Instruction for use: Biasten

Active substance: Budesonide + Salbutamol

ATX Code R03AK04 Salbutamol + Sodium cromolyn

Pharmacotherapeutic group:

Beta-adrenergic agonist in combination

The 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

The powder for inhalation dose 1 dose

budesonide 100 mcg

salbutamol hemisuccinate 200 mcg

Sodium Benzoate 9.7 mg

in a plastic bag 1 inhaler "tsiklohalera" 100 or 200 doses; in box 1 package.

Characteristic

Crystalline powder white or nearly white.

Pharmacological Properties
Pharmachologic effect

anti-inflammatory, bronchodilatory, antiallergic.

pharmacodynamics

Combined preparation containing the glucocorticosteroid topical (budesonide) and a selective beta2-agonists (salbutamol hemisuccinate).

Budesonide is a drug with high glucocorticoid local and low systemic pharmacological activity. It has anti-allergic, anti-inflammatory and antiekssudativnoe action that inhalation route of administration results in a reduction of bronchial obstruction.

The mechanism of action is inhibition of the release of mediators of inflammation and allergies, as well as to reduce the reactivity of the smooth muscle of the bronchi. Budesonide prevents the development of asthma attacks, but relieves bronchospasm. Therapeutic effect develops gradually over 7-10 days.

Salbutamol hemisuccinate - a highly selective beta2-adrenergic stimulant receptors. Possesses strong bronchodilator effect, prevents and relieves bronchospasm, reduces the resistance in the airways, increasing lung capacity. It prevents the release of histamine, slow reacting substances from mast cells. Bronchodilator effect occurs rapidly within 1-3 minutes after inhalation, and lasts for 5-7 hours after administration of a single dose. At therapeutic doses salbutamol hemisuccinate almost no chronotropic and inotropic effects.

Pharmacokinetics

Biasten bioequivalent to the respective monotherapies in relation to systemic exposure of budesonide and salbutamol hemisuccinate.

Indications

Asthma (as a basic therapy in cases where clinically justified the use of a combination of drugs: inhaled glucocorticosteroid and selective beta2-agonists).

Contraindications

Hypersensitivity to the drug, the active form of tuberculosis; fungal, viral, bacterial respiratory infections, pregnancy (I and II trimester), the threat of miscarriage, children up to 16 years.

Pregnancy and breast-feeding

Pregnancy (see. "Contraindications") and in breast-feeding period is possible only when the intended benefits to the mother outweighs the potential risk to the fetus or child.

Side effects

Irritation of the mucous membranes of the mouth and throat, coughing, hoarseness (dysphonia), and Athos, thrush and throat, dry mouth, bad taste in mouth, nausea, vomiting.

In rare cases - a feeling of inner restlessness and bland tremor of skeletal muscles, headache, hypotension, collapse, heart, paradoxical bronchospasm, skin rash.

There are neuropsychiatric symptoms: increased nervous irritability, depression, sleep disorders, behavioral disorders.

Interaction

Not established clinically significant interactions of budesonide, a component of the drug Biasten with other drugs used in the treatment of asthma. However, caution should be exercised while appointing Biastena and CYP3A4 enzyme inhibitors (eg ketoconazole, ritonavir) as systemic effect of budesonide may increase.

Salbutamol hemisuccinate, which is part of Biastena well with asthma medication other pharmacological groups (glucocorticosteroid hormones Membrane stabilizers, antihistamines, expectorants, mucolytics, anticholinergics, xanthine derivatives).

It is not recommended to use both Biasten and non-selective beta-adrenoceptor blockers, such as propranolol.

Hypokalemia may be enhanced by the simultaneous use of salbutamol hemisuccinate, which is part of the drug Biasten and xanthine derivatives, glucocorticoids, diuretics.

Dosing and Administration

Inhalation. Biasten not intended for the initial selection of therapy in the early stages of treatment of asthma. Selection of doses of the drugs included in the Biastena (budesonide and salbutamol hemisuccinate), is carried out individually and depending on the severity of the disease. After reaching stable remission reception replaced monotherapies Biastenom.

Recommended dosage: 1 inhalation three times a day or 2 times 2 inhalations per day.

After achieving optimal control of asthma symptoms in patients receiving the drug may reduce the daily dose to the minimum effective Biastena maintenance dose of up to receive one time per day. In applying the drug should comply with the instructions for use of the inhaler "tsiklohalera".

Overdose

Symptoms: tachycardia, weakness, decreased blood pressure, muscle tremors.

Treatment: symptomatic therapy, the introduction of cardioselective beta-blockers.

Precautionary measures

The drug is prescribed with caution in patients with tachyarrhythmias and other cardiac arrhythmias, myocarditis, heart defects (including aortic stenosis), hypokalemia, hypertension, congestive heart failure, diabetes, hyperthyroidism, glaucoma.

special instructions

Hoarseness, coughing, resulting from settling of the drug in the oropharynx as a result of incorrect inhalation technique typically tested after reducing the dose. Local infections caused by the yeast, quickly cease to local antifungal therapy without interrupting drug treatment.

In order to avoid the development of candidiasis oral cavity and pharynx must be well rinsed after inhalation of the mouth with water (do not swallow the water).

Switching from systemic corticosteroids to inhaled Biastena can cause allergic reactions such as rhinitis and eczema, which were previously suppressed by the systemic corticosteroids. When these symptoms should be the appointment of antihistamine and / or drugs with local action for the treatment of the above diseases.

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

In rare cases (for the complete abolition of oral corticosteroids) may experience symptoms caused by the systemic effects of oral corticosteroids, including adrenal hypofunction, depending on the size of the received dose, duration of treatment, concomitant or previous receiving glucocorticoids and individual sensitivity.

Storage conditions

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

Keep out of the reach of children.

The shelf life

3 years.

Do not use beyond the expiration date printed on the package.