DuoResp Spiromax, 320 mcg+9 mcg/dose 60 doses

Pharmacotherapeutic group: combined bronchodilator (beta2-adrenomimetic selective + local glucocorticosteroid)

ATC code: R03AK07

Pharmacological properties

Pharmacodynamics

DuoResp Spiromax contains formoterol and budesonide, which have different mechanisms of action and have an additive effect in reducing the frequency of exacerbations of bronchial asthma and chronic obstructive pulmonary disease (COPD).

The special properties of budesonide and formoterol make it possible to use their combination simultaneously as maintenance therapy and for attack control or as maintenance therapy for bronchial asthma.

Budesonide

Budesonide is a glucocorticosteroid (GCS) that has a rapid (within hours) and dose-dependent anti-inflammatory effect on the airways after inhalation, reducing the severity of symptoms and the frequency of exacerbations of bronchial asthma. When prescribing inhaled budesonide, there is a lower incidence of serious adverse effects than when using systemic GCS. It reduces the severity of bronchial mucosal edema, mucus production, sputum formation and airway hyperresponsiveness. The exact mechanism of anti-inflammatory action of GCS is unknown.

Formoterol

Formoterol is a selective β₂ agonist-adrenergic receptor agonist that causes rapid and prolonged relaxation of bronchial smooth muscle in patients with reversible airway obstruction after inhalation. The dose-dependent bronchodilator effect occurs rapidly, within 1-3 minutes after inhalation and persists for at least 12 hours after a single dose.

Budesonide + Formoterol

Bronchial asthma.

Clinical effectiveness as maintenance therapy

The addition of formoterol to budesonide reduces the severity of bronchial asthma symptoms, improves lung function, and reduces the frequency of exacerbations.

The effect of DuoResp Spiromax on lung function is consistent with the effect of the combination of budesonide and formoterol monotherapies and greater than that of budesonide alone. In all cases, a
β₂ short-acting adrenostimulant was used for seizure control. No decrease of antiasthmatic effect with time was noted. The drug has good tolerability.

Clinical efficacy as maintenance therapy and for seizure control (dosage 160/4.5 only)

. In a follow-up of 4,447 patients treated with budesonide/formoterol as maintenance therapy and for seizure control for 6 to 12 months, there was a statistically and clinically significant reduction in the number of severe exacerbations, an increase in the time to the first exacerbation compared to the combination of budesonide/formoterol or budesonide as maintenance therapy and β<₂-adrenoceptor for seizure control. There was also effective control of disease symptoms, pulmonary function, and a reduction in the frequency of prescribing inhalation for seizure control. The development of tolerance to prescribed therapy was not detected. In patients who sought medical care for an acute asthma attack, symptom control (relief of bronchospasm) was as fast and effective after budesonide/formoterol inhalation as after salbutamol and formoterol.

COPD

In two studies lasting 12 months in patients with moderate to severe COPD (baseline: prebronchodilatation ROB₁ < 50% of proper; median postbronchodilatation ROB₁ = 42% of proper) against the background of DuoResp Spiromax, there was a significant reduction in the rate of exacerbations compared with patients treated with formoterol or placebo alone (mean exacerbation rate of 1.4 compared with 1.8-1.9 in the placebo/formoterol group). No difference was noted between DuoResp Spiromax and formoterol administration on first-second forced expiratory volume (FEF₁).

Pharmacokinetics

Extraction. DuoResp Spiromax is bioequivalent to the respective monotherapies with respect to the systemic effects of budesonide and formoterol. Despite this, a slight increase in cortisol suppression was observed after administration of the combination drug compared to the monotherapies. This difference has no effect on clinical safety. There is no evidence of pharmacokinetic interaction between budesonide and formoterol.

The pharmacokinetic parameters for the respective substances are comparable after administration of budesonide and formoterol as monotherapies and as part of DuoResp Spiromax. For budesonide when administered as part of the combination drug the area under the curve “concentration-time” (AUC) is slightly greater, the drug is absorbed faster and the value of maximum concentration in blood plasma is higher.

For formoterol when administered as part of a combination drug, the maximum plasma concentration is the same as that of the monotherapy.

Inhaled budesonide is rapidly absorbed and reaches maximum plasma concentration 30 minutes after inhalation. The average dose of budesonide reaching the lungs after inhalation is 32-44% of the delivered dose. Systemic bioavailability is approximately 49% of the delivered dose. In children aged 6 to 16 years, the average dose of budesonide delivered to the lungs after inhalation does not differ from those of adult patients (the final concentration of the drug in plasma was not determined).

