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Alvesco®

Alvesco® is not indicated for the treatment of status asthmaticus or other acute attacks of bronchial asthma requiring intensive therapeutic measures.

The dose of Alvesco® may be reduced in patients requiring oral corticosteroids.

For patients transferred from oral corticosteroid therapy to inhaled treatment with Alvesco®, a decrease in adrenal function may persist for a significant period of time after the transfer. The possibility of developing undesirable effects from the use of oral corticosteroids may persist for some time after their discontinuation. In such cases, it is recommended to monitor the reserve function of the adrenal cortex. The possibility of residual deterioration of adrenal function in a critical situation (therapeutic or surgical) and in other individual cases that may be caused by a stress reaction should always be taken into account, and therefore appropriate treatment with corticosteroids should be initiated.

In case of insufficiency of adrenal cortex function or serious exacerbations, the dose of Alvesco® should be increased; if necessary, oral corticosteroids should be used.

If infection develops, antibiotics should be used.

Paradoxical bronchospasm with increased wheezing and other symptoms of bronchoconstriction that appear immediately after inhalation should be treated with a fast-acting bronchodilator, which usually leads to rapid relief. The patient should be examined and therapy with Alvesco® continued only if, after careful consideration, the expected benefit is higher than the possible risk. The relationship between the severity of asthma and the general susceptibility to acute bronchial reactions should be taken into account.

Transfer of patients taking oral corticosteroids to Alvesco®

When transferring to Alvesco® and subsequent management of patients treated with oral corticosteroids, physician supervision is required, because restoration of reduced adrenal function caused by prolonged systematic therapy with corticosteroids may take some time.

Patients receiving systemic corticosteroids for a long time or at high doses may experience suppression of adrenal function. The adrenal function of these patients should be monitored regularly, and the dose of systemic corticosteroids should be reduced gradually.

After approximately one week, gradual elimination of systemic corticosteroids can be started, reducing their daily dose by 1 mg of prednisolone, or its equivalent. For maintenance dosages of prednisolone greater than 10 mg daily, greater dose reductions over weekly intervals may be appropriate, but caution is warranted.

Some patients may feel unwell during drug withdrawal, despite maintaining or even improving respiratory function. They should be examined for the presence of adrenocortical insufficiency.

When transferring patients from taking systemic corticosteroids to inhalation therapy, allergic reactions (for example, allergic rhinitis, eczema), which were previously suppressed by systemic drugs, may occur. In such cases, symptomatic therapy with antihistamines should be carried out, incl. preparations for external and local use containing GCS.

Use in pediatrics

Use of the drug in children under 6 years of age

contraindicated.

The effect of inhaled corticosteroids during long-term use in children has not been fully elucidated. The physician should constantly monitor the development of growth in children taking GCS for a long period. If growth slows down, then therapy should be reconsidered in order to reduce the dose of inhaled corticosteroids, if possible, to the minimum effective, which allows to control the symptoms of bronchial asthma.

Impact on the ability to drive vehicles and operate machinery

There is no data on the effect of the drug on the ability to drive vehicles and machines.

Instructions for use of ALVESCO® (ALVESCO®)

The drug should be used with caution in patients with active or chronic pulmonary tuberculosis; in patients with bacterial, viral or fungal infections of the respiratory tract.

Alvesco® is not indicated for the treatment of status asthmaticus or other acute attacks of bronchial asthma requiring intensive therapeutic measures.

Alvesco® is not intended for the relief of symptoms of exacerbation of bronchial asthma, which requires the use of short-acting inhaled bronchodilators. Patients should be advised to carry such medications with them at all times.

Patients with severe bronchial asthma are at risk of having an attack of suffocation. Such patients should undergo regular examination to confirm the adequacy of treatment, including pulmonary function testing. The increasing use of short-acting bronchodilators to relieve asthma symptoms indicates that treatment is inadequate. If the patient feels that the effect of short-acting bronchodilators is weakening or an increase in the frequency of inhalations is noted, the patient's condition should be re-evaluated and, if necessary, the dose of Alvesco® should be increased or parenteral corticosteroids should be prescribed. Treatment for severe exacerbations of asthma is usual.

