Symbicort Turbuhaler powder 80 / 4.5 mcg / dose, 120 dose

Bronchial asthma (insufficiently controlled by the intake of inhaled GCS and short-acting beta2-adrenostimulants or adequately controlled by inhaled GCS and long-acting beta2-adrenostimulants).

Inhalation The selection of the dose is made individually and depends on the severity of the disease. Adults and children over 6 years of age: when using a powder for inhalation containing budesonide and formoterol in a ratio of 80 mcg / 4.5 mcg / dose - 1-2 inhalations 2 times a day; adults and children 12 years and older: when using the drug 160 mcg / 4.5 mcg / dose - 1-2 inhalations 2 times a day.

After achieving optimal control of the symptoms of bronchial asthma against the background of prescribing the drug 2 times a day, it is possible to reduce the dose to the lowest effective dose.

active substance:

budesonide (micronized)

formoterol fumarate dihydrate (micronized)

hypersensitivity to budesonide, formoterol, or inhaled lactose;

childhood

With care: pulmonary tuberculosis (active or inactive form); fungal, viral or bacterial infections of the respiratory system, thyrotoxicosis, pheochromocytoma, diabetes mellitus, uncontrolled hypokalemia, idiopathic hypertrophic subaortic stenosis, severe arterial hypertension, aneurysm of any localization or other severe cardiovascular diseases (ischemic heart disease, tachyarrhythmia) or , prolongation of the QT interval (taking formoterol can cause prolongation of the QTc interval), lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Pharmachologic effect.

Combined bronchodilator containing corticosteroids for topical use and selective beta2-adrenostimulant, exhibiting an additive effect in reducing the frequency of exacerbations of bronchial asthma. Budesonide - inhaled corticosteroids, in the recommended doses has an anti-inflammatory effect (has a lower frequency of side effects than systemic corticosteroids). Formoterol is a selective beta2-adrenergic receptor agonist that induces relaxation of bronchial smooth muscles in patients with reversible airway obstruction. Bronchodilator effect occurs quickly, within 1-3 minutes after inhalation, and persists for 12 hours after inhalation of a single dose. The addition of formoterol to budesonide reduces the severity of symptoms of bronchial asthma, improves bronchial function and reduces the frequency of exacerbations of the disease.The effect on bronchial function corresponds to that of a combination of monopreparations of budesonide and formoterol and exceeds the effect of one budesonide. The drug is well tolerated.

Indications.

Bronchial asthma (insufficiently controlled by the intake of inhaled GCS and short-acting beta2-adrenostimulants or adequately controlled by inhaled GCS and long-acting beta2-adrenostimulants).

Contraindications

Hypersensitivity to budesonide, formoterol or lactose. Children's age (up to 6 years old).

Carefully

Pregnancy, lactation period, pulmonary tuberculosis, fungal, viral or bacterial infections of the respiratory system, thyrotoxicosis, pheochromocytoma, diabetes mellitus, uncontrolled hypokalemia, GOKMP, severe arterial hypertension, aneurysm, coronary heart disease, tachyarrhythmia, decompensated CHF.

Dosing.

Inhalation The selection of the dose is made individually and depends on the severity of the disease. Adults and children over 6 years of age: when using a powder for inhalation containing budesonide and formoterol in a ratio of 80 mcg / 4.5 mcg / dose - 1-2 inhalations 2 times a day; adults and children 12 years and older: when using the drug 160 mcg / 4.5 mcg / dose - 1-2 inhalations 2 times a day.

After achieving optimal control of the symptoms of bronchial asthma against the background of prescribing the drug 2 times a day, it is possible to reduce the dose to the lowest effective dose.

Side effect

Frequent (more than 0.01%): headache, tachycardia, tremor, candidiasis and irritation of the mucous membrane of the oropharynx, cough, hoarseness.

Less frequent (0.01Ц0.001%): muscle cramps, agitation, anxiety, nausea, dizziness, sleep disturbances.

Rare (less than 0.001%): exanthema, urticaria, pruritus, bronchospasm.

Very rare: budesonide - depression, behavioral disturbances (mainly in children), systemic side effects of GCS (suppression of adrenal function, growth retardation in children and adolescents, decreased bone mineral density, cataracts and increased intraocular pressure), immediate or delayed hypersensitivity reactions types (including dermatitis, angioedema and bronchospasm), the appearance of bruising and 'bruising'.

