SIMBIKORT TURBUXALER

Active material: Budesonide, Formoterol
When ATH: R03BX
CCF: The drug is a bronchodilator and anti-inflammatory action
ICD-10 codes (testimony): J44, J45
When CSF: 04.03
Manufacturer: ASTRAZENECA AB (Sweden)

Pharmaceutical form, composition and packaging

The powder for inhalation dose in the form of granules from white to almost white, mostly rounded shape.

Excipients: lactose monohydrate.

60 doses – Symbicort (1) – packs cardboard.
120 doses – Symbicort (1) – packs cardboard.

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

Excipients: lactose monohydrate.

60 doses – Symbicort (1) – packs cardboard.
120 doses – Symbicort (1) – packs cardboard.

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

Excipients: lactose monohydrate.

60 doses – Symbicort (1) – packs cardboard.

* international non-proprietary name, recommended by the WHO – ʙudezonid.

Pharmacological action

Combined medication for the treatment of bronchial asthma. Soderzhit formoterol and budesonide, that have different mechanisms of action and exhibit an additive effect on reducing the incidence of exacerbations of asthma.

Budesonide – GCS, after inhalation at recommended doses has anti-inflammatory effect on the bronchial tubes, reducing the severity of symptoms and frequency of exacerbations of asthma. In the appointment of inhaled budesonide in the form of notes lower incidence of serious adverse effects, than with systemic corticosteroids. Reduces the severity of edema bronchial mucosa, mucus production, Education sputum and airway hyperresponsiveness.

Formoterol – selective agonist β₂-adrenoreceptorov. Causes relaxation of bronchial smooth muscle in patients with reversible airway obstruction. Bronchodilator effect is dose-dependent, occurs within 1-3 min after the inhalation, and is maintained for at least 12 hours after administration of a single dose of.

The combined use of formoterol and budesonide reduced the severity of asthma symptoms, improves lung function and reduces the frequency of exacerbations.

Action Symbicort^® Symbicort^® lung function corresponds to the effect of budesonide monotherapies and combination of formoterol and budesonide superior to one. The drug is well tolerated.

While taking Symbicort^® Symbicort^® as maintenance therapy for 12 weeks children from 6 to 11 years (two inhalations 80/4.5 ug / inhalation 2 times / day) improved lung function and was awarded with a good tolerability, compared to the corresponding dose of budesonide turbuhaler.

In patients with severe chronic obstructive pulmonary disease in patients receiving Symbicort^® Symbicort^® a significant decrease in the frequency of exacerbations of the disease compared with patients, receives as formoterol therapy alone or placebo (the average frequency of exacerbations 1.4 compared with 1.8-1.9 placebo / formoterol).

There was no difference between taking Symbicort^® Symbicort^® and formoterol against values ​​of FEV₁.

Pharmacokinetics

Absorption

Simʙikort^® Twrbwxaler^® bioequivalent to the respective monotherapies (budesonide and formoterol) in respect of their systemic action. Despite this, there was a slight increase in cortisol suppression after administration of Symbicort^® Symbicort^® compared to monotherapies. This difference does not affect the clinical safety of Symbicort^® Symbicort^®. Evidence of pharmacokinetic interactions between budesonide and formoterol are missing. Pharmacokinetic parameters of budesonide and formoterol were comparable after their admission as monotherapies and as part of Symbicort^® Symbicort^®.

When combined formulation of budesonide AUC was slightly longer, drug absorption occurs quickly and the value of C_max It was higher; C_max formoterol coincide with that of monotherapy. Inhaled budesonide is rapidly absorbed and reaches C_max through 30 m. Srednяя dose budesonide, got into the lungs after inhalation via Turbuhaler, is 32-44% of the delivered dose. Systemic bioavailability is approximately 49% of the delivered dose. Children between the ages of 6 to 16 years, the average dose of budesonide, got into the lungs after inhalation via Turbuhaler, It does not differ from that of adult patients (the final concentration of drug in blood plasma was not determined).

Inhaled formoterol is rapidly absorbed and reaches C_max through 10 min after inhalation. Studies have shown, that the average dose of formoterol, got into the lungs after inhalation via Turbuhaler, is 28-49% of the delivered dose. Systemic bioavailability – about 61% of the delivered dose.

Distribution

Plasma protein binding of budesonide is about 90%, formoterol – 50%.

