budesonide, formoterol |

Release form

Powder for inhalation.

Packing

120 doses.

Pharmacological action

Symbicort Turbuhaler - a combined drug for the treatment of bronchial asthma. It contains formoterol and budesonide, which have different mechanisms of action and exhibit an additive effect with respect to reducing the frequency of exacerbations of bronchial asthma.

Budesonide - GCS, after inhalation, it 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, a lower incidence of serious undesirable effects is noted than with systemic corticosteroids. Reduces the severity of edema of the bronchial mucosa, mucus production, sputum formation and respiratory tract hyperresponsiveness. The exact mechanism of the anti-inflammatory action of GCS is not known.

Formoterol is a selective 2-adrenergic receptor agonist. Causes relaxation of the smooth muscles of the bronchi 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 with the combined use of formoterol and budesonide, the severity of symptoms of bronchial asthma decreases, lung function improves, and the frequency of exacerbations of the disease decreases.

The effect of Symbicort Turbuhaler on lung function is consistent with the combination of budesonide and formoterol monotherapy and is greater than the effect of budesonide alone. There was no decrease in anti-asthma action over time. The drug has good tolerance. The drug has good tolerance.

While taking Symbicort Turbuhaler as maintenance therapy for 12 weeks in children aged 6 to 11 years (two inhalations of 80/4. 5 mcg / inhalation 2 times / day) lung function improved and drug tolerance was noted, compared with the corresponding dose of budesonide Turbuhaler.

In patients with severe chronic obstructive pulmonary disease (initial FEV1 - 36%) with the use of Symbicort Turbuhaler, there was a significant decrease in the frequency of exacerbations of the disease compared with patients who received only formoterol or placebo as the treatment (average exacerbation rate was 1.4 compared to 1.8- 1.9 in the placebo / formoterol group).

There was no difference between taking Symbicort and formoterol in terms of FEV1.

Contraindications

Children under 6 years.

Hypersensitivity to budesonide, formoterol, or inhaled lactose.

Special instructions

It is recommended to gradually reduce the dose of the drug before stopping treatment and it is not recommended to abruptly cancel the treatment.

SymbicortВ® TurbuhalerВ® (80 + 4.5 and 320 + 9 mcg / dose) is not intended for patients with severe bronchial asthma.

SymbicortВ® TurbuhalerВ® is not intended for the initial selection of therapy in the first stages of treatment of bronchial asthma.

Formoterol may cause an extended QTc interval.

An increase in the frequency of administration of bronchodilators as emergency drugs indicates a worsening of the course of the underlying disease and serves as a basis for reviewing 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 attention. 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 antibiotic treatment in case of infection. Patients are advised to always have emergency medications ( 2 short-acting adrenomimetics).

The patient should be advised of the need for regular use of the drug SymbicortВ® TurbuhalerВ® in accordance with the selected dose even in the absence of symptoms of the disease. Inhalations of SymbicortВ® TurbuhalerВ® for relieving seizures should be performed only if symptoms occur, but not indicated for regular prophylactic use, i.e. before physical exertion. In such cases, the use of a separate short-acting bronchodilator is indicated.

Treatment with SymbicortВ® TurbuhalerВ® should not be started during an 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. In this connection, it is necessary to stop therapy with SymbicortВ® TurbuhalerВ®, reconsider the treatment tactics and, if necessary, prescribe alternative therapy.

A systemic effect may occur when taking any inhaled GCS, especially when taking high doses of drugs for a long period of time. The manifestation of a systemic effect is less likely during inhalation therapy, than when using oral corticosteroids. Possible systemic effects include suppression of adrenal function, stunted growth in children and adolescents, decreased bone mineral density, cataracts and glaucoma.

It is recommended that you regularly monitor the growth of children who have been receiving glucocorticosteroid therapy in an inhaled form for a long time. In the case of established growth retardation, therapy should be reviewed to reduce the dose of inhaled GCS. It is necessary to carefully evaluate the ratio of the benefits of glucocorticosteroid therapy to the possible risk of stunting. When choosing therapy, it is recommended to consult a pediatric pulmonologist.

Based on limited research data on the long-term use of GCS, it can be assumed that most children and adolescents receiving inhaled budesonide therapy ultimately achieved normal adult growth rates. However, a slight (approximately 1 cm) short-term growth retardation was reported, mainly in the first year of treatment.

