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

Name: DuoResp Spiromax, 320 mcg+9 mcg/dose 60 doses
SKU: 276013
Availability: InStock

€48.01

EAN: 5391523120043 SKU: 276013 Categories: Bronchial asthma, Medicine, Respiratory system

Description

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

Chronic Obstructive Pulmonary Disease, Bronchial Asthma, Bronchospasm

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 therapy of bronchial asthma of any severity, when inhaled glucocorticosteroids are appropriate.
Chronic obstructive pulmonary disease (COPD) (symptomatic therapy in patients with severe COPD with post-bronchodilator EOB₁ < 70% of proper and with a history of exacerbations despite regular therapy with long-term bronchodilators).

320/9 mcg/dose:

Bronchial asthma (insufficiently controlled by administration of inhaled GCS and β₂-short-acting adrenergic stimulants as on-demand therapy or adequately controlled with inhaled GCS and long-acting β₂ adrenergic stimulants).
Chronic obstructive pulmonary disease (COPD) (symptomatic therapy in patients with COPD with post-bronchodilator EOB₁ < 70% of proper and with a history of exacerbations despite regular bronchodilator therapy).

Active ingredient

Budesonide, Formoterol

Composition

1 delivered dose contains: acting substances: budesonide (micronized) 160 µg/320 µg, formoterol fumarate dihydrate (micronized) 4.5 µg/9 µg; auxiliary substance:lactose monohydrate^* 5 mg/ 10 mg.

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

How to take, the dosage

For inhalation use.

160/4.5 µg/dose

Bronchial asthma

. The dosage of the drugs in DuoResp Spiromax is selected individually and according to the severity of the disease. This must be considered not only when starting treatment with the combination medication, but also when changing the maintenance dose of the medication.

Patients should be monitored by their physician at all times to ensure that the dose of DuoResp Spiromax is adjusted appropriately.

DuoResp Spiromax may be used according to different approaches to therapy:

DuoResp Spiromax for control of attacks/symptoms with anti-inflammatory effects (mild bronchial asthma patients).
DuoResp Spiromax as maintenance therapy and for relieving attacks/symptoms with anti-inflammatory effects.

Alternatively, DuoResp Spiromax may be used as fixed-dose therapy:

DuoResp Spiromax as maintenance therapy (fixed dose).

A. DuoResp Spiromax for seizure/symptom control with anti-inflammatory effects (patients with mild bronchial asthma)

DuoResp Spiromax is taken on demand to relieve bronchial asthma symptoms when they develop and to prevent bronchoconstriction caused by allergens or exercise (or to prevent symptoms in situations assessed by the patient as likely to trigger an asthma attack). Formoterol, the active ingredient in DuoResp Spiromax, provides a rapid onset of action (within 1-3 minutes) with prolonged bronchodilation (at least 12 hours after a single dose) for reversible airway obstruction. The patient should have DuoResp Spiromax on hand at all times for symptom relief.

The physician should discuss allergen exposure and exercise volume with the patient and consider these when recommending the frequency of administration.

No more than 8 inhalations per day are usually required, but the number of inhalations may be increased to 12 per day for short periods of time. Patients receiving more than 8 inhalations per day are advised to seek medical attention for reassessment and review of bronchial asthma therapy.

Dose-dependent side effects in patients using large numbers of inhalations on demand require close monitoring.

B. DuoResp Spiromax as maintenance therapy and for relief of attacks/symptoms with anti-inflammatory effects

. If maintenance therapy with a combination of an inhaled glucocorticosteroid and a long-acting beta2-adrenoreceptor agonist is needed, the patient may take DuoResp Spiromax as maintenance therapy and in addition to anti-inflammatory seizure/symptom management. The patient should have DuoResp Spiromax on hand at all times for symptom relief. DuoResp Spiromax as maintenance therapy and for relief of attacks/symptoms with anti-inflammatory effects is particularly indicated for patients with:

insufficient control of bronchial asthma and the need for frequent use of medications to manage attacks/symptoms;
having a history of bronchial asthma exacerbations that required medical intervention.

The physician should discuss allergen exposure and exercise volume with the patient and consider these in recommending the frequency of therapy.

Adults (18 years and older):Patients should take 1 inhalation on demand when symptoms develop and to prevent bronchoconstriction caused by allergens or exercise to control bronchial asthma. If symptoms further increase within a few minutes, 1 additional inhalation is prescribed, but no more than 6 inhalations to control 1 attack. Patients also take the recommended maintenance dose of 2 inhalations per day, 1 inhalation in the morning and evening or 2 inhalations once in the morning or evening only. For some patients, a maintenance dose of 2 inhalations twice a day may be prescribed.

