasting. The function of the hypothalamic-pituitary-adrenal axis should be monitored regularly. Also, patients who required emergency treatment with high doses of corticosteroids or long-term treatment with the highest recommended doses of inhaled corticosteroids belong to the group of increased risk of adrenal insufficiency. Symptoms of adrenocortical insufficiency may occur when exposed to severe stressful situations. During periods of increased stress or planned surgical treatment, additional systemic corticosteroid treatment should be considered. In the case of paradoxical bronchoconstriction, budesonide should be immediately discontinued, the patient's condition assessed and, if necessary, alternative therapy should be introduced. If, despite a well-controlled treatment, you get an acute attack of dyspnea, you should use a fast-acting inhaler bronchodilator and reassess the patient. If asthma symptoms are not controlled sufficiently despite the use of maximum doses of inhaled corticosteroids, then short-term systemic corticosteroid therapy may be necessary. During long-term treatment with high doses of inhaled corticosteroids, systemic side effects may occur. For this reason, it is important to regularly assess the patient's condition and reduce the dose of inhaled corticosteroid to the lowest dose that provides effective control of asthma symptoms. It is recommended to regularly control the growth in children who have been treated with inhaled corticosteroids for a long time. If the growth process is slowed down, the treatment should be evaluated to reduce the corticosteroid dose, if possible, to the lowest dose that provides effective asthma control.In addition, referral to a specialist in children's respiratory diseases should be considered. The exacerbation of clinical asthma symptoms may be caused by acute bacterial respiratory tract infections and may require the use of appropriate antibiotics. In this case, it may be necessary to increase the dose of inhaled budesonide and short-term treatment with oral corticosteroids. In patients with active and inactive pulmonary tuberculosis and in patients with fungal, viral or other respiratory tract infections, special care must be taken. In patients with excessive mucus secretion in the airways, short-term oral corticosteroid therapy may be necessary. In patients with hepatic impairment, the function of the hypothalamic-pituitary-adrenal axis should be monitored regularly, due to the risk of increased exposure to budesonide. Co-administration of budesonide and ketoconazole, HIV protease inhibitors or other potent CYP3A4 inhibitors should be avoided; if this is not possible, the interval between administration of these medicines should be kept as long as possible.

Administration of the drug during pregnancy requires an assessment of the benefit to the mother in relation to the risk to the fetus (epidemiological data indicate that budesonide used during pregnancy does not cause adverse reactions in the fetus and / or newborn). The lowest effective dose of budesonide should be used to ensure adequate control of asthma symptoms. Budesonide is excreted in breast milk, however, when administered in therapeutic doses, it has no effect on the breast-fed child. The drug can be used during breast-feeding.

Common: candidiasis of the mouth and throat, cough, hoarseness, throat irritation, dysphagia. Rare: immediate and delayed hypersensitivity reactions (including rash, contact dermatitis, angioneurotic edema and anaphylactic shock), signs and symptoms of systemic corticosteroid effects (including: adrenal suppression, inhibition of growth in children and adolescents), psychotic disorders, restlessness, nervousness, depression and behavioral changes (mainly in children), bronchospasm, skin atrophy, pruritus, erythema, bruising, irritability. Very rare: taste disorders, nausea, tongue pain, oral mucositis, dry mouth, back pain, reduced bone density. Frequency unknown: sleep disorders, anxiety, increased psychomotor activity, aggression, glaucoma, cataracts. There is an increased risk of pneumonia in patients with newly diagnosed COPD who are starting treatment with inhaled corticosteroids; however, the evaluation of clinical trials did not show an increased risk of pneumonia. Very rarely, acute adrenal crisis has been reported in young patients receiving long-term (several months or years) greater than the recommended (approximately 1000 μg / day) dose of inhaled corticosteroids.

Inhalation. Adults and children> 12 years: in severe asthma, early in treatment with inhaled corticosteroids or after dose reduction or discontinuation of oral corticosteroids, the recommended dose is 200 μg (1 spray) 2-4 times a day. During periods of exacerbation of asthma symptoms, the daily dose can be increased to a maximum of 1600 μg. The maintenance dose is set individually and should be the lowest dose to control the symptoms of asthma: 200 μg (1 spray) per day is usually sufficient. Children 6-12 years: usually 200 μg (one spray) per day. If necessary, the dose can be increased up to 400 μg daily.Patients untreated with corticosteroids: the therapeutic effect of budesonide usually occurs within 10 days of starting treatment; however, in patients with profuse bronchial secretion, short-term combination therapy (for about 2 weeks) with oral corticosteroids is recommended. It should start with the total dose and then gradually reduce the dose until the lowest dose at which the appropriate control of asthma symptoms is maintained with budesonide in the form of an aerosol. Exacerbations of asthma caused by bacterial infections should be treated with antibiotics and by increasing the dose of the aerosol.Patients treated with corticosteroids: Introduction to the treatment of inhalation aerosol can occur when the patient's condition is relatively stable.Budesonide in the form of an aerosol should be administered simultaneously with oral corticosteroids for approximately 10 days; then the dose of oral corticosteroids should be gradually reduced until the minimum dose is achieved which, in combination with the aerosol, stabilizes the patient's condition. In many cases, discontinuation of oral medications is possible, however, some patients will need to continue treatment with a minimum dose of oral corticosteroids. When changing from oral treatment to aerosol therapy, the systemic effects of steroids may be reduced, with symptoms such as rhinitis, eczema, headache, muscle and joint pain and, in rare cases, nausea and vomiting; simultaneous treatment of these symptoms should be used. Under certain conditions, such as physical stress caused by severe infections, injuries or surgical procedures, and in the case of asthma exacerbation, combined treatment with budesonide in the form of an aerosol and oral corticosteroids may be necessary.