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Salbutamol

Generic Name
Salbutamol
Brand Names
Airomir, Airsupra, Combivent, Proair, Proventil, Ventolin
Drug Type
Small Molecule
Chemical Formula
C13H21NO3
CAS Number
18559-94-9
Unique Ingredient Identifier
QF8SVZ843E

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.

Background

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
2021/02/11
Phase 4
Completed
2020/12/23
N/A
Completed
2020/12/21
Phase 4
Completed
2020/12/07
Phase 4
Recruiting
University of Tennessee Graduate School of Medicine
2020/11/04
Not Applicable
UNKNOWN
2020/10/28
Phase 4
Completed
Pulmonary Research Institute of Southeast Michigan
2020/10/12
Phase 4
Withdrawn
2020/09/25
Phase 2
Completed
2020/09/22
Not Applicable
Completed
2020/07/28
Phase 1
Completed

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Preferred Pharmaceuticals Inc.
68788-8492
RESPIRATORY (INHALATION)
0.83 mg in 1 mL
7/24/2023
American Health Packaging
60687-405
RESPIRATORY (INHALATION)
2.5 mg in 3 mL
10/4/2022
Padagis Israel Pharmaceuticals Ltd
45802-088
RESPIRATORY (INHALATION)
90 ug in 1 1
12/1/2021
Asclemed USA, Inc.
76420-087
RESPIRATORY (INHALATION)
2.5 mg in 3 mL
10/16/2020
Bryant Ranch Prepack
63629-2611
ORAL
4 mg in 1 1
2/3/2022
Ritedose Pharmaceuticals, LLC
76204-200
RESPIRATORY (INHALATION)
2.5 mg in 3 mL
12/20/2023
Amneal Pharmaceuticals NY LLC
69238-1344
ORAL
2 mg in 1 1
2/20/2023
Golden State Medical Supply
51407-367
ORAL
2 mg in 1 1
10/19/2023
NuCare Pharmaceuticals,Inc.
68071-2656
RESPIRATORY (INHALATION)
0.83 mg in 1 mL
3/15/2022
Rising Pharma Holdings, Inc.
64980-443
ORAL
4 mg in 1 1
2/3/2022

EMA Drug Approvals

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Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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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 Inhalation Solution
国药准字H20249565
化学药品
吸入制剂
12/1/2024
Salbutamol Sulfate Inhalation Solution
国药准字H20213251
化学药品
吸入用溶液剂
4/7/2021
Salbutamol Sulfate Inhalation Solution
国药准字H20213807
化学药品
吸入用溶液剂
10/26/2021
Salbutamol Sulfate Inhalation Solution
国药准字H20233513
化学药品
吸入溶液剂
4/28/2023
Salbutamol Sulfate Inhalation Solution
国药准字H20243310
化学药品
吸入制剂
3/5/2024
Salbutamol Sulfate Inhalation Solution
国药准字H20223938
化学药品
吸入溶液剂
12/30/2022
Salbutamol Sulfate Inhalation Solution
国药准字H20223942
化学药品
吸入制剂
12/30/2022
Salbutamol Sulfate Inhalation Solution
国药准字H20233355
化学药品
吸入溶液剂
3/24/2023
Salbutamol Sulfate Inhalation Solution
国药准字H20233512
化学药品
吸入溶液剂
4/28/2023
Salbutamol Sulfate Inhalation Solution
国药准字H20203547
化学药品
吸入用溶液剂
11/2/2020

PPB Drug Approvals

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Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.
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