Manufactured by WHO-GMP certified plant
World Class "Form-Fill-Seal" Technology obtained from Rommelag, Germany and Weiler, USA
Overview
Budaways respules is a sterile suspension of Budesonide 0.5mg per 2ml respules intended for inhalation via a jet nebulizer. Budesonide is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity.1
Pharmacokinetics of Budesonide 2
Budaways is indicated for :
Asthma
Croup disease
Nebulised Budesonide is the only ICS approved by FDA in young children.3
*FDA- Food and Drug Administration
*ICS- Inhaled Corticosteroid
GINA 2021 Recommends
ICS treatment should be initiated as soon as possible after diagnosis of Asthma
What is Asthma?
Asthma is a common lung condition that causes sporadic breathing difficulties. It often starts in childhood, although it can also develop in adults and affect people of all ages. There is currently no cure, but treatment can help control the symptoms. 4
Benefits of Budaways in Asthma5
- First line therapy in controlling and preventing persistent asthma exacerbations
- Suppress inflammation by inhibiting multiple activated inflammatory genes
- Nebulized budesonide can act as a valuable treatment for patients with uncontrolled Asthma and help them achieve optimal asthma control
- Provides an even onset of effect than systemic steroids in asthma patients6
- Enhances β2-agonist responsiveness6
- Shortens the length of hospital stay for children admitted for asthma exacerbations7
What is Croup Disease?8
- Croup is a viral disease of the larynx and trachea. It is the most common infectious cause of stridor in children.
- An estimated 3% to 5% of children have at least one episode of croup during childhood.
Budaways Benefits in Croup disease
- Significantly effective for mild-moderate croup treatment. 9
- Reduce symptoms of croup within 2 hours, which lasts for at least 24 hours. 10
- Shortens hospital stay by about 15 hours. 10
- A substantial reduction in health care expenditure, as the cost of a single dose of nebulized budesonide is dwarfed by the cost of two-day admission to hospital.
Dosage
| Indications | Age-Group | Dosage |
|---|---|---|
| Asthma | 1-5 years | 0.5mg |
| 6-11 years | 0.5mg-1.0mg | |
| Croup | Aged above 3 years | 1-2mg |
Recommended device
- For children aged between 3 months to 5 years - Nebulizer with face mask
- For 4-5 years - Nebulizer with mouthpiece or facemask
References
1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20929lbl.pdf
2. Allen B. et.al. Inhaled corticosteroids. Journal of Allergy and Clinical Immunology
3. Bloom CI, Drake TM et.al; ISARIC investigators. Risk of adverse outcomes in patients with underlying respiratory conditions admitted to hospital with COVID-19: a national, multicentre prospective cohort study using the ISARIC WHO Clinical Characterisation Protocol UK. Lancet Respir Med. 2021 Jul;9(7):699-711. doi: 10.1016/S2213-2600(21)00013-8. Epub 2021 Mar 4. PMID: 33676593; PMCID: PMC8241313.
4.https://www.who.int/news-room/questions-and-answers/item/chronic-respiratory-diseases-asthma
5. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020929s052lbl.pdf
6. van Essen-Zandvliet EE et.al. Effects of 22 months of treatment with inhaled corticosteroids and/or beta-2-agonists on lung function, airway responsiveness, and symptoms in children with asthma. 1992
7. https://doi.org/10.1159/000430443
8. Yi Cai and Anna Meyer,Pediatric Infectious Disease.
9. Allison Gates, PhD; David W. Johnson, MD; Terry P. Klassen, MD. Glucocorticoids for Croup in Children
10. Russell K, Wiebe N, Saenz A, et al. Glucocorticoids for croup. Cochrane .DatabaseSyst Rev, 2004;CD001955.
11. https://www.nejm.org/doi/full/10.1056/nejm199408043310501
12. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020929s052lbl.pdf
13. Bloom CI, Drake TM et.al; ISARIC investigators. Risk of adverse outcomes in patients with underlying respiratory conditions admitted to hospital with COVID-19: a national, multicentre prospective cohort study using the ISARIC WHO Clinical Characterisation Protocol UK. Lancet Respir Med. 2021 Jul;9(7):699-711. doi: 10.1016/S2213-2600(21)00013-8. Epub 2021 Mar 4. PMID: 33676593; PMCID: PMC8241313.
