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Pulmicort or Symbicort, which is better? Combined inhaled drugs are a new approach to the treatment of bronchial asthma. Combined use of Pulmicort with Berdual

An attack of bronchial asthma is a condition requiring emergency medical care. As a rule, patients suffering from this disease have in their arsenal means to relieve an attack. However, a more serious pathology is the development of croup or infection-mediated inflammatory process of the upper respiratory tract in children. Due to the peculiarities of the anatomical structure and functioning, the friability of the submucosal layer and rich vascularization, during the inflammatory process, swelling of the submucosal layer develops, blocking the child’s airways. Developed laryngospasm is a condition requiring emergency medical care. Pulmicort is a drug used to reduce swelling and ease breathing in this group of patients. Let's look not only at the drug itself, but also at an analogue of Pulmicort for inhalation.

Pharmacological characteristics

"Pulmicort" is the trade name of a drug with the main active ingredient called budesonide. This is a glucocorticosteroid agent that exhibits a pronounced anti-inflammatory effect when applied topically.

Due to inhalation, budesonide penetrates both the initial and more distant areas, helping to reduce swelling of the submucosal layer. When applied topically, budesonide does not have a systemic effect, which significantly reduces the frequency and severity of adverse reactions.

Indications for use

"Pulmicort" is used for a category of patients for whom the use of spraying the drug with compressed air or as a powder is unacceptable.

In addition, Pulmicort is used to relieve croup in childhood (starting from 6 months) with further hospitalization in a medical institution.

Mode of application

Considering that Pulmicort is a suspension for inhalation, the drug is administered using nebulizers, and the final effective dose that produces the effect may vary depending on the device used.

In the case when an analogue of Pulmicort is used for inhalation in the form of a special inhaler, an effective dose for children can be provided by injecting two or three doses of the drug into an inhalation mask. The latter can be made from a plastic bottle by cutting it off from one edge. The resulting edge must be sealed with adhesive tape and cotton wool, and the inhaler must be inserted into the second edge. Thus, without using Pulmicort, analogues for children can be inhaled by small children through such a mask.

Side effects

The drug "Pulmicort", despite its local effect, can have a resorptive effect and cause side effects characteristic of glucocorticosteroids. Of course, the frequency and severity of these effects with inhalation use is much less than with systemic use. Among such systemic effects, one can note a delay in the growth and development of children, a decrease in bone density and its mineralization. In addition, clouding of the lens, decreased visual acuity and increased intraocular pressure are likely.

Randomized studies indicate that Pulmicort causes hoarseness or cough with irritation of the throat mucosa with a high frequency.

Due to the immunosuppressive effect and deposition of the drug on the surface of the oropharyngeal mucosa, the development of candidiasis is noted. For preventive purposes, it is necessary to rinse the mouth after each inhalation.

With a much lower frequency, Pulmicort can cause disorders of the nervous system, which are manifested by nervousness, anxiety, depressive and behavioral disorders.

Allergic reactions are rare and manifest as skin rashes and dermatitis. Very rarely, angioedema and shock may occur.

Contraindications

The use of the drug is contraindicated in case of hypersensitivity or the occurrence of paradoxical bronchospasm. Pulmicort is not recommended for use as an inhalation agent in patients with open form of pulmonary tuberculosis or fungal infections of the respiratory tract.

"Pulmicort" - analogues for children

Today, a large number of analogues of the drug “Pulmicort” are presented on the pharmaceutical market. Among them we can note: “Apulein”, “Benacap”, “Benacort”, “Benarin”, “Budesonide”, “Bunoster” and many other drugs that are the Russian analogue of “Pulmicort” and contain glucocorticoid hormones.

But what if you don’t want to use inhaled hormonal medications? You can use selective adrenergic agonists, which are analogues of (cheap) Pulmicort. Refusal from hormonal medications is often due to poor patient awareness of the drug or its high cost.

Among the non-hormonal drugs that are an analogue of Pulmicort for inhalation, we can recommend beta-adrenergic receptor agonists: Salbutomol, Ventlin. This group of drugs, due to the peculiarities of the mechanism of action, does not help relieve swelling, however, it helps to increase the lumen of the bronchial tree by expanding the smooth muscles of the bronchi.

As a combination drug that can be used as an analogue of Pulmicort for inhalation, we can recommend Seretide. This drug contains the beta-adrenergic receptor agonist salmeterol, as well as the inhaled glucocorticosteroid fluticasone propionate. The effectiveness of using this drug is achieved by expanding the lumen of the bronchial tree, as well as by providing a local anti-inflammatory effect on the bronchial tree. It is worth saying that Seretide is not a liquid for inhalation, it is a powder with a special inhaler. This requires careful attention to the procedure, however, this drug may well act as an analogue of Pulmicort for inhalation for a 4-year-old child.

Cost of "Pulmicort" and its analogues

Do you want to purchase medicines in which the active ingredient is budesonide - “Pulmicort”, analogues? The price of the original drug is about 1000 rubles for 20 doses of 2 ml containing 0.25 mg/ml budesonide, and about 1400 rubles for 20 similar doses containing 0.5 mg/ml budesonide.

