|The name of the preparation||Character; dose; package||Manufacturer||Price 100%||Price after refund||In which pharmacy?|
|Alvesco 160||inhalation aerosol, solution; 160 μg / inhalation dose; 120 doses||AstraZeneca||146.62||
|Alvesco 160||inhalation aerosol, solution; 160 μg / inhalation dose; 60 doses||AstraZeneca||76.85||
Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.
Inflammatory drug with anti-inflammatory effect, containing a corticosteroid . It is used in the regular, long-term treatment of bronchial asthma. The preparation reduces swelling and irritation of the lower respiratory tract, reduces the severity of symptoms and the incidence of asthma exacerbations.
The active substance of the preparation is a pharmacologically active ciclesonide (prodrug), a synthetic corticosteroid. In the airway epithelium, ciclesonide undergoes enzymatic transformation to the active metabolite, which has anti-inflammatory activity. Administered with inhalation is to counteract the inflammatory process in the wall of the bronchi. It inhibits the inflammatory process (inhibits the activity of cells and mediators of inflammation), reduces swelling and irritation and also, at least partially, reverses anatomical changes occurring in the bronchial wall of asthmatic patients. It soothes the symptoms of asthma and prevents its exacerbations. The main mechanism of action of ciclesonide in the target cell is to inhibit or stimulate the expression of genes whose protein products influence the inflammatory process. Corticosteroids may also work in a different way without affecting gene expression. However, the mechanism of such their operation is still little known. Ciclesonide administered from a pressure inhaler is characterized by more than 50% drug deposition in the lungs. Absorbed into the blood, it binds to proteins and is rapidly metabolized in the liver to inactive metabolites. Systemic symptoms during inhalation do not occur (unless long-term high doses are used). Because ciclesonide is a prodrug, it does not cause side effects in the mouth. A reduction in the severity of asthma symptoms occurs within 24 hours of starting treatment, while full control of asthma is achieved after a longer period of regular use.
The preparation is indicated for the treatment of chronic bronchial asthma in adults and adolescents over 12 years of age.
Unfortunately, even if there are indications to use the preparation, it can not always be used. You can not use the preparation if you are allergic (you are hypersensitive) to any of the ingredients.
Do not use this product to stop an acute attack of breathlessness! In the case of an acute attack of dyspnoea, use a bronchodilator with a rapid onset of action (eg Salbutamol ).
Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups. Therefore, before using the preparation you should consult a doctor if you suspect or have been diagnosed with:
• diseases other than asthma
• pulmonary tuberculosis (active or inactive)
• fungal or viral respiratory tract infections
• severe liver problems.
The product is intended for regular and long-term use. Do not stop the treatment suddenly. The product is used preventively and should be used regularly at the recommended doses, even if the symptoms of the disease do not occur.
Do not use this product to stop an acute attack of breathlessness! In the case of an acute attack of dyspnoea, use a bronchodilator with a rapid onset of action, eg salbutamol. Always carry a inhaler with a fast-acting bronchodilator.
Important! If you use short-acting bronchodilators and you notice that the usual dose does not alleviate symptoms, you should consult your doctor as soon as possible. Similarly, if you observe that in order to alleviate the symptoms you need to use a larger dose of these drugs than before or you must use existing doses, you should consult your doctor immediately. Increased consumption of bronchodilator drugs indicates a worsening of the course of asthma and increases the risk of acute seizure. Your doctor will assess your condition and verify your further treatment. It can, for example, increase the dose of inhaled corticosteroids or introduce oral corticosteroids for treatment.
Remember that the sudden and rapidly progressing severity of asthma symptoms is potentially life-threatening and requires prompt medical consultation! Your doctor may advise you to increase the dose of corticosteroids.
In the case of inhaled corticosteroids, the risk of systemic side effects is significantly lower than when the drugs are administered orally. Inhaled drug limits its systemic side effects, however, long-term use of high doses of inhaled corticosteroids may inhibit the natural production of steroid hormones by the adrenal cortex as well as cause symptoms of Cushing's syndrome, rounding of the face (moon shape), slowdown in children and adolescents, density reduction bones, increased blood pressure, cataracts, glaucoma, and more rarely, psychiatric disorders or changes in behavior (eg, psychomotor hyperactivity disorder, sleep disorders, anxiety, depression, aggression). Therefore, the doctor always strives to use the lowest dose of corticosteroid that provides effective control of asthma symptoms. It is recommended that during prolonged treatment with an inhaled corticosteroid, regularly control the growth in children. Symptoms of adrenal insufficiency can be particularly manifested under the influence of severe stress. If you are particularly vulnerable to stress or planning surgery, please inform your doctor who may assess the degree of adrenal insufficiency and possibly recommend additional oral corticosteroids.
