Seretide Aerosol, 120 d, 25+250 mcg/dose, for inhalation


Seretide Aerosol, 120 d, 25+250 mcg/dose, for inhalation

special instructions

Seretide is not intended for the relief of acute symptoms, as in such cases a rapid and short-acting inhaled bronchodilator (eg salbutamol) should be used. Patients should be advised to always have medication available to relieve acute symptoms. The combination of salmeterol and fluticasone propionate can be used for initial maintenance therapy in patients with persistent bronchial asthma (daily occurrence of symptoms or daily use of drugs to relieve attacks) if there are indications for the use of corticosteroids and their approximate dosage has been determined. More frequent use of short-acting bronchodilators to relieve symptoms indicates worsening disease control, and in such situations the patient should consult a doctor. Sudden and increasing deterioration in control of bronchospastic syndrome poses a potential threat to life, and in such situations the patient should also consult a doctor. The physician should consider prescribing a higher dose of GCS. If the dose of Seretide used does not provide adequate control of the disease, the patient should also consult a doctor. Patients with asthma should not abruptly stop treatment with Seretide due to the risk of exacerbation; the dose of the drug should be reduced gradually under the supervision of a physician. In patients with COPD, drug withdrawal may be accompanied by symptoms of decompensation and requires medical supervision. Clinical studies have provided evidence of an increase in the incidence of pneumonia in patients with COPD receiving Seretide (see section Side effects). Clinicians should be aware of the possibility of developing pneumonia in COPD, since the clinical presentation of pneumonia and exacerbation of COPD are often similar. Any inhaled GCS can cause systemic effects, especially with long-term use in high doses; however, the likelihood of such symptoms occurring is much lower than with treatment with oral corticosteroids (see Overdose section). Possible systemic reactions include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, and glaucoma. Therefore, when treating asthma, it is important to reduce the dose to the lowest dose that provides effective control of the disease. In emergency and planned situations that can cause stress, it is always necessary to remember the possibility of adrenal suppression and be prepared to use GCS (see section Overdose). When carrying out resuscitation measures or surgical interventions, it is necessary to determine the degree of adrenal insufficiency. It is recommended to regularly measure the height of children who receive long-term therapy with inhaled corticosteroids. Due to the possibility of adrenal suppression, patients switched from oral corticosteroids to inhaled fluticasone propionate therapy should be treated with extreme caution and their adrenal function regularly monitored. After starting treatment with inhaled fluticasone propionate, systemic corticosteroids should be withdrawn gradually, and such patients should have a special patient card containing an indication of the possible need for additional administration of corticosteroids in stressful situations. In patients with exacerbation of bronchial asthma, hypoxia, it is necessary to control the concentration of K+ ions in the plasma. There are very rare reports of increased blood glucose levels, and this should be kept in mind when prescribing a combination of salmeterol and fluticasone propionate to patients with diabetes mellitus (see section Side effects). During the post-marketing period, there have been reports of clinically significant drug interactions between fluticasone propionate and ritonavir, leading to systemic effects of GCS, including Cushing's syndrome and adrenal suppression. Therefore, it is recommended to avoid the combined use of fluticasone propionate and ritonavir, except in cases where the potential benefit to the patient outweighs the risk associated with the systemic effects of GCS (see section Drug Interactions). Data from a clinical study of the safety of salmeterol added to the treatment of bronchial asthma compared with placebo showed that the incidence of deaths due to bronchial asthma was significantly higher in the salmeterol group. When taking salmeterol compared with placebo, the risk of serious respiratory adverse reactions or death in African-American patients appears to be greater than in other patients. The significance of pharmacogenetic factors or other causes is unknown. The effect associated with the use of GCS on the risk of death in patients with asthma was not studied in this study. Like other inhaled drugs, Seretide can cause paradoxical bronchospasm, manifested by an increase in shortness of breath immediately after use. In this case, you should immediately use a fast- and short-acting inhaled bronchodilator, discontinue the drug Seretide, examine the patient and, if necessary, begin alternative therapy (see section Side effects). There are reports of adverse reactions associated with the pharmacological action of beta2-antagonists, such as tremor, subjective palpitations and headache. However, these reactions are short-term in nature, and their severity decreases with regular therapy (see section Side effects). Effect on the ability to drive vehicles and operate machinery In clinical studies, no data were obtained on the effect of the drug on the ability to drive vehicles and other mechanisms, however, side effects that the drug may cause should be taken into account.