V_d budesonide is about 3 l / kg formoterol – 4 l / kg.

Metabolism

Budesonide undergoes intensive biotransformation (about 90%) at “first pass” through the liver to produce metabolites, have low glucocorticoid activity. The metabolism of budesonide is carried out mainly by the enzyme CYP3A4. Glucocorticoid activity of the major metabolites – 6-b-гидроксибудесонида и 16-a-гидроксипреднизолона – less than 1% similarity activities budesonide.

Formoterol is metabolized primarily in the liver by conjugation with the formation of the active O-demethylated metabolites, primarily – inaktivirovannыh konayugatov.

There is no evidence of interaction of metabolites or substitution reaction between budesonide and formoterol.

Deduction

Budesonide is excreted in urine as metabolites, or in the form of conjugates, and only a small amount of – in unchanged form. Budesonide has a high systemic clearance (about 1.2 l / min).

After inhalation 8-13% the delivered dose of formoterol is excreted unchanged in the urine. Formoterol has a high systemic clearance (about 1.4 l / min); T_1/2 averages 17 no.

Pharmacokinetics in special clinical situations

The pharmacokinetics of formoterol in children and patients with renal insufficiency has not been studied.

Budesonide and formoterol concentration in blood plasma can be increased in patients with liver diseases.

Testimony

- Bronchial asthma (insufficiently controlled by using inhaled corticosteroids and beta₂-short-acting agonists as therapy on demand, or adequately controlled with inhaled corticosteroids and β₂-agonists long-acting). Simʙikort^® Twrbwxaler^® 80/4.5 ug / dose and 160/4.5 mcg / dose can be used as maintenance therapy and cupping;

- Symptomatic therapy in patients with severe chronic obstructive pulmonary disease (OFV<50% the calculated level of the intended) and repeated exacerbations history, when there are significant symptoms, despite treatment with long-acting bronchodilators.

Dosage regimen

Simʙikort^® Twrbwxaler^® not intended for initial treatment of bronchial asthma and intermittent mild persistent currents.

Titration of drugs, members of the Symbicort^® Symbicort^®, It conducted individually and depending on the severity of the disease. It is necessary to consider not only at the beginning of the combination therapies, but when changing dose.

In that case, If individual patients require different doses of the combination of active substances, than in the drug Symbicort^® Twrbwxaler^®, should appoint a separate beta₂-agonists and / or corticosteroids in separate inhalers.

Bronchial asthma

Patients should be under constant medical supervision for an adequate selection of the dose of Symbicort^® Symbicort^®. The dosage should be reduced to the lowest, against which retained optimal control of asthma symptoms.

Simʙikort^® Twrbwxaler^® 80/4.5 ug / dose and 160/4.5 mg / dose

Upon reaching full control of asthma symptoms on a background of the minimum recommended dose product, the next step, you can try the appointment of monotherapy with inhaled corticosteroids.

As maintenance therapy the drug is prescribed in combination with a separate beta₂-agonists short-acting cupping. The patient should always carry an inhaler with a separate beta₂-agonists short-acting cupping.

Adults (18 and older) prescribe Symbicort^® Twrbwxaler^® 80/4.5 ug / dose and 160/4.5 ug / dose for 1-2 inhalation 2 times / day. If necessary, the dose may be increased to 4 inhalations 2 times / day.

Teenagers (12-17 years) prescribe Symbicort^® Twrbwxaler^® 80/4.5 ug / dose and 160/4.5 ug / dose for 1-2 inhalation 2 times / day.

Children under the age of 6 years prescribe Symbicort^® Twrbwxaler^® 80/4.5 ug / dose for 1-2 inhalation 2 times / day.

After achieving optimal control of asthma symptoms while taking the drug 2 times / day is recommended to titrate the dose to the lowest effective, until receiving 1 time / day, where, According to the doctor when the patient requires supportive therapy in combination with long-acting bronchodilators.

Increasing the frequency of the use of beta₂-agonists short action is indicative of deterioration of the general control of the disease and requires a review of anti-asthmatic therapy.

As maintenance therapy and cupping The drug is particularly indicated for patients with inadequate asthma control and the need for frequent use of drugs for cupping; When specifying a history of bronchial asthma exacerbations, requiring medical intervention. The patient must always carry Symbicort^® Twrbwxaler^® cupping.

It requires careful control the emergence of dose-related side effects in patients, using a large number of inhalations for cupping.