Due to the potential effect of inhaled corticosteroids on bone mineral density, special attention should be paid to patients taking high doses of the drug for a long period with risk factors for osteoporosis. Studies of the long-term use of inhaled budesonide in children at an average daily dose of 400 mcg (metered dose) or adults at a daily dose of 800 mcg (metered dose) have not shown a noticeable effect on bone mineral density. There is no data on the effect of the high dosage of SymbicortВ® TurbuhalerВ® on bone mineral density.

If there is reason to believe that against the background of previous systemic therapy of corticosteroids, adrenal function was impaired, precautions should be taken when transferring patients to Symbicort treatment.

The benefits of budesonide inhalation therapy usually minimize the need for oral GCS, but patients who stop oral gCS therapy may have insufficient adrenal function for a long time. Patients who in the past needed urgent administration of high doses of GCS or received long-term treatment with high-dose inhaled GCS may also be in this risk group. It is necessary to provide for the additional appointment of corticosteroids during periods of stress or surgery.

It is recommended that the patient is instructed to rinse his mouth with water after inhalation of maintenance doses in order to prevent the risk of candidiasis of the oral mucosa and pharynx.

Precautions should be observed when treating patients with an extended QTc interval. Formoterol may cause a prolonged QTc interval.

The need for the use and dose of inhaled GCS in patients with active or inactive forms of pulmonary tuberculosis, fungal, viral or bacterial infections of the respiratory system should be reviewed.

When co-administered with 2-adrenergic agonists with drugs that can cause or enhance the hypokalemic effect, such as xanthine derivatives, steroids or diuretics, the hypokalemic effect of 2-adrenergic agonists may be enhanced. Special precautions should be observed in patients with unstable bronchial asthma who use short-acting bronchodilators to relieve seizures during exacerbation of severe bronchial asthma, as the risk of hypokalemia increases against hypoxia and in other conditions, when the likelihood of developing a hypokalemia increases. In such cases, it is recommended to control the serum potassium content.

During the treatment period, the concentration of glucose in the blood should be monitored in patients with diabetes mellitus.

SymbicortВ® TurbuhalerВ® contains lactose (<1 mg / inhalation). Typically, this amount does not cause problems in patients with lactose intolerance.

Effect on the ability to drive a car or other machinery. SymbicortВ® TurbuhalerВ® does not affect the ability to drive and operate machinery.

May cause minor effects in the event of side effects.

Composition

Active ingredients:

budesonide,

formoterol fumarate dihydrate

Excipients:

lactose monohydrate.

Dosage and administration of

should be taken into account not only when starting treatment with combined drugs, but also when changing the dose of the drug.

In the event that individual patients require a different combination of doses of active substances than in Symbicort Turbuhaler, beta2-adrenergic agonists and / or GCS should be prescribed separately in separate inhalers.

The dose should be reduced to the lowest, against which optimal control of symptoms of bronchial asthma is maintained. Patients should be under the constant supervision of a doctor to adequately select the dose of Symbicort Turbuhaler. When achieving full control over the symptoms of bronchial asthma against the background of the minimum recommended dose of the drug, at the next stage, you can try the appointment of monotherapy with inhaled corticosteroids.

There are two approaches to prescribing therapy with Symbicort Turbuhaler.

A.

Symbicort Turbuhaler as maintenance therapy: the drug is prescribed as maintenance therapy in combination with a separate short-acting beta2-adrenostimulator to relieve seizures.

The patient must always have a separate inhaler with a short-acting beta2-adrenostimulator to stop attacks.

Adults (18 years of age and older) are prescribed Symbicort Turbuhaler 80 / 4.5 mcg / dose and 160 / 4.5 mcg / dose, 1-2 inhalations 2 times / day. If necessary, it is possible to increase the dose to 4 inhalations 2 times / day.

Adolescents (12-17 years old) are prescribed Symbicort Turbuhaler 80 / 4.5 mcg / dose and 160 / 4.5 mcg / dose, 1-2 inhalations 2 times / day.

Children over the age of 6 are prescribed Symbicort Turbuhaler 80/4. 5 mcg / dose for 1-2 inhalations 2 times / day.

After optimal control of symptoms of bronchial asthma is achieved while taking the drug 2 times / day, it is recommended to titrate the dose to the least effective, up to 1 time / day, in cases where, according to the doctor, the patient needs maintenance therapy in combination with long-acting bronchodilators.

An increase in the incidence of short-acting beta2-adrenostimulants is an indication of worsening overall disease control and requires a review of anti-asthma therapy.

