Instructions Pulmicort Turbuhaler powder for inhalation dosed 100 mcg/dose inhaler 200 doses No. 1
Composition
active ingredient: budesonide;
1 dose (inhalation) contains 100 mcg or 200 mcg of budesonide.
Dosage form
Inhalation powder.
Main physicochemical properties:
100 mcg/dose:
Specially designed powder inhaler made of plastic materials. Rotating dispenser, light brown in color. Budesonide 100 is extruded on the rotating dispenser base. Contents - round granules from white to almost white, crushed into a fine powder under slight impact. A powder fraction may be present.
200 mcg/dose:
Specially designed powder inhaler made of plastic materials. Rotating dispenser, brown color. Budesonide 200 is extruded on the rotating dispenser base. Contents - round granules from white to almost white color, crushed into a fine powder under slight impact. Powder fraction may be present.
Pharmacotherapeutic group
Inhalants used for the treatment of obstructive airway diseases. Glucocorticoids. ATX code R03B A02.
Pharmacological properties
Pharmacodynamics.
Budesonide is a glucocorticosteroid with a strong local anti-inflammatory effect.
The exact mechanism of action of glucocorticosteroids in the treatment of asthma is not fully understood. Anti-inflammatory effects such as suppression of the release of inflammatory mediators and inhibition of cytokine-mediated immune responses are of primary importance. Budesonide exerts its activity through an affinity for glucocorticosteroid receptors that is approximately 15 times greater than that of prednisolone.
Budesonide has an anti-inflammatory effect, which leads to a decrease in bronchial obstruction in both the early and late stages of an allergic reaction. Budesonide reduces the activity of histamine and methacholine in patients with airway hyperactivity.
Studies have shown that the earlier budesonide treatment is started from the onset of an asthma attack, the better lung function can be expected.
In patients with mild to moderate COPD, Pulmicort Turbuhaler 400 mcg twice daily resulted in an increase in forced expiratory volume in one second (FEV1) compared with placebo after 3–6 months of treatment. This effect was maintained over three years of therapy.
Studies of Pulmicort Turbuhaler in healthy volunteers have shown a dose-dependent effect on plasma and urinary cortisol. When used in recommended doses, Pulmicort Turbuhaler has a significantly lower effect on adrenal function than prednisone 10 mg, as demonstrated by ACTH tests.
In children aged 5 years and older, no systemic effects have been observed at doses up to 400 mcg/day. Biochemical signs of systemic effects may occur at doses of 400–800 mcg/day, while such signs are common at daily doses exceeding 800 mcg.
Asthma, as well as inhaled corticosteroids, can cause growth retardation. However, studies of children treated with budesonide for long periods (up to 13 years) have shown that patients achieve the expected adult height. In most cases, a slight growth retardation (approximately 1 cm) was observed during the first year of treatment. Inhaled budesonide therapy is effective in preventing the development of exercise-induced asthma.
Pharmacokinetics.
Absorption
Inhaled budesonide is rapidly absorbed. Peak plasma concentrations are reached within 30 minutes after inhalation. In studies, the average accumulation of budesonide in the lungs after inhalation via a Turbuhaler was 25–35% of the administered dose. Systemic bioavailability is approximately 38%.
Distribution and metabolism
Plasma protein binding is approximately 90%. The volume of distribution is approximately 3 l/kg.
Budesonide undergoes extensive (approximately 90%) first-pass metabolism in the liver to metabolites with low glucocorticosteroid activity. The glucocorticosteroid activity of the main metabolites, 6-beta-hydroxybutesonide and 16-alpha-hydroxyprednisolone, is less than 1% of that of budesonide.
Breeding
Budesonide is eliminated by metabolism, which is mainly catalyzed by the enzyme CYP3A4. The 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 plasma half-life after intravenous administration is on average 4 hours. The pharmacokinetics of budesonide are dose-proportional with respect to dosage.
The pharmacokinetics of budesonide in children and patients with renal impairment are unknown. The exposure to budesonide may be increased in patients with liver disease.
Indication
Persistent bronchial asthma, in which treatment with inhaled glucocorticoids is indicated.
Treatment of moderate to severe chronic obstructive pulmonary disease.
Contraindication
Hypersensitivity to budesonide.
Interaction with other medicinal products and other types of interactions
Hypersensitivity to budesonide.
Application features
COPD exacerbations should be treated with additional medications as determined by the treating physician.