Inhaled corticosteroids may cause systemic effects, especially when used in high doses for long periods of time. However, systemic effects are more likely to occur with oral corticosteroids. Possible systemic effects include Cushing's syndrome and Cushing-like symptoms such as adrenal suppression with hypoglycemic episodes, growth retardation in children and adolescents, decreased bone density, cataracts, and glaucoma. This is why it is important that the dose of inhaled corticosteroid is reduced to the lowest dose that provides satisfactory control of the disease.

The use of Alvesco® should be accompanied by a reduction in the need for parenteral corticosteroids.

For patients transferred from oral corticosteroid therapy to inhaled treatment with Alvesco®, the risk of decreased adrenal function may remain for a significant period of time after the transfer. The possibility of developing undesirable effects from the use of oral corticosteroids may persist for some time after their discontinuation. In such cases, before treatment, it is recommended to conduct a special study to determine the degree of decrease in adrenal function. The possibility of residual deterioration of adrenal function in critical situations (therapeutic or surgical) and in other individual cases that may be caused by a stress reaction should always be taken into account; therefore, appropriate treatment with corticosteroids should be initiated.

In case of insufficient therapeutic response or serious exacerbations, the dose of Alvesco® should be increased; if necessary, oral corticosteroids should be used.

If infection develops, antibiotics should be used.

Treatment with Alvesco® should not be abruptly stopped.

Patients' inhalation technique should be regularly monitored to ensure that the inhalation dose is taken correctly and that the delivery of the active substance to the lungs is optimal.

Transfer of patients taking oral corticosteroids to Alvesco®

Patients receiving systemic corticosteroids for a long time or at high doses may experience suppression of adrenal function. Adrenal function in these patients should be monitored regularly, and the dose of systemic corticosteroids should be reduced gradually.

Some patients may feel unwell during drug withdrawal, despite maintaining or even improving respiratory function. They should be examined for the presence of adrenocortical insufficiency.

Patients transitioned from oral corticosteroids and whose adrenal function is still compromised should be provided with a warning card indicating that they require additional systemic corticosteroids during periods of stress (eg, worsening asthma attacks, thoracic infections, significant intercurrent illnesses, surgical interventions, injuries, etc.).

Use in pediatrics

Use of the drug in children under 6 years of age

contraindicated.

Impact on the ability to drive vehicles and operate machinery

The effect of Alvesco® on the ability to drive vehicles and operate machinery has not been specifically studied and seems unlikely.

Alvesco d/ing 80mcg 60doses 5ml (Takeda)

Alvesco is not indicated for the treatment of status asthmaticus or other acute episodes of asthma requiring intensive therapeutic measures. The effect of inhaled corticosteroids during long-term use in children has not been fully elucidated. The doctor should constantly monitor the growth of children taking GCS for a long period. If growth slows down, therapy should be reconsidered in order to reduce the dose of inhaled corticosteroids. If possible, then to the lowest dose that maintains constant control of asthma symptoms. The dose of Alvesco may be reduced in patients requiring oral corticosteroids. For patients transferred from oral corticosteroid therapy to inhaled treatment with Alvesco, a decrease in adrenal function may persist for a significant period of time after the transfer. The possibility of developing undesirable effects from the use of oral corticosteroids may persist for some time after their discontinuation. In such cases, it is recommended to monitor the reserve function of the adrenal cortex. The possibility of residual deterioration of the adrenocortical response in a critical situation (therapeutic or surgical) and in other individual cases that may be caused by a stress reaction should always be taken into account, as a result of which appropriate GCS treatment should be started. In case of insufficient adrenocortical response or serious exacerbations, the dose Alvesco should be increased; if necessary, oral corticosteroids should be used. In case of infection, antibiotics should be used. Paradoxical bronchospasm with increased wheezing and other symptoms of bronchoconstriction that appear immediately after inhalation should be treated with a fast-acting bronchodilator, which usually leads to rapid relief. The patient should be assessed and therapy with Alvesco should only be continued if, after careful consideration, the expected benefit is greater than the possible risk. The relationship between the severity of asthma and the general susceptibility to acute bronchial reactions must be taken into account. Transfer of patients treated with oral corticosteroids to Alvesco. Transfer of patients treated with oral corticosteroids to Alvesco and their subsequent management requires attention, because Recovery of reduced adrenal function caused by prolonged systematic corticosteroid therapy may take some time. Patients taking systemic corticosteroids for a long period of time or in high doses may experience suppression of adrenal function. Adrenal function in these patients should be monitored regularly, and the dose of systemic corticosteroids should be reduced gradually. After approximately one week, gradual elimination of systemic corticosteroids can be started, reducing their daily dose by 1 mg of prednisolone or its equivalent. For maintenance doses of prednisolone above 10 mg daily, larger dose reductions cautiously undertaken over weekly intervals may be appropriate. Some patients may feel unwell during drug withdrawal, despite maintaining or even improving respiratory function. They need to be examined for adrenocortical insufficiency. When transferring patients from taking systemic corticosteroids to inhaled therapy, allergic reactions (for example, allergic rhinitis, eczema), which were previously suppressed by systemic drugs, may occur. These allergies should be treated symptomatically with antihistamines and/or topical agents, including topical corticosteroids. Impact on the ability to drive a car or perform work that requires an increased speed of physical and mental reactions. There is no data on the effect of the drug on the ability to drive vehicles and machines. Drug interactions According to in vitro data, CYP3A4 is the main enzyme involved in the metabolism of the active metabolite of ciclesonide - M1 (descyclesonide) in humans. In studies of drug interactions between ciclesonide and ketoconazole, as a strong CYP3A4 inhibitor, the effect on the active metabolite descyclesonide increased approximately 3.5-fold, while no effect on ciclesonide was noted. Based on this, the simultaneous use of potential CYP3A4 inhibitors and ciclesonide should be avoided. An interaction study between ciclesonide and the CYP3A4 substrate erythromycin did not show any interaction between them.

