Symbicort turbuhaler powder for inhalation 160mkg + 4.5mkg/dose 120doz

Dosage form

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

Composition

1 dose contains: Budesonide * 160 mcg, formoterol fumarate dihydrate 4.5 mcg.
Excipients: lactose monohydrate.
* - non-proprietary international name recommended by WHO; in the Russian Federation accepted the spelling of the international name - budesonide.

Packaging

120 dose vial.

Mechanism of action

Symbicort Turbuhaler - a 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 asthma.
Budesonide - GCS, after inhalation, has an anti-inflammatory effect on the respiratory tract, which lasts several hours and is dose-dependent. Reduces the severity of symptoms and the frequency of exacerbations of bronchial asthma. With the appointment of budesonide in the form of inhalation, there is a lower incidence of serious adverse effectsthan with the use of systemic GCS. Reduces the severity of bronchial mucosal edema, mucus production, sputum formation and airway hyperreactivity. The exact mechanism of the anti-inflammatory action of SCS is not known.
Formoterol is a selective β2-adrenoreceptor agonist. It causes relaxation of the smooth muscles of the bronchi in patients with reversible airway obstruction. Bronchodilatory effect is dose-dependent, occurs within 1-3 minutes after inhalation and lasts for at least 12 hours after taking a single dose.
In clinical studies, it was found that with the combined use of formoterol and budesonide, the severity of asthma symptoms decreases, lung function improves and the frequency of exacerbations of the disease decreases. The effect of Symbicort Turbuhaler on lung function corresponds to the effect of a combination of monodrugs budesonide and formoterol and exceeds the effect of budesonide. There was no decrease in anti-asthma over time. The drug is well tolerated. The drug is well tolerated. While receiving Symbicort Turbuchaler as maintenance therapy for 12 weeks in children aged 6 to 11 years (two inhalations of 80 / 4.5 μg / inhalation 2 times / day), lung function was improved and the drug was well tolerated compared to an appropriate dose of budesonide turbuhaler.
Patients with severe chronic obstructive pulmonary disease (baseline FEV1 - 36%) while receiving Symbicort Turbuhaler showed a significant decrease in the frequency of exacerbations of the disease compared with patients who received only formoterol or placebo as therapy (average frequency of exacerbations 1.4 compared to 1.8-1.9 in the placebo / formoterol group). There were no differences between Symbicort and formoterol in relation to FEV1 values.

Indications and usage

- Bronchial asthma (insufficiently controlled by the use of inhaled GCS and short-acting beta2-adrenomimetics as on-demand therapy, or adequately controlled by inhaled GCS and long-acting β2-adrenomimetics) - as a supportive therapy and for stopping seizures.
- Symptomatic therapy in patients with severe chronic obstructive pulmonary disease (FEV

Contraindications

- Children's age up to 6 years.
- Hypersensitivity to budesonide, formoterol or inhaled lactose.
Precautions should be used Symbicort Turbuhaler in patients with pulmonary tuberculosis (active or inactive form), fungal, viral or bacterial infections of the respiratory system in patients with thyrotoxicosis, pheochromocytoma, diabetes, uncontrolled hypokalemia, idiopathic hypertrophic subaortal stenosis, severe hypertension,aneurysm of any localization or other severe cardiovascular diseases (ischemic heart disease, tachyarrhythmia or severe heart failure), with prolongation of the QT interval (formoterol may cause

Pregnancy and Breastfeeding

There are no clinical data on the use of Symbicort Turbuhaler or the combined use of formoterol and budesonide during pregnancy. During pregnancy, Symbicort Turbuhaler should be prescribed only in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus. Budesonide should be used in the smallest effective dose necessary to maintain adequate control of the symptoms of bronchial asthma. It is not known whether formoterol and budesonide is excreted in human breast milk. Symbicort turbuhaler can be assigned to nursing women, if the expected benefit of therapy for the mother outweighs the potential risk to the child.

Dosage and administration

Inhalation. Dose selection is made individually and depends on the severity of the disease. Adults and children over 12 years old: when using powder for inhalation, containing budesonide and formoterol in a ratio of 80 μg / 4.5 μg / 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 the symptoms of bronchial asthma during the administration of the drug 2 times a day, the dose may be reduced to the lowest effective.