The price of medicines that have a different mechanism of action can vary significantly. For example, an inhalation aerosol “Salbutamol” will cost only 95-100 rubles, and the combined “Seretide” in the form of an inhalation aerosol will cost a little more than 2000 rubles.

Conclusion

With the help of the above medications, relieving an attack of bronchial asthma or croup in children at home becomes not such a difficult procedure. It is important to remember that croup is a direct indication for hospitalization in a medical facility.

If after two or three inhalations of medications the baby does not breathe easier, be sure to call an ambulance and inform your doctor. And lastly, if it is not possible to purchase a nebulizer, or it simply was not at hand at the right time, buy analogs (cheap) of Pulmicort.


For quotation: Avdeev S.N. Combined inhalation drugs - a new approach to the treatment of bronchial asthma // Breast Cancer. 2001. No. 21. S. 940

Research Institute of Pulmonology, Ministry of Health of the Russian Federation

IN It has now been proven that the most effective drugs for controlling bronchial asthma (BA) are inhaled glucocorticosteroids (ICS). ICS at recommended doses are well tolerated and considered safe. ICS are prescribed in cases where the need for b 2 -agonists to control symptoms in a patient with asthma is more than 3 times a week (Barnes & Godfrey, 1988). According to the recommendations of international consensus documents (GINA), ICS are indicated for all patients with persistent BA, including those with mild disease (NIH/NHLBI, 1998). Arguments for the early use of inhaled corticosteroids in asthma are: 1) inflammation of the respiratory tract mucosa is present even in the earliest stages of asthma; 2) ICS are the most effective anti-inflammatory drugs for asthma compared to other known drugs; 3) withdrawal of ICS in patients with mild asthma can lead to exacerbation of the disease; 4) ICS prevent the progressive decline in pulmonary functional parameters that occurs in patients with asthma over time (O'Byrne, 1999).

Often, when asthma is not controlled by the prescribed doses of ICS, the question arises: should the dose of ICS be increased or another drug added? From the point of view of ensuring a safe profile of the therapy used, selecting the lowest possible effective doses of ICS in combination with another drug is the most reasonable approach to control asthma.

Prerequisites for the use of combination drugs

Long-acting b 2 -agonists are currently considered the most effective drugs for combination with ICS (Barnes P.J., 2001). The scientific rationale for this combination stems from the complementary effects of ICS and b 2 -agonists. Steroids increase b 2 -receptor gene expression and reduce the potential for development of receptor desensitization, while b 2 -agonists activate inactive glucocorticoid receptors, making them more susceptible to steroid-dependent activation (Roth et al., 2001). In addition, a possible explanation for the greater effectiveness of combination therapy with ICS and long-acting b2-agonists compared to increasing doses of ICS may be the inhibitory effect of b2-agonists on stimulators of bronchial smooth muscle contraction, on the leakage of plasma into the airway lumen, and on the influx of inflammatory cells into the airways. the time of exacerbation of asthma, as well as an increase in the deposition of ICS in the respiratory tract due to their expansion after inhalation of b 2 agonists (Pauwels et al., 1997).

Other, even more compelling arguments in favor of the combined use of ICS with long-acting b 2 -agonists are the positive results of clinical studies that have proven the greater effectiveness of the drug combination compared to increased doses of ICS. Combinations of beclomethasone and salmeterol, fluticasone and salmeterol (Shrewsbury et al., 2000), and budesonide and formoterol (Pauwels et al., 1997) have been shown to be highly effective.

In a large multicenter study, FACET, which included 852 patients with asthma, the effectiveness of a combination of formoterol and budesonide and double doses of budesonide was compared for 1 year. All patients were divided into 4 groups: 1) budesonide at a dose of 400 mcg/day; 2) budesonide at a dose of 400 mcg/day plus formoterol 24 mcg/day; 3) budesonide at a dose of 800 mcg/day; 4) budesonide at a dose of 800 μg/day plus formoterol 24 μg/day (Pauwels et al., 1997). Patients taking the combination of drugs had greater improvements in daytime and nighttime symptoms, forced expiratory volume in 1 second (FEV 1) and peak expiratory flow (PEF) (Fig. 1). The number of severe and mild exacerbations of asthma was reduced when taking a high dose of budesonide by 49 and 37%, while taking low doses of budesonide and formoterol, by 26 and 40%, respectively, but the greatest reduction in exacerbations was observed in patients taking high doses of budesonide and formoterol (63 and 62%). Thus, the addition of formoterol to both high and low doses of budesonide provided better control of asthma compared with budesonide monotherapy. The FACET study also showed that combination therapy led to an improvement in the quality of life of patients (Juniper et al., 1999).

Rice. 1. Dynamics of FEV1 under various treatment regimens

Despite encouraging results from clinical trials, there was concern that the combination of low-dose ICS with long-acting b2-agonists had a lesser effect on inflammation compared with high-dose ICS, and better functional results were achieved due to the additive bronchodilation caused by b2-agonists. Direct evidence of the absence of “masking” of airway inflammation during combination therapy was recently confirmed by data from morphological studies. In a randomized controlled trial, Kips et al. a comparison was made of the effect of two treatment regimens on inflammatory markers of induced sputum in 60 patients with moderate asthma. Patients received either budesonide 800 mcg per day or budesonide 200 mcg per day plus formoterol 24 mg per day for 1 year. Both treatment regimens effectively reduced the number of eosinophils, EG2(+) cells, and eosinophil cationic protein levels; The groups of patients also did not differ significantly in the frequency of asthma exacerbations.

