Salticason-native por d/ing 50+250 mcg N60 with inhaler (Nativa)
Inhalation. To obtain the optimal effect, the drug should be used regularly, even in the absence of clinical symptoms of bronchial asthma and COPD. The course of treatment and dosage changes are prescribed by the doctor on an individual basis. The patient should be prescribed the drug in a dosage form that contains a dose of fluticasone propionate appropriate to the severity of the disease. Bronchial asthma. If the patient does not receive appropriate therapy, taking only inhaled corticosteroids, then replacing them with the drug Saltikazon®-native at a dose therapeutically equivalent to the dose of administered corticosteroids can improve asthma control. In patients in whom it is possible to control the course of asthma exclusively with the help of inhaled corticosteroids, replacing them with the drug Saltikazon®-native may allow reducing the dose of corticosteroids necessary to control the course of asthma. Adults (18 years and older). 1 inhalation (50 mcg salmeterol and 100 mcg fluticasone propionate) 2 times a day or 1 inhalation (50 mcg salmeterol and 250 mcg fluticasone propionate) 2 times a day or 1 inhalation (50 mcg salmeterol and 500 mcg fluticasone propionate) 2 times a day . In adults over 18 years of age, doubling the dosage of Salticazon®-native maintains the same safety and tolerability as with regular use of this combination 2 times a day. The dose may be doubled in cases where patients require additional short-term (up to 14 days) inhaled corticosteroid therapy, as described in the guidelines for the treatment of bronchial asthma. Currently, there is no data on the use of Saltikazon®-native in patients under the age of 18 years. The dose of Saltikazon®-native should be reduced to the lowest dosage that provides effective control of symptoms. If symptom control is ensured by taking Saltikazon®-native twice a day, reducing the dosage to the minimum effective may include taking the drug once a day. COPD The highest recommended dosage for adults is: one inhalation (50 mcg of salmeterol and 500 mcg of fluticasone propionate) 2 times a day. Special groups of patients There is no need to reduce the dose of Saltikazon®-native in elderly patients, as well as in patients with impaired renal or liver function. Inhalation instructions Powder inhaler “Inhaler CDM®” is a white plastic device with a movable upper part and a retractable compartment for the capsule, about 6 cm high. In order to ensure the correct use of the medicine, it should only be used with the help of the “Inhaler CDM® " Capsules are for inhalation use only and are not intended to be swallowed. The capsule should be removed from the blister pack immediately before use. Instructions for use of the Inhaler CDM® inhaler The Inhaler CDM® is a single-dose inhaler that allows you to dose and inhale the drug in very small doses. Salticasone®-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. You need to 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, use the index finger and thumb of the other hand to open the capsule compartment, as shown in Fig. 2. To do this, press PUSH with your index finger on the moving part of the Inhaler CDM®, moving it in the opposite direction. Step 3. Holding the device with one hand, insert the capsule with the drug into the compartment slot (Fig. 3). Make sure that the capsule is correctly inserted into the slot (Fig. 4). Step 4. While holding the Inhaler CDM® in a vertical position, close the compartment by pressing the thumb in the opposite direction until it stops until a click is heard (Fig. 5). Step 5. Holding the Inhaler CDM® device strictly vertically (Fig. 6), bring it 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 lower part of the device to the upper line. Then release the mouthpiece to return it to its original position. This will puncture the capsule, allowing the drug to enter the lumen of the mouthpiece. Step 6. Attention: before inhalation, you must exhale (Fig. 8). Do not exhale through the mouthpiece! Step 7. Gently squeeze the Inhaler CDM® mouthpiece between your teeth, purse your lips and inhale deeply and forcefully through your mouth (Fig. 9). A vibrating sound will be heard inside the capsule compartment as the capsule rotates and disperses the medication. It is forbidden to chew the mouthpiece or squeeze it tightly with your teeth! Step 8. After inhalation, open the capsule compartment, remove the empty capsule, and then close it, as shown in Fig. 5. Attention: when performing inhalation, do not close 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. 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 well. Repeat steps 5–7 again to ensure inhaled dosage of medication. 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.
Salticazon, 60 pcs., 50 mcg+100 mcg/dose, dosed powder for inhalation
Inhalation.
To obtain the optimal effect, the drug should be used regularly, even in the absence of clinical symptoms of bronchial asthma and COPD.
The course of treatment and dose changes are prescribed by the doctor on an individual basis.
The patient should be prescribed the drug in a dosage form that contains a dose of fluticasone propionate appropriate to the severity of the disease.
Bronchial asthma. If the patient does not receive appropriate therapy, taking only inhaled corticosteroids, then replacing them with the drug Saltikazon®-native at a dose therapeutically equivalent to the dose of administered corticosteroids may improve asthma control. In patients in whom the course of asthma can be controlled exclusively with the help of inhaled corticosteroids, replacing them with the drug Salticazon®-native may allow reducing the dose of corticosteroids required to control the course of asthma.