Inhaled formoterol is rapidly absorbed and reaches maximum plasma concentration 10 minutes after inhalation. The average dose of formoterol reaching the lungs after inhalation is 28-49% of the delivered dose. Systemic bioavailability is about 61% of the delivered dose.

Distribution. About 50% of formoterol and 90% of budesonide bind to plasma proteins. The volume of distribution for formoterol is about 4 l/kg and for budesonide 3 l/kg. Formoterol is inactivated by conjugation (active O-demethylated metabolites are formed, mostly as inactivated conjugates). Budesonide undergoes intensive biotransformation (about 90%) during the first passage through the liver to form metabolites with low glucocorticosteroid activity. Glucocorticosteroid activity of the main metabolites 6-β-hydroxybudesonide and 16-α-hydroxyprednisolone does not exceed 1% of that of budesonide. There is no evidence of metabolite interaction or substitution reaction between budesonide and formoterol.

Metabolism. The bulk of the formoterol dose is metabolized in the liver and then excreted by the kidneys. After inhalation, 8-13% of the delivered dose of formoterol is excreted unchanged in the urine. Formoterol has a high systemic clearance (approximately 1.4 L/min); the half-life of the drug is on average 17 hours.

Budesonide is metabolized predominantly with the enzyme CYP3A4. Budesonide metabolites are excreted with urine unchanged or as conjugates. Only small amounts of unchanged budesonide are detected in the urine. Budesonide has a high systemic clearance (approximately 1.2 L/min).

The pharmacokinetics of formoterol in children and patients with renal impairment have not been studied. Plasma concentrations of budesonide and formoterol may be elevated in patients with liver disease.

Indications

160/4.5 mcg/dose:

Bronchial asthma, to achieve overall disease control, including prevention and relief of symptoms, and reducing the risk of exacerbations. DuoResp Spiromax is suitable for the treatment of bronchial asthma of any severity, if it is advisable to use inhaled glucocorticosteroids.
Chronic obstructive pulmonary disease (COPD) (symptomatic treatment in patients with severe COPD with post-bronchodilator FEV1 < 70% predicted and with a history of exacerbations, despite regular therapy with long-acting bronchodilators).

320/9 mcg/dose:

Bronchial asthma (insufficiently controlled by taking inhaled GCS and short-acting β2-agonists as on-demand therapy or adequately controlled by inhaled GCS and long-acting β2-agonists).
Chronic obstructive pulmonary disease (COPD) (symptomatic therapy in patients with COPD with post-bronchodilator FEV1 < 70% predicted and with a history of exacerbations, despite regular bronchodilator therapy).

Pharmacological effect

Pharmacotherapeutic group: combined bronchodilator (selective beta2-adrenergic agonist + local glucocorticosteroid)

ATX code: R03AK07

Pharmacological properties

Pharmacodynamics

The drug DuoResp Spiromax contains formoterol and budesonide, which have different mechanisms of action and exhibit an additive effect in reducing the frequency of exacerbations of bronchial asthma and chronic obstructive pulmonary disease (COPD).

The special properties of budesonide and formoterol make it possible to use their combination simultaneously as maintenance therapy and for the relief of attacks or as maintenance therapy for bronchial asthma.

Budesonide

Budesonide is a glucocorticosteroid (GCS), which, after inhalation, has a rapid (within several hours) and dose-dependent anti-inflammatory effect on the airways, reducing the severity of symptoms and the frequency of exacerbations of bronchial asthma. When prescribing inhaled budesonide, there is a lower incidence of serious adverse effects than when using systemic corticosteroids. Reduces the severity of edema of the bronchial mucosa, mucus production, sputum formation and airway hyperreactivity. The exact mechanism of the anti-inflammatory effect of GCS is unknown.

Formoterol

Formoterol is a selective β2-adrenergic receptor agonist that, following inhalation, causes rapid and long-lasting relaxation of bronchial smooth muscle in patients with reversible airway obstruction. The bronchodilator dose-dependent effect occurs quickly, within 1-3 minutes after inhalation and persists for at least 12 hours after taking a single dose.

