DuoResp Spiromax
DuoResp Spiromax: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Duoresp spiromax
ATX code: R03AK07
Active ingredient: Budesonid (Budesonide), Formoterol (Formoterol)
Manufacturer: Teva Pharmaceutical Industries Ltd. (Israel)
Description and photo update: 18.10.2018
Prices in pharmacies: from 1460 rubles.
Buy
DuoResp Spiromax is a combined preparation with bronchodilating, glucocorticoid, beta2-adrenomimetic action.
Release form and composition
The dosage form of DuoResp Spiromax is a dosed powder for inhalation: almost white or white, without visible inclusions / lumps; placed in a multi-dose powder inhaler with a red translucent mouthpiece cover; the inhaler should not have visible damage; the dosing indicator window for 160 / 4.5 μg / dose should show N 120, 320/9 μg / dose - N 60 (in plastic inhalers, placed in foil, in a cardboard box, 1 or 3 inhalers).
Active substances in 1 delivered dose:
- micronized budesonide - 0.16 or 0.32 mg;
- micronized formoterol fumarate dihydrate - 0.0045 or 0.009 mg.
Auxiliary component: lactose monohydrate - 5 or 10 mg (approximately).
Pharmacological properties
Pharmacodynamics
DuoResp Spiromax is a combined bronchodilator drug. Its active components - formoterol and budesonide - have different mechanisms of action and exhibit an additive effect in terms of reducing the frequency of exacerbations of bronchial asthma and COPD (chronic obstructive pulmonary disease).
The special properties of the components allow their combined use for the relief of attacks and as a maintenance therapy, or as a maintenance therapy for bronchial asthma.
Properties of the active ingredients of DuoResp Spiromax:
- budesonide: is a glucocorticosteroid that, after inhalation, has a dose-dependent and rapid (usually within a few hours) anti-inflammatory effect on the respiratory tract, which helps to reduce the severity of symptoms and the frequency of exacerbations of bronchial asthma. With inhalation use, there is a decrease in the incidence of serious adverse effects more than when using drugs with a systemic effect. Reduces the production of mucus, the severity of edema of the bronchial mucosa, hyperreactivity and the formation of sputum in the respiratory tract. The exact mechanism of the anti-inflammatory action of budesonide is unknown;
- formoterol: is a selective β2-adrenergic receptor agonist. After inhalation, it causes prolonged and rapid relaxation of the smooth muscles of the bronchi in patients with reversible airway obstruction. The dose-dependent bronchodilator effect develops rapidly (usually from 1 to 3 minutes after application) and persists for at least 12 hours after taking a single dose.
DuoResp Spiromax in the treatment of bronchial asthma can reduce the severity of symptoms of the disease, reduce the frequency of its exacerbations and improve bronchial function. The drug is well tolerated.
In severe COPD, while taking DuoResp Spiromax, there is a significant decrease in the frequency of exacerbations of the disease.