Budesonide is not indicated for the relief of acute attacks of bronchial asthma in cases where the use of short-acting inhaled bronchodilators is required.
Switching from oral corticosteroids
Patients receiving systemic corticosteroid therapy should be transferred to Pulmicort Turbuhaler when their symptoms are controlled. In patients with generally impaired adrenal function, systemic corticosteroid therapy should be discontinued gradually rather than abruptly. Pulmicort Turbuhaler should be continued for approximately 1 week at the start of the transfer. The daily dose of systemic corticosteroids may then be reduced to the equivalent of 2.5 mg prednisone over a period of 1 to 2 weeks, depending on the patient's response.
Particular care is required in the treatment of patients who are being transferred from oral steroids, as they may remain at risk of adrenal insufficiency for a significant period of time. Patients who require emergency treatment with high doses of corticosteroids or long-term treatment with inhaled corticosteroids at the highest recommended dose may also be at risk. Such patients may develop symptoms of adrenal insufficiency during periods of severe stress. Additional treatment with systemic corticosteroids should be considered during periods of stress or elective surgery.
If stressful or emergency situations (e.g. severe infections, trauma, surgery) occur within the first few months after switching from systemic corticosteroids to inhaled treatment, re-administration of systemic corticosteroids may be necessary.
Systemic effects of inhaled corticosteroids
Systemic effects of inhaled corticosteroids may occur, particularly when used at high doses for long periods. These effects are much less likely than with oral corticosteroids. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, glaucoma and, less commonly, a number of psychological and behavioural effects, including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (especially in children). It is therefore important that the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained.
Impact on growth
Regular growth monitoring is recommended in children and adolescents receiving long-term corticosteroid treatment, regardless of the formulation used. The benefits of corticosteroid treatment should be weighed against the potential risk of growth retardation. Referral to a pediatric pulmonologist should also be considered.
In the event of growth retardation and in order to reduce possible systemic effects, it is important to re-evaluate therapy to ensure that the dose of inhaled corticosteroid is adjusted to the lowest dose at which effective disease control is still achieved.
Use in patients with impaired liver function
Decreased liver function affects the ability to excrete corticosteroids, leading to a reduced rate of drug elimination and high systemic exposure. The possibility of systemic side effects should be considered.
Concomitant use with other medicines
Concomitant use of the drug with ketoconazole, itraconazole, HIV protease inhibitors or other potent CYP3A4 inhibitors should be avoided. If this cannot be avoided, the interval between use of the drugs should be as long as possible (see section "Interaction with other medicinal products and other forms of interaction").
Respiratory tract infections
Particular caution is required in patients with active pulmonary tuberculosis or latent pulmonary tuberculosis, as well as patients with fungal or viral respiratory tract infections.
Oral candidiasis
Oral candidiasis may develop during treatment with inhaled corticosteroids. To reduce the risk of developing candidal infections in the mouth and throat, Pulmicort Turbuhaler should be used before meals or the patient should rinse their mouth with water after each inhalation. If necessary, appropriate antifungal agents may be used, and some patients may need to discontinue treatment with Pulmicort Turbuhaler (see section 4.2).
Bronchospasm
Patients should be advised to seek medical advice if the overall effect of treatment is reduced, as repeated inhalations for severe asthma attacks should not delay the initiation of other essential therapy. In the event of a sharp deterioration in the condition, treatment should be supplemented with oral steroids for a short period.
When switching from oral steroid therapy to Pulmicort Turbuhaler, the patient may experience pre-existing symptoms such as muscle and joint pain. In such cases, a temporary increase in the dose of oral steroids may be necessary. If (in isolated cases) increased fatigue, headache, nausea, vomiting or similar symptoms occur, in most cases an insufficient effect of the steroids should be suspected.
When replacing systemic steroid treatment with Pulmicort Turbuhaler, allergies, such as rhinitis and eczema, that were previously controlled by systemic treatment, are sometimes detected.
Pneumonia in patients with COPD
An increased incidence of pneumonia, including pneumonia requiring hospitalization, has been observed in patients with chronic obstructive pulmonary disease (COPD) receiving inhaled corticosteroids. There is some evidence of an increased risk of pneumonia with increasing corticosteroid dose, but this has not been conclusively demonstrated in any of the studies.
For inhaled corticosteroid drugs, there is no comprehensive clinical evidence of intraclass differences in the magnitude of the risk of developing pneumonia.
Physicians should remain vigilant for the possible development of pneumonia in patients with COPD, as the clinical signs of such infections overlap with symptoms of COPD exacerbations.
