Symbicort turbuhaler powder for inhalation 80mkg + 4.5mkg/dose 120doz

Dosage form

Powder for inhalation

Composition

1 dose (delivered) contains Budesonide 80 mcg, formoterol fumarate dihydrate 4.5 mcg.

Packaging

120 doses.

Mechanism of action

Combined medication 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 for inhalation use. When used in recommended doses, it has an anti-inflammatory effect in the lungs, reducing the severity of symptoms and the frequency of exacerbations of asthma with a lower incidence of side effects than when using systemic corticosteroids. The exact mechanism responsible for the anti-inflammatory effect of the drug is unknown.
Formoterol is a selective agonist b₂-adrenoreceptors. It causes relaxation of the smooth muscles of the bronchi in patients with reversible airway obstruction. Bronchodilatory effect occurs quickly, within 1-3 minutes after inhalation, and lasts for 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. The drug is well tolerated.
While receiving Symbicort Turbuchaler for 12 weeks (two inhalations of 80 / 4.5 mcg / 1 dose twice a day), lung function was improved in children aged 6 to 11 years, and the drug was well tolerated.
Patients with severe chronic obstructive disease 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 a 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 intake on expiratory forced exponent (FEV₁).

Indications and usage

- supportive therapy of bronchial asthma in those cases when the use of a combination of inhaled GCS and agonists is clinically justified₂long-acting adrenoreceptors: in patients whose condition is not sufficiently controlled by the use of inhaled corticosteroids and inhaled beta₂- short-acting adrenomimetics used as emergency medications "as needed", or in patients whose condition is already adequately controlled by inhaled GCS and agonists b₂- long-acting adrenoreceptors.
- symptomatic therapy in patients with severe chronic obstructive pulmonary disease (COPD) (FEV₁ 50% of the estimated normal level) and with recurring exacerbations in history, which have pronounced symptoms of the disease, despite the long-acting bronchodilator therapy.

Contraindications

- children's age up to 6 years;
- hypersensitivity to budesonide, formoterol or inhaled lactose.

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 penetrate into 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

Selection of the dose of drugs that are part of Symbicort Turbuhaler, is carried out individually and depending on the severity of the disease. This must be taken into account when starting treatment with combination drugs. In the event that individual patients require a dosage that goes beyond the recommended treatment regimen, a separate beta should be administered.₂-adrenomimetics and / or glucocorticoids in the appropriate dosage.
Symbicort turbuhaler with a content in 1 dose of budesonide 80 mcg and formoterol 4.5 mcg is not indicated for patients with severe bronchial asthma.
Atbronchial asthma Adults and adolescents (12 years and older) are prescribed Symbicort Turbuhaler 80 / 4.5 mcg / dose 1-2 inhalations 2 times / day, Symbicort Turbuhaler 160 / 4.5 mcg / dose - 1-2 inhalations 2 times / day
After achieving optimal control of the symptoms of bronchial asthma while taking the drug 2 times / day, the dose may be reduced to the lowest effective level, up to and including 1 time / day.
Children aged 6 to 12 years prescribed Symbicort Turbuhaler 80 / 4.5 mg / dose 1-2 inhalations 2 times / day.
AtCOPD Adults are prescribed Symbicort Turbuhaler 160 / 4.5 mcg / dose, 2 inhalations, 2 times / day.
There is no need for a special selection of the dose of the drug for elderly patients.
There is no data on the use of Symbicort Turbuhaler in patients with renal or hepatic insufficiency. Since budesonide and formoterol are excreted mainly by the kidneys, with the participation of hepatic metabolism, in patients with severe cirrhosis of the liver, we can expect a slower rate of excretion of the drug.

Adverse reactions

Since Symbicort Turbuhaler contains budesonide and formoterol, we can expect the development of the same side effects, which are noted in the case of the use of these drugs separately. 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 for beta.₂-adrenomimetikov undesirable side effects, like tremor and tachycardia, which usually have a moderate degree of severity and disappear in a few days after the start of treatment.
Side effects that are associated with budesonide or formoterol are listed below.
From the side of the central nervous system: often (1/100) - headache; possible excitement, anxiety, nausea, dizziness, sleep disturbances.
Cardiovascular: often (1/100) - tachycardia; more pronounced tachycardia is possible.
Musculoskeletal system: often (1/100) - tremor; possible muscle cramps.
Respiratory: often (1/100) - candidiasis of the oral mucosa, mild throat irritation, cough, hoarseness, pneumonia; rarely (1/1000) - bronchospasm; in rare cases, paradoxical bronchospasm.
Dermatologic: often (1/100) - hemorrhages in the subcutaneous fat; rarely (1/1000) - rash, urticaria, pruritus.
Symptoms of systemic action of budesonide: in rare cases - depression, behavioral disturbance (mainly in children), adrenal hypofunction, allergic reactions of immediate or delayed types (includingdermatitis, angioedema and bronchospasm).
Symptoms associated with the action of formoterol: in isolated cases - angina, hyperglycemia, change in taste, fluctuations in blood pressure.
For other beta₂-adrenomimetic cardiac arrhythmias such as atrial fibrillation, supraventricular tachycardia and extrasystole were noted.