The high effectiveness of combination therapy with long-acting b 2 -agonists with ICS in asthma served as a prerequisite for the creation of combination drugs, an example of which is the drug Symbicort Turbuhaler (budesonide 160 mcg + formoterol 4.5 mcg).

Symbicort Turbuhaler

One of the main advantages of the drug Symbicort Turbuhaler is the ability to flexibly adapt the dose of the drug (number of doses and number of doses of the drug) depending on the severity of symptoms and the course of asthma. The initial dose of the drug to achieve asthma control is two inhalations (dose 160/4.5 mcg) twice a day (Shaw & Jackson, 2001). After improvement of asthma symptoms, it is possible to switch to one inhalation twice a day using the same inhaler or even to a single dose of the drug. If symptoms worsen, for example, during an acute respiratory viral infection, the dose of the drug can be increased again without the need to switch to a new drug.

A distinctive feature of the combination drug Symbicort Turbuhaler is the high rate of development of the therapeutic effect, which is certainly associated with the properties of formoterol (onset of action in 1-3 minutes). In addition, the properties of budesonide (good solubility in the aqueous phase) also provide a rapid effect: the effect on pulmonary functional parameters is manifested within 1 hour, and on inflammatory markers within 3-5 hours (Le Merre, 1997).

In a double-blind crossover study, Palmquist et al. compared the speed of onset of the bronchodilator effect of one and two inhalations of Symbicort Turbuhaler 160/4.5 mcg and one inhalation of Seretide Diskus 50/250 mcg in 13 patients with asthma during the first 3 hours after inhalation. The benefit of both doses of Symbicort was noticeable already 3 minutes after inhalation (FEV 1: 2.74 l, 2.75 l and 2.56 l, respectively, p<0,001) и сохранялось на протяжении 3 часов.

Aerosol delivery device

The effectiveness of inhalation therapy depends not only on the chemical structure of the drug, but also on the device for delivering the aerosol to the respiratory tract. An ideal delivery device should ensure the deposition of a large fraction of the drug in the lungs, be fairly easy to use, reliable and accessible for use at any age and in severe forms of the disease. Delivery of the drug to the respiratory tract depends on many factors, the most important of which is the particle size of the drug aerosol. For inhalation therapy, particles with sizes up to 5 microns - respirable particles - are of interest. The powder inhaler Turbuhaler is used as a delivery system for the budesonide/formoterol combination. This delivery system does not use a drug carrier, is easy to handle, and also has two new additions - a dose counter and a more convenient mouthpiece.

Turbuhaler is one of the most effective forms of powder inhalers, providing the highest drug deposition in the lungs - up to 32% of the metered dose (Edsbacker, 1999). However, the results reported were obtained with inhaled budesonide, while the fraction of the drug delivered to the respiratory tract depends more on the drug/delivery device combination than on the device itself. When prescribing doses of inhaled drugs, it is very important to take into account such an indicator as the variability of drug deposition; it should be minimal.

Research conducted in vitro, demonstrated that when using the Turbuhaler inhaler, the respirable dose of the budesonide/formoterol combination was within the limits of acceptable dose variability (Lindblad et al., 2000). Another bench study comparing the properties of the Symbicort Turbuhaler and Seretide Diskus inhalation systems found that the delivery of respirable particles by the Symbicort Turbuhaler system was up to 50% compared to 20% for the Seretide Diskus system (Granlund et al., 2000).

Comparative effectiveness

A recently published 12-week, double-blind, randomized controlled trial compared the efficacy of Symbicort Turbuhaler with a single-drug combination of budesonide (Pulmicort Turbuhaler) and formoterol (Oxis Turbuhaler) (Zetterstrom et al., 2001). The study included 362 patients with moderate asthma (average FEV 1 73.8%), in whom the course of the disease was not controlled by ICS monotherapy. Patients were randomized into 3 treatment groups: 1) Symbicort 160/4.5 mcg twice a day; 2) Pulmicort 200 mcg plus Oxis twice a day; 3) Pulmicort 200 mcg twice a day. In the Symbicort and Pulmicort plus Oxis combination treatment groups, there was a significant improvement in morning PEF compared with the Pulmicort monotherapy group: 35.7 l/min, 32.0 l/min and 0.20 l/min, respectively (p< 0,001) (рис. 2). В первых двух группах было также выявлено достоверное улучшение вечерних показателей ПСВ, снижение числа ингаляций b 2 -агонистов короткого действия. Терапия Симбикортом и комбинацией Пульмикорт плюс Оксис сопровождалась увеличением дней, свободных от симптомов заболевания в среднем на 15% по сравнению с Пульмикортом. Риск развития легких обострений БА также был достоверно ниже в первых двух группах (p<0,01), и время, в течение которого у больных не наблюдалось обострений БА, значительно удлинялось в группах комбинированной терапии (рис. 3). Следует отметить, что улучшение показателей ПСВ и достижение контроля БА достигались быстрее при терапии Симбикортом по сравнению с комбинацией Пульмикорт плюс Оксис, что является аргументом в пользу большей эффективности комбинированного препарата.

