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 |
|---|---|---|---|---|---|
2016/10/05 | Not Applicable | Completed | University Hospital, Grenoble | ||
2016/09/27 | Not Applicable | UNKNOWN | |||
2016/09/26 | Phase 4 | Completed | |||
2016/08/31 | Phase 3 | Completed | |||
2016/08/24 | Phase 4 | Completed | Central Hospital, Nancy, France | ||
2016/08/19 | Phase 1 | Completed | |||
2016/06/29 | Not Applicable | Completed | |||
2016/06/16 | Not Applicable | Completed | |||
2016/06/13 | Phase 4 | Active, not recruiting | |||
2016/05/10 | Not Applicable | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Cipla USA Inc. | 69097-142 | RESPIRATORY (INHALATION) | 90 ug in 1 1 | 5/29/2023 | |
| RPK Pharmaceuticals, Inc. | 53002-1554 | RESPIRATORY (INHALATION) | 90 ug in 1 1 | 12/1/2022 | |
| A-S Medication Solutions | 50090-1382 | RESPIRATORY (INHALATION) | 2.5 mg in 3 mL | 12/19/2022 | |
| Proficient Rx LP | 63187-529 | RESPIRATORY (INHALATION) | 2.5 mg in 3 mL | 11/1/2019 | |
| Rising Pharma Holdings, Inc | 64980-643 | RESPIRATORY (INHALATION) | 0.63 mg in 3 mL | 4/17/2025 | |
| NuCare Pharmaceuticals,Inc. | 68071-1525 | RESPIRATORY (INHALATION) | 90 ug in 1 1 | 6/15/2020 | |
| A-S Medication Solutions | 50090-4326 | RESPIRATORY (INHALATION) | 108 ug in 1 1 | 10/12/2016 | |
| Chartwell RX, LLC | 62135-828 | RESPIRATORY (INHALATION) | 2.5 mg in 3 mL | 2/21/2024 | |
| Chartwell RX, LLC | 62135-827 | RESPIRATORY (INHALATION) | 1.25 mg in 3 mL | 2/21/2024 | |
| Rising Pharma Holdings, Inc. | 64980-642 | RESPIRATORY (INHALATION) | 2.5 mg in 0.5 mL | 4/17/2025 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| 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H11022158 | 化学药品 | 片剂 | 11/26/2020 | |
| Salbutamol Sulfate Tablets | 国药准字H10983170 | 化学药品 | 片剂 | 4/29/2020 | |
| Salbutamol Sulfate Tablets | 国药准字H32024129 | 化学药品 | 片剂 | 9/9/2020 | |
| Salbutamol Sulfate Tablets | 国药准字H32025021 | 化学药品 | 片剂 | 7/14/2020 | |
| Salbutamol Sulfate Tablets | 国药准字H20013396 | 化学药品 | 片剂 | 4/21/2020 | |
| Salbutamol Sulfate Tablets | 国药准字H31021377 | 化学药品 | 片剂 | 12/17/2019 | |
| Salbutamol Sulfate Tablets | 国药准字H51020445 | 化学药品 | 片剂 | 2/3/2021 | |
| Salbutamol Sulfate Tablets | 国药准字H42021598 | 化学药品 | 片剂 | 6/10/2020 | |
| Salbutamol Sulfate Tablets | 国药准字H23021210 | 化学药品 | 片剂 | 4/19/2020 | |
| Salbutamol Sulfate Tablets | 国药准字H20063231 | 化学药品 | 片剂 | 1/30/2024 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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