Formoterol - angina pectoris, hyperglycemia, taste change, blood pressure lability, paradoxical bronchospasm, arrhythmia, atrial fibrillation, supraventricular tachycardia and extrasystole.

Overdose.

Symptoms: tremors, headache, palpitations and tachycardia, decreased blood pressure, metabolic acidosis, hypokalemia and hyperglycemia. With prolonged use of excessive doses - the systemic action of GCS (hypercortisolism and suppression of adrenal function).

Treatment: symptomatic.

Interaction.

Taking 200 mg of ketoconazole once a day increases the plasma concentration of orally taken budesonide at a dose of 3 mg by an average of 6 times. With the appointment of ketoconazole 12 hours after taking budesonide, the concentration of the latter in plasma increases by 3 times. There is no information on such an interaction with inhaled budesonide, however, a noticeable increase in the concentration of the drug in plasma should be expected (if such a combination cannot be excluded, the interval between the appointment of ketoconazole and budesonide should be maximized or reduced in doses of budesonide). Dr. CYP3A4 inhibitors are also likely to significantly increase the plasma concentration of budesonide.

Beta-adrenergic receptor blockers (including in the form of eye drops) weaken the effect of formoterol.

Quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), MAO inhibitors and tricyclic antidepressants increase the risk of QT prolongation and ventricular arrhythmias.

Dopamine, levothyroxine sodium, oxytocin and ethanol reduce the tolerance of beta2-adrenostimulants by the myocardium.

MAO inhibitors, furazolidone and procarbazine increase the risk of high blood pressure.

Halogenated hydrocarbon drugs for general anesthesia increase the risk of arrhythmias.

Dr. beta-adrenostimulants increase the severity of the side effects of formoterol.

Xanthine derivatives, ISS, some diuretics, cardiac glycosides increase the risk of hypokalemia.

special instructions

Powder for inhalation containing budesonide and formoterol in a ratio of 80 / 4.5 ?g / dose is not indicated for patients with severe bronchial asthma.

It is not intended for the initial selection of therapy in the early stages of bronchial asthma treatment.

It is recommended to gradually reduce the dose of the drug before stopping treatment.

An increase in the frequency of taking bronchodilators for emergency care indicates a deterioration in the course of the underlying disease and serves as a basis for revising the tactics of treating bronchial asthma.

To minimize the possibility of developing a fungal infection of the oropharynx, rinse your mouth with water after each inhalation.

There is no data on the use of the drug for the relief of acute attacks of bronchial asthma. Patients should be strongly advised to carry emergency medications with them at all times.

Treatment should not be started during an exacerbation of bronchial asthma. As with any other inhalation therapy, paradoxical bronchospasm may occur (in this case, treatment tactics should be reviewed and alternative therapy should be prescribed, if necessary).

The manifestation of a systemic effect during inhalation therapy is less likely than when using oral corticosteroids. However, it can manifest itself when taking any inhaled GCS, especially when using high doses for a long period of time (it is very important to use the lowest effective dose of inhaled GCS, which ensures optimal control of the symptoms of bronchial asthma).

Doctors need to carefully monitor the growth of children and adolescents who take GCS for a long time in any dosage form, and evaluate the ratio of the benefits of GCS therapy and the possible risk of growth retardation.

If, against the background of previous systemic therapy with GCS, adrenal function was impaired, precautions should be taken when transferring patients to inhalation treatment with the drug (in patients who discontinue therapy with oral GCS, insufficient adrenal function may persist for a long time). In stressful situations, it is always necessary to remember about the possibility of residual adrenal dysfunction in such patients.

There is no clinical data on the use of the drug or the combined use of formoterol and budesonide during pregnancy. In pregnant women, the drug should be used only if the intended benefit to the mother outweighs the potential risk to the fetus, and the smallest effective dose of budesonide necessary to maintain adequate control of the symptoms of bronchial asthma should be used.

It is not known whether formoterol or budesonide passes into the breast milk of women (the drug can be prescribed to lactating women only if the expected benefit to the mother is greater than any possible risk to the child).

During the treatment period, it is recommended to control the concentration of K + in the blood serum, as well as glucose in patients with diabetes mellitus.

Contains lactose (less than 1 mg / dose). Usually this amount does not cause problems in patients with lactose intolerance.