Budesonide Easyhaler, powder for inhalation dosed 200 μg / dose in an inhaler 200 doses — Made in Finland — Free Delivery

Brand: ORION PHARMA
Product Code: Budesonide Easyhaler
Availability: In Stock

$28.81

Description

Indications

Persistent ba of mild, moderate and severe course. Budesonide Easyhaler is not suitable for the relief of acute BA attacks.

Application

Method of application: inhalation. To ensure an optimal response to treatment, Budesonide Easyhaler should be taken regularly. the therapeutic effect occurs a few days after the start of taking the preparation and reaches a maximum after a few weeks of treatment.

When transferring patients to Budesonide Easyhaler from other inhalers, the treatment regimen should be selected individually. In this case, it is necessary to take into account the previous active substance, dosage and method of administration of the preparation.

The dosage of the preparation Budesonide Easyhaler should be selected individually.

The dose should always be reduced to the minimum necessary to ensure effective control of the course of asthma.

Dosing 2 times a day

Adults (including the elderly) and adolescents aged 12 years and older: at the beginning of therapy, in severe asthma, when the dose is reduced or when oral corticosteroids are canceled, the dose is 200-1600 mcg / day, divided into 2 inhalations.

Mild to moderate asthma: the dose is 200–800 mcg / day, divided into 2 inhalations. During periods of severe asthma, the daily dose can be increased to 1600 mcg, divided into 2 inhalations.

Children aged 5-12 years: the dose is 200-800 mcg / day, divided into 2 inhalations. During periods of severe BA, the daily dose may be increased to 800 mcg.

Dosing once a day

Adults (including the elderly) and adolescents aged 12 years and older: the dose is 200-800 mcg / day for mild to moderate asthma in patients who have not previously received inhaled GCS.

Patients in whom the course of the disease was previously controlled by inhaled steroids (for example, budesonide or beclomethasone dipropionate), which are prescribed 2 times a day, can be increased to 800 mcg / day.

Children aged 5-12 years: the dose is 200-400 mcg / day for mild to moderate asthma in patients who have not previously received inhaled GCS or in whom the course of the disease has already been controlled by inhaled steroids (for example, budesonide or beclomethasone dipropionate), which are prescribed twice a day.

The patient should be transferred to inhalation of the preparation once a day at the same daily dose (taking into account the characteristics of the preparation and the route of administration). After that, the dose should be reduced to the minimum necessary to ensure effective control of the BA course. Patients should be trained to take the preparation once a day, in the evening. It is important that the preparation is taken continuously and carried out at the same time in the evening.

Data for the development of recommendations for the transfer of patients without previous inhalation therapy of GCS for inhalation with Budesonide Easyhaler once a day is not enough.

Patients receiving the preparation once a day should be advised to double the dose of corticosteroids taken by them by switching to their inhalation 2 times a day if the course of asthma worsens (for example, with an increase in the frequency of bronchodilator use or if symptoms from the respiratory system persist). However, patients should be advised to see a doctor as soon as possible.

When treating patients for whom an increased therapeutic effect is desired, it is usually necessary to give preference to increasing the dose of Budesonide Easyhaler over combination therapy with oral corticosteroids, since when using Budesonide Easyhaler, the risk of systemic side effects is lower. The patient should always have fast-acting inhaled bronchodilators at hand, designed to relieve asthma attacks.

Patients using oral steroids. When switching from oral steroids to Budesonide Easyhaler, the patient should be in a relatively stable state. Within 10 days, a high dose of Budesonide Easyhaler should be used in combination with the previously used oral steroid dose. Thereafter, the oral dose should be gradually reduced, for example by 2.5 mg of prednisolone or equivalent per month, to the lowest possible level. Often, oral steroid use can be stopped completely.

There is no experience in treating patients with impaired hepatic and renal functions. Since budesonide is excreted mainly by hepatic metabolism, an enhanced effect can be expected in patients with severe liver cirrhosis.

Operation and maintenance manual. The Easyhaler inhaler is controlled by the flow of inhaled air. This means that when the patient inhales air through the mouthpiece, the preparation enters the respiratory tract along with the inhaled air.

1. Remove the protective cap from the Easyhaler mouthpiece.

2. Shake the inhaler 3-5 times in an upright position.

3. To release the 1st dose of the preparation, place the Easyhaler between the thumb and forefinger and press the inhaler once. A click will be heard when pressed.