Rice. 2. Dynamics of PEF under various treatment regimens

Rice. 3. Number of patients without exacerbation of asthma under various treatment regimens

Can be used once a day

Despite the proven effectiveness of ICS in asthma, a significant problem is compliance, i.e. patient adherence to follow prescribed therapy. Only about 40% of all asthma patients conscientiously follow doctor's orders (Schmier & Leidy, 1998). The reasons for poor compliance with therapy are quite varied, one of them is too complex a drug regimen, so reducing the number of drug doses can improve compliance, and, consequently, the effectiveness of ICS therapy. Several studies have been conducted that compared the effectiveness of taking a daily dose of ICS once a day or in 2-4 doses; Most of these works are devoted to budesonide and its unique ability to bind to fatty acids inside the cell (Edsbacker, 1999). Conjugated budesonide does not bind to receptors, but remains inside the cell. Over time, under the influence of intracellular lipases, budesonide is slowly released and regains the ability to interact with receptors, thus providing a prolonged anti-inflammatory effect. The effectiveness of a single dose of budesonide has been shown in patients with mild to moderate asthma, both in those who have already taken ICS and in those who have not previously taken ICS (Shaw & Jackson, 1998; Campbell, 1999).

Despite the proven effectiveness of ICS in asthma, a significant problem is compliance, i.e. patient adherence to follow prescribed therapy. Only about 40% of all asthma patients conscientiously follow doctor's orders (Schmier & Leidy, 1998). The reasons for poor compliance with therapy are quite varied, one of them is too complex a drug regimen, so reducing the number of drug doses can improve compliance, and, consequently, the effectiveness of ICS therapy. Several studies have been conducted that compared the effectiveness of taking a daily dose of ICS once a day or in 2-4 doses; Most of these works are devoted to budesonide and its unique ability to bind to fatty acids inside the cell (Edsbacker, 1999). Conjugated budesonide does not bind to receptors, but remains inside the cell. Over time, under the influence of intracellular lipases, budesonide is slowly released and regains the ability to interact with receptors, thus providing a prolonged anti-inflammatory effect. The effectiveness of a single dose of budesonide has been shown in patients with mild to moderate asthma, both in those who have already taken ICS and in those who have not previously taken ICS (Shaw & Jackson, 1998; Campbell, 1999).

Considering the long-term effect of formoterol, the question arises about the possibility of a single use of a fixed combination of budesonide/formoterol in patients with asthma. The use of just one inhaler and only once a day has a very high chance of increasing patient compliance with therapy, and, consequently, its effectiveness.

At the 2001 annual Congress of the European Respiratory Society in Berlin, the first results of studies on the single use of Symbicort in patients with asthma were presented. In a double-blind randomized controlled study, Buhl et al., which included 523 patients with mild to moderate asthma, compared therapy with Symbicort 160/4.5 mcg once (in the evening) and Symbicort 160/4.5 mcg twice a day for 12 weeks. and budesonide 200 μg once (Buhl et al., 2001). A single use of Symbicort was not inferior in its effectiveness to a double dose, and was superior to budesonide therapy in such indicators as an increase in PEF, FEV 1, and the use of short-acting bronchodilators (p<0,05). Кроме того, однократный прием Симбикорта снижал риск развития легких обострений БА на 38% по сравнению с будесонидом (р=0,002), повышал число дней, свободных от симптомов БА (р=0,01). В другом, сходном по своему дизайнуисследовании, включавшем 616 больных БА легкого и среднетяжелого течения, были получены примерно такие же результаты: однократное использование Симбикорта по сравнению с будесонидом более эффективно контролировало такие показатели, как ПСВ и ОФВ 1 , число дней, свободных от симптомов БА и потребность в бронхолитиках короткого действия (Kuna et al., 2001). Таким образом, на основании результатов данных исследований можно сделать выводы о хорошей эффективности однократного использования Симбикорта при легкой и среднетяжелой БА.

Impact on quality of life

A study by Rosenthal et al was devoted to comparing the effect of therapy with Symbicort and the combination of Pulmicort plus Oxis on quality of life. (2001), which included 586 patients with asthma. Patients received either Symbicort 160/4.5 mcg twice daily or a combination of Pulmicort 200 mcg plus Oxis 4.5 mcg twice daily for 6 months. Quality of life, assessed using the Mini Asthma Quality of Life Questionnaire, increased in both groups of patients (from 5.32 to 5.87 and from 5.42 to 5.80 points, respectively), asthma control, assessed using the Asthma Control Questionnaire , also improved (from 1.58 to 1.08 and from 1.46 to 1.00 points, respectively). Thus, both methods of using combination drugs have approximately the same effect on quality of life and asthma control.