It is not usually necessary to prescribe more than 8 inhalations per day, but the number of inhalations may be increased to 12 per day for short periods of time. Patients receiving more than 8 inhalations per day are advised to seek medical advice to reassess and review maintenance therapy.

Dose-dependent side effects in patients using large numbers of inhalations on demand require close monitoring.

C. DuoResp Spiromax as maintenance therapy (fixed dose)

. If maintenance therapy with a combination of an inhaled glucocorticosteroid and a long-acting beta2-adrenoreceptor agonist is needed, the patient may take DuoResp Spiromax in a fixed daily dose and use a separate short-acting bronchodilator for symptom relief. Adults (18 years and older): 1-2 inhalations twice daily. If necessary, it is possible to increase the dose to 4 inhalations twice a day.

The dose should be reduced to the lowest dose against which optimal control of bronchial asthma symptoms is maintained. After optimal control of bronchial asthma symptoms is achieved with twice-daily dosing, it is recommended that the dose be titrated to the lowest effective dose, up to once-daily dosing, when the physician believes the patient requires maintenance therapy with a long-acting bronchodilator in combination with an inhaled glucocorticosteroid.

When individual patients require a different active ingredient dose combination than in DuoResp Spiromax, beta2-adrenomimetics and/or glucocorticosteroids should be prescribed in separate inhalers. Increased frequency of use of short-acting beta2-adrenomimetics is an indicator of worsening overall disease control and requires a review of anti-asthmatic therapy.

COPD

Adults:2 inhalations twice daily.

Special patient groups:There is no need for special dosage selection for elderly patients. There are no data on the use of DuoResp Spiromax in patients with renal or hepatic impairment. Because budesonide and formoterol are primarily eliminated by hepatic metabolism, a slower elimination rate can be expected in patients with severe hepatic cirrhosis.

320/9 mcg/dose

.strong>Bronchial asthma

DuoResp Spiromax is not intended as an initial treatment for intermittent and mild persistent bronchial asthma. The dosage of the drugs in DuoResp Spiromax is adjusted individually and according to the severity of the disease. This must be considered not only when starting treatment with the combination drugs, but also when changing the maintenance dose of the drug.

When individual patients require a different combination of doses of active ingredients than in DuoResp Spiromax, β₂-adrenomimetics and/or GCS in separate inhalers should be prescribed.

Patients should see their physician regularly to monitor the optimal dose of DuoResp Spiromax. The dose should be reduced gradually to the lowest dose that maintains optimal control of bronchial asthma symptoms. Once optimal bronchial asthma control has been achieved with twice-daily dosing, it is recommended that the dose be titrated to the lowest effective dose, up to once-daily dosing, when the physician believes the patient requires maintenance therapy in combination with a long-acting bronchodilator.

Adults (18 years and older): DuoResp Spiromax 320/9 mcg/dose: 1 inhalation twice daily. If necessary, the dose may be increased to 2 inhalations twice daily. After optimal control of bronchial asthma symptoms has been achieved with twice-daily dosing, the dose may be reduced to the lowest effective dose up to once-daily dosing.

DuoResp Spiromax 320/9 mcg/dose is for maintenance therapy only.

COPD

Adults: 1 inhalation of DuoResp Spiromax 320/9 mcg/dose twice daily.

Special patient groups

There is no need for special dosing for elderly patients (65 years and older). There are no data on the use of DuoResp Spiromax in patients with renal or hepatic impairment. Since budesonide and formoterol are excreted primarily by the kidneys with hepatic metabolism, a slower excretion rate can be expected in patients with severe liver cirrhosis.

How to use

DuoResp Spiromax is an inhalation-activated medication, which means the active ingredient enters the airway when the patient inhales it from the mouthpiece.

Patients with moderate to severe asthma are able to develop enough inspiratory flow to deliver a therapeutic dose of DuoResp Spiromax.

To ensure effective treatment, DuoResp Spiromax must be used correctly. Patients should therefore be advised to read the directions for use carefully and follow the instructions for medical use.

The use of DuoResp Spiromax involves three steps.

Open the cap of the mouthpiece by twisting it down until you hear a click and it opens.
Place the mouthpiece between your teeth and close your lips around it without biting the inhaler mouthpiece. Take a deep breath from the dispenser. Take the mouthpiece out of your mouth and hold your breath for 10 seconds or longer, as long as it is comfortable for the patient.
Gently exhale the air and close the lid of the pipette.