Risk factors for developing pneumonia in patients with COPD include smoking, older age, low body mass index (BMI), and severe COPD.
Vision impairment
Visual disturbances have been reported with systemic and topical corticosteroids. If a patient presents with symptoms such as blurred vision or other visual disturbances, they should be referred to an ophthalmologist for evaluation of the possible cause, which may include cataracts, glaucoma, or rare conditions such as central serous chorioretinopathy, which have been reported with systemic and topical corticosteroids.
Note.
Pulmicort Turbuhaler is not suitable for the treatment of an acute attack of bronchial asthma.
Information for patients who have not received previous treatment with corticosteroids.
In patients who have not previously received corticosteroid treatment or who have received treatment only occasionally for a short period, improvement in breathing may be observed after about 1 week of regular use of Pulmicort Turbuhaler as prescribed by a doctor. However, severe edema and inflammatory changes may cause such bronchial obstruction that budesonide cannot be fully effective when used topically.
In this case, therapy should be initiated with the addition of systemic corticosteroids (initially at a dose equivalent to 40–60 mg of prednisone per day). Inhalation should be continued after a gradual reduction in the dose of systemic corticosteroids.
Exacerbation of symptoms in acute respiratory infections.
In case of exacerbation of symptoms in acute respiratory infections, the possibility of prescribing appropriate antibiotics should be considered. If necessary, the dose of Pulmicort Turbuhaler may be adjusted, and in certain circumstances, systemic administration of glucocorticoids may be indicated.
The use of the drug Pulmicort Turbuhaler may lead to positive results in doping tests.
Use during pregnancy or breastfeeding
Pregnancy
Most prospective epidemiological studies and post-marketing data from around the world have failed to identify an increased risk of adverse effects for the fetus and newborn child associated with the use of inhaled budesonide during pregnancy. It is important for both the fetus and the mother that adequate asthma treatment is maintained during pregnancy. As with the use of other drugs during pregnancy, the benefits of budesonide for the mother should be weighed against the risks to the fetus.
Animal studies have shown that glucocorticosteroids can cause developmental disorders, but these data are not considered relevant for humans when used at the recommended dosage.
Animal studies have also shown effects of excess prenatal glucocorticoids on intrauterine growth retardation, cardiovascular disease in adulthood, and permanent changes in glucocorticoid receptor density, neurotransmitter metabolism, and behavior at doses below teratogenic levels.
During pregnancy, the lowest effective dose of budesonide should be used, taking into account the risk of worsening asthma.
Breastfeeding period
Budesonide is excreted in breast milk in women.
Maintenance treatment with inhaled budesonide (200 or 400 micrograms twice daily) in women with bronchial asthma who are breastfeeding results in only a small systemic exposure of budesonide in the breastfed infant. In a pharmacokinetic study, the calculated daily dose in the infant was 0.3% of the maternal daily dose for both doses.
The mean plasma concentration in infants was estimated to be one six hundredth of the concentration observed in maternal plasma, assuming full bioavailability in the infant. Budesonide concentrations in all infant plasma samples were below the limit of quantification.
The ability to influence the reaction speed when driving or working with other mechanisms
Does not affect.
Method of administration and doses
Bronchial asthma
The dosage of Pulmicort Turbuhaler should be selected individually.
When initiating inhaled corticosteroid therapy for the treatment of severe asthma exacerbations, or when reducing the dose or withdrawing oral corticosteroids, the dosage should be as follows:
Children aged 5–7 years: 100–400 mcg per day, divided into 2–4 inhalations. The entire daily dose can be administered once.
Children aged 7 years and over: 100–800 mcg per day, divided into 2–4 inhalations. When using daily doses up to and including 400 mcg, the entire dose can be administered once.
Adults: The usual dose is 200–800 mcg per day, divided into 2–4 inhalations. In severe cases, daily doses up to and including 1600 mcg may be required. When daily doses up to and including 400 mcg are used, the entire dose can be administered as a single dose.
The maintenance dose should be as low as possible.
When using the Turbuhaler inhaler, an inspiratory flow of approximately 35–60 l/min., which is observed in most patients (even in children), provides the body with a sufficient amount of the drug, which determines the therapeutic efficacy of the drug. Inspiratory flow below 35 l/min also has a proven therapeutic effect. The effectiveness of the drug Pulmicort Turbuhaler is at least equivalent to the effectiveness of a conventional glucocorticoid when using metered-dose aerosols under pressure.