4. Take a full breath, grasp the mouthpiece tightly with your lips and inhale deeply, holding your breath for 5-10 seconds.

5. If more than 1 dose is prescribed, repeat steps 2, 3 and 4.

6. Close the Easyhaler mouthpiece with a protective cap.

7. The counter of doses on the inhaler helps to control the number of remaining doses of the preparation. The counter switches every 5 doses. A red zone on the counter means there are 20 doses left in Easyhaler.

It is important to draw the patient's attention to the following.

It is necessary to carefully read the instruction manual.

After opening the laminated bag, it is recommended to store the device in a protective container to protect it from shocks and to ensure reliable operation of the device.

Shake the device and operate it before each inhalation.

In a sitting or standing position, inhale through the mouthpiece actively and deeply enough to ensure that the optimal dose of the substance enters the bronchi.

Do not exhale through the mouthpiece as this will reduce the delivered dose. If this nevertheless happened, it is necessary to knock the inhaler on the surface of the table or on the palm to remove the powder from the mouthpiece, and then repeat the procedure for taking the preparation.

Do not operate the device more than 1 time without inhaling the powder. If this nevertheless happened, it is necessary to knock the inhaler on the surface of the table or on the palm of the hand to remove the powder from the mouthpiece, and then repeat the procedure for taking the preparation.

Always wear a dust cap and close the lid of the protective container after using the inhaler to prevent accidental spraying of powder from the device (which could lead to either an overdose or inhalation of an insufficient amount of the preparation with subsequent use of the inhaler).

Rinse your mouth with water or brush your teeth after inhalation to minimize the risk of oropharyngeal candidiasis and hoarseness.

Clean the mouthpiece regularly with a dry cloth. You cannot use water for cleaning, as the powder is hygroscopic.

Replace the Budesonide Easyhaler inhaler when zero appears on the counter, even if some powder is still visible inside the device.

Contraindications

Hypersensitivity to budesonide or lactose (which contains small amounts of milk proteins).

Side effects

Possible adverse reactions are presented by organ systems and distributed according to the frequency of development: very often (≥1 / 10), often (≥1 / 100 to 1/10), infrequently (≥1 / 1000 to 1/100), rarely (≥1 / 10,000 to 1/1000), very rare (1 / 10,000), frequency unknown (cannot be estimated from available data).

Infectious and parasitic diseases: often - oropharyngeal candidiasis.

Immune system disorders: rarely - hypersensitivity reactions (including rash, contact dermatitis, urticaria, angioedema and anaphylactic reaction).

Endocrine system disorders: rarely - hypocorticism, hypercortisolism, signs and symptoms of systemic effects of corticosteroids, including suppression of adrenal cortex function and growth retardation.

Mental disorders: rarely - depression, behavior change (mainly in children), anxiety, nervousness;

the frequency is unknown - psychomotor hyperactivity, sleep disturbance, excitability, aggressiveness, irritability, psychosis.

Violations of the organ of vision: very rarely - cataract, glaucoma.

Disturbances from the respiratory system, chest and mediastinal organs: often - cough, throat irritation; rarely - hoarseness, dysphonia, bronchospasm.

Digestive system disorders: often - difficulty swallowing.

Violations of the skin and subcutaneous tissue: rarely - itching, erythema, hematoma.

Disorders of the musculoskeletal system and connective tissue: very rarely - a decrease in bone density.

Treatment with inhalation of budesonide can lead to the development of candidal infections of the pharynx and oral cavity. Clinical experience shows that candidal infection develops less often if inhalation is carried out before meals and / or rinsing the mouth after inhalation. In most cases, local antifungal preparations are effective for this disease, and treatment with inhalation of budesonide does not need to be stopped.

When taking inhaled corticosteroids, especially with prolonged use in high doses, systemic side effects may develop. Potential systemic side effects include: suppression of adrenal function, stunted growth in children and adolescents, decreased bone mineral density, cataracts, glaucoma, and susceptibility to infectious diseases. The ability to adapt to stress may be impaired. Nevertheless, the likelihood of developing the described systemic side effects for the inhaled dosage form of budesonide is significantly lower than for oral corticosteroids.

