Airsupra (Aerosol) Instructions for Use

Marketing Authorization Holder

AstraZeneca AB (Sweden)

Manufactured By

AstraZeneca Dunkerque Production (France)

ATC Code

R03AK15 (Salbutamol and Budesonide)

Active Substances

Budesonide (Rec.INN registered by WHO)

Salbutamol (Rec.INN registered by WHO)

Dosage Form

Airsupra

Metered dose inhalation aerosol 80 mcg+90 mcg/dose

Dosage Form, Packaging, and Composition

Metered dose inhalation aerosol

(120 doses) – inhalers – carton packs – By prescription

Clinical-Pharmacological Group

Combined bronchodilator drug – selective beta₂-adrenomimetic + topical glucocorticosteroid

Pharmacotherapeutic Group

Drugs for the treatment of obstructive airway diseases; adrenergic agents for inhalation administration; adrenergic agents in combination with glucocorticoids or other drugs, except anticholinergic agents

Pharmacological Action

A combined drug containing a glucocorticosteroid and a selective beta₂-adrenomimetic.

Budesonide is a glucocorticosteroid with high local and low systemic pharmacological activity. It has anti-allergic, anti-inflammatory, and anti-exudative effects, which, when administered by inhalation, lead to a reduction in bronchial obstruction. The mechanism of action involves the suppression of the release of inflammatory and allergic mediators, as well as a reduction in the reactivity of bronchial smooth muscle. Budesonide prevents the development of bronchial asthma attacks but does not relieve bronchospasm. The therapeutic effect develops gradually over 7-10 days.

Salbutamol is a selective stimulant of β₂-adrenergic receptors. It has a bronchodilatory effect, prevents and relieves bronchospasm, reduces airway resistance, and increases vital lung capacity. It prevents the release of histamine and leukotrienes from mast cells. The bronchodilatory effect occurs rapidly, within 1-3 minutes after inhalation, and lasts for 5-7 hours after a single dose. In therapeutic doses, it has practically no chronotropic or inotropic effects.

Indications

Bronchial asthma.

ICD codes

Dosage Regimen

By inhalation. The dose selection for the medicinal products included in the drug is individual and depends on the severity of the disease. The recommended dose is 1 inhalation 3 times/day or 2 inhalations 2 times/day.

After achieving optimal control of bronchial asthma symptoms while taking the drug, it is possible to reduce the daily dose to the minimum effective maintenance dose, even down to once-daily administration.

Adverse Reactions

Local reactions: irritation of the oral and pharyngeal mucosa, cough, hoarseness (dysphonia) and aphonia, candidal stomatitis and pharyngitis, dry mouth and unpleasant taste in the mouth, nausea, vomiting.

Systemic reactions: rarely – anxiety, skeletal muscle tremor, headache, decreased blood pressure, collapse, palpitations, paradoxical bronchospasm, skin rash, increased nervous excitability, depression, sleep disorders, behavioral disorders, systemic side effects of glucocorticosteroids.

Contraindications

Hypersensitivity to the components of the combination; pulmonary tuberculosis (active phase); fungal, viral, bacterial respiratory tract infections; first and second trimesters of pregnancy; threatened miscarriage; children under 16 years of age.

With caution

Arrhythmias (especially tachyarrhythmias), myocarditis, heart disease (including aortic stenosis), hypokalemia, arterial hypertension, acute heart failure, diabetes mellitus, thyrotoxicosis, glaucoma, pregnancy, lactation period.

Use in Pregnancy and Lactation

Contraindicated in the first and second trimesters of pregnancy, in cases of threatened miscarriage, and during lactation (breastfeeding).

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Special Precautions

Not intended for initial therapy selection in the early stages of bronchial asthma treatment.

Hoarseness and cough resulting from the deposition of the drug in the oropharynx due to incorrect inhalation technique usually resolve after reducing the dose of the drug.

Local infections caused by yeast-like fungi are quickly eliminated with local antifungal treatment without the need to interrupt treatment with the drug.

To avoid the development of local candidiasis of the oral cavity and pharynx, it is necessary to rinse the mouth thoroughly with water after inhalation, without swallowing.

Switching from systemic glucocorticosteroids to inhalations of the drug may cause allergic reactions, such as rhinitis and eczema, which were previously suppressed by systemic glucocorticosteroids. If these symptoms appear, it is necessary to prescribe antihistamines.

During the transition from systemic glucocorticosteroids to inhaled ones, patients may experience increased fatigue, headache, arthralgia and myalgia, and sometimes nausea and vomiting.

Drug Interactions

Caution should be exercised when co-administering with inhibitors of the CYP3A4 isoenzyme (ketoconazole, ritonavir), as the systemic effect of budesonide may develop.

Incompatible with non-selective beta-blockers.

Xanthine derivatives, glucocorticosteroids, diuretics – risk of hypokalemia.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.