Instruction for use: Budesonid-nativ

ATX Code R03BA02 Budesonide

Active substance: Budesonide

Pharmacological group

Glucocorticosteroid for topical use [Glucocorticosteroids]

Nosological classification (ICD-10)

J44 Other chronic obstructive pulmonary disease

Allergic bronchitis, Bronchitis asthma, Asthmatic bronchitis, wheeze bronchitis, Bronchitis is an obstructive, bronchi disease, Shortness of sputum in acute and chronic respiratory diseases, Cough in inflammatory diseases of the lung and bronchus, Reversible airflow obstruction, Reversible obstructive airway disease, Obstructive bronchitis disease, Obstructive lung disease, Obstructive bronchitis, Spastic bronchitis, Chronic lung disease, Chronic nonspecific lung diseases, Chronic obstructive pulmonary disease, Chronic obstructive bronchitis, Chronic obstructive airway disease, Chronic obstructive pulmonary disease, Restrictive lung pathology

J44.9 Chronic obstructive pulmonary disease, unspecified

Obstructive pulmonary diseases, Bronchial obstruction, bronchial obstruction, Exacerbation of chronic obstructive pulmonary disease, reversible airflow obstruction, Reversible airway obstruction, panbronchiolitis, Panbronhit, COPD, Chronic pulmonary infection, Chronic infection of the lower respiratory tract, Chronic obstructive pulmonary disease, Chronic obstructive pneumonia, Chronic lung disease, Chronic obstructive pulmonary disease, Chronic bronchopulmonary disease, Chronic broncho-pulmonary diseases, Airway obstruction

J45 Asthma

Asthma physical effort, status asthmaticus, Bronchial asthma, Asthma lung flow, Bronchial asthma with obstruction of sputum discharge, Bronchial asthma heavy currents, Bronchial asthma physical effort, hypersecretory asthma, Hormone-dependent form of bronchial asthma, Relief of asthma attacks in bronchial asthma, Non-allergic asthma, nocturnal asthma, Exacerbation of asthma, Asthma attacks, Endogenous forms of asthma, Night asthma, Cough with bronchial asthma

Composition

Solution for inhalation 1 ml

active substance:

Budesonide 0.25 / 0.5 mg

Auxiliary substances: methylparahydroxybenzoate (nipagin) - 0.5 mg; Succinic acid 1.5 mg; Disodium edetate (Trilon B) 0.5 mg; Macrogol 400 (polyethylene oxide 400) - 350 mg; Propylene glycol 200 mg; Purified water - up to 1 ml

pharmachologic effect

Pharmacological action - bronchodilator, glucocorticoid.

Dosing and Administration

Inhalation.

The dosage of Budesonide-native must be individual. The initial dose in adults for the treatment of bronchial asthma and COPD (chronic obstructive pulmonary disease) is 1-2 mg / day. The dose with maintenance treatment is 0.5-4 mg / day.

After receiving the effect, the dose is reduced to the minimum effective dose necessary to maintain a stable state. In some cases, the dose of the drug may be increased in patients in whom treatment is necessary to achieve a rapid therapeutic effect.

In case the patient took the GCS (glucocorticosteroids) orally, the transfer to treatment with budesonide-native should be done with the patient's stable state of health, for 10-14 days they combine inhalation and ingestion of GCS inside.

Within 10 days, it is recommended to take high doses of budesonide-native against the background of taking oral GCS in a selected dose. In the future, the dose of oral GCS should be gradually reduced (for example, 2.5 mg of prednisolone) to the lowest possible level. In many cases, it is possible to completely refuse the use of oral GCS. Data on the use of budesonide in patients with renal insufficiency or liver dysfunction are absent. Since the excretion of budesonide occurs due to biotransformation in the liver, an increase in the duration of action of the drug in patients with severe hepatic cirrhosis can be expected. When appointing patients with cirrhosis of the liver requires more careful observation.

Children older than 16 years - the initial dose of 0.25-0.5 mg / day. If necessary, the dose may be increased to 1 mg / day. The maintenance dose is 0.25-2 mg / day.

The drug is used with a nebulizer. The bottle contains 1 single dose.

Instructions for use

Open the bottle with the drug. Fill the nebulizer through the upper hole with the required amount of the drug. Nebulization should be performed in accordance with the instructions for the type of nebulizer used.

The volume of budesonide solution delivered to the patient's lungs by a nebulizer is variable and depends on several factors, including the following:

- time of inhalation;

- level of filling the chamber;

- technical characteristics of the nebulizer;

- the ratio of volume when inhaling / expiring and the patient's breathing volume;

- the use of a mouthpiece or mask.

Note.

1. After each inhalation, rinse the mouth with water.

2. If the patient uses a mask, he should make sure that with the inhalation mask tightly fitted to the face. After inhalation, wash face.

Cleaning

The nebulizer chamber should be cleaned after each use.

The nebulizer chamber and the mouthpiece or mask are washed with warm water, using a mild detergent or in accordance with the manufacturer's instructions.

Form of issue

Solution for inhalation, 0.25 mg / ml, 0.5 mg / ml. For 2 ml in bottles of drug for medicines or bottles of orange glass, sealed with rubber stoppers, crimped aluminum caps. For 10 fl. In a pack of cardboard box.

Terms of leave from pharmacies

On prescription.

Storage conditions

In dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life

3 years.

Do not use after the expiry date printed on the package.