It is important not to shake the inhaler before using, not to exhale into the mouthpiece and not to hold your breath in preparation for inhalation.

After inhalation, you should rinse your mouth with water.

The patient may taste something different when using DuoResp Spiromax because of the excipient lactose.

Interaction
Interaction
The administration of 200 mg of ketoconazole once daily increases the plasma concentration of oral budesonide (single dose of 3 mg) when they are administered together, on average, by 6 times. When administered ketoconazole 12 hours after budesonide administration, the plasma concentration of the latter increased, on average, by 3 times. There is no information about such interaction with inhaled budesonide, but a marked increase in plasma concentrations of the drug 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 ketoconazole and budesonide should be maximized. Decreasing the dose of budesonide should also be considered. Other potent CYP3A4 inhibitors are also likely to significantly increase budesonide plasma concentrations.
The β₂-adrenergic receptor blockers may attenuate the effects of formoterol. The combination formoterol + budesonide should not be administered simultaneously with
β-adrenoblockers (including eye drops), except when necessary.
The co-administration 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 may decrease cardiac muscle tolerance to β₂-adrenomimetics.
The concomitant use of MAO inhibitors, as well as drugs with similar properties, such as furazolidone and procarbazine, may cause an increase in BP. There is an increased risk of arrhythmias in patients undergoing general anesthesia with preparations of halogenated hydrocarbons.
The simultaneous use of the combination formoterol + budesonide and other
β-adrenergic drugs may increase the side effect of formoterol.
The use of β₂-adrenomimetics may result in hypokalemia, which may be increased by concomitant treatment with xanthine derivatives, GCS or diuretics. Hypokalemia may increase the predisposition to develop arrhythmias in patients taking cardiac glycosides.
No interactions of budesonide and formoterol with other medications used to treat bronchial asthma have been noted.