Side effects

From the digestive system: uncommon (>1/1000, <1/100) – unpleasant taste in the mouth, nausea, vomiting; rarely (>1/10,000, <1/1000) – dyspepsia, abdominal pain;
From the cardiovascular system: rarely - increased blood pressure, as well as increased heart rate (with simultaneous use of drugs that can have side effects on the heart rhythm, for example, theophylline or salbutamol);
From the respiratory system: infrequently - cough after inhalation, dysphonia, paradoxical bronchospasm;
Infectious and parasitic diseases: infrequently - fungal infections of the oral cavity;
From the nervous system: infrequently – headache;
From the skin: infrequently – skin rash, eczema;
Allergic reactions: rarely - angioedema, hypersensitivity reactions;
Local reactions: infrequently - dryness of the mucous membrane of the mouth and pharynx, a feeling of soreness and irritation in the throat;
Systemic side effects: when using the drug in high doses for a long time - Cushing's syndrome and Cushing-like symptoms, such as decreased bone density, glaucoma, cataracts, growth retardation in children and adolescents, adrenal suppression.

Immediately after inhalation, paradoxical bronchospasm is possible. It is an acute nonspecific reaction to any inhaled drug and may be associated with the active substance, auxiliary components or cooling due to evaporation of the propellant when using metered dose inhalers. In most cases, bronchospasm is an adverse reaction that resolves on its own and does not require discontinuation of treatment.

Directions for use and dosage

Alvesco is intended for oral inhalation. The drug should be used daily, treatment is long-term.

The initial dose is selected by the doctor depending on the severity of the disease. After achieving the required clinical effect, the dose is reduced to the minimum necessary to control the manifestations of the disease.

Adolescents over 12 years of age and adults, including the elderly, with mild to moderate bronchial asthma are prescribed 160-640 mcg per day, the highest daily dose is divided into 2 applications. In severe cases of the disease, it is possible to increase the dose to 640 mcg 2 times a day daily.

Improvement is noted within 24 hours after inhalation of Alvesco. The maximum effect should be achieved after 2-3 months of therapy.

Children over 6 years of age are prescribed 80-160 mcg once a day or 80 mcg twice a day.

An important condition for effective treatment is continuous use of the drug, even in the absence of symptoms of bronchial asthma.

Alvesco can be used either alone or with a spacer. In the latter case, it is recommended to choose the AeroChamber Plus spacer.

For severe bronchial asthma in adults and adolescents constantly receiving oral corticosteroids (for example, prednisolone), the dose of Alvesco is 640 mcg 2 times a day. The duration of treatment is 10 days, after which the daily dose is gradually (by no more than 2.5 mg each week) reduced until the minimum effective dose is reached.

In the stage of remission of the disease, it is possible to transfer patients from oral GCS to Alvesco.