Side effects

There was no increase in the incidence of adverse reactions with the joint administration of the two drugs. The most common adverse reactions associated with taking the drug, Adverse events that are pharmacologically expected for β2-adrenergic agonists, such as tremors and palpitations, usually have a moderate 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 (p <0.001 and p <0.01, respectively).

- Often (> 1/100, <1/10)

From the central nervous system: headache

From the CCC: heartbeat

From the musculoskeletal system: tremor

From the respiratory tract: candidiasis of the oral mucosa and pharynx, cough, hoarseness, mild sore throat

- Less frequent (> 1/1000, <1/100) From the CCC:

tachycardia From the musculoskeletal system: muscle cramps

From the central nervous system: psychomotor agitation, anxiety, nausea, dizziness, sleep disturbances

from the skin: bruising

- Rarely (> 1/10000, <1/1000)

from the skin: exanthema, urticaria, pruritus, dermatitis, angioedema

From the respiratory tract: bronchospasm

Metabolic disorders: hypokalemia

From the CCC: atrial fibrillation, supraventricular tachycardia, extrasystole

- Very rare (<1/10000) Metabolic disorders: symptoms of hypertension or hyperglycemia effects (including adrenal hypofunction)

Psychiatric symptoms: depression, behavioral disorders (mainly in children)

CNS: taste disorder

CCC: angina pectoris, fluctuations in blood pressure

The systemic effect of inhaled corticosteroids may occur when taking high doses for a long time.

The use of? 2-adrenergic agonists can lead to an increase in blood levels of insulin, free fatty acids, glycerol and ketone derivatives.

Drug Interactions

Taking 200 mg of ketoconazole once a day increases the plasma concentration of oral budesonide (single dose - 3 mg) when used together, on average, 6 times. When prescribing ketoconazole 12 hours after taking budesonide, the plasma concentration of the latter increased, on average, 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 is expected. Since there are no data for dose recommendations, the above combination of drugs should be avoided. If this is not possible, the time interval between the appointment of ketoconazole and budesonide should be maximized. Consideration should also be given to reducing the dose of budesonide. Other potent CYP3A4 inhibitors are also likely to significantly increase plasma budesonide concentrations.

-adrenergic receptor blockers may attenuate the effects of formoterol. Symbicort should not be prescribed at the same time as -Adrenoblockers (including eye drops), with the exception of forced cases.

Combined use of Symbicort® Turbuhaler® and quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), MAO inhibitors, and tricyclic antidepressants can lengthen the QTc interval and increase the risk of ventricular arrhythmias.

In addition, levodopa, levothyroxine, oxytocin, and alcohol may decrease heart muscle tolerance to 2-adrenergic agonists.

Co-administration of MAO inhibitors, as well as drugs with similar properties, such as furazolidone and procarbazine, can cause an increase in blood pressure. There is an increased risk of developing arrhythmias in patients during general anesthesia with halogenated hydrocarbon preparations.

With the combined use of Symbicort® Turbuhaler® and other -adrenergic drugs, the side effect of formoterol may be enhanced.

As a result of the use of 2-adrenergic agonists, hypokalemia may occur, which may be aggravated with concomitant treatment with xanthine derivatives, mineral derivatives of corticosteroids, or diuretics. Hypokalemia may increase susceptibility to developmentthiyu arrhythmias in patients taking cardiac glycosides.

No interaction of budesonide with other drugs used to treat bronchial asthma has been observed.

Overdose

Symptoms of formoterol overdose: tremor, headache, palpitations. In some cases, the development of tachycardia, hyperglycemia, hypokalemia, QTS-lengthening, arrhythmia, nausea and vomiting has been reported.

In case of withdrawal of Symbicort® Turbuhaler® due to overdosage of formoterol included in the combination drug, consideration should be given to prescribing appropriate ACS.

Treatment: supportive and symptomatic. Patients with acute bronchial obstruction of formoterol 90 mg for 3 h are safe.

Clinically significant effects are not expected with an acute overdose of budesonide, even at significant doses. In chronic administration of excessive doses, systemic action of ACS, such as hypercorticism and suppression of adrenal function, may occur.

Storage conditions

At a temperature not exceeding 30 РC.

Shelf life

2 years.

Terms and conditions

prescription

Dosage form

powder for inhalation

Appointment Appointment



adults prescribed by a doctor, pregnant by a doctor, children over 6 years of age, nursing mothers, For children prescribed by a doctor

AstraZeneca, Britain