Adverse reactions

Against the background of co-administration of two drugs, there was no increase in the incidence of adverse reactions. The most frequent adverse reactions associated with taking the drug are those pharmacologically expected undesirable side effects, such as tremor and tachycardia, for beta2-adrenergic mimetics, which usually have a moderate severity and disappear several days after the start of treatment. During the use of budesonide in COPD, bruising and pneumonia occurred at 10% and 6%, respectively, compared with 4% and 3% in the placebo group (p> 0.001 and p> 0.01, respectively).
From the side of the central nervous system: often (> 1/100, but 1/1000, but Cardiovascular: often (> 1/100, but 1/1000, but 1/10 000, but Musculoskeletal system: often (> 1/100, but 1/1000, but Respiratory: often (> 1/100, but 1/10 000, but Dermatologic: less often (> 1/1000, but 1/10 000, but Metabolic disorders: rarely (> 1/10 000, but the systemic effect of inhaled GCS can occur when taking the drug in high doses for a long time. The use of beta2-adrenomimetics can lead to an increase in blood levels of insulin, free fatty acids, glycerol, ketone derivatives.

Special notes

Powder for inhalation, containing budesonide and formoterol in a ratio of 80/4/4 mcg / dose, is not indicated for patients with severe bronchial asthma. Not intended for the initial selection of therapy in the early stages of bronchial asthma treatment.A gradual reduction in the dose of the drug before discontinuing treatment is recommended. An increase in the frequency of receiving bronchodilators for emergency treatment indicates a worsening of 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, it is necessary to 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 always carry drugs for emergency care. Treatment should not begin in the period of exacerbation of bronchial asthma. As with any other inhalation therapy, paradoxical bronchospasm may occur (in this case, the treatment tactics should be reviewed and, if necessary, alternative therapy should be prescribed). The manifestation of systemic action during inhalation therapy is less likely than with the use of oral GCS. However, it can occur 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 provides optimal control of 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 assess the ratio of the benefits of GCS therapy and the possible risk of growth retardation.If, against the background of previous systemic treatment of GCS, adrenal function was impaired, precautions should be taken when transferring patients to inhalation treatment with the drug (patients discontinuing therapy with oral GCS may not have sufficient adrenal function 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 joint 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 administered to nursing women only if the expected benefit to the mother is greater than any possible risk to the baby). During treatment, it is recommended to control the concentration of K + in the serum, as well as glucose in patients with diabetes. Contains lactose (less than 1 mg / dose). Usually this amount does not cause problems in patients with lactose intolerance .

Taking 200 mg of Ketoconazole 1 time per day increases the plasma concentration of orally taken budesonide at a dose of 3 mg on average 6 times. With the appointment of ketoconazole 12 hours after taking budesonide, the concentration of the latter in plasma increases 3 times. There is no information about such interaction with inhaled budesonide, however, a significant increase in plasma concentration should be expected (if it is impossible to exclude such a combination, the interval between the administration of ketoconazole and budesonide should be maximized or reduced in doses of budesonide). Dr. CYP3A4 inhibitors are also likely to significantly increase plasma concentration of budesonide. Blockers of beta-adrenergic receptors (including in the form of eye drops) weaken the action of formoterol. Quinidine, disopyramide, procainamide, phenothiazines, antihistamine drugs (terfenadine), MAO inhibitors and tricyclic antidepressants increase the risk of developing Q-T prolongation and ventricular arrhythmias. Dopamine, levothyroxine sodium, oxytocin and ethanol reduce the tolerance of beta2-adrenostimulyatorov myocardium. MAO inhibitors, furazolidone and procarbazine increase the risk of increasing blood pressure. Halogenated hydrocarbon drugs for general anesthesia increase the risk of arrhythmias. Dr. beta-adrenergic stimulants increase the severity of side effects of formoterol. Xanthine derivatives, MKS, some diuretics, cardiac glycosides increase the risk of hypokalemia.