Instructions for using the inhaler:

Remove the protective cap from the spray bottle, check the mouthpiece inside and out and make sure it is dry and clean;
Turn the inhaler upside down, place your index finger at the bottom of the can, and your thumb under the mouthpiece;
If the inhaler is new or has not been used for more than 1 week, perform the first 3 valve presses into the air;
Exhale as much as possible to the side (not into the inhaler);
Place the mouthpiece in your mouth and close your lips around it;
Inhale slowly and deeply and press the top of the inhaler with your index finger. Make sure that the drug cannot pass through the space between the mouthpiece and the lips;
Hold your breath, remove the mouthpiece from your mouth, and remove your finger from the top of the inhaler. Breathing should be held for at least 10 seconds, longer if possible;
Exhale slowly through your mouth (not through the mouthpiece);
If you need to take another dose, wait 30 seconds, then repeat steps 4-8;
Place the protective cap on the can, close it tightly and lock it in place.

The can does not need to be shaken, because... aerosol dissolved.

For hygiene purposes:

You should regularly clean the mouthpiece with a dry cloth, outside and inside;
Wipe the surface with the small hole from which the medicine comes out using a dry folded cloth;
Do not use water or other liquids for cleaning.

Alvesco, 80 mcg/spray, dosed aerosol for inhalation, 5 ml, 1 pc.

Alvesco® is not indicated for the treatment of status asthmaticus or other acute episodes of asthma requiring intensive therapeutic measures.

The effect of inhaled corticosteroids during long-term use in children has not been fully elucidated. The doctor should constantly monitor the growth of children taking GCS for a long period. If growth slows down, therapy should be reconsidered in order to reduce the dose of inhaled corticosteroids. If possible, then to the lowest dose that maintains constant control of asthma symptoms. The dose of Alvesco® may be reduced in patients requiring oral corticosteroids.

For patients transferred from oral corticosteroid therapy to inhaled treatment with Alvesco®, a decrease in adrenal function may persist for a significant period of time after the transfer. The possibility of developing undesirable effects from the use of oral corticosteroids may persist for some time after their discontinuation. In such cases, it is recommended to monitor the reserve function of the adrenal cortex. The possibility of residual deterioration of the adrenocortical response in a critical situation (therapeutic or surgical) and in other individual cases that may be caused by a stress reaction should always be taken into account, as a result of which appropriate GCS treatment should be initiated.

In case of insufficient adrenocortical response or severe exacerbations, the dose of Alvesco® should be increased; if necessary, oral corticosteroids should be used. In case of infection, antibiotics should be used. Paradoxical bronchospasm with increased wheezing and other symptoms of bronchoconstriction that appear immediately after inhalation should be treated with a fast-acting bronchodilator, which usually leads to rapid relief. The patient should be assessed and therapy with Alvesco® should only be continued if, after careful consideration, the expected benefit is greater than the possible risk. The relationship between the severity of asthma and the general susceptibility to acute bronchial reactions should be taken into account.

Transfer of patients taking oral corticosteroids to Alvesco®.

The transfer of patients treated with oral corticosteroids to Alvesco® and their subsequent management requires attention, because restoration of reduced adrenal function caused by prolonged systematic corticosteroid therapy may take some time.

Patients taking systemic corticosteroids for a long period of time or at high doses may experience suppression of adrenal function. Adrenal function in these patients should be monitored regularly, and the dose of systemic corticosteroids should be reduced gradually. After approximately one week, gradual elimination of systemic corticosteroids can be started, reducing their daily dose by 1 mg of prednisolone or its equivalent. For maintenance doses of prednisolone above 10 mg daily, larger dose reductions over weekly intervals may be appropriate, cautiously undertaken.

Some patients may feel unwell during drug withdrawal, despite maintaining or even improving respiratory function. They should be evaluated for adrenocortical insufficiency.

When transferring patients from taking systemic corticosteroids to inhalation therapy, allergic reactions (for example, allergic rhinitis, eczema), which were previously suppressed by systemic drugs, may occur. These allergies should be treated symptomatically with antihistamines and/or topical agents, including topical corticosteroids.

Impact on the ability to drive a car or perform work that requires increased speed of physical and mental reactions.

There is no data on the effect of the drug on the ability to drive vehicles and machines.