Description
Pharmacological action
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 at the same time to relieve seizures or as a supportive therapy for bronchial asthma.
Budesonide
Budesonide – GCS, which after inhalation has a quick (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. With the appointment of inhaled budesonide, a lower incidence of serious undesirable effects is noted than when using systemic corticosteroids. Reduces the severity of edema of the bronchial mucosa, mucus production, sputum formation and respiratory tract hyperresponsiveness.
Formoterol
Formoterol is a selective 2-adrenergic receptor agonist, which, after inhalation, causes rapid and prolonged relaxation of the smooth muscles of the bronchi 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 the drug DuoResp Spiromax on the function of the bronchi corresponds to the action of a combination of the single drugs budesonide and formoterol and exceeds the effect of one budesonide. In all cases, a short-acting 2-adrenostimulator was used to relieve seizures. There was no decrease in anti-asthma effect over time. The drug has good tolerance.
Clinical efficacy as maintenance therapy and for relieving seizures (only for dosage 160 / 4.5). During the observation of 4447 patients receiving budesonide / formoterol therapy as maintenance therapy and for relieving seizures for 6 to 12 months, there was a statistically and clinically significant decrease in the number of severe exacerbations, an increase in the period before the onset of the first exacerbation compared with the combination formoterol + budesonide or budesonide as maintenance therapy and a 2 adrenostimulator for relief of attacks. Effective control over the symptoms of the disease, pulmonary function, and a decrease in the frequency of inhalation for relieving seizures were also noted. No development of tolerance to the prescribed therapy was detected. In patients who sought medical attention in connection with the development of an acute attack of bronchial asthma, after inhalation of budesonide / formoterol, the relief of symptoms (removal of bronchospasm) occurred as quickly and efficiently as after the administration of salbutamol and formoterol.
COPD In patients with severe COPD, while taking DuoResp Spiromax, 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 (the average frequency of exacerbations was 1.4 compared to 1.8-1.9 in the group placebo / formoterol). There were no differences between taking DuoResp Spiromax and formoterol by the OFB1 index.
Indications
Bronchial asthma (not adequately controlled by the administration of inhaled corticosteroids and short-acting 2-adrenostimulants controlled by inhaled corticosteroids and long-acting 2-adrenostimulants)
Chronic obstructive pulmonary disease (symptomatic therapy in patients with severe chronic obstructive pulmonary disease – FEV1
counterrendering
Hypersensitivity to budesonide, formoterol or inhaled lactose
Children under 18 years of age.
Precautions: pulmonary tuberculosis (active or inactive), 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 type of cardiovascular disease or other (coronary heart disease, severe tachyarrhythmia or heart failure), prolongation of the QT interval (taking formoterol can cause an extension of QT c-interval), lactose intolerance, lactase deficiency or glucose-galactose malabsorption.
Use during pregnancy and lactation
There are no clinical data on the use of the drug DuoResp Spiromax or the combined use of formoterol and budesonide during pregnancy.
During pregnancy, the drug DuoResp Spiromax should be used only in cases where the benefits of using the drug outweigh the potential risk to the fetus.
Use the lowest effective dose of budesonide necessary to maintain adequate control of asthma symptoms.
Igigiruyemy budesonide is excreted in breast milk, however, when used in therapeutic doses, the effect on the child is not marked. Unknown Does formoterol pass into breast milk of women. The drug DuoResp Spiromax can be prescribed to lactating women only if the expected benefit to the mother is greater than any possible risk to the child.
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.
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 a prolonged QT 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 pay attention to the need for regular administration of the drug 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 an exacerbation or significant deterioration of the course 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, therapy with DuoResp Spiromax should be discontinued, treatment tactics reviewed and, if necessary, prescribed alternative therapy. A systemic effect can 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, decreased BMD, cataracts, and glaucoma.
Based on limited research data on the long-term use of corticosteroids, it can be assumed that most children and adolescents receiving inhaled budesonide therapy will ultimately achieve normal adult growth rates. However, an insignificant (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 BMD, particular 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 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 BMD. There is no data on the effect of high doses of DuoResp Spiromax on BMD.
