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
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2015/09/04 | Phase 2 | Completed | |||
2015/08/14 | Not Applicable | Completed | |||
2015/07/20 | Phase 3 | Completed | |||
2015/07/16 | Not Applicable | Terminated | |||
2015/06/24 | Phase 2 | Completed | |||
2015/06/01 | Not Applicable | Withdrawn | |||
2015/04/27 | Phase 2 | Completed | |||
2015/04/01 | Phase 4 | Completed | |||
2015/02/25 | Phase 4 | Completed | |||
2014/12/18 | Phase 4 | Withdrawn |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Mylan Pharmaceuticals Inc. | 0378-9671 | RESPIRATORY (INHALATION) | 2.5 mg in 3 mL | 12/12/2018 | |
HF Acquisition Co LLC, DBA HealthFirst | 51662-1513 | RESPIRATORY (INHALATION) | 90 ug in 1 1 | 12/10/2022 | |
NuCare Pharmaceuticals,Inc. | 68071-4777 | RESPIRATORY (INHALATION) | 90 ug in 1 1 | 2/17/2021 | |
Cipla USA Inc. | 69097-173 | RESPIRATORY (INHALATION) | 2.5 mg in 3 mL | 8/25/2020 | |
Aurobindo Pharma Limited | 65862-858 | RESPIRATORY (INHALATION) | 0.83 mg in 1 mL | 11/21/2022 | |
Virtus Pharmaceuticals LLC | 69543-291 | ORAL | 4 mg in 1 1 | 11/19/2019 | |
Cardinal Health 107, LLC | 55154-2132 | RESPIRATORY (INHALATION) | 2.5 mg in 3 mL | 2/3/2023 | |
Sun Pharmaceutical Industries, Inc. | 53489-176 | ORAL | 2 mg in 1 1 | 1/30/2019 | |
GlaxoSmithKline LLC | 0173-0682 | RESPIRATORY (INHALATION) | 90 ug in 1 1 | 8/18/2021 | |
Preferred Pharmaceuticals Inc. | 68788-8103 | RESPIRATORY (INHALATION) | 3 mg in 3 mL | 7/17/2023 |
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 Inhalation Aerosol | 国药准字H44023669 | 化学药品 | 气雾剂(溶液型) | 4/9/2024 | |
Salbutamol Inhalation Aerosol | 国药准字H14020757 | 化学药品 | 气雾剂 | 7/16/2021 | |
Salbutamol Inhalation Aerosol | 国药准字H37020544 | 化学药品 | 气雾剂 | 2/15/2020 | |
Salbutamol Inhalation Aerosol | 国药准字H37022314 | 化学药品 | 气雾剂(溶液型) | 1/10/2021 | |
Salbutamol Inhalation Aerosol | 国药准字H37022161 | 化学药品 | 气雾剂 | 2/8/2020 | |
Salbutamol Inhalation Aerosol | 国药准字H37020653 | 化学药品 | 气雾剂 | 2/3/2020 | |
Salbutamol Inhalation Aerosol | 国药准字H23020333 | 化学药品 | 气雾剂 | 7/19/2020 | |
Salbutamol Inhalation Aerosol | 国药准字H44023668 | 化学药品 | 气雾剂(混悬型) | 4/9/2024 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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