Cost-effectiveness ratio

Studies conducted to date show that the use of combination drugs is more cost-effective compared to a combination of separate drugs. In a study by Rosenthal et al. An analysis of direct and indirect costs was carried out for two combination drug treatment regimens. Direct costs (cost of medications, doctor's consultation, hospitalization, etc.) were significantly lower in the group of patients taking Symbicort compared to patients taking the Pulmicort plus Oxis combination: approximately $91 per patient over 6 months (p = 0.003 ). Indirect costs (loss of ability to work) were also lower in patients taking Symbicort, on average by $119 per patient over 6 months.

Security Profile

The safety and tolerability of Symbicort Turbuhaler's constituents, budesonide and formoterol, is based on experience gained over 9 billion person-days of use for budesonide and 345 million person-days for formoterol. In all clinical studies conducted on Symbicort, the number of side effects while taking the drug was insignificant, and cases of patients dropping out from the study due to complications that developed were extremely rare.

A placebo-controlled, double-blind study by Ankerst et al., 2001 was devoted to studying the cardiovascular effects when taking high doses of Symbicort. During this study, patients received two inhalations of Symbicort 160/4.5 mcg daily for 4-8 weeks, with On one day, the patient was prescribed 10 inhalations of Symbicort 160/4.5 mcg, or placebo, or Oxis 4.5 mcg. As it turned out, even the administration of high doses of Symbicort did not lead to significant changes in blood pressure, QT interval, potassium, glucose and lactate levels in the blood. There was only a slight increase in heart rate (by 5.4 beats per minute compared to placebo). Thus, even if, as asthma symptoms worsen, the patient significantly increases the dose of the combination inhaler, this will not entail serious side effects.

Literature:

1. Barnes PJ, Godfrey S. Asthma therapy. Martin Dunitz Ltd, London, 1998: pp. 1- 150.

2. National Heart, Lung and Blood Institute, National institutes of Health, Word Health Organization. Global Initiative for Asthma. Bethesda: NIH/NHLBI, 1998; publication number 96-3659B

3. O'Byrne PM. Inhaled corticosteroid therapy in newly detected mild asthma. Drugs 1999; 58 (Suppl.4): 17- 24

4. Barnes PJ. Clinical outcome of adding long-acting beta-agonists to inhaled corticosteroids. Respir Med 2001 Aug;95 Suppl B:S12-6

5. Roth M., Rudiger J. J., Bihl M. P., Leufgen H., Cornelius B. C., Gencay M., Soler M., Perruchoud A. P., Tamm M. The b2-agonist formoterol activates the glucocorticoid receptor in vivo. Eur Respir J 2000; 18 (Suppl 31): 437s-438s.

6. Pauwels RA, Lofdahl CG, Postma DS, et al. Effect of inhaled formoterol and budesonide on exacerbations of asthma. N Engl J Med 1997; 337:1405-11

7. Shrewsbury S, Pyke S, Britton M. Meta-analysis of increased dose of inhaled steroid or addiction of salmeterol in symptomatic asthma (MIASMA). Brit Med J 2000; 320: 1368-73.

8. Juniper EF, Svensson K, O'Byrne PM, Barnes PJ, Bauer C-A, Lofdahl C-GA,. Postma DS, Pauwels RA, Tattersfield AE, Ullman A. Asthma quality of life during 1 year of treatment with budesonide with or without formoterol. Eur Respir J 1999; 14: 1038-1043.

9. Kips JC, O'Connor BJ, Inman MD, Svensson K, Pauwels RA, O'Byrne PM. A long-term study of the antiinflammatory effect of low-dose budesonide plus formoterol versus high-dose budesonide in asthma. Am J Respir Crit Care Med 2000 Mar;161(3 Pt 1):996-1001

10. Shaw M, Jackson W. Symbicort. Product Monograph. The single inhaler for asthma. Clinical Vision Ltd and AstraZeneka, 2001: pp.1-52.

11. Palmqvist M, Arvidsson P, Beckman O, Peterson S, Lotvall J. Onset of bronchodilation of budesonide/formoterol vs. salmeterol/fluticasone in single inhalers. Pulm Pharmacol Ther 2001;14(1):29-34

12. Edsbacker S. Pharmacological factors that influence the choice of inhaled corticosteroids. Drugs 1999; 58(Suppl.4): 7-16.

13. Lindblad T., Granlund K. M., Rollwage U., Steckel H., Trofast E. Characteristics of a dry powder inhaler containing both budesonide and formoterol. Eur Respir J 2000; 18 (Suppl 31): 455s

14. Granlund K. M., Asking L., Lindblad T., Rollwage U., Steckel H. An in-vitro comparison of budesonide/formoterol and fluticasone/salmeterol in dry powder inhalers. Eur Respir J 2000; 18 (Suppl 31): 455s

15. Zetterstrom O, Buhl R, Mellem H, Perpina M, Hedman J, O’Neill S, Ekstrom T. Improved asthma control with budesonide/formoterol in a single inhaler, compared with with budesonide alone. Eur Respir J 2001 Aug;18(2):262-8

16. Schmier JK, Leidy NK. The complexity of treatment adherence in adults with asthma challenges and opportunities. J Asthma 1998; 35: 455-72.