Budesonide + Formoterol

Bronchial asthma

Clinical effectiveness as maintenance therapy

The addition of formoterol to budesonide reduces the severity of asthma symptoms, improves lung function and reduces the frequency of exacerbations of the disease.

The effect of DuoResp Spiromax on lung function corresponds to the effect of the combination of budesonide and formoterol monotherapy and exceeds the effect of budesonide alone. In all cases,
was used to relieve attacks
Short-acting β2-agonist. There was no decrease in the anti-asthmatic effect over time. The drug is well tolerated.

Clinical effectiveness as maintenance therapy and for the relief of attacks (only for dosage 160/4.5)

During the observation of 4447 patients receiving budesonide/formoterol therapy as maintenance therapy and for the relief of attacks for 6 to 12 months, there was a statistically and clinically significant decrease in the number of severe exacerbations, an increase in the period of time until the onset of the first exacerbation in comparison with the combination of budesonide/formoterol or budesonide as maintenance therapy and a β2-agonist for the relief of attacks. Effective control of disease symptoms, pulmonary function, and a decrease in the frequency of inhalation prescriptions to relieve attacks were also noted. There was no development of tolerance to the prescribed therapy. In patients who sought medical help due to the development of an acute attack of bronchial asthma, after inhalation of budesonide/formoterol, relief of symptoms (relief of bronchospasm) occurred as quickly and effectively as after the administration of salbutamol and formoterol.

COPD

In two 12-month studies in patients with moderate to severe COPD (baseline: pre-bronchodilator FEV1 < 50% predicted; median post-bronchodilator FEV1 = 42% predicted) with DuoResp Spiromax, there was a significant reduction in exacerbation rates compared with patients receiving formoterol or placebo alone (mean exacerbation rate 1.4 compared to 1.8-1.9 in the placebo/formoterol group). There were no differences observed between taking DuoResp Spiromax and formoterol on forced expiratory volume in the first second (FEV1).

Pharmacokinetics

Suction. The drug DuoResp Spiromax is bioequivalent to the corresponding monopreparations with regard to the systemic action of budesonide and formoterol. Despite this, there was a slight increase in cortisol suppression after taking the combination drug compared to the single drug. This difference does not have an impact on clinical safety. There is no evidence of a pharmacokinetic interaction between budesonide and formoterol.

Pharmacokinetic parameters for the corresponding substances are comparable after the administration of budesonide and formoterol in the form of single drugs and as part of the drug DuoResp Spiromax. For budesonide, when administered as part of a combination drug, the area under the concentration-time curve (AUC) is slightly larger, absorption of the drug is faster and the maximum plasma concentration is higher.

For formoterol, when administered as part of a combination drug, the maximum concentration in blood plasma coincides with that for the single drug.

Inhaled budesonide is rapidly absorbed and reaches maximum plasma concentration 30 minutes after inhalation. The average dose of budesonide that enters the lungs after inhalation is 32-44% of the delivered dose. Systemic bioavailability is approximately 49% of the delivered dose. In children aged 6 to 16 years, the average dose of budesonide entering the lungs after inhalation does not differ from that in adult patients (the final concentration of the drug in the blood plasma was not determined).

Inhaled formoterol is rapidly absorbed and reaches maximum concentration in blood plasma 10 minutes after inhalation. The average dose of formoterol that enters the lungs after inhalation is 28-49% of the delivered dose. Systemic bioavailability is approximately 61% of the delivered dose.

Distribution. Approximately 50% of formoterol and 90% of budesonide are bound to plasma proteins. The volume of distribution for formoterol is about 4 l/kg and for budesonide 3 l/kg. Formoterol is inactivated by conjugation (active O-demethylated metabolites are formed, mainly in the form of inactivated conjugates). Budesonide undergoes intense biotransformation (about 90%) during the first passage through the liver with the formation of metabolites with low glucocorticosteroid activity. Glucocorticosteroid activity of the main metabolites 6-β-hydroxybudesonide and 16-α­ hydroxyprednisolone – does not exceed 1% of the same activity of budesonide. There is no evidence of metabolite interactions or substitution reactions between budesonide and formoterol.

Metabolism. The bulk of the dose of formoterol is metabolized in the liver and then excreted by the kidneys. After inhalation, 8-13% of the delivered dose of formoterol is excreted unchanged in the urine. Formoterol has a high systemic clearance (approximately 1.4 L/min); The half-life of the drug averages 17 hours.