Adults (18 and older) prescribe Symbicort^® Twrbwxaler^® 80/4.5 ug / dose and 160/4.5 mg / dose; the recommended dose – 2 inhalations per day: by 1 inhalation in the morning and evening, or 2 inhalation 1 time / day in the morning or in the evening. Some patients can be assigned to a maintenance dose of the drug Symbicort^® Twrbwxaler^® 160/4.5 mg / dose 2 inhalation 2 times / day. If you experience symptoms should appointment 1 more inhalations. With further increase of the symptoms within a few minutes, yet assigned 1 additional inhalations, but not more 6 inhalations for relief 1 Access.

Not normally required destination more 8 inhalations per day, however, you can increase the number of inhalations to 12 per day for a short time. Patients, which are used more 8 inhalations per day, recommended revising therapy.

Simʙikort^® Twrbwxaler^® 320/9 mg / dose

Adults (18 and older) the drug is prescribed for 1 inhalation 2 times / day. If necessary, the dose may be increased to 2 inhalations 2 times / day. After achieving optimal control of asthma symptoms while taking the drug 2 times / day is recommended to titrate the dose to the lowest effective, until receiving 1 time / day.

Teenagers aged 12-17 years appoint 1 inhalation 2 times / day.

After achieving optimal control of asthma symptoms while taking the drug 2 times / day is recommended to titrate the dose to the lowest effective, until receiving 1 time / day, where, According to the doctor when the patient requires supportive therapy in combination with long-acting bronchodilators.

COPD

Adults prescribe Symbicort^® Twrbwxaler^® 160/4.5 ug / dose for 2 inhalation 2 times / day or Symbicort^® Twrbwxaler^® 320/9 ug / dose for 1 inhalation 2 times / day.

There is no need for a special selection for dose elderly patients.

There are no data on the use of Symbicort^® Symbicort^® in Patients with renal or hepatic insufficiency. As budesonide and formoterol are derived primarily involving liver metabolism, that in patients with severe liver cirrhosis can be expected to slow the rate of excretion of the drug.

Terms of Use turbuhaler

The mechanism of action is such turbuhaler, that when a patient inhales through the mouthpiece, air flows entrain the drug in the airways.

It is necessary to instruct the patient:

- To carefully study “Instructions for use” Symbicort;

- Inhale strongly and deeply through the mouthpiece, to ensure optimal dose entering the lungs;

- Never to breathe out through the mouthpiece;

- for, to minimize the possibility of fungal infections of the oropharynx, rinse your mouth with water after each inhalation. It is also necessary to rinse your mouth with water after inhalation for the relief of symptoms and the case of candidiasis of the oral mucosa and pharynx.

The patient may not taste or feel after using the drug turbuhaler, due to a small amount of the substance to be delivered.

Instructions for use turbuhaler

Twrbwxaler- multidose inhaler, allows to dose and inhale the medication in very small doses. When you inhale the powder from turbuhaler delivered to the lungs. therefore it is important, the patient is strong and took a deep breath through the mouthpiece.

Before first use Symbicort is necessary to prepare for work:

1. Unscrew and remove the cap.

2. Hold the inhaler upright red feeder bottom. Do not keep the inhaler for the mouthpiece during the rotation dosing. Rotate spout all the way in one direction, and then also the way – in the opposite direction. Perform this procedure twice.

Now, the inhaler is ready for use, repeat this procedure for the preparation turbuhaler to work before each use is not required.

For single dose the patient must use the following procedure:

1. Unscrew and remove the cap.

2. Hold the inhaler upright red feeder bottom. Do not keep the inhaler for the mouthpiece during the rotation dosing. For, to measure the dose, turn the spout all the way in one direction, and then also the way – in the opposite direction.

3. Breathe out. Do not breathe out through the mouthpiece.

4. Carefully place the mouthpiece between your teeth, your lips and inhale strongly and deeply through your mouth. The mouthpiece does not chew and do not compress the teeth.

5. Before you exhale, remove the inhaler from the mouth.

6. If inhalation is required more than one dose, should be repeated claims. 2-5.

7. Close inhaler cap, check, the cap of the inhaler has been thoroughly screwed.

8. Rinse mouth with water, not swallowing.

Do not remove the mouthpiece, tk. it is fixed on the inhaler and not removed. The mouthpiece is rotated turbuhaler, but we should not turn it without having to.