Pharmacokinetics
- absorption: DuoResp Spiromax is bioequivalent to the corresponding monopreparations with regard to the systemic action of formoterol and budesonide. However, after using the drug, there was a slight increase in cortisol suppression in comparison with monopreparations (it does not affect clinical safety). When used as part of a combined preparation, AUC of budesonide is slightly higher, the value of C max in the blood plasma of the drug is higher and absorption is faster. For formoterol, when administered as part of DuoResp Spiromax, C max in blood plasma is the same as for the monopreparation. Inhaled budesonide is quickly absorbed and reaches C max 30 minutes after inhalationin plasma. The average dose of budesonide that has entered the lungs varies from 32% to 44% of the delivered dose, systemic bioavailability is approximately 49%. Inhaled formoterol is rapidly absorbed and within 10 minutes after inhalation reaches C max in blood plasma. The average dose of formoterol that has entered the lungs is from 28% to 49% of the delivered dose, systemic bioavailability is about 61%;
- distribution: binding to plasma proteins of budesonide is 90%, formoterol - 50%. V d budesonide is about 3 l / kg, formoterol - 4 l / kg;
- metabolism and excretion: about 90% of budesonide undergoes intensive biotransformation during the "first pass" through the liver with the formation of metabolites that have low glucocorticoid activity. The glucocorticoid activity of the main metabolites 16-α-hydroxyprednisolone and 6-β-hydroxybudesonide does not exceed 1% of the similar activity of budesonide. Formoterol is inactivated by conjugation to form active O-demethylated metabolites, mainly as inactivated conjugates. There is no evidence of the interaction of metabolites or the substitution reaction between formoterol and budesonide. Budesonide is predominantly metabolized with the participation of the CYP3A4 enzyme. Its metabolites unchanged or as conjugates are excreted in the urine. Unchanged budesonide is found in urine only in small amounts. The systemic clearance of budesonide is high (approximately 1.2 L / min). Formoterol is mainly metabolized in the liver, after which it is excreted by the kidneys. 8-13% of the delivered dose of formoterol is excreted unchanged in the urine after inhalation. Systemic clearance of formoterol is high (approximately 1.4 L / min). The half-life is on average 17 hours.
In patients with liver disease, the plasma concentration of the active components of DuoResp Spiromax in the blood may increase.
Indications for use
- bronchial asthma, which does not lend itself to sufficient control by taking inhaled GCS and short-acting beta2-adrenostimulants, or is adequately controlled by inhaled GCS and long-acting beta2-adrenostimulants;
- COPD - for symptomatic treatment in severe disease (FEV1 <50% of the estimated estimated level) and the presence of recurrent exacerbations in the history that have severe symptoms of the disease, despite the use of long-acting bronchodilators.
Contraindications
Absolute:
- age up to 18 years;
- individual intolerance to the components of the drug, as well as inhaled lactose.
Relative (diseases / conditions in which the use of DuoResp Spiromax requires caution):
- lactose intolerance, glucose-galactose malabsorption or lactase deficiency;
- arterial hypertension in severe course;
- aneurysm of any localization or other cardiovascular diseases in severe course (tachyarrhythmia, ischemic heart disease or severe heart failure);
- pulmonary tuberculosis in active / inactive form;
- uncontrolled hypokalemia;
- respiratory infections of fungal, viral or bacterial etiology;
- pheochromocytoma;
- thyrotoxicosis;
- diabetes;
- prolongation of the QT interval (associated with the likelihood of developing a prolongation of the QT interval c when using formoterol);
- idiopathic hypertrophic subaortic stenosis;
- the period of pregnancy and breastfeeding.
Instructions for the use of DuoResp Spiromax: method and dosage
DuoResp Spiromax is an inhalation-activated drug, which means the entry of active ingredients into the respiratory tract when the patient inhales it from the mouthpiece.
In moderate to severe asthma, patients are able to develop a sufficient inspiratory flow rate to deliver a therapeutic dose of the drug.
Before use, open the lid of the mouthpiece (turn it down until you hear a click and it opens). Then place the mouthpiece between your teeth, closing your lips around it. Do not bite the mouthpiece. After that, you need to take a deep breath from the dispenser. After removing the mouthpiece from the mouth, you need to hold your breath for 10 seconds or longer (as far as the patient is comfortable). Then you should carefully exhale the air.
Do not shake the inhaler before use. Also, do not exhale into the mouthpiece and hold your breath while preparing to inhale.
After inhalation, the mouth should be rinsed with water.
When using DuoResp Spiromax, a sensation of a specific taste is possible (associated with an auxiliary component - lactose).
Bronchial asthma
DuoResp Spiromax is not intended for the initial therapy of bronchial asthma of intermittent and mild persistent course.
The dose should be selected individually based on the severity of the course of the disease (it is important to take into account not only at the beginning of therapy, but also when adjusting the maintenance dose). If the use of doses other than that of DuoResp Spiromax is indicated, it is necessary to use the active ingredients in separate inhalers.