Budesonide is metabolized primarily with the participation of the CYP3A4 enzyme. Budesonide metabolites are excreted in the urine unchanged or in the form of conjugates. Only a small amount of unchanged budesonide is found in the urine. Budesonide has a high systemic clearance (approximately 1.2 L/min).

The pharmacokinetics of formoterol in children and in patients with renal failure have not been studied. Plasma concentrations of budesonide and formoterol may be increased in patients with liver disease.

Special instructions

Dosage Directions

If the symptoms of bronchial asthma are controlled, you can gradually reduce the dose of DuoResp Spiromax. It is important to constantly monitor the condition of patients. The lowest effective dose of DuoResp Spiromax should be prescribed (see section “Dosage and Administration”).

Patients are recommended to always carry emergency medications or DuoResp Spiromax with them (for patients with bronchial asthma using DuoResp Spiromax for relief of attacks/symptoms with anti-inflammatory effects – therapy A or B), or short-acting beta2-agonists (for all patients using DuoResp Spiromax only for maintenance therapy – therapy C).

When using the drug DuoResp Spiromax as maintenance therapy, the patient should be drawn to the need to regularly take a maintenance dose of the drug in accordance with the selected therapy, even in cases where there are no symptoms of the disease.

It is recommended to instruct the patient to rinse the mouth with water after inhaling maintenance doses in order to prevent the risk of developing candidiasis of the oral and pharyngeal mucosa. It is also necessary to rinse your mouth with water after inhalation on demand in case of development of candidiasis of the oral mucosa and pharynx.

It is recommended to gradually reduce the maintenance dose of the drug before stopping treatment and it is not recommended to abruptly discontinue treatment. Inhaled glucocorticosteroids should not be completely discontinued, except in cases where temporary withdrawal is necessary to confirm the diagnosis of bronchial asthma.

Increased symptoms of the disease

During therapy with DuoResp Spiromax, exacerbations and the development of serious adverse events associated with bronchial asthma may occur. Patients should continue treatment but seek medical attention if asthma symptoms are not controlled or if symptoms worsen after starting therapy.

If therapy is insufficiently effective or the maximum recommended doses of DuoResp Spiromax are exceeded, it is necessary to reconsider treatment tactics. Sudden and progressive deterioration in control of symptoms of asthma or COPD is a potentially life-threatening condition and requires urgent medical attention. In this situation, you should consider increasing the dose of glucocorticosteroids, for example, prescribing a course of oral glucocorticosteroids, or treatment with antibiotics in case of infection. In case of severe exacerbation, monotherapy with a combination of an inhaled glucocorticosteroid and a long-acting beta2-adrenergic agonist is not enough.

Transfer from oral therapy

If there is reason to believe that adrenal function has been impaired due to previous systemic glucocorticosteroid therapy, precautions should be taken when transferring patients to treatment with DuoResp Spiromax.

The benefits of inhaled budesonide therapy generally minimize the need for oral corticosteroids, but patients who discontinue oral corticosteroid therapy may experience long-term adrenal insufficiency. Patients who have previously required acute high-dose corticosteroids or have received long-term treatment with high-dose inhaled corticosteroids may also be at risk. It is necessary to provide additional administration of glucocorticosteroids during periods of stress or surgery.

Excipients

DuoResp Spiromax contains lactose (< 1 mg/inhalation). Typically this amount does not cause problems in patients with lactose intolerance.

Precautions for specific diseases

Precautions should be taken when treating patients with a prolonged QTc interval. Taking formoterol may cause a prolongation of the QTc interval.

When beta2-agonists are used together with drugs that can cause or enhance the hypokalemic effect, for example, xanthine derivatives, steroids or diuretics, the hypokalemic effect of beta2-agonists may be enhanced. Special precautions should be taken in patients with unstable bronchial asthma who use short-acting bronchodilators to relieve attacks during exacerbation of severe bronchial asthma, since the risk of developing hypokalemia increases against the background of hypoxia and in other conditions when the likelihood of developing a hypokalemic effect increases. In such cases, it is recommended to monitor serum potassium levels.

During treatment, blood glucose concentrations should be monitored in patients with diabetes mellitus.

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

Systemic action

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

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 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) did not show a significant effect on bone mineral density. There is no data regarding the effect of high doses of DuoResp Spiromax on bone mineral density.