It is possible that when using Pulmicort Turbuhaler, the patient will not feel either the taste or the medicine itself; this is explained by the small size of the substance released during its use.
After a single dose, the effect should be expected within a few hours. The full therapeutic effect is achieved only after several weeks of treatment. Treatment with Pulmicort Turbuhaler is a preventive therapy that has no proven effect on acute disorders.
In clinical studies, it has been shown that Pulmicort Turbuhaler delivers a higher amount of budesonide to the lungs than Pulmicort in a pressurised metered dose inhaler (pMDI). Switching a stable patient from Pulmicort in a metered dose inhaler to Pulmicort Turbuhaler may require a dose reduction.
When treating patients for whom an increased therapeutic effect is desired, increasing the dose of Pulmicort Turbuhaler should usually be preferred to combination therapy with oral corticosteroids, since there is a lower risk of systemic side effects with Pulmicort Turbuhaler.
Patients using oral steroids
Pulmicort may allow for the replacement or significant reduction of oral corticosteroid dosage while maintaining asthma control.
When switching from oral steroids to Pulmicort Turbuhaler, the patient should be in a relatively stable condition. A high dose of Pulmicort Turbuhaler should be used for 10 days in combination with the dose of oral steroid previously used. The oral dose should then be gradually reduced, for example by 2.5 mg/month of prednisolone or equivalent per month to the lowest possible level. The oral steroid can often be discontinued completely.
Chronic obstructive pulmonary disease (COPD)
The recommended dose of Pulmicort Turbuhaler is 400 mcg 2 times a day.
For patients who have a positive response to treatment during the first 3–6 months of Pulmicort Turbuhaler therapy, the drug should be used for a long time.
When prescribing Pulmicort Turbuhaler to patients with COPD who use oral glucocorticosteroids, in case of a reduction in the dose of oral steroid, treatment should be carried out in accordance with the recommendations for the treatment of bronchial asthma.
Liver or kidney dysfunction
There is no experience in patients with impaired hepatic or renal function. Since budesonide is eliminated mainly by hepatic metabolism, an increased effect can be expected in patients with severe cirrhosis of the liver.
Instructions for the correct use of Pulmicort Turbuhaler
The active substance enters the body through inhaled air, that is, when the patient inhales through the nozzle, the substance enters the respiratory tract along with the air he inhales.
It is important to instruct the patient that it is necessary to:
follow the instructions for use;
inhale strongly and deeply through the nozzle to ensure that the optimal dose reaches the lungs;
never exhale through the nozzle;
Rinse your mouth with water after inhaling a maintenance dose to minimize the risk of oral candidiasis.
Instructions for the correct use of Pulmicort Turbuhaler
Pulmicort Turbuhaler is a multi-dose inhaler that uses a very small amount of powder. The powder enters the lungs when you inhale it through the mouthpiece. It is therefore important to inhale strongly and deeply through the mouthpiece.
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| | Mouthpiece → Dose inhaler → (window) Dosing disc → Dosing disc → |
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How to use an inhaler
1Unscrew and remove the protective cap.
2. Hold the inhaler vertically, with the dosing disc facing down. It is not recommended to hold the inhaler by the mouthpiece when turning the dosing disc.
3. Turn the dosing disc in one direction as far as it will go, then back in the opposite direction until it stops. It does not matter which way you turn the dosing disc first. You will hear a click during this procedure. (This step must be repeated twice for the first use. For the second and subsequent uses, only once.)
Overdosing is impossible, even if the dosing disc accidentally operates several times.
4. First, exhale completely without using the device. Then place the mouthpiece between your lips and inhale strongly and deeply through the device. Do not chew or bite the mouthpiece as it may become loose or detached!
Do not use the device if it is damaged or if the mouthpiece has become detached.
5. Remove the device from your mouth and hold your breath for a few seconds.
Do not exhale through the device!
If more than one inhalation has been prescribed, steps 2–5 must be repeated.
6. Replace the protective cap by screwing it tightly back onto the device immediately after use.
Notes
Never exhale through the mouthpiece.
Always replace the protective cap immediately after using the device.
Since each dose of the drug contains only the pure active substance and does not contain any inactive substances, in most cases you can not feel when the particles of the drug hit the mucous membrane of the oral cavity. In rare cases, you can feel a bitter taste. Even if the drug cannot be distinguished by taste or smell after inhalation, you can be sure that the patient received a dose of the drug when inhaled, if the instructions were strictly followed. To reduce the risk of developing an infection caused by fungi of the genus Candida, the patient should use Pulmicort Turbuhaler before meals or rinse the mouth after inhalation.