14. Husby, S., Agertoft, L., Mortensen, S., & Pedersen, S. (1993). Treatment of croup with nebulised steroid (budesonide): a double blind, placebo controlled study. Archives of disease in childhood, 68(3), 352–355. https://doi.org/10.1136/adc.68.3.352
15.Andersson, M., Lindqvist, N., Svensson, C., Ek, L., &Pipkorn, U. (1993). Dry powder inhalation of budesonide in allergic rhinitis. Clinical otolaryngology and allied sciences, 18(1), 30–33. https://doi.org/10.1111/j.1365-2273.1993.tb00805.x
16. O'Donnell, S., &O'Morain, C. A. (2010). Therapeutic benefits of budesonide in gastroenterology. Therapeutic advances in chronic disease, 1(4), 177–186. https://doi.org/10.1177/2040622310379293
17.Kalola UK, Ambati S. Budesonide. [Updated 2021 Dec 20]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK563201/
2. Allen B. et.al. Inhaled corticosteroids. Journal of Allergy and Clinical Immunology
3. Bloom CI, Drake TM et.al; ISARIC investigators. Risk of adverse outcomes in patients with underlying respiratory conditions admitted to hospital with COVID-19: a national, multicentre prospective cohort study using the ISARIC WHO Clinical Characterisation Protocol UK. Lancet Respir Med. 2021 Jul;9(7):699-711. doi: 10.1016/S2213-2600(21)00013-8. Epub 2021 Mar 4. PMID: 33676593; PMCID: PMC8241313.
4.https://www.who.int/news-room/questions-and-answers/item/chronic-respiratory-diseases-asthma
5. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020929s052lbl.pdf
6. van Essen-Zandvliet EE et.al. Effects of 22 months of treatment with inhaled corticosteroids and/or beta-2-agonists on lung function, airway responsiveness, and symptoms in children with asthma. 1992
7. https://doi.org/10.1159/000430443
8. Yi Cai and Anna Meyer,Pediatric Infectious Disease.
9. Allison Gates, PhD; David W. Johnson, MD; Terry P. Klassen, MD. Glucocorticoids for Croup in Children
10. Russell K, Wiebe N, Saenz A, et al. Glucocorticoids for croup. Cochrane .DatabaseSyst Rev, 2004;CD001955.
11. https://www.nejm.org/doi/full/10.1056/nejm199408043310501
12. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020929s052lbl.pdf
13. Bloom CI, Drake TM et.al; ISARIC investigators. Risk of adverse outcomes in patients with underlying respiratory conditions admitted to hospital with COVID-19: a national, multicentre prospective cohort study using the ISARIC WHO Clinical Characterisation Protocol UK. Lancet Respir Med. 2021 Jul;9(7):699-711. doi: 10.1016/S2213-2600(21)00013-8. Epub 2021 Mar 4. PMID: 33676593; PMCID: PMC8241313.
14. Husby, S., Agertoft, L., Mortensen, S., & Pedersen, S. (1993). Treatment of croup with nebulised steroid (budesonide): a double blind, placebo controlled study. Archives of disease in childhood, 68(3), 352–355. https://doi.org/10.1136/adc.68.3.352
15.Andersson, M., Lindqvist, N., Svensson, C., Ek, L., &Pipkorn, U. (1993). Dry powder inhalation of budesonide in allergic rhinitis. Clinical otolaryngology and allied sciences, 18(1), 30–33. https://doi.org/10.1111/j.1365-2273.1993.tb00805.x
16. O'Donnell, S., &O'Morain, C. A. (2010). Therapeutic benefits of budesonide in gastroenterology. Therapeutic advances in chronic disease, 1(4), 177–186. https://doi.org/10.1177/2040622310379293
17.Kalola UK, Ambati S. Budesonide. [Updated 2021 Dec 20]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK563201/