To control the optimal dose of the drug, patients need to regularly visit a doctor. The dose should be the lowest dose that maintains optimal control of disease symptoms. After achieving optimal control when using the drug 2 times a day, it is recommended to titrate the dose to the minimum effective, up to the use of DuoResp Spiromax 1 time a day, in cases where the patient needs maintenance therapy in combination with a long-acting bronchodilator.
160 / 4.5 mcg / dose - maintenance therapy
DuoResp Spiromax is prescribed 2 times a day for 1-2 inhalations. If necessary, a single dose can be increased to 4 inhalations. In order to relieve seizures, the patient must always carry a separate inhaler with a short-acting beta2-adrenostimulator. An increase in the frequency of its use is an indicator of a deterioration in overall control over the disease (a revision of anti-asthma therapy is required).
160 / 4.5 mcg / dose - maintenance therapy and relief of seizures
DuoResp Spiromax can be prescribed as continuous maintenance therapy or as on-demand therapy in cases of seizures. The drug is especially indicated in case of insufficient control over the disease and the need for frequent use of drugs to stop seizures, as well as with a burdened history of exacerbations of bronchial asthma, which required medical intervention.
When using a large number of inhalations for the relief of attacks, the patient's condition must be carefully monitored, taking into account the likelihood of dose-dependent adverse reactions.
The recommended scheme for using DuoResp Spiromax: 1 time a day (morning or evening), 2 inhalations, or 1 inhalations in the morning and in the evening. In some cases, a maintenance dose may be prescribed - 2 times a day, 2 inhalations. When symptoms develop, 1 additional inhalation is required. If a further increase in symptoms is observed within a few minutes, another 1 additional inhalation may be required (maximum 6 inhalations to stop 1 attack).
The average daily dose is 8 inhalations, sometimes for a short time it can be increased to 12 inhalations (therapy may need to be revised).
320/9 mcg / dose
DuoResp Spiromax is prescribed 2 times a day for 1 inhalation, in some cases a single dose can be increased to 2 inhalations. After achieving optimal control of symptoms, the dose may be reduced to the lowest effective dose, up to once a day.
COPD
The recommended single dose of DuoResp Spiromax (frequency of application - 2 times a day):
- 160 / 4.5 mcg / dose: 2 inhalations;
- 320/9 mcg / dose: 1 inhalation.
Side effects
An increase in the incidence of side effects associated with the combined use of budesonide and fenoterol is not observed.
The most common disorders include the pharmacologically expected side effects of beta2-agonists, including heart palpitations and tremors. Symptoms are usually mild and subside within a few days of starting treatment.
Possible violations (> 10% - very often;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01% - very rare):
- respiratory system: often - hoarseness, candidiasis of the mucous membrane of the pharynx and mouth, cough, throat irritation; rarely - bronchospasm; very rarely - paradoxical bronchospasm;
- cardiovascular system: often - palpitations; infrequently - tachycardia; rarely - arrhythmia, including atrial fibrillation, extrasystole, supraventricular tachycardia; very rarely - lengthening of the QT interval, angina pectoris, fluctuations in blood pressure;
- musculoskeletal system: infrequently - muscle cramps;
- digestive system: infrequently - nausea;
- immune system: rarely - hypersensitivity reactions of delayed / immediate type, including exanthema, urticaria, pruritus, anaphylactic reactions, dermatitis, angioedema;
- endocrine system: very rarely - Cushing's syndrome, growth retardation, adrenal suppression, decreased bone mineral density;
- nervous system: often - tremor, headache; infrequently - dizziness; very rarely - taste disturbance;
- organ of vision: very rarely - glaucoma, cataract;
- psyche: infrequently - sleep disturbances, psychomotor agitation, agitation, anxiety; very rarely - behavioral disorders, depression;
- skin / subcutaneous tissue: infrequently - bruising;
- metabolism: rarely - hypokalemia; very rarely - signs of systemic glucocorticoid effects, including adrenal hypofunction, hypoglycemia.
