Overview
Salbutamol is a short-acting, selective beta2-adrenergic receptor agonist used in the treatment of asthma and COPD. It is 29 times more selective for beta2 receptors than beta1 receptors giving it higher specificity for pulmonary beta receptors versus beta1-adrenergic receptors located in the heart. Salbutamol is formulated as a racemic mixture of the R- and S-isomers. The R-isomer has 150 times greater affinity for the beta2-receptor than the S-isomer and the S-isomer has been associated with toxicity. This lead to the development of levalbuterol, the single R-isomer of salbutamol. However, the high cost of levalbuterol compared to salbutamol has deterred wide-spread use of this enantiomerically pure version of the drug. Salbutamol is generally used for acute episodes of bronchospasm caused by bronchial asthma, chronic bronchitis and other chronic bronchopulmonary disorders such as chronic obstructive pulmonary disorder (COPD). It is also used prophylactically for exercise-induced asthma.
Indication
Salbutamol is indicated for (i) the symptomatic relief and prevention of bronchospasm due to bronchial asthma, chronic bronchitis, reversible obstructive airway disease, and other chronic bronchopulmonary disorders in which bronchospasm is a complicating factor, and/or (ii) the acute prophylaxis against exercise-induced bronchospasm and other stimuli known to induce bronchospasm.
Associated Conditions
- Asthma
- Asthmatic Bronchitis
- Bronchial Asthma
- Bronchoconstriction
- Bronchospasm
- Chronic Asthma
- Chronic Bronchitis
- Cough
- Emphysema
- Exacerbation of asthma
- Exercise-Induced Bronchospasm
- Hyperkalemia
- Wheezing
- Excess mucus or phlegm
Research Report
Salbutamol (Albuterol): A Comprehensive Pharmacological and Clinical Monograph
Introduction
Salbutamol, known as albuterol in the United States, stands as a cornerstone in the management of respiratory diseases characterized by reversible airway obstruction. For over half a century, this short-acting β2-adrenergic receptor agonist (SABA) has been a first-line rescue medication, providing rapid and effective relief from the distressing symptoms of bronchospasm.[1] Discovered in 1966 by a team at Allen and Hanburys in the UK and launched in 1969 as Ventolin, its profound impact on patient care is underscored by its inclusion on the World Health Organization's List of Essential Medicines and its immense global utilization; in 2022, it was the seventh most commonly prescribed medication in the United States, with over 59 million prescriptions filled.[1]
The enduring success of salbutamol lies in its targeted and potent pharmacological action, which provides immediate bronchodilation and symptom relief, making it an indispensable tool for patients with asthma and chronic obstructive pulmonary disease (COPD).[1] However, the very efficacy that cemented its status as a life-saving medication has also revealed a critical paradox in its long-term use. The reliance on salbutamol for symptom relief can mask underlying chronic airway inflammation, the true driver of disease progression in asthma. This has led to a phenomenon of SABA over-reliance, which is now recognized as a marker of poor disease control and is associated with an increased risk of severe exacerbations and mortality.[2]
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2018/01/19 | Phase 4 | Completed | Dr. Denis O'Donnell | ||
2017/12/21 | Phase 4 | Completed | |||
2017/12/14 | Phase 1 | Completed | Concentrx Pharmaceuticals, Inc. | ||
2017/12/13 | Phase 2 | Completed | |||
2017/12/06 | Phase 2 | Completed | |||
2017/11/29 | N/A | Completed | |||
2017/11/17 | Phase 2 | Terminated | |||
2017/11/06 | Phase 4 | Completed | |||
2017/09/05 | Not Applicable | UNKNOWN | |||
2017/09/01 | Phase 2 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Ritedose Pharmaceuticals, LLC | 76204-600 | RESPIRATORY (INHALATION) | 2.5 mg in 3 mL | 12/20/2023 | |
Mylan Pharmaceuticals Inc. | 0378-7058 | RESPIRATORY (INHALATION) | 1.25 mg in 3 mL | 4/15/2022 | |
A-S Medication Solutions | 50090-4138 | RESPIRATORY (INHALATION) | 90 ug in 1 1 | 1/31/2023 | |
Rebel Distributors Corp. | 21695-423 | RESPIRATORY (INHALATION) | 108 ug in 1 1 | 9/1/2009 | |
H.J. Harkins Company, Inc. | 52959-978 | RESPIRATORY (INHALATION) | 90 ug in 1 1 | 11/4/2011 | |
Medical Purchasing Solutions, LLC | 71872-7054 | RESPIRATORY (INHALATION) | 2.5 mg in 3 mL | 5/30/2023 | |
Sandoz | 66758-959 | RESPIRATORY (INHALATION) | 108 ug in 1 1 | 6/14/2023 | |
Mylan Pharmaceuticals Inc. | 0378-7057 | RESPIRATORY (INHALATION) | 0.63 mg in 3 mL | 4/15/2022 | |
Golden State Medical Supply | 51407-368 | ORAL | 4 mg in 1 1 | 10/19/2023 | |
Bryant Ranch Prepack | 72162-1212 | RESPIRATORY (INHALATION) | 108 ug in 1 1 | 3/21/2024 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Salbutamol Sulfate Tablets | 国药准字H22020315 | 化学药品 | 片剂 | 6/12/2020 | |
Salbutamol Sulfate Tablets | 国药准字H33021914 | 化学药品 | 片剂 | 4/17/2020 | |
Salbutamol Sulfate Tablets | 国药准字H12020418 | 化学药品 | 片剂 | 8/27/2020 | |
Salbutamol Sulfate Tablets | 国药准字H45020178 | 化学药品 | 片剂 | 9/1/2020 | |
Salbutamol Sulfate Tablets | 国药准字H14020993 | 化学药品 | 片剂 | 4/10/2020 | |
Salbutamol Sulfate Tablets | 国药准字H44022457 | 化学药品 | 片剂 | 3/4/2020 | |
Salbutamol Sulfate Tablets | 国药准字H22021047 | 化学药品 | 片剂 | 3/23/2020 | |
Salbutamol Sulfate Tablets | 国药准字H41025358 | 化学药品 | 片剂 | 7/6/2020 | |
Salbutamol Sulfate Tablets | 国药准字H32023510 | 化学药品 | 片剂 | 8/21/2020 | |
Salbutamol Sulfate Tablets | 国药准字H11020032 | 化学药品 | 片剂 | 11/26/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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