People with severe hepatic impairment may experience an increase in ciclesonide blood levels, which may cause systemic side effects of corticosteroids and suppression of the adrenal cortex. Your doctor may recommend regular monitoring of the hypothalamic-pituitary-adrenal axis.
If you have used steroids / steroids orally (systemically acting) and replace them with inhalation steroids (Alvesco), determine with your doctor what precautions you should keep. There is a risk of symptoms of adrenocortical insufficiency. This particularly applies to people who have used high doses of steroids in the past, as well as emergency and stress-related situations. Replacing oral steroids with inhaled steroids may also reveal symptoms previously suppressed by the systemic effects of drugs such as allergic rhinitis or eczema.In this case, these symptoms should be treated with antihistamines or other topical agents (including steroids). In some patients, non-specific symptoms of malaise occur during the reduction of oral steroid doses. Despite this, dose reduction should be continued as long as there are no objective signs of adrenocortical insufficiency.
After inhalation of inhaled steroids, the reduction of oral steroids may only take place under strict medical supervision. Do not suddenly stop taking oral steroids, but reduce their dosage must be done gradually, strictly according to the doctor's instructions. Restoration of normal adrenal function after stopping treatment with oral steroids may be long-term and the risk of adrenal dysfunction persists for a longer period. Caution should be exercised when changing treatment and regular control of the hypothalamic-pituitary-adrenal axis. You should have a document with you on the need to provide additional steroids that work in general in stress situations (eg surgery, injuries, asthma attacks, chest infections and others).
Rarely, some people, after taking a dose of an inhaler, may experience, contrary to the intended effect, a violent bronchoconstriction (the so-called paradoxical bronchospasm) manifested by wheezing immediately after taking the drug. The contraction may be so intense that it may be life-threatening. In this case, discontinue use immediately and use another quick-acting inhaler bronchodilator and seek medical attention.
Co-administration with ritonavir, Itraconazole , ketoconazole and other drugs that strongly inhibit cytochrome P450 3A4 is recommended.
Additional information about the other ingredients of the preparation:
• the product contains a small amount of ethanol per dose
• the product contains tetrafluoroethane (HFA 134a).
Important information about the use of the preparation
The preparation is intended for inhalation use only. One inhalation dose contains, depending on the package, 80 or 160 micrograms of ciclesonide. The delivered dose depends on properly conducted inhalation. Therefore, it is very important to properly master the inhalation technique. Inhalation of the drug allows its rapid access directly to the airways, or the place of its operation. Only a small amount of inhaled substance reaches the circulatory system, which minimizes systemic side effects.
• To always buy your prescription in time and buy a new one before you use up the previous one.
• Always carry a inhaler with a fast-acting bronchodilator.
• Keep the inhaler clean. The inner and outer surface of the mouthpiece should be cleaned regularly with a dry tissue. It is important not to moisten the inhaler and therefore do not wash the inhaler with water or use any liquid.
Does this preparation affect the ability to drive vehicles?
There was no effect on the ability to drive or use machines / machines.
Use the product as directed by your doctor. The preparation is intended for inhalation use only. Do not exceed the recommended doses because it will not increase the effectiveness of the drug and may harm your health and life. If you have any doubts regarding the use of the preparation, consult a physician. For effective treatment, the product should be used daily, even if the symptoms do not occur. The doctor determines the dosage individually depending on the severity of the disease.
Adults and adolescents after 12 years of age:
the recommended dose is 160 micrograms once daily; this dose allows you to control the symptoms in most patients; in some patients, the maintenance dose can be reduced by a doctor up to 80 micrograms once a day; in severe asthma your doctor may recommend a dose of 320 micrograms twice a day.
Unless the doctor recommends otherwise, the product should be taken in the evening.
The doctor always strives to use the lowest dose to ensure effective control of asthma symptoms. If you have good control of asthma symptoms your doctor may recommend a dose reduction.
There is no need to modify the dosage in the elderly, with impaired renal or hepatic function.
There are insufficient data on the safety and efficacy of the preparation in children under 12 years of age.