17. Shaw M, Jackson W. Pulmicort Turbuhaler once daily. Clinical Vision Ltd and Astra Drago AB, 1998: pp.1-43.

18. Campbell LM. Once-daily inhaled corticosteroids in mild to moderate asthma. Drugs 1999; 58(Suppl.4): 25-33.

19. Buhl R., Creemers J.P.H.M., Vondra V., Martelli N.A. Once-daily budesonide/formoterol via a single inhaler is effective in mild-to-moderate persistent asthma. Eur Respir J 2001; 18 (Suppl 33): 21s

20. Buhl R., Creemers J.P.H.M., Vondra V., Martelli N.A. Improved and maintained asthma control with once-daily budesonide/formoterol single inhaler therapy in mild-to-moderate persistent asthma. Eur Respir J 2001; 18 (Suppl 33): 21s

21. Kuna P., Chuchalin A., Ringdal N., De la Padilla E.A., Black P., Lindqvist A., Nihlen U., Vogelmeier C. Low-dose single-inhaler budesonide/formoterol administered once daily is effective in mild -persistent asthma. Eur Respir J 2001; 18 (Suppl 33): 158s

22. Ankerst J., Persson G., Weibull E. A high dose of budesonide/formoterol in a single inhaler was well tolerated by asthmatic patients. Eur Respir J 2000; 18 (Suppl 31): 33s

23. Rosenhall L., Stahl E., Heinig J.H., Lindqvist A., Leegard J., Bergqvist P.B.F. Health-related quality of life and asthma control in patients treated with budesonide and formoterol in a single inhaler. Eur Respir J 2001; 18 (Suppl 33): 46s

24. Rosenhall L., Ericsson K., Borg S., Andersson F. Healthcare costs are reduced when asthma is treated with budesonide and formoterol in a single inhaler compared with the same medication via separate inhalers. Eur Respir J 2001; 18 (Suppl 33): 54s

Budesonide + formoterol -

Symbicort Turbuhaler(tradename)

Pulmicort- a synthetic glucocorticosteroid drug that is prescribed for bronchial asthma, as well as. Pulmicort is produced in Sweden.

This drug is available in the form of a suspension, which is used for inhalation. There are also other dosage forms. For procedures with Pulmicort, it is recommended to use a compressor nebulizer with a mouthpiece and a special mask, with which inhalations will be most effective. Let's consider whether it is possible to replace Pulmicort for inhalation with something, but first we will familiarize ourselves with the composition of the drug and find out how it affects the body.

Composition and pharmacological action of Pulmicort

The active component of the drug is budesonide. Auxiliary ingredients in the suspension: sodium chloride, sodium citrate, disodium edetate, citric acid, polysorbate 80, prepared water.

Budesonide is a local glucocorticoid, which, when administered by inhalation, is quickly and easily absorbed from the lungs (the maximum concentration in the blood is observed 15–45 minutes after the procedure). The substance has a powerful anti-inflammatory and antiallergic effect, directly affecting cells and glucocorticosteroid receptors and regulating the synthesis of various substances. The drug promotes:

  • reducing swelling of the mucous membranes of the bronchi;
  • reduction of mucus secretion;
  • reducing airway hyperresponsiveness;
  • reducing the severity of manifestations and frequency of exacerbations of the disease.

The practice of using Pulmicort has shown that it is well tolerated during long-term treatment and does not affect water-electrolyte metabolism. Due to the selectivity of the effect, side effects during the treatment of the drug occur only in rare cases. The drug is excreted in urine and bile.

Analogues of Pulmicort for inhalation

There are a number of drugs based on the same active ingredient as Pulmicort and intended for inhalation:

  • Budesonide (Spain);
  • Benacort (Russia);
  • Tafen Novolizer (Slovenia);
  • Novopulmon E Novolizer (Germany);
  • Symbicort Turbuhaler (Sweden).

The listed medications are substitutes for Pulmicort and can be used for the same indications with the permission of the attending physician. Dosages are selected individually in each specific case.

The cheapest analogue of Pulmicort from the above list is the domestically produced drug – Benacort. This medicine for inhalation is available in several forms: capsules with powder for inhalation, powder, solution, suspension.

There are also several drugs whose active ingredient is also budesonide. However, these drugs are available in other dosage forms, and their indications for use may differ from those of Pulmicort. These are tools such as:

  • Buderin (nasal spray);
  • Budecort (aerosol);
  • Benarine (nasal drops);
  • Budenofalk (capsules for oral administration), etc.

Berodual or Pulmicort?

Berodual is a drug that in some cases is prescribed for use in parallel with Pulmicort. This is a combination a medicinal product whose action is based on two active compounds - ipratropium bromide and fenoterol hydrobromide. Basically, Berodual is prescribed for bronchospastic syndromes accompanied by obstructive pulmonary disease.

Pulmicort turbuhaler is a hormonal therapeutic agent produced in the form of a device for individual use. The contents are powder and are reusable for inhalation. The product is in a plastic bottle equipped with a special nozzle that ensures dosed delivery of the medication. In pharmacy chains, the drug is sold only by prescription.

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Classmates

Instructions for use of an inhaler with a dose of budesonide 100 mcg, 200 mcg

Pharmacological therapy should be approached with all responsibility. The nuances of using Pulmicort Turbuhaler are described in detail in the instructions for use. Deviation from the rules is permissible only on the recommendation of a therapist or pulmonologist.