Adults (18 years and older). 1 inhalation (50 mcg salmeterol and 100 mcg fluticasone propionate) 2 times a day or 1 inhalation (50 mcg salmeterol and 250 mcg fluticasone propionate) 2 times a day or 1 inhalation (50 mcg salmeterol and 500 mcg fluticasone propionate) 2 times a day .
In adults over 18 years of age, doubling the dose of Salticazon®-native maintains the same safety and tolerability as with regular use of this combination 2 times a day. The dose may be doubled in cases where patients require additional short-term (up to 14 days) inhaled corticosteroid therapy, as described in the treatment guidelines for asthma.
Currently, there is no data on the use of Saltikazon®-native in patients under the age of 18 years.
The dose of Saltikazon®-native should be reduced to the lowest dose that provides effective control of symptoms.
If symptom control is ensured by taking Saltikazon®-native 2 times a day, reducing the dose to the minimum effective may include a single dose of the drug per day.
COPD The maximum recommended dose for adults is: one inhalation (50 mcg of salmeterol and 500 mcg of fluticasone propionate) 2 times a day.
Special patient groups
There is no need to reduce the dose of Saltikazon®-native in elderly patients, as well as in patients with impaired renal or liver function.
Instructions for inhalation
The powder inhaler “Inhaler CDM®” is a white plastic device with a movable top part and a retractable compartment for the capsule, about 6 cm high. In order to ensure the correct use of the drug, it should be used only with the help of the “Inhaler CDM®”.
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. Salticasone®-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. You must follow the step-by-step instructions 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, use the index finger and thumb of the other hand to open the capsule compartment, as shown in Fig. 2. To do this, press PUSH with your index finger on the moving part of the Inhaler CDM®, moving it in the opposite direction.
Step 3. Holding the device with one hand, insert the capsule with the drug into the compartment slot (Fig. 3). Make sure that the capsule is correctly inserted into the slot (Fig. 4).
Step 4. While holding the Inhaler CDM® in a vertical position, close the compartment by pressing the thumb in the opposite direction until it stops until a click is heard (Fig. 5).
Step 5. Holding the Inhaler CDM® device strictly vertically (Fig. 6), bring it 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 lower part of the device to the upper line. Then release the mouthpiece to return it to its original position. This will puncture the capsule, allowing the drug to enter the lumen of the mouthpiece.
Step 6. Attention: before inhalation you should exhale (Fig. 8). Do not exhale through the mouthpiece!
Step 7. Gently squeeze the Inhaler CDM® mouthpiece between your teeth, purse your lips and inhale deeply and forcefully through your mouth (Fig. 9). A vibrating sound will be heard inside the capsule compartment as the capsule rotates and disperses. The mouthpiece must not be chewed or squeezed tightly with your teeth!
Step 8. After inhalation, open the capsule compartment, remove the empty capsule, and then close it, as shown in Fig. 5.
Attention: when inhaling, do not close 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.
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 5–7 again to ensure the inhaled dose of the drug.
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.
Saltikazon-native
Since it contains salmeterol and fluticasone, one should expect the development of adverse reactions characteristic of each component separately. No additional side effects were noted with the simultaneous use of two components of the drug.
From the cardiovascular system: tachycardia, palpitations, cardiac arrhythmias, myocardial ischemia.
From the nervous system: headaches, including migraines, sleep disorders, tremors, behavioral disorders, including hyperreactivity and irritability, anxiety.
From the immune system: hypersensitivity reactions, including rash and angioedema, in isolated cases, angioedema of the face and oropharynx, the development of respiratory symptoms - shortness of breath and bronchospasm and, extremely rarely, anaphylactic reactions, allergic rhinitis and conjunctivitis.
From the respiratory system: nosebleeds, nasal congestion, dry mucous membranes of the nasal cavity, laryngitis, hoarseness.
From the gastrointestinal tract: irritation of the mucous membranes of the oropharynx, changes in taste, hyposalivation, infections of the gastrointestinal tract, damage to the hard tissues of the teeth, abdominal pain, increased gas formation, constipation, hemorrhoids.
From the skin: hemorrhages, eczema, dermatitis and dermatoses.
From the musculoskeletal system: muscle cramps, pain in bones and joints.
Infections and infestations: candidiasis of the oral and pharyngeal mucosa, urinary tract infections, respiratory infections, other bacterial and viral infections.
As with the use of other inhaled drugs, paradoxical bronchospasm may develop during use. In this case, you should immediately stop using the drug, evaluate the patient's condition and, if necessary, prescribe alternative therapy.
Theoretically, it is possible to develop systemic reactions, including Itsenko-Cushing syndrome, suppression of adrenal function, growth retardation in children and adolescents, decreased bone mineral density, cataracts, glaucoma, and hyperglycemia.
In case of overdose, tremor, headache, and tachycardia may develop.
Cardioselective beta-adrenergic blockers are used as optimal antidotes, which should be used with caution when treating patients with a history of bronchospasm. If treatment must be discontinued due to an overdose of a beta2-agonist included in the drug, the patient should be prescribed appropriate GCS replacement therapy.
With long-term use in doses exceeding the recommended ones, some suppression of the function of the adrenal cortex is possible, and therefore it is recommended to monitor the reserve function of the adrenal cortex.