Since the amount of the inhaled powder is very small, You can not taste the powder after inhalation.

However, absolutely accurate compliance manual provides inhalation (inhalation of) required dose.

If before receiving the drug by mistake was repeated with inhaler to load more than once, the inhalation of patients will still receive a single dose of the drug. At this dose indicator will show the total number of metered doses.

Sound, which can be heard when shaking the inhaler, It produced a drying agent, instead of the drug substance.

The need to replace the inhaler

The indicator indicates the approximate number of doses doses, remaining in the inhaler, Countdown doses for completing turbuhaler begins with the 60th or 120th dose (depending on the total number of doses acquired turbuhaler). The indicator shows the interval 10 doses, however it does not show each metered (downloaded) dose.

Turbuhaler delivers the necessary dose, even if no noticeable change in the window display of doses.

The appearance of a red background in the window display of doses means, that Symbicort remains 10 doses. When the numbers 0 on a red background in the middle of the window dose inhaler should be discarded.

It should be noted that, that even when a window of the indicator displays the digit 0, dispenser continues to rotate. However, the dose indicator stops to fix the number of doses (ceases to move) and in the window dose inhaler remains digit 0.

Cleaning

Regularly (1 once a week) Clean the outside of the mouthpiece with a dry cloth. Do not use water or other liquids to clean the mouthpiece.

Disposing

Care should be taken when handling used inhaler and remember, inside the inhaler may be some drug.

Side effect

Against the backdrop of a joint appointment of two drugs has not been observed to increase the incidence of adverse reactions.

The most common adverse reactions, drug-related, They are such pharmacologically expected beta₂-agonists unwanted side effects, as tremor and tachycardia, which typically have moderate severity and tested within a few days after treatment.

In the application of budesonide in COPD bruises and pneumonia occurred at a frequency 10% and 6% respectively, compared with 4% and 3% in the placebo group (p>0.001 and p>0.01 respectively).

CNS: often (>1/100, <1/10) – headache; less frequently (>1/1000, <1/100) – psychomotor agitation, anxiety, nausea, dizziness, sleep disorders; rarely (<1/10 000) – depression, behavioral disturbances (mainly, children), taste disturbances.

Cardio-vascular system: often (>1/100, <1/10) – tachycardia; less frequently (>1/1000, <1/100) – tachycardia; rarely (>1/10 000, <1/1000) – Atrial fibrillation, supraventricular tachycardia, arrythmia; rarely (<1/10 000) – angina, fluctuations in blood pressure.

On the part of the musculoskeletal system: often (>1/100, <1/10) – tremor; less frequently (>1/1000, <1/100) – muscle cramps.

The respiratory system: often (>1/100, <1/10) – candidiasis of the oral mucosa and pharynx, slight irritation of the throat, cough, hripota; rarely (>1/10 000, <1/1000) – bronchospasm.

Dermatological reactions: less frequently (>1/1000, <1/100) – bruising; rarely (>1/10 000, <1/1000) – rash, hives, itch, Dermatitis, angioedema.

Metabolic disorders: rarely (>1/10 000, <1/1000) – kaliopenia; rarely (<1/10 000) – giperglikemiâ, symptoms of systemic effects of GCS (including hypoadrenalism).

Systemic effects of inhaled corticosteroids may occur while taking the drug in high doses for a long time.

Applications Beta₂-agonists may increase the blood levels of insulin, free fatty acids, glycerol, ketone derivatives.

Contraindications

- Children up to age 6 years (for all dosage forms);

- Children up to age 12 years (for the dosage form, soderzhaщeй budesonide 320 mcg + formoterol 9 g);

- Hypersensitivity to budesonide, formoterolu or ingaliruemoy of lactose.

Caution should be used Simbikort® 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, uncontrollable gipokaliemieй, idiopathic hypertrophic stenosis subaortal, severe hypertension, aneurysm of any location or other severe cardiovascular diseases (CHD, tachyarrhythmias or severe heart failure), with QT prolongation (formoterol may cause lengthening of the QTc interval).

Pregnancy and lactation

No clinical data are Simbikorta® Turbuhalera® or combined use of budesonide and formoterol during pregnancy.

When pregnancy Simbikort® Turbuhaler® should be administered only in cases, when the expected benefit of therapy for the mother outweighs the potential risk to the fetus. Budesonide should be used in the lowest effective dose, required to maintain adequate control of asthma symptoms.