If there is reason to believe that adrenal function was impaired against previous systemic therapy for corticosteroids, precautions should be taken when transferring patients to treatment with DuoResp Spiromax. The benefits of inhaled therapy with budesonide, as a rule, minimize the need for oral steroids, however, in patients discontinuing therapy with oral corticosteroids, insufficient adrenal function may persist for a long time.
Patients who in the past needed emergency treatment with high doses of corticosteroids or received long-term treatment with high-dose inhaled corticosteroids may also be at risk. 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 in order to prevent the development of candidiasis of the oral mucosa.
Precautions should be observed when treating patients with an extended QTc interval.
Taking 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 should be reviewed, fungal, viral or bacterial infections of the respiratory system. With the co-administration of 2-adrenergic agonists with drugs that can cause or enhance the hypokalemic effect, for example, xanthine derivatives, steroids or diuretics, it is possible to enhance the hypokalemic effect of 2-adrenergic agonists. 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 in patients with diabetes should be monitored.
Effect on the ability to drive vehicles and mechanisms. The drug DuoResp Spiromax does not affect the ability to drive vehicles and mechanisms. May have a slight effect in case of side effects. Caution must be exercised when driving vehicles and mechanisms in connection with the possibility of side effects
Composition
Inhalation powder, metered white or almost white, without visible lumps and inclusions, the metering indicator window should show No. 120.
1 delivered dose
budesonide (micronized) 160 mcg
formoterol fumarate dihydrate (micronized) 4.5 mcg
Excipients: lactose monohydrate – 5 mg.
Dosage and Administration
Inhalation.
Bronchial asthma
The drug DuoResp Spiromax is not intended for the initial treatment of bronchial asthma with intermittent and mild persistent course. The selection of the dose of drugs that are part of the drug DuoResp Spiromax occurs individually and depending on the severity of the disease. This must be taken into account not only at the beginning of treatment with combined drugs, but also when changing the maintenance dose of the drug.
In the event that individual patients require a different combination of doses of the active components than in the DuoResp Spiromax preparation, 2-adrenergic agonists and / or glucocorticosteroids should be prescribed in separate inhalers.
Patients should be regularly visited by a doctor to monitor the optimal dose of DuoResp Spiromax. The dose should be reduced to the smallest, against the background of which optimal control of symptoms of bronchial asthma is maintained. 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, according to the doctor, the patient needs maintenance therapy in combination with a long-acting bronchodilator .
Adults (18 years of age and older): DuoResp Spiromax 160 / 4.5 mcg / dose as maintenance therapy 1–2 inhalations 2 times a day. If necessary, it is possible to increase the dose to 4 inhalations 2 times a day. The patient must always have a separate inhaler with a short-acting 2-adrenostimulator to stop attacks. An increase in the frequency of use of short-acting 2 adrenostimulants is an indication of a deterioration in overall disease control and requires a review of anti-asthma therapy.
The drug DuoResp Spiromax 160 / 4.5 mcg / dose as maintenance therapy and for relieving seizures. The drug DuoResp Spiromax can be prescribed both as a continuous maintenance therapy, and as therapy on demand in case of attacks. In particular, it is indicated for patients as supportive therapy and for relieving seizures:
– with insufficient control over bronchial asthma and the need for frequent use of drugs for relieving
attacks – the presence in the history of exacerbations of bronchial asthma requiring medical intervention.
Careful monitoring of dose-dependent side effects in patients using a large number of inhalations to relieve seizures is required. The recommended dose for maintenance therapy is 2 inhalations per day, no 1 inhalation is taken 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 Ојg / 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 for stopping 1 attack. Usually, more than 8 inhalations per day are not required, but you can increase the number of inhalations to 12 inhalations per day for a short time.
Patients receiving more than 8 inhalations per day are advised to seek medical attention to review therapy.