Lactose, an excipient of the preparation, contains small amounts of milk proteins and therefore can cause allergic reactions.

Due to the risk of stunted growth in children and adolescents, the growth of patients must be monitored regularly.

special instructions

Budesonide Easyhaler is not intended for the treatment of acute shortness of breath or status asthma. to treat these conditions, inhalation of short-acting bronchodilators is required.

Patients should remember that Budesonide Easyhaler powder for inhalation is a prophylactic preparation, therefore, to ensure optimal action, it must be used regularly, even in the absence of AD symptoms, and not abruptly stopped.

In patients who required urgent treatment with high doses of corticosteroids or who have been treated for a long time with inhaled corticosteroids at the highest recommended doses, adrenal cortex dysfunction may be impaired. These patients may show signs and symptoms of adrenal insufficiency under the influence of stress. Consideration should be given to the need for additional treatment with systemic corticosteroids during stressful periods and during elective surgery.

Patients with a history of oral corticosteroid dependence associated with prolonged therapy with systemic corticosteroids develop adrenal dysfunction. It can take a long time to recover after treatment with oral corticosteroids, and therefore, when transferring patients with dependence from oral corticosteroids to budesonide, the risk of dysfunction of the adrenal cortex may persist for quite a long time. In such cases, it is necessary to regularly monitor the function of the "hypothalamus - pituitary gland - adrenal cortex" system.

When switching from oral administration to inhalation of budesonide, it is possible to develop symptoms that were previously suppressed by systemic therapy with GCS, for example, symptoms of allergic rhinitis, eczema, muscle and joint pain. To relieve such symptoms, in addition to therapy, it is necessary to use specific methods of treatment.

In some patients, nonspecific development of general malaise is possible due to the cancellation of systemic administration of corticosteroids, despite the maintenance or even improvement of respiratory function. In such cases, patients should be strongly advised to continue using budesonide inhalation and to stop taking oral corticosteroids, despite the presence of clinical indications for the withdrawal of inhalation, for example, symptoms indicating the presence of adrenal cortex insufficiency.

As with other methods of inhalation therapy, paradoxical bronchospasm may develop, which is manifested by an immediate increase in wheezing and shortness of breath after inhalation of a dose of the preparation. Paradoxical bronchospasm is treated with fast-acting inhaled bronchodilators, and treatment should be carried out immediately. Budesonide should be discontinued immediately, the patient should be examined and, if necessary, alternative treatments should be prescribed.

If, despite proper monitoring of treatment, an episode of acute dyspnea occurs, a fast-acting inhaled bronchodilator should be used and the prescribed treatment should be reviewed. In cases where AD symptoms cannot be adequately controlled despite the maximum dose of inhaled corticosteroids, patients may need a short course of systemic corticosteroids. In such situations, therapy with inhaled corticosteroids should be supplemented with systemic preparations.

Systemic effects of inhaled corticosteroid use can occur, in particular, with the appointment of high doses for a long period, but they are much less likely than the effects of taking oral corticosteroids. Possible systemic effects include Cushing's syndrome, Cushingoid appearance, adrenal suppression, stunted growth in children and adolescents, decreased bone mineral density, cataracts, glaucoma, and, much less commonly, various psychological and behavioral abnormalities, including psychomotor hyperactivity, sleep disturbances, anxiety, depression, or aggressiveness (especially in children).

Therefore, it is important that the dose of the inhaled corticosteroid is brought to the minimum level at which the effectiveness of asthma control is maintained.

Regular growth measurements are recommended in children receiving long-term inhaled corticosteroid therapy. If growth is slowing down, the treatment regimen should be reviewed in order to reduce the dose of inhaled corticosteroid to the lowest possible dose, which ensures effective control of asthma. In addition, it is necessary to refer the patient to a pediatric pulmonologist.

Oral candidiasis may occur during therapy with inhaled corticosteroids. To reduce the risk of oral candidiasis and hoarseness, patients should thoroughly rinse their mouth or brush their teeth after each inhaled corticosteroid dose. Oral candidiasis may require treatment with appropriate antifungal medications, and some patients may even need to stop treatment with inhaled corticosteroids.