Cleaning the mouthpiece
It is recommended to clean the outside of the mouthpiece with a dry cloth once a week. Do not use water or other liquids to clean the mouthpiece.
When the device contents have been used
When a red marker appears in the dose indicator window below the mouthpiece, it is assumed that about 20 inhalations are still available.
Mouthpiece
About 20 doses still available
When the red marker reaches the bottom of the window, this means that these 20 doses of the drug have been used. Although the active substance is still available in small quantities, for technical reasons the device should no longer be used for inhalation.
Mouthpiece
empty empty
The sound produced when the Turbuhaler inhaler is shaken is caused by the shaking off of the remaining drying agent, which protects the active substance from excess moisture. The active substance does not produce a sound.
Children.
Do not use in children under 5 years of age.
Overdose
Acute overdose of Pulmicort Turbuhaler, even at high doses, is not expected to cause any clinical problems. Chronic use of high doses may cause systemic glucocorticosteroid effects such as hypercorticism and adrenal suppression.
Side effects
Adverse reactions are classified by frequency of occurrence:
very common (> 1/10), common (> 1/100 to < 1/10), uncommon (> 1/1000 to < 1/100), rare (> 1/10000 to < 1/1000), very rare (< 1/10000), frequency unknown (cannot be estimated from the available data).
Adverse reactions by organ system and frequency of development when using the drug
| Organ system | Frequency | Adverse reactions to the use of the drug |
| Infections and infestations | Often | Candida infections of the mouth and throat, pneumonia (in patients with COPD) |
| On the part of the immune system | Rarely | Immediate and delayed hypersensitivity reactions, including rash, pruritus, contact dermatitis, urticaria, angioedema and anaphylactic reaction. |
| From the endocrine system | Symptoms suggestive of systemic corticosteroid effects, including adrenal suppression and growth retardation*, increased susceptibility to infectious diseases |
| From the organs of vision | Frequency unknown | Glaucoma. |
| Infrequently | Cataract**, Blurred vision (see also section "Special warnings and precautions for use"). |
| Mental disorders | Rarely | Restlessness, nervousness, changes in behavior (mainly in children). |
| Frequency unknown | Sleep disturbances, psychomotor hyperactivity, aggression. |
| Infrequently | Anxiety, depression. |
| Neurological disorders | Infrequently | Tremor |
| Respiratory, thoracic and mediastinal disorders | Often | Cough, throat irritation. |
| Rarely | Bronchospasm, dysphonia, hoarseness |
| Skin and subcutaneous tissue disorders | Rarely | Bruising. |
| Musculoskeletal and connective tissue disorders | Infrequently | Osteoporosis (with long-term use), muscle spasm. |
* See "Children" below.
** See below “Visual disorders”.
Sometimes, symptoms of systemic glucocorticosteroid side effects may occur with the use of inhaled glucocorticosteroids, which probably depends on the dose, time of exposure, concomitant and previous exposure to corticosteroids, and individual sensitivity.
Infections and infestations
Due to the risk of developing candidal infection in the mouth and throat, the patient should rinse their mouth with water after each dose of the drug.
Visual impairment
Also, in placebo-controlled studies, cataracts were reported as an uncommon side effect in the placebo group.
Mental disorders
In the pooled clinical trials, 13,119 patients received inhaled budesonide and 7,278 patients received placebo. The incidence of anxiety was 0.52% for inhaled budesonide and 0.63% for placebo; the incidence of depression was 0.67% for inhaled budesonide and 1.15% for placebo.
Children
Due to the risk of growth retardation in children, growth parameters should be monitored regularly (see section "Special instructions for use").
Reporting of suspected adverse reactions
It is important to report suspected adverse reactions during the post-marketing period of a medicinal product. This allows for continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions through the national reporting system.
Expiration date
2 years.
Storage conditions
Store out of the reach of children at a temperature not exceeding 30 ° C. Close the inhaler with a protective cap after use.
Packaging
200 doses (for 100 mcg/dose) or 100 doses (for 200 mcg/dose) in a plastic inhaler. 1 inhaler in a cardboard box.
Vacation category
According to the recipe.
Producer
AstraZeneca AB/AstraZeneca AB.
Location of the manufacturer and its business address.
Forskargatan 18, Sodertalje, 151 36, Sweden.
