Pulmicort Turbuhaler powder for ing 100mcg/dose 200doses
Active substance
Budesonide
pharmachologic effect
Glucocorticosteroid for local use.
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. Anti-inflammatory effects, 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 cortisone 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/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 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 1 or 2 times a day 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).
Before use, consultation with a specialist is required.
Method of use, storage mode, contraindications and side effects are indicated in the instructions
Pulmicort Turbuhaler powder for inhalation dosed 100 mcg/dose 200 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.
Pulmicort, 20 pcs., 2 ml, 0.5 mg/ml, dosed suspension for inhalation
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.
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 using 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, carefully shake the container with a gentle rotational 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.
Pulmicort Turbuhaler por d/ing doses 200 mcg 100 doses
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.
Clinical studies and meta-analyses have shown that the use of inhaled corticosteroids for COPD may lead to an increased risk of pneumonia. However, the absolute risk with budesonide is small. A meta-analysis of 11 double-blind studies involving 10,570 patients with COPD did not demonstrate a statistically significant increase in the risk of pneumonia in patients receiving budesonide (including in combination with formoterol) compared with patients receiving therapy without budesonide (placebo or formoterol). The incidence of the serious adverse event of pneumonia was 1.9% per year with budesonide-containing therapy and 1.5% per year with budesonide-free therapy. The pooled hazard ratio comparing therapy containing budesonide to therapy without budesonide was 1.15 (95% confidence interval (CI): 0.83, 1.57). The pooled hazard ratio comparing budesonide monotherapy with placebo was 1.57 (95% CI: 0.90, 2.74).
The cause-and-effect relationship between the development of pneumonia and the use of drugs containing budesonide has not been established.