Paradoxical bronchospasm

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 regard, therapy with DuoResp Spiromax should be discontinued, treatment tactics should be reconsidered and, if necessary, alternative therapy should be prescribed.

Population of patients with COPD

Data from clinical studies of the drug DuoResp Spiromax in patients with COPD with pre-bronchodilator FB1 > 50% of predicted and post-bronchodilator FB1 < 70% of predicted are not available (see section “Pharmacodynamics”).

Clinical studies and meta-analyses have shown that the use of inhaled corticosteroids for COPD may lead to an increased risk of pneumonia. However, the absolute risk with budesonide is small. A meta-analysis of 11 double-blind studies involving 10,570 patients with COPD did not demonstrate a statistically significant increase in the risk of pneumonia in patients receiving budesonide (including in combination with formoterol) compared with patients receiving therapy without budesonide (placebo or formoterol). The incidence of the serious adverse event of pneumonia was 1.9% per year with budesonide-containing therapy and 1.5% per year with budesonide-free therapy. The pooled hazard ratio comparing therapy containing budesonide to therapy without budesonide was 1.15 (95% confidence interval (CI): 0.83, 1.57). The pooled hazard ratio comparing budesonide/formoterol with formoterol or placebo was 1.00 (95% CI: 0.69, 1.44). The cause-and-effect relationship between the development of pneumonia and the use of drugs containing budesonide has not been established.

Impact on the ability to drive vehicles and machinery

The drug DuoResp Spiromax may affect the ability to drive vehicles and machinery if side effects occur, so care must be taken when driving vehicles and machinery.

Active ingredient

Budesonide, Formoterol

Composition

1 delivered dose contains: active ingredients: budesonide (micronized) 160 mcg/320 mcg, formoterol fumarate dihydrate (micronized) 4.5 mcg/9 mcg; excipient: lactose monohydrate* 5 mg/10 mg.

*The target amount of lactose monohydrate in the delivered dose is indicated (it is approximate).

Pregnancy

Pregnancy

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

During pregnancy, DuoResp Spiromax should be used only in cases where the benefit of the drug outweighs the potential risk to the fetus. The lowest effective dose of budesonide needed to maintain adequate control of asthma symptoms should be used.

Breast-feeding

Inhaled budesonide is excreted in breast milk, however, when used in therapeutic doses, no effects on the child were noted. It is not known whether formoterol passes into women’s breast milk. DuoResp Spiromax can be prescribed to breastfeeding women only if the expected benefit to the mother is greater than any possible risk to the baby.

Fertility

There is no data on the effect on fertility.

Contraindications

Hypersensitivity to budesonide, formoterol or inhaled lactose.
Children under 18 years of age.
Lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

With caution

Pulmonary tuberculosis (active or inactive form); fungal, viral or bacterial infections of the respiratory system, thyrotoxicosis, pheochromocytoma, diabetes mellitus, decreased function of the adrenal cortex, uncontrolled hypokalemia, hypertrophic obstructive cardiomyopathy, idiopathic hypertrophic subaortic stenosis, severe arterial hypertension, aneurysm of any location or other severe cardiovascular diseases (coronary heart disease, tachyarrhythmia or severe heart failure), prolongation of the QT interval (taking formoterol may cause prolongation of the QT interval).

Side Effects

There was no increase in the incidence of adverse reactions observed during the concomitant administration of the two drugs. The most common adverse reactions associated with taking the drug are those pharmacologically expected for
β2-agonists have undesirable side effects such as tremor and rapid heartbeat. Symptoms are usually mild and disappear within a few days of starting treatment. During a 3-year clinical study of budesonide in COPD, skin bruising and pneumonia occurred at an incidence of 10% and 6%, respectively, compared with 4% and 3% in the placebo group (p < 0.001 and p < 0.01, respectively).

The frequency is defined as follows: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000) and frequency unknown (cannot be estimated from available data).

