Biasten^® (Powder) Instructions for Use

ATC Code

R03BX (Other inhalation preparations for the treatment of obstructive airway diseases)

Active Substances

Budesonide (Rec.INN registered by WHO)

Salbutamol (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug with anti-inflammatory and bronchodilator action

Pharmacotherapeutic Group

Bronchodilator agent (selective beta2-adrenomimetic + topical glucocorticosteroid)

Pharmacological Action

Biasten^® is a combination drug containing Budesonide and Salbutamol hemisuccinate, which have different mechanisms of action and are used for the basic therapy of bronchial asthma.

Budesonide is a glucocorticosteroid (GCS) 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 inhibition 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 hemisuccinate is a highly effective selective stimulant of β₂-adrenergic receptors. It has a pronounced bronchodilatory effect, prevents and relieves bronchospasm, reduces resistance in the airways, and increases vital lung capacity. It prevents the release of histamine and slow-reacting substance 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, Salbutamol hemisuccinate has virtually no chronotropic or inotropic effects.

Biasten^® is bioequivalent to the corresponding monodrugs in terms of the systemic exposure of budesonide and salbutamol hemisuccinate.

Indications

• Basic therapy of bronchial asthma in cases where the use of a combination of drugs (inhaled glucocorticosteroid and selective β₂-adrenomimetic) is clinically justified.

ICD codes

Dosage Regimen

Powder

Biasten^® is not intended for the initial selection of therapy in the early stages of bronchial asthma treatment. The dose of the active substances included in Biasten^® (budesonide and salbutamol hemisuccinate) is selected individually and depending on the severity of the disease. Upon achieving stable remission, the use of monodrugs is replaced by Biasten^®. Patients should regularly visit a doctor to control the optimal dose of Biasten^®.

Recommended doses

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 of Biasten^® to the minimum effective maintenance dose, up to application once a day.

When using the drug, the instructions for using the “Cyclohaler” inhaler should be followed.

Adverse Reactions

Since Biasten^® contains Budesonide and Salbutamol hemisuccinate, its side effects are characteristic of each of these drugs. Their simultaneous use does not cause additional side effects.

Possible irritation of the mucous membranes of the oral cavity and pharynx, cough, hoarseness and aphonia, candidal stomatitis and pharyngitis, dry mouth, unpleasant taste in the mouth, nausea, vomiting.

In rare cases, feelings of inner restlessness and mild skeletal muscle tremor, headache, arterial hypotension, collapse, palpitations, paradoxical bronchospasm, skin rash may occur.

Possible psychoneurological symptoms such as increased nervous excitability, depression, sleep disturbance, behavioral disorders.

Contraindications

• Active form of pulmonary tuberculosis;
• Fungal, viral, bacterial infections of the respiratory organs;
• I and III trimesters of pregnancy, threat of miscarriage;
• Children under 16 years of age;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The use of the drug during pregnancy and lactation is possible only if the intended benefit to the mother outweighs the potential risk to the fetus or child.
Contraindication: I and III trimesters of pregnancy, threat of miscarriage.

Pediatric Use

Contraindicated: children under 16 years of age

Special Precautions

Hoarseness, cough, resulting from the deposition of the drug in the oropharynx due to incorrect inhalation technique, usually disappear after reducing the dose of the drug. Local infections caused by yeast-like fungi are quickly relieved by local antifungal therapy without the need to interrupt treatment with the drug.

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

Switching from systemic GCS to Biasten^® inhalations may cause allergic reactions, such as rhinitis and eczema, which were previously suppressed by systemic GCS. If these symptoms appear, it is necessary to prescribe antihistamines and/or drugs with local action to treat the above diseases.

During the transition from systemic GCS to inhaled ones, patients may experience increased fatigue, headache, muscle and joint pain, and sometimes nausea and vomiting.

In rare cases, symptoms caused by the systemic action of GCS may occur, including adrenal hypofunction, depending on the dose taken, duration of treatment, concomitant or prior use of GCS, as well as individual sensitivity.

The drug is prescribed with caution to patients with tachyarrhythmia and other rhythm disorders, myocarditis, heart defects (including aortic stenosis), hypokalemia, arterial hypertension, acute heart failure, diabetes mellitus, thyrotoxicosis, glaucoma.

Overdose

Symptoms tachycardia, weakness, decreased blood pressure, muscle tremor.

Emergency care for overdose symptomatic therapy, administration of cardioselective beta-blockers.

Drug Interactions

No clinically significant interaction of budesonide, which is part of the Biasten^® drug, with other drugs used in the treatment of bronchial asthma has been established. However, caution should be exercised when prescribing Biasten^® and inhibitors of the CYP3A4 enzyme (e.g., ketoconazole, ritonavir) simultaneously, as the systemic effect of budesonide may increase.

Salbutamol hemisuccinate, which is part of the Biasten^® drug, combines well with anti-asthma drugs of other pharmacological groups (GCS, membrane stabilizers, antihistamines, expectorants, mucolytics, anticholinergics, xanthine derivatives).

It is not recommended to use Biasten^® and non-selective beta-adrenergic receptor blockers, such as propranolol, simultaneously.

Hypokalemia may be enhanced as a result of the simultaneous use of salbutamol hemisuccinate, which is part of the Biasten^® drug, and xanthine derivatives, GCS, diuretics.

Storage Conditions

List B. Store at a temperature of 25°C (77°F) in a dry place, protected from light and out of reach of children.

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is dispensed by prescription.

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.