Symbicort Turbuhaler, inhalation powder 320/9mcg/dose, 60 doses

Composition

1 dose contains:  

Active ingredients:

budesonide 320 mcg,

frmoterol fumarate dihydrate 9 mcg.

Auxiliary substances:

lactose monohydrate – 491 mcg.

Pharmacological action

Symbicort Turbuhaler is a combined drug for the treatment of bronchial asthma. Contains formoterol and budesonide, which have different mechanisms of action and show an additive effect on reducing the frequency of exacerbations of bronchial asthma.

Budesonide-corticosteroids, after inhalation, has an anti-inflammatory effect on the respiratory tract, which lasts for several hours and is dose-dependent. Reduces the severity of symptoms and frequency of exacerbations of bronchial asthma. When prescribing budesonide in the form of inhalation, there is a lower frequency of serious adverse effects than with the use of systemic corticosteroids. Reduces the severity of edema of the bronchial mucosa, mucus production, sputum formation and hyperreactivity of the respiratory tract. The exact mechanism of anti-inflammatory action of corticosteroids is not known.

Formoterol is a selective beta-2-adrenergic agonist. Causes relaxation of bronchial smooth muscle in patients with reversible airway obstruction. The bronchodilator effect is dose-dependent, occurs within 1-3 minutes after inhalation and persists for at least 12 hours after taking a single dose.

In clinical studies, it was found that the combined use of formoterol and budesonide reduces the severity of symptoms of bronchial asthma, improves lung function and reduces the frequency of exacerbations of the disease. The effect of the Turbuhaler Symbicort on lung function corresponds to the effect of a combination of monopreparations budesonide and formoterol and exceeds the effect of budesonide alone. There was no decrease in the anti-asthmatic effect over time. The drug is well tolerated.

The drug is well tolerated. While taking Symbicort Turbuhaler as maintenance therapy for 12 weeks, children aged 6 to 11 years (two inhalations of 80/4.5 mcg/inhalation 2 times/day) improved lung function and showed good tolerability of the drug, compared with the corresponding dose of budesonide Turbuhaler.

Patients with severe chronic obstructive pulmonary disease (baseline FEV 1 – 36%) who received Turbuhaler Symbicort showed a significant reduction in the frequency of exacerbations of the disease compared to patients who received only formoterol or placebo as therapy (the average frequency of exacerbations was 1.4 compared to 1.8-1.9 in the placebo/formoterol group). There were no differences between the use of Symbicort and formoterol with respect to FEV 1 values.

Indications

• Bronchial asthma (insufficiently controlled by inhaled corticosteroids and short-acting beta-2-adrenostimulants or adequately controlled by inhaled corticosteroids and long-acting beta-2-adrenostimulants).
• COPD (Symptomatic treatment in patients with severe chronic obstructive pulmonary disease (FEV

Use during pregnancy and lactation

There are no clinical data on the use of Turbuhaler Symbicort or the combined use of formoterol and budesonide during pregnancy.

During pregnancy, Symbicort Turbuhaler should only be used in cases where the benefits of the drug outweigh the potential risk to the fetus.

The lowest effective dose of budesonide needed to maintain adequate control of asthma symptoms should be used.

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

Contraindications

Children under 6 years of age.

With caution:

Tuberculosis of the lungs (active or inactive form); fungal, viral or bacterial infections of the respiratory system, thyrotoxicosis, pheochromocytoma, diabetes mellitus, uncontrolled hypokalismia, idiomatic hypertrophic subaortic stenosis, severe arterial hypertension, aneurysm of any localization or other severe cardiovascular diseases (ischemic heart disease, tachyarrhythmia or severe heart failure), prolongation of the QT interval (taking medication). formoterol may cause prolongation of the QTc interval).

Side effects

From the central nervous system:  headache; psychomotor agitation, restlessness, nausea, dizziness, sleep disorders; depression, behavioral disorders (mainly in children), taste disorders.

From the cardiovascular system:  palpitations; tachycardia; atrial fibrillation, supraventricular tachycardia, extrasystole; angina pectoris, blood pressure fluctuations.

Musculoskeletal disorders:  tremor; muscle cramps.

Respiratory system disorders:  candidiasis of the oral and pharyngeal mucosa, mild irritation in the throat, cough, hoarseness; bronchospasm.

Dermatological reactions:   bruising; exanthema, pruritus, dermatitis.

Allergic reactions:  urticaria, angioedema, anaphylactic reactions.

Metabolic disorders: hypokalemia; hyperglycemia, symptoms of systemic corticosteroid action (including adrenal hypofunction).

