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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
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
2017/08/22
Phase 3
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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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 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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Registration No.
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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