Drug DuoResp Spiromax 320/9 mcg / dose. 1 inhalation 2 times a day. If necessary, it is possible to increase the dose to 2 inhalations 2 times a day.
After achieving optimal control of symptoms of bronchial asthma while taking the drug 2 times a day, it is possible to reduce the dose to the least effective, up to taking it once a day.
COPD
Adults (18 years of age 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 dose selection for elderly patients.
There is no data on the use of the drug DuoResp Spiromax in patients with renal or hepatic insufficiency. Since budesonide and formoterol are excreted mainly by the kidneys, with the participation of hepatic metabolism, in patients with severe cirrhosis of the liver, a slowdown in the excretion rate of the drug can be expected.
Side effects
An increase in the incidence of adverse reactions was not observed against the background of the joint administration of the two drugs. The most common adverse reactions associated with taking the drug are undesirable side effects, such as tremors and heart palpitations, pharmacologically expected for ?2-adrenergic agonists. Symptoms usually have a moderate severity and disappear a few days after the start of treatment. During a 3-year clinical study of the use of budesonide for COPD, bruising on the skin and pneumonia occurred with a frequency of 10 and 6%, respectively, while in the placebo group with a frequency of 4 and 3% (p
Frequency is determined as follows: very often (? 1/10) often (? 1/100,
On the part of the immune system: rarely, immediate and delayed hypersensitivity reactions (exanthema, urticaria, pruritus, angioedema dermatitis and anaphylactic reaction).
From the endocrine system: very rarely – Cushing’s syndrome, adrenal suppression, growth retardation, decreased BMD.
From the side of metabolism and nutrition: rarely – hypokalemia very rarely – hyperglycemia, signs or symptoms of systemic corticosteroids effects (including hypofunction of the adrenal glands).
From the psyche: infrequently – agitation, psychomotor agitation, anxiety, sleep disturbances very rarely – depression, behavior disorders.
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 interaction
Taking 200 mg of ketoconazole once a day increases the plasma concentration of oral budesonide (single dose 3 mg) when used together, an average of 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 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 intervals 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. Blockers of? 2-adrenergic receptors can weaken the effect of formoterol. The combination of formoterol + budesonide should not be prescribed simultaneously with? -Adrenoblockers (including eye drops), with the exception of forced cases.
Co-administration of the combination of formoterol + budesonide and quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), MAO inhibitors and tricyclic antidepressants can prolong the QT interval and increase the risk of ventricular arrhythmias.
In addition, levodopa, levothyroxine, oxytocin and alcohol may decrease the tolerance of the heart muscle to? 2-adrenergic agonists.
The simultaneous use 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 simultaneous use of the combination of formoterol + budesonide and other? -adrenergic drugs, side effects 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, corticosteroids, or diuretics. Hypokalemia may increase the predisposition to the development of arrhythmias in patients taking cardiac glycosides.
No interaction of budesonide and formoterol with other drugs used to treat bronchial asthma has been observed.
Overdose
Formoterol
Symptoms: tremors, headache, heart palpitations. In some cases, the development of tachycardia, hyperglycemia, hypokalemia, lengthening of the QTc interval, arrhythmia, nausea and vomiting. If it is necessary to cancel the drug DuoResp Spiromax due to an overdose of formoterol, which is part of the combined drug, consideration should be given to prescribing the appropriate GCS.
Treatment: supportive and symptomatic. Reception by patients with acute bronchial obstruction of formoterol at a dose of 90 mcg for 3 hours is safe.
Budesonide
In acute overdose, even in significant doses, no clinically significant effects are expected. In chronic use of excessive doses, a systemic effect of GCS may appear, such as hypercorticism and suppression of adrenal function.
Pharmacy terms
Prescription
dosage form
powder for inhalation
Prescription
Adults as prescribed by a doctor, For children as prescribed by the doctor, Pregnant as prescribed by the doctor, Nursing mothers
Indications
Bronhialynaya asthma Nizkaya obuchaemosty, bronchospasm
Norton (Waterford ) Limited, Ireland