Long-term use of high doses of inhaled corticosteroids can lead to systemic effects, the use of beta2-adrenostimulants - to an increase in the blood content of free fatty acids, insulin, ketone derivatives and glycerol.
Overdose
The main symptoms are:
- formoterol: heart palpitations, headache, tremors; in some cases - tachycardia, hyperglycemia, hypokalemia, lengthening the interval QT c, arrhythmia, nausea and vomiting;
- budesonide: acute overdose - clinically significant effects are not expected; chronic use of excessive doses - the systemic action of GCS in the form of hypercortisolism and suppression of adrenal function.
In cases of overdose, symptomatic / supportive treatment should be carried out. If DuoResp Spiromax is canceled due to an overdose of formoterol, the issue of prescribing an appropriate GCS is usually considered.
For acute bronchial obstruction, the use of formoterol at a dose of 90 mcg for 3 hours is safe.
special instructions
Cancellation of DuoResp Spiromax should be carried out with a gradual dose reduction. Abrupt withdrawal of therapy is not recommended.
For the initial selection of treatment at the first stages of bronchial asthma therapy, the drug is not used.
The use of formoterol can lead to prolongation of the QT interval.
An increase in the frequency of use of bronchodilators as emergency drugs is a sign of a worsening course of the underlying disease and a basis for revising treatment tactics. Progressive / unexpected deterioration in the control of symptoms of bronchial asthma or COPD refers to conditions that are potentially life-threatening in nature, requiring urgent medical attention. In such situations, it is necessary to consider the likelihood of increasing the dose of GCS or adding systemic anti-inflammatory therapy, for example, antibiotic treatment in case of infection or a course of oral GCS.
According to the instructions, DuoResp Spiromax should be used regularly even in the absence of symptoms.
It is not recommended to start therapy during an exacerbation or with a significant deterioration in the course of bronchial asthma.
The systemic effect can manifest itself when taking any inhaled corticosteroids, especially with prolonged use of high doses. The development of a systemic effect during inhalation therapy is less likely than when using oral corticosteroids. Possible systemic effects are suppression of adrenal function, a decrease in bone mineral density, glaucoma and cataracts.
Due to the potential effect on bone mineral density, special attention should be paid to patients taking long-term high doses of the drug with the presence of risk factors for osteoporosis.
As with any other inhalation treatment, paradoxical bronchospasm may develop with an immediate increase in wheezing after the dose is applied (it may be necessary to cancel DuoResp Spiromax, revise therapy tactics and, if necessary, prescribe alternative treatment).
Rinsing the mouth with water after inhalation is a preventive measure for the occurrence of candidiasis of the oral mucosa.
If there is reason to believe that, against the background of previous systemic therapy with GCS, there were functional disorders of the adrenal glands, when transferring patients to treatment with DuoResp Spiromax, precautions should be taken.
Patients who in the past received long-term treatment with high doses of inhaled corticosteroids, or needed urgent intake of high doses of corticosteroids, can also be attributed to this risk group. During periods of stress or surgical intervention, it is necessary to provide for the additional appointment of GCS.
Precautions must be taken when treating patients with extended intervals QT c (formoterol can cause QT interval elongation c).
Special precautions should be taken in patients with unstable bronchial asthma who use short-acting bronchodilators to relieve attacks in cases of exacerbation of severe bronchial asthma, since the likelihood of hypokalemia increases against the background of hypoxia and in other conditions in which there is an increase in the risk of hypokalemic effect. In these cases, it is recommended to monitor serum potassium.
With diabetes mellitus during the period of therapy, it is necessary to control the concentration of glucose in the blood.
Influence on the ability to drive vehicles and complex mechanisms
Due to the likelihood of adverse reactions, care must be taken when driving.
