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Duoresp Spiromax 160 mcg/4.5 mcg 120 doses N1 powder for inhalation

pharmachologic effect

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

Budesonide

Budesonide is a corticosteroid that, after inhalation, has a rapid (within several hours) and dose-dependent anti-inflammatory effect on the respiratory tract, 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.

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

The effect of DuoResp Spiromax on bronchial function corresponds to the effect of the combination of budesonide and formoterol monotherapy and exceeds the effect of budesonide alone. In all cases, a short-acting β2-agonist agonist was used to relieve attacks. 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, a statistically and clinically significant decrease in the number of severe exacerbations was noted, an increase in the period of time until the onset of the first exacerbation compared with the combination formoterol + budesonide or budesonide as maintenance therapy and β2-adrenergic agonist to relieve attacks. Effective control of disease symptoms, pulmonary function, and a decrease in the frequency of inhalation prescriptions to relieve attacks were also noted. The development of tolerance to the prescribed therapy was not detected. 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 patients with severe COPD while taking DuoResp Spiromax, there was a significant reduction in the frequency of exacerbations of the disease compared with patients receiving only formoterol or placebo as therapy (average frequency of exacerbations - 1.4 compared with 1.8–1.9 in the group placebo/formoterol). There were no differences observed between taking DuoResp Spiromax and formoterol on FB1.

Indications

— Bronchial asthma (insufficiently controlled by taking inhaled GCS and short-acting β2-agonists or adequately controlled by inhaled GCS and long-acting β2-agonists);

— Chronic obstructive pulmonary disease (symptomatic therapy in patients with severe chronic obstructive pulmonary disease — FEV1

Contraindications

- Hypersensitivity to budesonide, formoterol or inhaled lactose;

— Children under 18 years of age.

Carefully:

pulmonary tuberculosis (active or inactive form); fungal, viral or bacterial infections of the respiratory system, thyrotoxicosis, pheochromocytoma, diabetes mellitus, uncontrolled hypokalemia, 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 QTc interval), lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Use during pregnancy and breastfeeding

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.

Iigalated budesonide is excreted in breast milk, but when used in therapeutic doses, no effect on the child was 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.

special instructions

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

The drug DuoResp Spiromax is not used for the initial selection of therapy in the first stages of treatment of bronchial asthma.

Taking formoterol may cause QT prolongation.

An increase in the frequency of taking bronchodilators as emergency medications indicates a worsening of the underlying disease and serves as a basis for revising the treatment tactics for bronchial asthma.

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 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 carry emergency medications (short-acting β2-agonists) with them at all times. The patient's attention should be drawn to the need to regularly take DuoResp Spiromax in accordance with the selected dose, even in cases where there are no symptoms of the disease.

Treatment with DuoResp Spiromax should not be started during periods of exacerbation or significant worsening of bronchial asthma.

As with any other inhaled 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. Systemic effects may occur when taking any inhaled corticosteroids, especially when taking high doses of drugs over a long period of time. Systemic effects are less likely to occur with inhalation therapy than with oral corticosteroids. Possible systemic effects include suppression of adrenal function, decreased BMD, cataracts and glaucoma.

Based on the limited data from studies of long-term corticosteroid use, it can be assumed that most children and adolescents receiving inhaled budesonide therapy will eventually achieve normal adult growth rates. However, slight (approximately 1 cm), short-term growth retardation has been reported, mainly in the first year of treatment.

Due to the potential effect of inhaled corticosteroids on BMD, special attention should be paid to patients taking high doses of the drug for a long period with the presence of 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 BMD. There is no data regarding the effect of high doses of DuoResp Spiromax on BMD.

If there is reason to believe that adrenal function has been impaired due to previous systemic GCS 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 steroids, but patients who discontinue oral corticosteroid therapy may experience long-term adrenal insufficiency.

Patients who in the past required acute use of high doses of corticosteroids or received long-term treatment with high-dose inhaled corticosteroids may also be at this risk. It is necessary to provide additional administration of GCS during periods of stress or surgery. It is recommended to instruct the patient to rinse the mouth with water after inhalation in order to prevent the development of candidiasis of the oral mucosa.

Precautions should be taken when treating patients with a prolonged QTc interval.

Taking formoterol may cause a prolongation of the QTc interval. The need for the use and dose of inhaled GCS should be reconsidered in patients with active or inactive forms of pulmonary tuberculosis, fungal, viral or bacterial infections of the respiratory system. When β2-adrenergic agonists are co-administered with drugs that can cause or enhance the hypokalemic effect, such as xanthine derivatives, steroids or diuretics, the hypokalemic effect of β2-agonists may be enhanced. Special precautions should be taken in patients with unstable bronchial asthma using short-acting bronchodilators to relieve attacks during exacerbation of severe bronchial asthma, because 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.

Effect on the ability to drive vehicles and machinery. The drug DuoResp Spiromax does not affect the ability to drive vehicles and machinery. May have a minor effect if side effects occur. Caution must be exercised when operating vehicles and machinery due to the possibility of developing side effects.

Compound

Powder for inhalation, dosed, white or almost white, without visible lumps or inclusions; The dosing indicator window should show No. 120.

1 dose delivered

budesonide (micronized) 160 mcg

formoterol fumarate dihydrate (micronized) 4.5 mcg

Excipients: lactose monohydrate 5 mg.

Directions for use and doses

Inhalation.