Special Instructions
Special Instructions
Dosing instructions
If the symptoms of bronchial asthma can be controlled, the dose of DuoResp Spiromax may be gradually reduced. The lowest effective dose of DuoResp Spiromax should be given (see section “Dosage and administration”).
Patients are advised to keep emergency medications or DuoResp Spiromax (for patients with bronchial asthma using DuoResp Spiromax to manage attacks/symptoms with anti-inflammatory effects – therapy A or B) or short-acting beta2-adrenomimetics (for all patients using DuoResp Spiromax for maintenance therapy only – therapy C) on hand at all times.
When using DuoResp Spiromax as maintenance therapy, patients should be advised to take regular maintenance doses of the drug according to the therapy chosen, even in cases without symptoms.
Patients should be instructed to rinse their mouth with water after inhaling maintenance doses to prevent the risk of oral candidiasis and pharyngeal candidiasis. It is also necessary to rinse the mouth with water after inhalation on demand if oral and pharyngeal candidiasis develops.
It is recommended that the maintenance dose of the drug be gradually reduced before discontinuing treatment, and abrupt withdrawal of treatment is not recommended. Inhaled glucocorticosteroids should not be completely withdrawn unless temporary withdrawal is necessary to confirm the diagnosis of bronchial asthma.
Enhancement of symptoms
An exacerbation and development of serious adverse events associated with bronchial asthma may occur during therapy with DuoResp Spiromax. Patients should continue treatment, but should seek medical attention if bronchial asthma symptoms are not controlled or if their condition worsens after starting therapy.
If therapy is not effective enough or the maximum recommended doses of DuoResp Spiromax are exceeded, the therapy should be reconsidered. Unexpected and progressive worsening of bronchial asthma or COPD symptom control is a potentially life-threatening condition and requires urgent medical intervention. In this situation, consideration should be given to increasing the dose of glucocorticosteroids, such as prescribing a course of oral glucocorticosteroids, or antibiotic treatment if infection has set in. In severe exacerbations, monotherapy with a combination inhaled glucocorticosteroid and a long-acting beta2-adrenomimetic is insufficient.
Transfer from oral therapy
. If there is reason to believe that adrenal function has been impaired on prior 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 glucocorticosteroids, but patients who discontinue oral glucocorticosteroid therapy may have long-term impaired adrenal function. Patients who in the past have required urgent high-dose glucocorticosteroids or have received long-term treatment with high-dose inhaled glucocorticosteroids may also be at risk. Additional glucocorticosteroids should be considered in times of stress or surgery.
Associates
DuoResp Spiromax contains lactose (< 1 mg/inhalation). Usually this amount does not cause problems in patients with lactose intolerance.
Cautions for Certain Conditions
Precaution should be taken when treating patients with a prolonged QTc interval. Taking formoterol may cause prolongation of the QTc interval.
In co-administration of beta2-adrenomimetics with drugs that may cause or exacerbate hypokalemic effects, such as xanthine derivatives, steroids, or diuretics, the hypokalemic effects of beta2-adrenomimetics may be enhanced. Special precautions should be observed in patients with unstable bronchial asthma who use short-acting bronchodilators to relieve attacks, in exacerbation of severe bronchial asthma, because the risk of hypokalemia increases against hypoxia and in other conditions, when the probability of hypokalemic effect increases. In such cases it is recommended to monitor serum potassium content.
The blood glucose concentration in patients with diabetes mellitus should be monitored during treatment.
The necessity of use and dose of inhaled glucocorticosteroid should be reconsidered in patients with active or inactive pulmonary tuberculosis, fungal, viral or bacterial respiratory infections.
Systemic action
Systemic action may occur with any inhaled glucocorticosteroid, especially when high doses are taken over an extended period of time. Systemic effects are less likely to occur with inhaled therapy than with oral glucocorticosteroids. Possible systemic effects include suppression of adrenal function, growth retardation in children and adolescents, decreased bone mineral density, cataracts and glaucoma.
Because of the potential effect of inhaled glucocorticosteroids on bone mineral density, special attention should be paid to patients taking high doses of the drug over a long period of time with risk factors for osteoporosis. Studies of long-term use of inhaled budesonide in children at an average daily dose of 400 mcg (measured dose) or in adults at a daily dose of 800 mcg (measured dose) showed no marked effect on bone mineral density. There are 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 immediate increased wheezing after taking a dose of the drug. Therefore, DuoResp Spiromax should be discontinued, the therapy should be reconsidered, and alternative therapy should be prescribed if necessary.
Population of patients with COPD
Data from clinical studies of DuoResp Spiromax in patients with COPD with prebronchodilatation OEF₁ > 50% of proper and with postbronchodilatation OEF₁ < 70% of proper are not available (see Pharmacodynamics section).
Clinical studies and meta-analyses have shown that the use of inhaled glucocorticosteroids in COPD can lead to an increased risk of pneumonia. However, the absolute risk with budesonide is small. A meta-analysis of 11 double-blind studies involving 10570 patients with COPD showed no statistically significant increase in the risk of pneumonia in patients receiving budesonide (including in combination with formoterol) compared to patients receiving therapy without budesonide (placebo or formoterol). The incidence of serious adverse event pneumonia was 1.9% per year for therapy including budesonide and 1.5% per year for therapy without budesonide. The pooled risk ratio when comparing therapy including budesonide with therapy without budesonide was 1.15 (95% confidence interval (CI:) 0,83, 1,57). The pooled risk ratio when comparing budesonide/formoterol to formoterol or placebo was 1.00 (95% CI: 0.69, 1.44). There was no causal relationship of pneumonia with the use of budesonide-containing drugs.
Influence on driving and operating ability
DuoResp Spiromax may affect driving and operating ability with adverse events; therefore, caution should be exercised when driving vehicles and operating machinery.

Synopsis
Synopsis
White or almost white powder without visible lumps or inclusions placed in a multi-dose powder inhaler with a translucent red mouthpiece cap. The inhaler should be without visible damage or leakage of powder. The dispensing indicator window should show #120 for the 160/4.5 µg/dose and #60 for the 320/9 µg/dose.

Contraindications
Contraindications
High sensitivity 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 respiratory infections, thyrotoxicosis, pheochromocytoma, diabetes mellitus, decreased adrenal cortex function, uncontrolled hypokalemia, hypertrophic obstructive cardiomyopathy, idiopathic hypertrophic subaortic stenosis, Severe arterial hypertension, aneurysm of any localization, or other severe cardiovascular disease (coronary artery disease, tachyarrhythmia, or severe heart failure), QT interval prolongation (formoterol administration may cause QT interval prolongation).

