Formisonide-native por d/ing 320+9mcg+device 60 doses (Nativa)
The drug is not intended for oral administration. The dose of Formoterol-native is selected individually depending on the needs of the patient. The lowest dose that provides a therapeutic effect should be used. When control of bronchial asthma symptoms is achieved during therapy with Formoterol-native, it is necessary to consider the possibility of gradually reducing the dose of the drug. Reducing the dose of Formoterol-native is carried out under regular medical supervision of the patient’s condition. The drug consists of capsules with powder for inhalation, which should be used only with the help of a special device - the Inhaler CDM® inhaler, which is included in the package. Bronchial asthma The dose of the drug Formoterol-native for regular maintenance therapy (is 12-24 mcg (contents 1-2 capsules) 2 times / day. Formoterol-native should be used only as additional therapy to inhaled corticosteroids. The maximum recommended dose should not be exceeded of the drug 48 mcg/day (contents 4 capsules). Considering that the maximum daily dose of the drug Formoterol-native is 48 mcg, if necessary, you can additionally use 12-24 mcg/day to relieve the symptoms of bronchial asthma. If there is a need for additional doses of the drug Formoterol-native ceases to be episodic (for example, it becomes more often than 2 days a week), this may indicate a worsening of bronchial asthma, you should consult a doctor. Against the background of exacerbation of bronchial asthma, you should not start treatment with Formoterol-native or change the dosage of the drug Formoterol-native should not be used to relieve acute attacks of bronchial asthma. Prevention of bronchospasm caused by physical activity or inevitable exposure to a known allergen. Formoterol-native should be used in a dose of 12 mcg (contents 1 cap.) 15 minutes before expected contact with the allergen or before exercise . Additional inhalations of the drug should not be carried out over the next 12 hours. Prevention of severe bronchospasms Patients with a history of severe bronchospasms may require a single inhalation at a dose of 24 mcg (contents of 2 capsules). COPD The dose of Formotsrol-native for regular maintenance therapy of COPD is 12-24 mcg (contents of 1-2 capsules) 2 times a day. Adolescents (12-17 years): Formisonide native 80 mcg + 4.5 mcg and 160 mcg + 4.5 mcg 1-2 inhalations twice a day Formisonide native 320 mcg + 9 mcg 1 inhalation twice a day Children over 6 years: Formisonide native 80 mcg + 4.5 mcg 1-2 inhalations twice a day.
Formisonide®-native ()
The dose selection of the active substances included in the drug Formisonide®-native is carried out individually and depending on the severity of the disease. This must be taken into account not only when starting treatment with combination drugs, but also when changing the dose of the drug.
Bronchial asthma
Formisonide®-native is not intended for the initial treatment of intermittent and mild persistent asthma.
In the event that individual patients require a different combination of doses of active substances than in the drug Formisonide®-nashiv, β2-adrenergic agonists and/or corticosteroids should be prescribed separately in separate inhalers.
Patients should regularly visit their doctor to monitor the optimal dose of Formisonide®-native. The dose should be reduced to the lowest dose that maintains optimal control of asthma symptoms. After achieving control of bronchial asthma when taking the drug 2 times a day, it is recommended to titrate the dose to the minimum effective, up to 1 inhalation per day, in cases where, in the opinion of the doctor, the patient requires maintenance therapy in combination with a long-acting bronchodilator. At the next stage, when complete control is achieved, you can try monotherapy with inhaled glucocorticosteroids.
There are two approaches to prescribing therapy for bronchial asthma with Formisonide®-native:
A. As maintenance therapy: Formisonide®-native is prescribed for continuous maintenance therapy in combination with a separate short-acting β2-adrenergic agonist to relieve attacks;
B. As maintenance therapy and for the relief of attacks: Formisonide®-native is prescribed both for continuous maintenance therapy and on demand when symptoms appear.
As maintenance therapy: prescribed in combination with a separate short-acting β2-agonist to relieve attacks. The patient must always have with him a separate inhaler with a short-acting β2-agonist to relieve attacks.
Formisonide®-native 80 mcg + 4.5 mcg and 160 mcg + 4.5 mcg
The drug is prescribed 1-2 inhalations 2 times a day. If necessary, the dose can be increased to 4 inhalations 2 times a day.