Instructions for use of the preparation
The product is an inhaled aerosol and is intended for inhalation through the mouth. During inhalation the patient should sit or stand. The inhaler should be used in an upright position. It is not necessary to shake the inhaler with the medicine before use.
Inhaler with a mouthpiece:
Before the first use (and if the inhaler has not been used for more than a week), remove the cap from the mouthpiece and press the bottom of the container three times (release 3 spray doses) directing the mouthpiece to the air. To take a dose always follow the instructions below:
• calm your breath
• remove the cap from the mouthpiece of the inhaler; check that the mouthpiece inside and outside is clean and free from contaminants that could accidentally be sucked into the respiratory tract during inhalation
• keep the inhaler in a vertical position (with the bottom of the container pointing upwards and the mouthpiece at the bottom) between the thumb and forefinger
• take a calm, long exhale (as long as possible); do not breathe out the inhaler
• place the mouthpiece in your mouth and clamp it around the mouthpiece
• press the bottom of the container 1 time (the dose will be released) while making a deep, calm breath; it is very important to properly synchronize the inhalation and the moment of release of the dose of the drug, therefore it is very important that the inhaler is pressed at the beginning of a calm breath
• hold your breath for a few seconds (important!), Remove the mouthpiece from the mouth and exhale (do not blow out the inhaler)
• if you should take another dose, wait about half a minute and repeat the steps described above
• after use, protect the mouthpiece with a protective cap (press the cover and snap it into place).
The first few inhalations are best done in front of the mirror. If you have problems using the inhaler, consult a doctor or nurse. People who have trouble with proper synchronizing the inhalation and the moment of release of the dose should ask the doctor about the possibility of using an inhalation chamber.
If you have difficulty using the inhaler, your doctor may recommend using the inhaler with a spacer (inhalation chamber) AeroChamber Plus. To take a dose of medicine, follow the instructions that came with this device.
During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or plan to become pregnant, please inform the doctor prescribing the prescription for this medicine.
In pregnant women the use of the preparation is limited only to cases where, in the opinion of the physician, the expected benefit to the mother outweighs the potential risk to the fetus.
It is not known whether ciclesonide passes into breast milk. Consult a physician because only the doctor can assess the risk ratio for the child to the benefits for the mother associated with the use of the preparation during breastfeeding.
Tell your doctor about all medicines you have recently taken, including those that are over the counter.
Tell your doctor if you have been using systemic corticosteroids (by mouth or injections). This will reduce the risk associated with adrenal dysfunction. Replacing oral corticosteroids with inhaled corticosteroids requires caution and strict adherence to the doctor's instructions. There is a risk of symptoms of adrenocortical insufficiency. After inhalation of inhaled steroids, the dose reduction of oral steroids must be done gradually, strictly according to the doctor's instructions. Do not suddenly stop taking oral steroids.
Ritonavir, nelfinavir, itraconazole, ketoconazole and other drugs that strongly inhibit cytochrome P450 3A4 isoenzyme activity may cause a significant increase in the concentration of active ciclesnide metabolite, which is associated with the risk of systemic adverse reactions of corticosteroids (Cushing's syndrome, adrenal suppression). The use of such combination of drugs should be avoided.However, if your doctor thinks that the expected benefits are greater than the risks of such treatment, he will also recommend taking appropriate precautions (increasing the interval between taking medication, reducing the dose of ciclesonide).
Like all medicines, Alvesco can cause side effects, although they will not occur in all patients who use this medicine. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
This preparation, like other inhalation medicines, may cause irritation of the airways, cough, dry mouth, as well as the occurrence of sudden and strong bronchospasm (so-called paradoxical bronchospasm) causing difficulty in breathing. If paradoxical bronchoconstriction occurs, stop using the product immediately, use a fast-acting inhaler bronchodilator and seek medical attention. Uncommonly possible: unpleasant taste in the mouth, nausea, vomiting, oral fungal infections, eczema and rash. Rare side effects include: abdominal pain, indigestion, hypertension, palpitations (usually seen when other medicines with known cardiovascular effects were taken in parallel), hypersensitivity reactions, angioneurotic edema , including swelling of the lips, tongue, throat and larynx that may impede breathing . Rarely, especially in the case of high doses used for a long time, possible symptoms of general corticosteroid (including suppression of adrenocortical function, Cushing's syndrome, moon face, hypertension, slowdown in children and adolescents, reduction in bone density, cataracts, glaucoma). Possible increased psychomotor activity, sleep disorders, anxiety, anxiety, depression, aggression, behavioral changes (especially in children).