Unknown, stand whether budesonide and formoterol in breast milk in humans. Simbikort® Turbuhaler® can be assigned to nursing mothers, if the expected benefit of therapy for the mother outweighs the potential risk to the child.

Cautions

It is recommended to gradually reduce the dose before stopping treatment is not recommended to stop treatment abruptly.

Symbykort® Turbuhaler® 80/4.5 ug / dose and 320/9 ug / dose not intended for treatment of patients with severe asthma.

Simbikort® Turbuhaler® not intended for the initial selection of therapy in the early stages of treatment of bronchial asthma.

Formoterol may cause QT prolongation, therefore, the drug should be used with caution in patients with an increased QT interval.

Increasing the frequency of receiving bronchodilator as rescue medication indicates a worsening of the underlying disease and is the basis for the revision of tactics of treatment of bronchial asthma. Sudden and progressive deterioration in control of asthma symptoms or COPD is potentially life-threatening condition and requires urgent medical intervention. In this situation, you should consider increasing the dose of corticosteroids, t. e. purpose of the course of oral corticosteroids, or antibiotic treatment if an infection connection.

Patients are advised to always carry emergency medications, or Simbikort® Turbuhaler® (for patients with bronchial asthma, Simbikort® Turbuhaler® use for maintenance therapy and cupping), beta2-agonists of short action (for all patients, Simbikort® Turbuhaler® use only for maintenance therapy).

Attention should be paid to the need for regular patient receiving a maintenance dose Simbikorta® Turbuhalera® in accordance with the chosen therapy, Even in the absence of symptoms. Inhalation Simbikorta® Turbuhalera® cupping should be performed only when symptoms occur, but use of the drug is not indicated for routine prophylactic use, ie. before exercise. In such cases, shows the use of a separate short-acting bronchodilator.

Simbikortom® Turbuhalerom® Treatment should not be initiated during an exacerbation of asthma.

As with any other inhalation therapy, paradoxical bronchospasm may occur with an immediate intensification of wheezing after taking the dose. In this connection should be discontinued therapy Simbikortom® Turbuhalerom®, review the tactics of treatment and, if necessary, appoint an alternative therapy.

Systemic effects may occur when taking any inhaled corticosteroids, especially when high doses of drugs over a long period of time. The manifestation of systemic effects are less likely during inhalation therapy, than with oral corticosteroids. Possible systemic effects include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.

It is recommended to regularly monitor the growth of children, receiving long-term inhaled corticosteroids. In the case of established growth retardation therapy should be reconsidered with a view to reducing the dose of inhaled corticosteroids. It is necessary to carefully balance the benefits of SCS therapy to a possible risk of growth retardation. When selecting therapy is recommended consultation pediatric pulmonology.

Based on the limited research data on the chronic administration of corticosteroids, We can assume, that the majority of children and adolescents, receiving therapy with inhaled budesonide, eventually reached normal adult growth indicators. However it reported minor (about 1 cm), short-term growth retardation, mainly in the first year of treatment.

Because of the potential actions of inhaled corticosteroids on bone mineral density should pay particular attention to patients, receiving the drug in high doses for a long time with the presence of risk factors for osteoporosis. Studies have long-term use of inhaled budesonide in children at mean daily dose 400 micrograms or adults in an average daily dose 800 micrograms showed no significant effect on bone mineral density. No data on the effect of high doses of the drug to the bone mineral density.

If there is reason to believe, against the background of previous systemic therapy SCS was disturbed adrenal function, precautions should be taken when transferring patients to treatment Simbikortom® Turbuhalerom®.

The benefits of inhaled budesonide therapy, usually, minimize the need for acceptance of oral corticosteroids, however, patients, stopping therapy with oral corticosteroids, for a long time can be maintained adrenal insufficiency. Patients, which in the past in urgent need of high doses of GCS, receiving prolonged treatment with inhaled corticosteroids at high doses also may be in the risk group. In extreme cases and all situations, which can cause stress (incl. surgery), always be aware of the possibility of residual dysfunction of the adrenal glands in these patients. In such situations it is necessary to provide adequate treatment of GCS. Depending on the degree of dysfunction of the adrenal glands may need to consult a specialist before the recommended procedures.

It should reconsider the need for, and dose of inhaled corticosteroids in patients with active or inactive pulmonary tuberculosis, fungal, viral or bacterial infections of the respiratory system.