Formisonide®-native 320 mcg + 9 mcg
The drug is prescribed 1 inhalation 2 times a day. If necessary, the dose can be increased to 2 inhalations 2 times a day.
An increase in the frequency of use of short-acting 02-adrenergic agonists is an indicator of deterioration in overall disease control and requires a revision of anti-asthmatic therapy.
As a maintenance therapy and to relieve attacks, the drug is especially indicated for patients with insufficient control of bronchial asthma and the need for frequent use of drugs to relieve attacks; if there is a history of exacerbations of bronchial asthma that required medical intervention. The patient must always have Formisonide®-native with him to relieve attacks.
It is necessary to carefully monitor the occurrence of dose-dependent side effects in patients using a large number of inhalations to relieve attacks.
Formisonide®-native 80 mcg + 4.5 mcg and 160 mcg + 4.5 mcg
The recommended dose is 2 inhalations per day: 1 inhalation in the morning and evening, or 2 inhalations 1 time per day only in the morning or only in the evening. Some patients may be prescribed a maintenance dose of Formisonide®-native 160 mcg + 4.5 mcg 2 inhalations 2 times a day. If symptoms of bronchial asthma occur, 1 additional inhalation is necessary. With a further increase in symptoms within a few minutes, 1 additional inhalation is prescribed, but no more than 6 inhalations to relieve 1 attack.
Usually it is not necessary to prescribe more than 8 inhalations per day, but you can increase the number of inhalations to 12 per day for a short time. In patients who use more than 8 inhalations per day, a review of therapy is recommended.
Chronic obstructive pulmonary disease
Formisonide®-native 160 mcg + 4.5 mcg
Recommended dose: 2 inhalations 2 times a day.
Formisonide®-native 320 mcg + 9 mcg
Recommended dose: 1 inhalation 2 times a day.
Special patient groups
There is no data on the use of Formisonide-native in patients with liver failure.
Since budesonide and formoterol are eliminated primarily by the kidneys via hepatic metabolism, a slower rate of elimination of the drug can be expected in patients with severe cirrhosis.
There is no need for special selection of the drug dose for elderly patients.
Instructions for use of the Inhaler CDM® inhaler
In order to ensure correct use of the drug, Formisonide®-native should be used only with the help of the Inhaler CDM® device. Capsules are for inhalation use only and are not intended to be swallowed.
The capsule should be removed from the blister packaging immediately before use.
Instructions for use of the Inhaler CDM® inhaler
Inhaler CDM® is a single-dose inhaler that allows you to dose and inhale the drug in very small doses. Formisonide®-native enters the patient’s respiratory tract along with air flows when active inhalation is performed through the mouthpiece. Inhaler CDM® is very easy to use. When using it, you must follow the step-by-step instructions given below:
Step 1.
Remove the transparent cap from the Inhaler CDM® device as shown in Fig. 1.
Step 2.
Hold the device firmly with one hand, and use the index finger and thumb of the other hand to open the capsule compartment as shown in Fig. 2. To do this, press “PRESS” with your index finger on the moving part of the Inhaler CDM® inhaler, moving the compartment in the opposite direction.
Step 3.
Holding the device with one hand, insert the capsule with the drug into the compartment slot (Fig. 3).
Step 4.
Make sure the capsule is inserted correctly into the slot (Figure 4).
Step 5.
While holding the Inhaler CDM® in an upright position, close the compartment by pushing your thumb back until it clicks until you hear a click (Figure 5).
Step 6.
Hold the Inhaler CDM® device strictly vertically (Fig. 6).
Step 7
Bring the device into working condition, as shown in Fig. 7. To do this, press firmly on the mouthpiece so that the arrow marked on the body disappears beyond the boundaries of the bottom part of the device to the top line. Then release the mouthpiece to return it to its original position. Thus, you will puncture the capsule, allowing the drug to enter the lumen of the mouthpiece.
Caution: Due to the destruction of the gelatin capsule, small pieces of gelatin may enter the mouth or throat as a result of inhalation. In order to minimize this phenomenon, you should not pierce the capsule more than once.