Application during pregnancy and lactation
Features of the use of DuoResp Spiromax in pregnant and lactating women have not been studied.
During pregnancy and breastfeeding, the use of the drug is possible only in cases where the expected benefit outweighs the possible harm. The drug can be prescribed in the minimum effective dose, which is necessary to maintain adequate control of the symptoms of bronchial asthma.
Pediatric use
For pediatric patients (under 18 years of age), DuoResp Spiromax is contraindicated.
With impaired renal function
The safety profile in patients with renal impairment has not been studied. The active components of DuoResp Spiromax are excreted mainly by the kidneys, with the participation of hepatic metabolism, therefore, in severe liver cirrhosis, a slowdown in the rate of its excretion can be expected.
For violations of liver function
The safety profile in patients with hepatic impairment has not been studied. The active components of DuoResp Spiromax are excreted mainly by the kidneys, with the participation of hepatic metabolism, therefore, in severe liver cirrhosis, a slowdown in the rate of its excretion can be expected.
Drug interactions
With the combined use of DuoResp Spiromax with certain drugs / substances, the following effects may develop:
- general anesthesia with halogenated hydrocarbon preparations: increased risk of arrhythmias;
- ketoconazole (at a dose of 200 mg once a day) and other potent inhibitors of CYP3A4: a significant increase in the plasma concentration of budesonide (combinations are recommended to be avoided; if combined use is necessary, the interval between their use should be maximized; a reduction in the dose of budesonide may also be required);
- quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), monoamine oxidase inhibitors, tricyclic antidepressants: prolongation of the QT interval and an increase in the likelihood of ventricular arrhythmias;
- formoterol: a decrease in the intensity of its action (the combination is not recommended, except in forced cases);
- alcohol, levothyroxine, levodopa, oxytocin: decreased tolerance of the heart muscle to beta2-adrenergic agonists;
- monoamine oxidase inhibitors, as well as drugs with similar properties, including procarbazine and furazolidone: increased blood pressure;
- other beta-adrenergic drugs: increased side reactions of formoterol; hypokalemia is likely to develop, which may increase with concomitant therapy with xanthine derivatives, diuretics, or GCS; hypokalemia may increase the predisposition to arrhythmias in patients taking cardiac glycosides.
When using DuoResp Spiromax with other drugs used for the treatment of bronchial asthma, the development of interaction is not observed.
Analogs
The analogue of DuoResp Spiromax is Symbicort Turbuhaler.
Terms and conditions of storage
Store at temperatures up to 25 ° C. Keep out of the reach of children.
Shelf life is 2 years.
After the foil wrapper has been opened, DuoResp Spiromax can be used for 6 months.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about DuoResp Spiromax
Reviews of DuoResp Spiromax are few, since the drug has been registered relatively recently.
Price for DuoResp Spiromax in pharmacies
The price for DuoResp Spiromax 160 / 4.5 mcg / dose (120 doses) varies from 1840 to 2125 rubles; 320/9 mcg / dose (60 doses) is approximately 1,790 rubles.
DuoResp Spiromax: prices in online pharmacies
|
Drug name Price Pharmacy |
|
DuoResp Spiromax 320 mcg + 9 mcg / dose 60 doses powder for inhalation metered 1 pc. 1460 RUB Buy |
|
DuoResp Spiromax 160 mcg + 4.5 mcg / dose 120 doses powder for inhalation dosed 1 pc. RUB 1,500 Buy |
|
Duoresp Spiromax powder for inhalation. dosage. 160 / 4.5 mcg / dose 120 doses 1581 RUB Buy |
|
Duoresp Spiromax powder for in ha l. to zir. 320/9 μg / dose 60 doses 1783 RUB Buy |
|
DuoResp Spiromax 160 mcg + 4.5 mcg / dose 120 doses powder for inhalation dosed 3 pcs. 3787 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