An exacerbation of the clinical manifestations of asthma can be caused by acute bacterial infections of the respiratory tract, and this may require treatment with appropriate antibiotics. In such cases, it may sometimes be necessary to increase the dose of inhaled budesonide and provide a short course of oral corticosteroid therapy. Fast-acting inhaled bronchodilators should be used as an emergency therapy for the relief of acute attacks of asthma.

Before starting therapy with Budesonide Easyhaler, patients with active or inactive pulmonary tuberculosis need to take special adequate specific therapeutic measures to ensure control of this disease. Similarly, for patients with fungal, viral or other respiratory tract infections, careful monitoring and specific therapy should be provided and the Budesonide Easyhaler inhaler should be used only when adequate therapy for these infections is provided.

Patients with excessive secretion of mucus in the airways may require a short course of oral corticosteroid therapy.

Dysfunction of the liver negatively affects the excretion of corticosteroids, reducing the rate of excretion and increasing systemic exposure, therefore, in such patients, the function of the "hypothalamus - pituitary gland - adrenal cortex" system should be regularly monitored.

Concomitant use of ketoconazole, HIV protease inhibitors and other potent inhibitors of the CYP 3A4 enzyme should be avoided. If this is not possible, the intervals between doses of interacting preparations should be as long as possible.

Patients with rare hereditary syndromes of lactose intolerance, lactase deficiency (Lapp syndrome) or malabsorption of glucose and galactose should not take this preparation.

Use during pregnancy and lactation

Pregnancy. The results of a large prospective epidemiological study and the world experience of post-registration use indicate that inhaled budesonide taken during pregnancy does not have a harmful effect on the health of the fetus / newborn. During pregnancy, the lowest effective dose of budesonide should be used, taking into account the risk of worsening the asthmatic condition.

Breastfeeding period. Budesonide is excreted in breast milk. The possibility of use by women who are breastfeeding should be considered if the expected benefit to the woman outweighs any possible risk to the child.

Children. Do not use in children under 5 years of age.

The ability to influence the reaction rate when driving vehicles or other mechanisms. Does not affect.

Interactions

The metabolism of budesonide is primarily mediated by the cyp 3a4 isoenzyme. therefore, inhibitors of this enzyme, for example, itraconazole, ketoconazole, ritonavir, nelfinavir, cyclosporine, ethinyl estradiol and troleandomycin, can increase the systemic effect of budesonide by several times.

With short courses of therapy (1–2 weeks), this increase has little clinical significance, but with prolonged use, it should be taken into account.

Since there is no data on ensuring the required dosage in such cases, the combination of these preparations with budesonide should be avoided. If this is not possible, you should maximize the interval between taking these preparations and consider reducing the dose of budesonide.

Limited data indicate a significant increase in the level of budesonide in blood plasma (on average by 4 times) with a single use of budesonide in high doses by inhalation (1000 μg) in combination with itraconazole 200 mg. An increase in the concentration of corticosteroids in the blood plasma and an increase in their effect were noted in women who were simultaneously prescribed estrogens and steroid contraceptives with corticosteroids, but no effect was recorded with budesonide therapy and concomitant administration of combined oral contraceptives in low doses.

Due to the possibility of suppressing the function of the adrenal glands, the ACTH stimulation test in the diagnosis of pituitary insufficiency can give false results (low values).

Overdose

Symptoms the frequency of acute toxic reactions to budesonide is low. with prolonged use of the preparation in excessively high doses, systemic reactions to GCS may occur, such as increased sensitivity to infections, the development of hypercortisolism and suppression of adrenal function. atrophy of the adrenal cortex may occur and the ability to adapt to stress may deteriorate.

Preparation therapy for preparation overdose. In acute overdose, even with excessive doses, clinical problems are not expected. Treatment with inhaled budesonide should be continued at the dose recommended to control the course of asthma. The function "hypothalamus - pituitary gland - adrenal cortex" is restored in a few days.

In stressful situations, corticosteroids (such as high-dose hydrocortisone) may be necessary as a precautionary measure. Patients with atrophy of the adrenal cortex are considered steroid-dependent and, until stabilization of the state is achieved, they are selected for adequate maintenance therapy with systemic glucocorticosteroids.

Storage conditions

Before opening the laminated package, the preparation does not require special storage conditions.

After opening the laminated bag, store at a temperature not exceeding 30 ° C in a place protected from moisture.

0 reviews

There are no reviews for this product.