Step 8
Attention: exhale before inhalation (Fig. 8). Do not exhale through the mouthpiece!
Step 9
Gently squeeze the mouthpiece of the Inhaler CDM® device with your teeth, wrap your lips tightly around it, and take a deep, strong breath through your mouth (Figure 9). You will hear a vibrating sound inside the capsule compartment as the capsule rotates and disperses the medication.
Attention: the mouthpiece must not be chewed or squeezed tightly with your teeth!
Do not press on the mouthpiece when inhaling. This may block the movement of the capsule. Hold your breath for about 10 seconds or longer as possible.
Remove the inhaler from your mouth. Exhale slowly. Then breathe normally. Repeat steps 8-9 again to ensure the inhaled dose of the drug.
Step 10
After inhalation, open the capsule compartment (Fig. 2), remove the empty capsule and then close it as shown in Fig. 5.
Attention:
When inhaling, try not to cover the holes located on the sides of the mouthpiece. This may prevent the free movement of air within the inhaler, thereby reducing the dispersion of the capsule contents.
Always close the Inhaler CDM® cap tightly after use, this will keep the mouthpiece clean.
Clean the outside of the mouthpiece regularly (once a week) with a dry cloth.
Formisonide-native, 60 pcs., 160 mcg+4.5 mcg/dose, dosed powder for inhalation
The dose selection of the active substances included in the drug Formisonide®-native is carried out individually and depending on the severity of the disease. This must be taken into account not only when starting treatment with combination drugs, but also when changing the dose of the drug.
Bronchial asthma
Formisonide®-native is not intended for the initial treatment of intermittent and mild persistent asthma.
In the event that individual patients require a different combination of doses of active substances than in the drug Formisonide®-native, β2-adrenergic agonists and/or corticosteroids should be prescribed separately in separate inhalers.
Patients should regularly visit their doctor to monitor the optimal dose of Formisonide®-native. The dose should be reduced to the lowest dose that maintains optimal control of asthma symptoms. After achieving control of bronchial asthma when taking the drug 2 times a day, it is recommended to titrate the dose to the minimum effective, up to 1 inhalation per day, in cases where, in the opinion of the doctor, the patient requires maintenance therapy in combination with a long-acting bronchodilator. At the next stage, when complete control is achieved, you can try monotherapy with inhaled glucocorticosteroids.
There are two approaches to prescribing therapy for bronchial asthma with Formisonide®-native:
A. As maintenance therapy: Formisonide®-native is prescribed for continuous maintenance therapy in combination with a separate short-acting β2-adrenergic agonist to relieve attacks;
B. As maintenance therapy and for the relief of attacks: Formisonide®-native is prescribed both for continuous maintenance therapy and on demand when symptoms appear.
As maintenance therapy: prescribed in combination with a separate short-acting β2-agonist to relieve attacks. The patient must always have with him a separate inhaler with a short-acting β2-agonist to relieve attacks.
Formisonide®-native 80 mcg + 4.5 mcg and 160 mcg + 4.5 mcg
The drug is prescribed 1-2 inhalations 2 times a day. If necessary, the dose can be increased to 4 inhalations 2 times a day.
Formisonide®-native 320 mcg + 9 mcg
The drug is prescribed 1 inhalation 2 times a day. If necessary, the dose can be increased to 2 inhalations 2 times a day.
An increase in the frequency of use of short-acting β2-agonists is an indicator of deterioration in overall disease control and requires a review of anti-asthmatic therapy.
As a maintenance therapy and to relieve attacks, the drug is especially indicated for patients with insufficient control of bronchial asthma and the need for frequent use of drugs to relieve attacks; if there is a history of exacerbations of bronchial asthma that required medical intervention. The patient must always have Formisonide®-native with him to relieve attacks.
It is necessary to carefully monitor the occurrence of dose-dependent side effects in patients using a large number of inhalations to relieve attacks.
Formisonide®-native 80 mcg + 4.5 mcg and 160 mcg + 4.5 mcg
The recommended dose is 2 inhalations per day: 1 inhalation in the morning and evening, or 2 inhalations 1 time per day only in the morning or only in the evening. Some patients may be prescribed a maintenance dose of Formisonide®-native 160 mcg + 4.5 mcg 2 inhalations 2 times a day. If symptoms of bronchial asthma occur, 1 additional inhalation is necessary. With a further increase in symptoms within a few minutes, 1 additional inhalation is prescribed, but no more than 6 inhalations to relieve 1 attack.