Bronchial asthma

The drug DuoResp Spiromax is not intended for the initial treatment of intermittent and mild persistent bronchial asthma. Selection of the dose of the drugs included in the drug DuoResp Spiromax occurs individually and depending on the severity of the disease. This must be taken into account not only when starting treatment with combination drugs, but also when changing the maintenance dose of the drug.

In the event that individual patients require a different combination of doses of active components than in the drug DuoResp Spiromax, β2-adrenergic agonists and/or corticosteroids should be prescribed in separate inhalers.

Patients should visit their doctor regularly to monitor the optimal dose of DuoResp Spiromax. The dose should be reduced to the lowest dose that maintains optimal control of asthma symptoms. After achieving optimal control of bronchial asthma when taking the drug 2 times a day, it is recommended to titrate the dose to the minimum effective, up to taking the drug 1 time per day, in cases where, in the opinion of the doctor, the patient requires maintenance therapy in combination with a long-acting bronchodilator .

Adults (18 years and older): DuoResp Spiromax 160/4.5 mcg/dose as maintenance therapy 1-2 inhalations 2 times a day. If necessary, the dose can be increased to 4 inhalations 2 times a day. The patient must always have with him a separate inhaler with a short-acting β2-agonist to relieve attacks. An increase in the frequency of use of short-acting β2-agonists is an indicator of deterioration in overall disease control and requires a review of anti-asthmatic therapy.

The drug DuoResp Spiromax 160/4.5 mcg/dose as maintenance therapy and for the relief of attacks. The drug DuoResp Spiromax can be prescribed both as continuous maintenance therapy and as on-demand therapy when attacks occur. As a maintenance therapy and to relieve attacks, the following is especially indicated for patients:

- with insufficient control over bronchial asthma and the need for frequent use of drugs to relieve attacks;

- a history of exacerbations of bronchial asthma that required medical intervention.

Careful monitoring of dose-related side effects is required in patients using large numbers of inhalations to relieve attacks. The recommended dose for maintenance therapy is 2 inhalations per day, taken no 1 inhalation in the morning and evening, or 2 inhalations once - only in the morning or only in the evening. For some patients, a maintenance dose of DuoResp Spiromax 160/4.5 mcg/dose 2 inhalations 2 times a day may be prescribed. If symptoms occur, 1 additional inhalation is necessary. With a further increase in symptoms within a few minutes, 1 additional inhalation is prescribed, but no more than 6 inhalations to relieve 1 attack. Usually, more than 8 inhalations per day are not required, but the number of inhalations can be increased to 12 inhalations per day for a short time.

Patients receiving more than 8 inhalations per day are advised to seek medical help to review therapy.

The drug DuoResp Spiromax 320/9 mcg/dose. 1 inhalation 2 times a day. If necessary, the dose can be increased to 2 inhalations 2 times a day.

After achieving optimal control of bronchial asthma symptoms while taking the drug 2 times a day, it is possible to reduce the dose to the lowest effective dose, up to once a day.

COPD

Adults (18 years and older): DuoResp Spiromax 160/4.5 mcg/dose 2 inhalations of the drug 2 times a day. DuoResp Spiromax 320/9 mcg/dose 1 inhalation of the drug 2 times a day.

Special patient groups

There is no need for special selection of the drug dose for elderly patients.

There is no data on the use of DuoResp Spiromax in patients with renal or hepatic impairment. Since budesonide and formoterol are eliminated primarily by the kidneys, with the participation of hepatic metabolism, a slower rate of elimination of the drug can be expected in patients with severe cirrhosis.

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 such pharmacologically expected undesirable side effects for β2-adrenergic agonists, such as tremor and rapid heartbeat. Symptoms are usually mild and disappear within a few days of starting treatment. During a 3-year clinical trial of budesonide in COPD, skin bruising and pneumonia occurred at rates of 10% and 6%, respectively, compared with rates of 4% and 3% in the placebo group (p

The frequency is determined as follows:

very often (≥1/10); often (≥1/100,

From the immune system:

rarely - immediate and delayed hypersensitivity reactions (exanthema, urticaria, itching, angioedema dermatitis and anaphylactic reaction).

From the endocrine system:

very rarely - Cushing's syndrome, adrenal suppression, growth retardation, decreased BMD.

Metabolism and nutrition:

rarely - hypokalemia; very rarely - hyperglycemia, signs or symptoms of systemic GCS effects (including adrenal hypofunction).

From the mental side:

infrequently - agitation, psychomotor agitation, anxiety, sleep disturbances; very rarely - depression, behavioral disorders.

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.

Drug interactions

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 on 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 strong 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), MAO inhibitors 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 the combination of formoterol + budesonide and other β-adrenergic drugs, the side effects of formoterol may be increased. 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

Formoterol

Symptoms:

tremor, headache, rapid heartbeat. In isolated cases, the development of tachycardia, hyperglycemia, hypokalemia, prolongation of the QTc interval, arrhythmia, nausea and vomiting was reported. 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 an appropriate GCS should be considered.

Treatment:

supportive and symptomatic. Formoterol at a dose of 90 mcg over 3 hours is safe for patients with acute bronchial obstruction.

Budesonide

In case of acute overdose, even in significant doses, clinically significant effects are not expected. With chronic use of excessive doses, systemic effects of GCS, such as hypercortisolism and suppression of adrenal function, may occur.