In what cases is it prescribed?

The reusable powder inhaler Pulmicort turbuhaler is effective for serious pathologies of the respiratory tract. It is recommended for detection of diseases caused by a prolonged inflammatory process.

Table 1. In what cases is a powder inhaler effective?

Name of the diseaseMore detailsCausesClinical manifestations
Chronic obstructive pulmonary disease (COPD)It is a pathology leading to progressive, partially irreversible obstruction of the bronchial tubes, leading to negative changes in lung tissueAs a rule, the disease occurs against the background of a chronic inflammatory process that affects the lung tissue. Irritation of the respiratory organs by foreign particles and gases leads to the development of chronic obstructionThe defining symptoms of the pathology include shortness of breath, coughing, accompanied by the release of viscous tracheobronchial secretion.
Bronchial asthmaChronic pathology of the respiratory tract, leading to narrowing of the lumen of the bronchiAllergic reaction, sensitization, nonspecific mechanisms of occurrenceChest congestion, whistling during breathing, asthma attacks, coughing, etc.

Active substance

According to the instructions for use, the active component in the multi-dose inhaler is budesonide. This is a glucocorticoid hormone intended for local use. It is this that causes such actions of Pulmicort turbuhaler as:

  • anti-inflammatory;
  • antihistamine;
  • immunosuppressive;
  • anti-shock;
  • antitoxic.

The mechanism of action of the glucocorticoid hormone has not been fully studied, but the pronounced local anti-inflammatory effect of the active component is a proven fact. The rate of structural changes affecting lung tissue and blood vessels is significantly reduced by reducing the response to histamine release.

Timely administration of Pulmicort turbuhaler during and in the early stages leads to a marked improvement in pulmonary activity.

Bronchial asthma

Contraindications

There are some restrictions on treatment with the individual Pulmicort Turbuhaler inhaler. It is contraindicated for children under 6 years of age. This is due to the fact that the use of budesonide can interfere with the normal growth and development of the child's body. In addition, the product is prohibited from use if you are individually intolerant to the components in the composition. Caution should be exercised when using the Pulmicort Turbuhaler inhaler when:

  • parallel administration of inhalations with glucocorticoids;
  • for various etiologies;
  • respiratory tract diseases caused by the penetration of biological agents (fungi, bacteria, viruses).

Doses

The amount of the drug is regulated for each patient individually depending on the diagnosis, age and distinctive features.

When selecting the amount of the drug, it is important to prescribe the minimum effective dose.

How to use?

The success of therapy carried out using a reusable inhaler depends not only on the dosage, but also on the correct use of the device itself. It is very important to deeply inhale the vapors of the product, as well as to ensure proper care of the inhaler itself.

Table 3. How to use the Pulmicort Turbuhaler inhaler

It should be remembered that exhaling through the mouthpiece is prohibited under any circumstances. It is recommended to clean the inhaler with a cloth once a week. The instructions for use note that the use of any liquids to clean it is prohibited.

How to use it in the treatment of children?

The drug in question is a hormonal drug. The use of a reusable inhaler in childhood and adolescence requires strict adherence to the instructions and dosage regimen.

The transition to a one-time dose of Pulmicort Turbuhaler should only occur under the supervision of a pediatrician.

If long-term therapy is required for a child or adolescent, it is essential to continually monitor growth.

Special instructions for use

An impressive part of the instructions for using the reusable inhaler is a description of special instructions. No less important is the question of the compatibility of Pulmicort turbuhaler with certain medications.

Table 4. Features of therapy with a reusable inhaler

The nuances of using an inhalerDescription

During therapy

Mouth rinseTo avoid the development of mycoses, be sure to rinse your mouth with water after each procedure.
Switching from tablet hormonal drugsAdrenal insufficiency is likely to develop. Special supervision is required. Unpleasant sensations in the muscles/joints, decreased performance, headaches, dyspeptic disorders, etc. are allowed.
Reduced efficiencyIf Pulmicort Turbuhaler no longer works as well as at the very beginning of treatment, then you should immediately consult a doctor. In some cases, it is necessary to switch to tablet hormonal drugs

Pharmacological combinations

Cytochrome P450 inhibitorsPulmicort turbuhaler should not be used together with these drugs. If it is impossible to give up inhibitors, then the maximum possible gap should be made between the first and second doses.

The use of a reusable inhaler does not reduce the rate of reactions. That is why pharmacological therapy does not imply giving up driving and other activities that require attention and concentration.

Review Reviews

Mostly reviews of Pulmicort Turbuhaler are written in a positive manner, and the average patient rating is 4.2-4.8 points out of 5 possible. The advantages of the drug include:

  • high efficiency;
  • speed of action;
  • the possibility of treatment during pregnancy;
  • convenient bottle.

Reviews about the treatment of children also describe positive experiences. However, there are also negative sides to using Pulmicort Turbuhaler. The most obvious disadvantage is the high cost. In addition, many are afraid to use hormonal drugs to get rid of respiratory tract pathologies.

Some patients note that it is not always clear whether the aerosol was inhaled during the procedure due to the lack of any taste in the drug.

