Instruction for use: Budesonide

ATX Code R03BA02 Budesonide

Active substance: Budesonide

Pharmacological group

Glucocorticosteroid

Nosological classification (ICD-10)

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 and form of release

Aerosol dosage with minimal dosage / action 1 dose

Budesonide 50 μg (mite) or 200 μg (forte)

In a bottle of 10 ml - 200 doses; In a cardboard box 1 pc.

pharmachologic effect

Pharmacological action - anti-inflammatory, anti-allergic.

Oppresses the synthesis of leukotrienes and PG (prostaglandins), inhibits the production of cytokines, prevents the migration and activation of inflammatory cells, increases the sensitivity of beta-adrenoreceptors in the smooth muscles of the bronchi.

Pharmacokinetics

After inhalation in the lungs is not metabolized. Entered in the gastrointestinal tract almost completely (by 90%) is destroyed during the "first passage" through the liver: active metabolites account for 1% of the total. Cmax is achieved 15-45 minutes after inhalation. T1 / 2 is 2.8 hours. Systemic bioavailability is 23%. It is excreted in the urine, partly with bile.

Clinical Pharmacology

It suppresses non-specific hyperreactivity of bronchi in patients with bronchial asthma and improves pulmonary parameters and respiratory system function. In therapeutic doses (0.2-1.6 mg / day) does not adversely affect the pituitary-adrenal system and does not cause changes in the concentration of cortisol in the blood; Long-term use (for 12 months) in children does not change the growth rate and body weight.

Indications

Bronchial asthma.

Contraindications

Hypersensitivity, active form of pulmonary tuberculosis, viral and bacterial infections of the respiratory system.

pregnancy and lactation

Perhaps, if the expected benefit for the mother exceeds the potential risk to the fetus.

Side effects

Irritation of the larynx, cough, candidiasis of the cavity of the oral mucosa, paradoxical bronchospasm.

Dosing and Administration

Inhalation, the dose is set individually, depending on the severity. Adults - 1-2 doses (forte) 2 times a day. The highest daily dose is 1.6 mg.

Children - 1-2 doses (mite) 2 times a day. The highest daily dose is 0.4 mg.

Storage conditions

In a cool place protected from overheating and fire.

Keep out of the reach of children.

Shelf life

2 years.

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