Side effects
Side effects
There was no increase in the incidence of adverse reactions when the two drugs were coadministered. The most frequent adverse reactions associated with taking the drug are such pharmacologically expected for
β₂-adrenomimetic adverse events such as tremor and palpitations. The symptoms are usually of moderate severity and disappear within a few days of starting treatment. During a 3-year clinical trial of budesonide use in COPD, skin bruising and pneumonia occurred at a rate of 10% and 6%, respectively, whereas in the placebo group the rates were 4% and 3% (p< 0.001 and p< 0.01, respectively).
The frequency is defined as follows: very frequent (≥1/10), frequent (≥1/100, < 1/10), infrequent (≥1/1000, < 1/100), rare (≥1/10000, < 1/1000), very rare (< 1/10000) and frequency unknown (cannot be estimated from available data).
Perhaps more often.
.Class of organ systems
Frequency
Side effects
/strong>
Immune system disorders
Rarely
width=”50%”>
Immediate and delayed-type hypersensitivity reactions (exanthema, urticaria, pruritus, angioedema dermatitis and anaphylactic reaction)
Endocrine system disorders
Very rare
Cushing’s syndrome, adrenal suppression, growth retardation, decreased bone mineral density
/p>
Metabolic and nutritional disorders
Rarely
/p>
Hypokalemia
Very rarely
Hyperglycemia, signs or symptoms of systemic glucocorticosteroid
effects (including adrenal hypofunction)
/p>
Mental disorders
Infrequent
Aggression, psychomotor agitation, anxiety, sleep disturbances
Very rare
Depression, behavioral disorders
Nervous system disorders
Often
Headache, tremor
Infrequent
Dizziness
Very rare
Taste disorders
Visual disturbances
Infrequent
Visual impairment
Very rare
cataracts and glaucoma
Periodic visual impairment/p>
Frequency unknown
/td>
Central serous neuropathy
Cardiac disturbances
./p>
Often
Heart palpitations
Infrequent
Tachycardia
Rarely
Arrhythmia (e.g., atrial fibrillation, supraventricular tachycardia, extrasystole)
Very rare
Stenocardia, prolonged QT interval
Vascular disorders
Very rare
Variations in blood pressure (BP)
Respiratory system, thoracic and mediastinal organ disorders
Respiratory system, chest and mediastinal organ disorders/p>
Often
Oral and pharyngeal mucosa candidiasis, pharyngeal irritation, cough, hoarseness, pneumonia (in patients with COPD)*
Rarely
Bronchospasm
Very rarely
Paradoxical bronchospasm
Gastrointestinal disorders
Infrequent
/p>
Nausea
Skin and subcutaneous tissue disorders
Infrequent
Bleeding
Musculoskeletal and connective tissue disorders
Infrequent
Muscle cramps
* against the background of treatment with inhaled corticosteroids in patients with COPD.
Systemic effects of inhaled GCSs may occur when high doses are taken over an extended period of time. Use of β_2-adrenomimetics may increase blood levels of insulin, free fatty acids, glycerol and ketone derivatives.

Overdose
Overdose
Symptoms of formoterol overdose: tremor, headache, palpitations. In some cases tachycardia, hyperglycemia, hypokalemia, prolongation of the QT interval, arrhythmia, nausea and vomiting have been reported.
In acute overdose of budesonide, even in significant doses, no clinically significant effects are expected. In chronic overdose, systemic GCS effects such as hypercorticism and suppression of adrenal function may occur.
If DuoResp Spiromax needs to be discontinued because of an overdose of formoterol in the combination product, an inhaled GKS should be considered.
Treatment: supportive and symptomatic.

Pregnancy use
Pregnancy use
Pregnancy
There are no clinical data on the use of DuoResp Spiromax or the combined use of formoterol and budesonide during pregnancy.
In pregnancy, DuoResp Spiromax should only be used when the benefits of the drug outweigh the potential risk to the fetus. The lowest effective dose of budesonide necessary to maintain adequate control of bronchial asthma symptoms should be used.
Breastfeeding
Inhaled budesonide is excreted with breast milk, but no effect on the baby has been noted when used in therapeutic doses. It is not known whether formoterol penetrates into the breast milk of women. DuoResp Spiromax may be prescribed to breastfeeding women only if the expected benefit to the mother is greater than any possible risk to the baby.
Fertility
There are no data on effects on fertility.

Similarities
Similarities
Simbicort Turbuhaler, Formisonide-Nativ, Simbicort Rapihaler

Additional information
Weight 0.077 kg
Shelf life
3 years. Shelf life of the drug after opening the foil wrapper is 6 months. Do not use after the expiration date.
Conditions of storage
Store at a temperature not exceeding 25 °C. Keep out of the reach of children.
Manufacturer
Norton (Waterford) Limited, Ireland
Medication form
metered inhalation powder
Brand
Norton (Waterford) Limited