Symbicort 80 / 4.5 mcg / dose 60 doses

Tradename

Symbicort

Symbicort

Composition and form of release:

Each dose contains: micronized budesonide 80 mcg, formoterol fumarate dihydrate 4.5 mcg.

Excipients: lactose monohydrate — 810 mcg.

Powder for inhalation, dosed in the form of granules from white to almost white.

Properties

Combined drug for the treatment of bronchial asthma. Contains formoterol and budesonide, which have different mechanisms of action and exhibit an additive effect in reducing the frequency of exacerbations of bronchial asthma. The special properties of budesonide and formoterol make it possible to use their combination simultaneously as supportive therapy and to relieve attacks, or as a supportive therapy for bronchial asthma.

Budesonide — GCS, after inhalation has a quick (within a few hours) and dose-dependent antiinflammatory effect on the respiratory tract, reducing the severity of symptoms and the frequency of exacerbations of bronchial asthma. When prescribing budesonide in the form of inhalation, there is a lower incidence of serious adverse effects than when using systemic GCS. Reduces the severity of edema of the bronchial mucosa, mucus production, sputum formation and airway hyperresponsiveness.

Formoterol is a selective ß 2 -adrenoceptor agonist . After inhalation, it causes a rapid and prolonged relaxation of the smooth muscles of the bronchi in patients with reversible airway obstruction. The bronchodilator effect is dosedependent, occurs within 1-3 minutes after inhalation and persists for at least 12 hours after taking a single dose.

Indications

Bronchial asthma (insufficiently controlled by the use of inhaled GCS and short-acting beta 2 -adrenomimetics as therapy on demand, or adequately controlled by inhaled GCS and long-acting ß 2 -adrenomimetics). Symbicort Turbuhaler 80 / 4.5 mcg / dose and 160 / 4.5 mcg / dose can be used as maintenance therapy and to relieve seizures;

COPD (symptomatic therapy in patients with severe COPD (FEV <50% of the estimated estimated level) and with a history of recurrent exacerbations, in the presence of severe symptoms of the disease, despite therapy with long-acting bronchodilators).

Contraindications

Children under 6 years of age (for all dosage forms);

Children under 12 years of age (for a dosage form containing 320 mcg budesonide + 9 mcg formoterol);

Hypersensitivity to budesonide, formoterol or inhaled lactose.

Side effects

Against the background of the joint appointment of the two drugs, there was no increase in the incidence of adverse reactions.

The most common adverse reactions associated with taking the drug are such undesirable side effects, pharmacologically expected for beta 2 -adrenomimetics, as tremor and tachycardia, which are usually moderate in severity and disappear a few days after the start of treatment.

During the use of budesonide for COPD, bruising and pneumonia occurred at a frequency of 10% and 6%, respectively, compared with 4% and 3% in the placebo group.

Storage

At temperatures up to 30 0 C. Keep container tightly closed to protect against moisture penetration.

Packaging:

The cardboard box holds 60 or 120 doses of «turbuhaler» plastic inhalers.