Analogs

Pharmacy chains also sell other products based on budesonide. The following analogues of Pulmicort turbuhaler exist:

  • Budenit Steri-Neb;
  • Budesonide-native and others.

Budenit Steri-Neb is a fine liquid intended for inhalation using a nebulizer. The active substance in the drug begins to act approximately 60-120 minutes after the procedure. Steady improvement is noted after a couple of weeks of use. The drug is recommended for preventing asthma attacks, but is not effective for acute bronchospasm. The drug is not available in a reusable inhaler form.

Budesonide native has a pronounced bronchodilator and glucocorticosteroid effect. Used for topical use. Administered by inhalation using a nebulizer. Indications for use, as in the case of Pulmicort turbuhaler, are bronchial asthma and COPD. The product is not sold in the form of an aerosol, so it cannot be considered a full replacement.

The decision to prescribe any drug is made by the doctor

What is better Pulmicort or Symbicort?

Symbicort turbuhaler is a combination drug whose key components are budesonide and formoterol. The latter is a bronchodilator, whose effectiveness is due to its selective effect on beta receptors. Symbicort promotes:

  • relief of inflammation;
  • relieving bronchospasm;
  • getting rid of allergies.

In addition, the drug has a glucocorticosteroid effect. It is recommended for patients diagnosed with bronchial asthma or chronic pulmonary obstruction. The product is sold in the form of reusable powder inhalers. Indeed, Symbicort and Pulmicort turbuhaler are quite similar, which raises the question of which is better to choose for treatment.

The decision to prescribe any of the remedies can only be made by a specialist. It is directly related to the diagnosis and individual characteristics of the patient.

Conclusion

  1. Pulmicort turbuhaler is an effective drug prescribed for a number of respiratory tract pathologies.
  2. Its distinctive feature is its high efficiency in the fight against inflammation and a pronounced antiallergic effect.
  3. The product is made on the basis of a substance that competitively binds to glucocorticosteroid receptors, and therefore requires strict adherence to the instructions and recommendations of a specialist.
  4. The drug is not used to treat children under 6 years of age.

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Active substance
›› Budesonide*

Latin name
Pulmicort Turbuhaler

ATX:
›› R03BA02 Budesonide

Pharmacological group
›› Glucocorticoids

Composition and release form
Turbuhaler inhaler contains 100 doses; in a cardboard box 1 pc.

Directions for use and doses
Inhalation. Bronchial asthma, chronic obstructive pulmonary disease: the dose is selected individually. Recommended doses of the drug in case of initiation of inhaled glucocorticoid therapy during severe exacerbations of bronchial asthma, as well as against the background of dose reduction or discontinuation of oral glucocorticoids, are as follows:
Children over 6 years old - 100-800 mcg/day (the total daily dose can be divided into 2-4 inhalations). If the recommended dose does not exceed 400 mcg/day, the entire dose of the drug can be taken at one time (at a time).
In children, the transition to a single dose of the drug should be carried out under the supervision of a pediatrician.
Adults - the usual dose is 200-800 mcg/day (the total daily dose can be divided into 2-4 inhalations). For the treatment of severe exacerbation of bronchial asthma, the daily dose can be increased to 1600 mcg. If the recommended dose does not exceed 400 mcg/day, the entire dose of the drug can be taken at one time (at a time).
When selecting a maintenance dose, it is necessary to strive to prescribe the minimum effective dose.
The onset of the therapeutic effect after inhalation of 1 dose is several hours. The maximum therapeutic effect is achieved after several weeks of treatment. Pulmicort Turbuhaler has a preventive effect on the course of bronchial asthma and does not affect the acute manifestations of the disease. The effectiveness of budesonide has been demonstrated to be better when using Turbuhaler compared to a similar dose of budesonide in the form of a metered-dose aerosol. If a patient in stable condition is transferred from Pulmicort aerosol to Pulmicort Turbuhaler, the possibility of reducing the daily dose of budesonide should be considered. To enhance the therapeutic effect, it is possible to recommend increasing the daily dose of Pulmicort Turbuhaler instead of combining the drug with oral steroids, due to the lower risk of developing systemic effects.
Patients receiving oral glucocorticoids
Cancellation of oral glucocorticoids should be carried out against the background of a stable health condition of the patient. For 10 days, it is recommended to take a high dose of Pulmicort while taking oral glucocorticoids in a selected dose. Subsequently, the dose of oral glucocorticoids should be gradually reduced (for example, 2.5 mg of prednisolone or its analogue) to the minimum possible level. In many cases, it is possible to completely stop taking oral glucocorticoids.
There are no data on the use of budesonide in patients with renal failure or impaired liver function. Taking into account the elimination of budesonide due to biotransformation in the liver, an increase in the duration of action of the drug can be expected in patients with severe liver cirrhosis.

Best before date
2 years

Storage conditions
List B.: At a temperature not exceeding 30 °C.

Found in 12 questions:


allergo-immunologist April 6, 2009 / Daria

Symptomatic. Doctors insist on hormonal treatment, prescribe pulmicort turbuhaler. I'm afraid of prescribing hormonal treatment. really...hormone therapy? what should we do? how dangerous pulmicort?how will the use of hormones affect the endocrine,...