Indications for use of the drug Seretide™

Reversible obstructive diseases of the respiratory tract Systematic treatment of reversible broncho-obstructive diseases of the respiratory tract, including asthma in children and adults if it is necessary to prescribe a bronchodilator in combination with inhaled corticosteroids. The drug is intended for the treatment of:

  • patients receiving effective maintenance doses of selective long-acting β2-adrenergic receptor agonists and inhaled corticosteroids;
  • patients who experience symptoms of the disease during treatment with inhaled corticosteroids;
  • patients regularly receiving bronchodilators and requiring the use of inhaled corticosteroids.

COPD Basic therapy for COPD, including chronic bronchitis and emphysema.

Use of the drug Seretide™

The drug is intended for inhalation use only. Patients should understand that the drug should be used regularly, even in the absence of attacks of bronchial obstruction, since it is prescribed to prevent the disease. Patients should be under regular medical supervision, they need to select the optimal dose of Seretide, which can only be changed as directed by a doctor. Reversible obstructive airway diseases. Seretide is prescribed in the minimum effective dose to ensure control of the symptoms of the disease. When control is achieved by using the drug 2 times a day, you can try to reduce the dose to the minimum effective, the frequency of use is 1 time a day. The amount of fluticasone propionate in the chosen form should correspond to the severity of the disease. If asthma symptoms are not sufficiently controlled using inhaled corticosteroids alone, such control can be improved by replacing inhaled corticosteroid therapy with Seretide at a therapeutically equivalent dose of corticosteroids. For patients whose asthma symptoms are sufficiently controlled by the use of corticosteroids alone, replacing them with Seretide may allow a reduction in the dose of corticosteroids while maintaining control of asthma symptoms. Seretide Discus is for inhalation use only. Recommended doses Adults and adolescents over 12 years of age: 1 inhalation (50 mcg salmeterol/100 mcg fluticasone propionate) 2 times a day; or 1 inhalation (50 mcg salmeterol/250 mcg fluticasone propionate) 2 times a day; or 1 inhalation (50 mcg salmeterol/500 mcg fluticasone propionate) 2 times a day. Adults aged 18 years and older: If an adult patient aged 18 years or older requires short-term (up to 14 days) additional therapy with inhaled corticosteroids, he can be prescribed a double dose of any form of Seretide, comparable in safety and tolerability profile to the usual dose of Seretide 2 times. per day. Children aged 4 to 12 years : 1 inhalation (50 mcg salmeterol/100 mcg fluticasone propionate) 2 times a day. There are no data on the use of the drug in children under 4 years of age, so use is not recommended. COPD . For adult patients, the maximum recommended dose is 1 inhalation (50 mcg salmeterol/500 mcg fluticasone propionate) 2 times a day. Selected groups of patients: There is no need for dose adjustment in elderly patients and in patients with liver or kidney pathology. Discus is a device designed to release powder and then inhale it. Before use, open and charge the device by sliding the lever. Then place the mouthpiece in your mouth and wrap your lips around it, then inhale the dose and close the device. The indicator shows the number of doses remaining in the Discus. Rules for using the Discus inhaler The new Discus inhaler must be closed. Contains 60 doses of the drug in powder form. The dose indicator at the top shows how many doses are left. In this way, every dose is precisely measured and hygienically protected. There is no need for special care of the inhaler and refilling doses. Numbers 5 to 0 appear in red to indicate remaining doses. Usage:

  • open the inhaler;
  • move the lever;
  • inhale;
  • close the inhaler.