Class of organ systems

Frequency

Side effect

Immune system disorders

Rarely

Immediate and delayed hypersensitivity reactions (exanthema, urticaria, pruritus, angioedema dermatitis and anaphylactic reaction)

Endocrine system disorders

Very rarely

Cushing’s syndrome, adrenal suppression, growth retardation, decreased bone mineral density

Metabolic and nutritional disorders

Rarely

Hypokalemia

Very rarely

Hyperglycemia, signs or symptoms of systemic glucocorticosteroids

effects (including adrenal hypofunction)

Mental disorders

Uncommon

Aggression, psychomotor agitation, anxiety, sleep disturbances

Very rarely

Depression, behavioral disorders

Nervous system disorders

Often

Headache, tremor

Uncommon

Dizziness

Very rarely

Taste disorders

Visual disorders

Uncommon

Visual impairment

Very rarely

Cataracts and glaucoma

Frequency unknown

Central serous neuropathy

Heart disorders

Often

Feeling of heartbeat

Uncommon

Tachycardia

Rarely

Arrhythmia (eg, atrial fibrillation, supraventricular tachycardia, extrasystole)

Very rarely

Angina pectoris, QT interval prolongation

Vascular disorders

Very rarely

Fluctuations in blood pressure (BP)

Respiratory, thoracic and mediastinal disorders

Often

Candidiasis of the oral and pharyngeal mucosa, pharyngeal irritation, cough, hoarseness, pneumonia (in patients with COPD)*

Rarely

Bronchospasm

Very rarely

Paradoxical bronchospasm

Gastrointestinal disorders

Uncommon

Nausea

Skin and subcutaneous tissue disorders

Uncommon

Bruising

Musculoskeletal and connective tissue disorders

Uncommon

Muscle cramps

* during treatment with inhaled corticosteroids in patients with COPD.

Systemic effects of inhaled corticosteroids can occur when taking high doses over a long period of time. The use of β2-adrenergic agonists can lead to an increase in the blood levels of insulin, free fatty acids, glycerol and ketone derivatives.

Interaction

Taking ketoconazole 200 mg once a day increases the plasma concentration of oral budesonide (single dose 3 mg) when administered together by an average of 6 times. When ketoconazole was prescribed 12 hours after taking budesonide, the plasma concentration of the latter increased by an average of 3 times. There is no information about such an interaction with inhaled budesonide, but a noticeable increase in the concentration of the drug in the blood plasma should be expected. Since there are no data for dose recommendations, the above combination of drugs should be avoided. If possible, the time interval between the administration of ketoconazole and budesonide should be increased as much as possible. A dose reduction of budesonide should also be considered. Other potent CYP3A4 inhibitors are also likely to significantly increase budesonide plasma concentrations.

β2-adrenergic receptor blockers may reduce the effect of formoterol. The combination of formoterol + budesonide should not be prescribed simultaneously with
β-blockers (including eye drops), except in cases of emergency.

Co-administration of a combination of formoterol + budesonide and quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine) and tricyclic antidepressants may prolong the QT interval and increase the risk of ventricular arrhythmias.

In addition, levodopa, levothyroxine, oxytocin and alcohol can reduce the tolerance of the heart muscle to β2-agonists.

The simultaneous use of MAO inhibitors, as well as drugs with similar properties, such as furazolidone and procarbazine, may cause an increase in blood pressure. There is an increased risk of developing arrhythmias in patients undergoing general anesthesia with halogenated hydrocarbon preparations.

With simultaneous use of a combination of formoterol + budesonide and other
β-adrenergic drugs may increase the side effects of formoterol.

As a result of the use of β2-agonists, hypokalemia may occur, which may be exacerbated by concomitant treatment with xanthine derivatives, corticosteroids or diuretics. Hypokalemia may increase the susceptibility to the development of arrhythmias in patients taking cardiac glycosides.

There was no interaction between budesonide and formoterol with other drugs used to treat bronchial asthma.

Overdose

Symptoms of formoterol overdose: tremor, headache, rapid heartbeat. In some cases, the development of tachycardia, hyperglycemia, hypokalemia, prolongation of the QT interval, arrhythmia, nausea and vomiting was reported.

In case of acute overdose of budesonide, even in significant doses, no clinically significant effects are expected. With chronic use of excessive doses, systemic effects of GCS, such as hypercortisolism and suppression of adrenal function, may occur.

If it is necessary to discontinue the drug DuoResp Spiromax due to an overdose of formoterol, which is part of the combination drug, the issue of prescribing inhaled GCS should be considered.

Treatment: supportive and symptomatic.

Storage conditions

Store at a temperature not exceeding 25 °C.
Keep out of the reach of children.

Shelf life

3 years.
The shelf life of the drug after opening the foil wrapper is 6 months.
Do not use after expiration date.

Manufacturer

Norton (Waterford) Limited, Ireland