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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.

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Withdrawn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Withdrawn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
No EMA approvals found for this drug.

HSA Drug Approvals

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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 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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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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