Interaction

Taking 200 mg of ketoconazole once a day increases the plasma concentration of orally administered budesonide at a dose of 3 mg by an average of 6 times. When ketoconazole is prescribed 12 hours after taking budesonide, the concentration of the latter in plasma increases by 3 times.

There is no information about such an interaction with inhaled budesonide, but 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 use of ketoconazole and budesonide should be maximized or the dose of budesonide should be reduced). Other CYP3A4 inhibitors are also likely to significantly increase the concentration of budesonide in plasma.

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 Q-T interval prolongation and ventricular arrhythmias. Dopamine, levothyroxine sodium, oxytocin and ethanol reduce the tolerance of beta-2-adrenostimulants to the myocardium. MAO inhibitors, furazolidone and procarbazine increase the risk of increased blood pressure. Halogen-containing hydrocarbon drugs for general anesthesia increase the risk of arrhythmias.

Dr. beta-adrenostimulants increase the severity of formoterol side effects. Xanthine derivatives, MCS, certain diuretics, and cardiac glycosides increase the risk of hypokalemia.

How to take, course of use and dosage

By inhalation. The dose is selected individually and depends on the severity of the disease.

Adults and children over 12 years of age: when using powder for inhalation containing budesonide and formoterol in the ratio of 80 mcg/4.5 mcg / dose-1-2 inhalations 2 times a day; 160 mcg/4.5 mcg / dose-1-2 inhalations 2 times a day.

After achieving optimal control of 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 one.

Overdose

Symptoms:  acute overdose of budesonide, even in significant doses, is not expected to cause clinically significant symptoms. Chronic use of budesonide in excessive doses may cause systemic effects of corticosteroids, such as hypercorticism and suppression of adrenal function.

In case of overdose of formoterol – tremor, headache, rapid heartbeat; in some cases, the development of tachycardia, hyperglycemia, hypokalemia, prolongation of the QTc interval, arrhythmia, nausea, vomiting has been reported.

In acute bronchial obstruction, taking formoterol at a dose of 90 mcg for 3 hours was safe.

Treatment:  supportive and symptomatic treatment is indicated.

If it is necessary to cancel the Turbuhaler Symbicort due to an overdose of formoterol, which is also part of the combined drug, the appointment of appropriate corticosteroids should be considered.

Special instructions

Powder for inhalation containing budesonide and formoterol in a ratio of 80/4.5 mcg / dose is not indicated for patients with severe bronchial asthma. It is not intended for initial selection of therapy at the first stages of treatment of bronchial asthma. It is recommended to gradually reduce the dose of the drug before discontinuing treatment.

An increase in the frequency of taking bronchodilators for emergency care indicates a worsening of the course of the underlying disease and serves as a basis for reviewing the tactics of treatment of bronchial asthma. To minimize the possibility of developing a fungal lesion of the oropharynx, it is necessary to rinse your mouth with water after each inhalation. There are no data on the use of the drug for the relief of acute attacks of bronchial asthma.

Patients should be strictly advised to carry emergency medications at all times. Treatment should not be started during the period of acute bronchial asthma. As with any other inhaled therapy, paradoxical bronchospasm may occur (in this case, the treatment strategy should be reviewed and, if necessary, alternative therapy should be prescribed). The manifestation of systemic action during inhalation therapy is less likely than when using oral corticosteroids.

However, it can occur when taking any inhaled corticosteroids, especially when using high doses over a long period of time (it is very important to use the lowest effective dose of inhaled corticosteroids, which provides optimal control of asthma symptoms). Doctors should carefully monitor the growth of children and adolescents who take corticosteroids in any dosage form for a long time, and evaluate the ratio of the benefits of corticosteroid therapy and the possible risk of growth retardation.

If the adrenal function has been impaired during previous systemic corticosteroid therapy, precautions should be taken when transferring patients to inhaled drug treatment (patients who stop therapy with oral corticosteroids may have insufficient adrenal function for a long time).

In stressful situations, it is always necessary to keep in mind the possibility of residual adrenal dysfunction in such patients. There are 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 only be used if the intended benefit to the mother exceeds the potential risk to the fetus, and the lowest effective dose of budesonide should be used, which is necessary to maintain adequate control of asthma symptoms.

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

Form of production

Powder for inhalation in the form of granules from white to almost white in color, mostly rounded in shape.

Storage conditions

At a temperature not exceeding 30 °C

Shelf life

2 years

Active ingredient

Budesonide, Formoterol

Conditions of release from pharmacies

By prescription

Dosage form

powder for inhalation

Purpose

Adults as prescribed by a doctor, Children over 9 years of age, Nursing mothers, Pregnant women as prescribed by a doctor, Children as prescribed by a doctor

Indications

Bronchial Asthma, Bronchospasm, Low Learning Rate