How the Discus inhaler works: when you press the lever in the inhaler, a small hole in the mouthpiece opens slightly and a dose is unpacked for inhalation. When closing the inhaler, the lever automatically rotates to its original position and the inhaler is ready to prepare the next dose if necessary. The case protects the inhaler when not in use. Caring for your Discus inhaler: wipe the mouthpiece of the inhaler with a dry cloth. Need to remember:

  • the inhaler is stored in a dry place;
  • the inhaler must be closed when not in use;
  • never exhale into a Discus inhaler;
  • press the lever only when you are ready to take a dose;
  • never exceed the recommended dose.

Seretide Evohaler is for inhalation use only. Recommended doses Adults and adolescents 12 years of age and older: 2 inhalations of 25 mcg salmeterol/50 mcg fluticasone propionate 2 times daily; or 2 inhalations of 25 mcg salmeterol/125 mcg fluticasone propionate 2 times a day; or 2 inhalations of 25 mcg salmeterol/250 mcg fluticasone propionate 2 times a day. Adults 18 years of age and older: If an adult requires short-term (up to 14 days) adjunctive therapy with an inhaled corticosteroid, a double dose of any form of Seretide Evohaler can be administered, which will have a safety and tolerability profile comparable to the usual dose of Seretide Evohaler twice daily. day. Children aged 4 years and older : 2 inhalations of 25 mcg salmeterol/50 mcg fluticasone propionate 2 times a day. There are no data regarding the use of Seretide Evohaler in children under 4 years of age. COPD For adult patients, the maximum recommended dose is 2 inhalations (25 mcg salmeterol/250 mcg fluticasone propionate) 2 times a day. Selected patient groups: There is no need to adjust the dose in elderly patients or in patients with insufficient renal or hepatic function. For patients who find it difficult to coordinate inhalation with nebulization of the inhaler, it is recommended to use a spacer (a device for facilitating the administration of inhaled drugs AeroChamber Plus - see below). Use of a device for administering metered inhalation aerosols AeroChamber Plus To avoid deterioration of disease control due to improper use of metered inhalation aerosols, it is recommended to use an additional device - a Spencer with an AeroChamber Plus mask. This is a volumetric chamber through which the aerosol from the inhaler enters the patient's respiratory tract. The AeroChamber Plus spacer can be used in children under the age of 4 years, and the spacer with a face mask can be used from the first days of life (0-18 months - orange mask, 1 year-5 years - yellow mask). The use of AeroChamber Plus allows you to reduce the oropharyngeal disposition of the drug: fewer aerosol particles are retained in the oropharynx, larynx and trachea, and more reach the lower respiratory tract (due to the presence of a valve and diaphragm in this spacer). In addition, it slows down the speed of the aerosol jet, due to which its large non-respirable particles (4.7 microns) are eliminated. AeroChamber Plus has a universal adapter. Rules for using the AeroChamber Plus spacer :

  • carefully check the spacer for damage or foreign objects;
  • remove the cap from the inhaler mouthpiece;
  • shake the inhaler;
  • insert the inhaler mouthpiece into the adapter;
  • carefully and tightly press the mask to your face;
  • press the inhaler once and inhale slowly;
  • keep the mask pressed to your face for 6 breaths after pressing the inhaler;
  • Carefully remove the mask from your face.

Rules for caring for the AeroChamber Plus spacer:

  • it is necessary to wash the spacer before the first use, after which the spacer is washed once a week;
  • disconnect the adapter for the inhaler, do not disconnect the mask and valves;
  • immerse the spacer with the disconnected adapter in warm water with detergent for 15 minutes;
  • rinse the spacer thoroughly with warm water;
  • shake off any remaining water from the spacer, do not wipe it dry;
  • leave the spacer at room temperature in a vertical position until completely dry, then reattach the adapter;
  • After 24 months with constant use, the spacer should be replaced.
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