Observe special precautions in patients with unstable asthma, Short-acting bronchodilators applying, to relieve attacks during exacerbation of severe asthma, tk. the risk of hypokalemia is increased by hypoxia and in other conditions, when it increases the likelihood of developing symptoms gipokaliemicheskogo action. In such cases it is advisable to control the content of potassium in the serum.

Admission of patients with acute bronchial obstruction in a dose of formoterol 90 xg for 3 h safe. The treatment should monitor the concentration of glucose in the blood of patients, diabetes.

Simbikort® Turbuhaler® contains lactose (less 1 mg / dose). Generally, such amount does not cause unwanted reactions in patients with lactose intolerance.

Use in Pediatrics

Symbykort® Turbuhaler® 80/4.5 ug / dose and 160/4.5 micrograms / dose is contraindicated in children under the age of 6 years.

Symbykort® Turbuhaler® 80/4.5 ug / dose and 160/4.5 micrograms / dose is not recommended as maintenance therapy and cupping for children and adolescents under the age of 18 years.

Symbykort® Turbuhaler® 320/9 micrograms / dose is contraindicated in children under the age of 12 years due to the lack of clinical data.

Effects on ability to drive vehicles and management mechanisms

Simbikort® Turbuhaler® does not affect the ability to drive vehicles and management mechanisms. It may affect the ability to drive vehicles and management mechanisms in the development of side effects.

Overdose

Symptoms: in acute overdose of budesonide, even in large doses, not expected clinically relevant symptoms. In chronic receiving budesonide in excessive doses can manifest systemic effects of GCS, such as hypercortisolism and adrenal suppression.

In case of overdose of formoterol – tremor, headache, tachycardia, in some cases – giperglikemiâ, kaliopenia, QTc prolongation, Arrhythmia, nausea, vomiting.

In acute bronchial obstruction receiving formoterol in a dose 90 xg for 3 h was safe.

Treatment: It shows the supported and symptomatic treatment.

In case you need to cancel Simbikorta® Turbuhalera® due to overdose of formoterol, inbound and structure of a combined preparation, should consider designating an appropriate GCS.

Drug Interactions

With the simultaneous ingestion of a dose of ketoconazole 200 mg 1 time / day and the dose of budesonide 3 mg budesonide concentration in plasma increased on average 6 time. In accept ketoconazole cherez 12 hours after administration of budesonide concentration in plasma increased on average 3 times. Information about such interactions with budesonide inhalation administration is absent, however, one should expect a significant increase in concentration of the drug in the blood plasma. Since there is currently no data for recommendations on the selection of doses, Avoid this combination of drugs. If this is not possible, the intervals between doses of ketoconazole and budesonide should be possible to increase the. You should also consider reducing the dose of budesonide. Other potent inhibitors of CYP3A4, probably, can also significantly increase the content of budesonide in plasma. Not recommended the appointment of Simbikorta® Turbuhalera® as maintenance therapy and cupping patients, receiving potent inhibitors of CYP3A4.

Β-adrenergic blockers can weaken or inhibit the effect of formoterol. Simbikort® Turbuhaler® should not be administered simultaneously with beta-blockers (including eye drops), except in cases of emergency.

In an application Simbikorta® Turbuhalera® and quinidine, dizopiramida, prokaynamyda, phenothiazine, antihistamines (Terfenadine), MAO inhibitors and tricyclic antidepressants may prolong the QT interval and increased risk of ventricular arrhythmias.

Besides, levodopa, levotiroksin, oxytocin and ethanol can reduce the tolerance of the heart muscle to beta2-agonists.

When concomitant administration of MAO inhibitors, as well as preparations, having similar properties (furazolidon, procarbazine), may increase blood pressure.

When anesthesia drugs halogenated hydrocarbons during treatment Simbikorta® Turbuhalera® there is an increased risk of arrhythmias in patients.

At simultaneous reception Simbikorta® Turbuhalera® and other agonists of β-adrenergic receptors may increase the side effects of formoterol.

Hypokalemic effect of beta2-agonists may be enhanced while the appointment of xanthine derivatives, mineral derivatives SCS and diuretics. Hypokalemia increases the susceptibility to the development of arrhythmias in patients, taking cardiac glycosides.

There was no interaction with other budesonide drugs, used for the treatment of asthma.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored at temperatures not above 30 ° C out of reach of children. Shelf life – 2 year.