Usually it is not necessary to prescribe more than 8 inhalations per day, but you can increase the number of inhalations to 12 per day for a short time. In patients who use more than 8 inhalations per day, a review of therapy is recommended.
Chronic obstructive pulmonary disease
Formisonide®-native 160 mcg + 4.5 mcg
Recommended dose: 2 inhalations 2 times a day.
Formisonide®-native 320 mcg + 9 mcg
Recommended dose: 1 inhalation 2 times a day.
Special patient groups
There is no data on the use of Formisonide-native in patients with liver failure. Since budesonide and formoterol are eliminated primarily by the kidneys via hepatic metabolism, a slower rate of elimination of the drug can be expected in patients with severe cirrhosis.
There is no need for special selection of the drug dose for elderly patients.
Instructions for use of the Inhaler CDM® inhaler
In order to ensure correct use of the drug, Formisonide®-native should be used only with the help of the Inhaler CDM® device. Capsules are for inhalation use only and are not intended to be swallowed.
The capsule should be removed from the blister packaging immediately before use.
Instructions for use of the Inhaler CDM® inhaler
Inhaler CDM® is a single-dose inhaler that allows you to dose and inhale the drug in very small doses. Formisonide®-native enters the patient’s respiratory tract along with air flows when active inhalation is performed through the mouthpiece.
Inhaler CDM® is very easy to use. When using it, you must follow the step-by-step instructions given below:
Step 1.
Remove the transparent cap from the Inhaler CDM® device as shown in Fig. 1.
Step 2.
Hold the device firmly with one hand, and use the index finger and thumb of the other hand to open the capsule compartment as shown in Fig. 2. To do this, press the “Press” button on the moving part of the Inhaler CDM® inhaler with your index finger, moving the compartment in the opposite direction
Step 3.
Holding the device with one hand, insert the capsule with the drug into the compartment slot (Fig. 3).
Step 4.
Make sure the capsule is inserted correctly into the slot (Figure 4).
Step 5.
While holding the Inhaler CDM® in an upright position, close the compartment by pushing your thumb back until it clicks until you hear a click (Figure 5).
Step 6.
Hold the Inhaler CDM® device strictly vertically (Fig. 6).
Step 7
Bring the device into working condition, as shown in Fig. 7. To do this, press firmly on the mouthpiece so that the arrow marked on the body disappears beyond the boundaries of the bottom part of the device to the top line. Then release the mouthpiece to return it to its original position. Thus, you will puncture the capsule, allowing the drug to enter the lumen of the mouthpiece.
Caution: Due to the destruction of the capsule, small pieces of it may enter the mouth or throat as a result of inhalation. In order to minimize this phenomenon, you should not pierce the capsule more than once.
Step 8
Attention: before inhalation you should exhale (Fig. 8). Do not exhale through the mouthpiece!
Step 9
Gently squeeze the mouthpiece of the Inhaler CDM® device with your teeth, wrap your lips tightly around it, and take a deep, strong breath through your mouth (Figure 9). You will hear a vibrating sound inside the capsule compartment as the capsule rotates and disperses the medication.
Attention: the mouthpiece must not be chewed or squeezed tightly with your teeth! Do not press on the mouthpiece when inhaling. This may block the movement of the capsule. Hold your breath for about 10 seconds or longer as possible.
Remove the inhaler from your mouth. Exhale slowly. Then breathe normally.
Repeat steps 8-9 again to ensure the inhaled dose of the drug.
Step 10
After inhalation, open the capsule compartment (Fig. 2), remove the empty capsule and then close it as shown in Fig. 5.
Attention:
When inhaling, try not to cover the holes located on the sides of the mouthpiece. This may prevent the free movement of air within the inhaler, thereby reducing the dispersion of the capsule contents.
Always close the Inhaler CDM® cap tightly after use to keep the mouthpiece clean.
Clean the outside of the mouthpiece regularly (once a week) with a dry cloth.