Special notes

Care should be taken when using Symbicort Turbuchaler in patients with active or inactive forms of pulmonary tuberculosis, fungal, viral or bacterial respiratory infections.
Symbicort turbuhaler should be prescribed with caution in patients with thyrotoxicosis, pheohromocytoma, diabetes
Care should be taken when using the drug in patients with an extended QTc interval, because budesonide may cause further prolongation of the QTc interval.
With extreme caution should use the drug for acute exacerbation of severe bronchial asthma, since the risk of hypokalemia increases due to hypoxia. During the treatment of exacerbation of severe bronchial asthma, it is recommended to monitor the content of potassium in serum.
When using the drug in patients with diabetes, it is necessary to additionally monitor the concentration of glucose in the blood.
It is recommended to gradually reduce the dose of the drug before discontinuing treatment.
The increase in the frequency of taking bronchodilators as emergency drugs indicates a worsening of the course of the underlying disease and serves as a basis for revising the tactics of treating bronchial asthma. An unexpected and progressive deterioration in the control of symptoms of bronchial asthma or COPD is a potentially life-threatening condition and requires urgent medical intervention. In this situation, you should consider increasing the dose of GCS, or adding systemic anti-inflammatory therapy (for example, a course of oral GCS), or treating with antibiotics in the event of an infection being added.
Patients are advised to keep emergency medications with them at all times (beta₂short-acting adrenomimetics).
Treatment Symbicort turbuhaler should not begin in the period of exacerbation of bronchial asthma.
As with any other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after taking a dose of the drug. When a severe reaction develops, the treatment tactics should be reviewed and, if necessary, alternative therapy should be prescribed.
Systemic effects can occur when taking any inhaled GCS, especially when taking high doses of drugs over a long period of time.The manifestation of systemic action is less likely with inhalation therapy than with the use of oral corticosteroids. Possible systemic effects include suppression of adrenal function, growth retardation in children and adolescents, a decrease in bone mineral density, cataracts, and glaucoma. Special attention should be paid to elderly patients with COPD and low bone mineral density due to possible effects on bone tissue. Therefore, it is very important to use the lowest effective dose of inhaled GCS, which provides optimal control of the symptoms of bronchial asthma.
It is necessary 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 to the possible risk of growth retardation.
If there is reason to believe that, against the background of previous systemic treatment of GCS, the adrenal function was impaired, precautions should be taken when transferring patients to Symbicort Turbuhaler.
Advantages of inhaled budesonide therapy, as a rule, minimize the need to take oral GCS, however, patients who discontinue therapy with oral GCS for a long time may have insufficient adrenal function. Patients who in the past needed emergency high-dose corticosteroids may also be in this risk group.In extreme cases and any situations that can cause stress, it is always necessary to remember about the possibility of residual adrenal dysfunction in such patients. In such situations it is necessary to provide adequate treatment of corticosteroids. Depending on the degree of adrenal dysfunction, it may be necessary to consult a specialist before carrying out the recommended procedures.
Symbicort turbuhaler contains lactose (less than 1 mg / dose). Usually this amount does not cause problems in patients with lactose intolerance .
Pediatric use
In children under 6 years of age, the efficacy and safety of the drug have not been fully studied. Symbicort Turbuhaler is not recommended for use in this category of patients.
Influence on ability to drive motor transport and control mechanisms
Symbicort turbuhaler does not affect the ability to drive vehicles and control mechanisms.

With simultaneous ingestion of Ketoconazole at a dose of 200 mg 1 time / day and budesonide at a dose of 3 mg, the concentration of budesonide in plasma increases on average 6 times. When taking ketoconazole 12 hours after taking budesonide, the concentration of the latter in plasma increases by an average of 3 times. There is no information about such interaction with budesonide during inhalation, but a noticeable increase in the plasma concentration of the drug should be expected.Since no data are currently available for advice on dose selection, this combination of drugs should be avoided. If this is not possible, the intervals between taking ketoconazole and budesonide should be maximized. The possibility of reducing the dose of budesonide should also be considered. Other potent inhibitors of CYP3A4 may also significantly increase the content of budesonide in plasma.
Β-adrenoreceptor blockers can weaken or inhibit the action of formoterol. Symbicort turbuhaler should not be administered simultaneously with beta-blockers (including eye drops), unless absolutely necessary.
With simultaneous use of Symbicort Turbuhaler and quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), MAO inhibitors and tricyclic antidepressants, the QT interval may be prolonged and the risk of ventricular arrhythmias may increase.
L-dopa, L-thyroxin, oxytocin and ethanol can reduce the tolerance of the heart muscle to beta₂-adrenomimetikam.
With the simultaneous appointment of MAO inhibitors, as well as drugs with similar properties (furazolidone, procarbazine), hypertensive reactions may develop.
When conducting anesthesia with halogenated hydrocarbon preparations with Symbicort Turbuhaler, there is an increased risk of arrhythmias in patients.
With the simultaneous use of other b-adrenoreceptor agonists, additive action is possible.
Hypokalemic effect can be enhanced with the simultaneous appointment of xanthine derivatives, steroids and diuretics. Hypokalemia increases the susceptibility to the development of arrhythmias in patients taking digitalis glycosides.
No interaction of budesonide with other drugs used to treat bronchial asthma.

Symptoms: in case of overdose of formoterol, reactions typical of agonists are most likely to occur b₂-adrenoreceptors: tremor, headache, tachycardia. Arterial hypotension, metabolic acidosis, hypokalemia and hyperglycemia may also occur.
With an acute overdose of budesonide, even in large doses, clinically significant symptoms are not expected. Chronic administration of budesonide in excessive doses may result in systemic action of corticosteroids.
For acute bronchial obstruction, formoterol administration at a dose of 90 mcg for 3 hours was safe.
Treatment: shown supportive and symptomatic treatment.

The drug should be stored at a temperature not exceeding 30 ° C out of the reach of children.

2 years.