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
Research Report
Salbutamol (Albuterol): A Comprehensive Pharmacological and Clinical Monograph
Introduction
Salbutamol, known as albuterol in the United States, stands as a cornerstone in the management of respiratory diseases characterized by reversible airway obstruction. For over half a century, this short-acting β2-adrenergic receptor agonist (SABA) has been a first-line rescue medication, providing rapid and effective relief from the distressing symptoms of bronchospasm.[1] Discovered in 1966 by a team at Allen and Hanburys in the UK and launched in 1969 as Ventolin, its profound impact on patient care is underscored by its inclusion on the World Health Organization's List of Essential Medicines and its immense global utilization; in 2022, it was the seventh most commonly prescribed medication in the United States, with over 59 million prescriptions filled.[1]
The enduring success of salbutamol lies in its targeted and potent pharmacological action, which provides immediate bronchodilation and symptom relief, making it an indispensable tool for patients with asthma and chronic obstructive pulmonary disease (COPD).[1] However, the very efficacy that cemented its status as a life-saving medication has also revealed a critical paradox in its long-term use. The reliance on salbutamol for symptom relief can mask underlying chronic airway inflammation, the true driver of disease progression in asthma. This has led to a phenomenon of SABA over-reliance, which is now recognized as a marker of poor disease control and is associated with an increased risk of severe exacerbations and mortality.[2]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/06/25 | Not Applicable | Not yet recruiting | |||
2025/05/20 | Phase 3 | Not yet recruiting | |||
2025/04/27 | Phase 3 | Recruiting | |||
2025/04/10 | Phase 1 | Completed | |||
2025/04/09 | Phase 4 | Completed | Children's Hospital and Institute of Child Health, Multan | ||
2024/10/24 | Phase 2 | Completed | |||
2024/10/01 | Phase 3 | Not yet recruiting | |||
2024/07/01 | Phase 2 | Active, not recruiting | Università degli Studi di Ferrara | ||
2024/05/30 | Phase 1 | Recruiting | |||
2024/05/30 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Lupin Pharmaceuticals, Inc. | 68180-963 | RESPIRATORY (INHALATION) | 90 ug in 1 1 | 12/1/2022 | |
A-S Medication Solutions | 50090-0516 | RESPIRATORY (INHALATION) | 2.5 mg in 3 mL | 12/19/2022 | |
American Health Packaging | 68084-952 | ORAL | 4 mg in 1 1 | 10/4/2022 | |
Prasco Laboratories | 66993-019 | RESPIRATORY (INHALATION) | 90 ug in 1 1 | 12/19/2014 | |
Proficient Rx LP | 63187-026 | RESPIRATORY (INHALATION) | 90 ug in 1 1 | 10/1/2023 | |
A-S Medication Solutions | 50090-6288 | RESPIRATORY (INHALATION) | 2.5 mg in 3 mL | 12/9/2021 | |
Sun Pharmaceutical Industries, Inc. | 53489-177 | ORAL | 4 mg in 1 1 | 1/30/2019 | |
Sun Pharmaceutical Industries, Inc. | 47335-703 | RESPIRATORY (INHALATION) | 0.83 mg in 1 mL | 12/6/2023 | |
Direct_Rx | 72189-002 | INTRABRONCHIAL | 2.5 mg in 3 mL | 7/30/2019 | |
H.J. Harkins Company, Inc. | 76519-1175 | RESPIRATORY (INHALATION) | 90 ug in 1 g | 4/26/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
AZMASOL HFA INHALATION AEROSOL 100MCG | SIN13980P | AEROSOL, METERED | 100mcg/actuation | 6/24/2011 | |
VENTOLIN RESPIRATOR SOLUTION 0.5% w/v | SIN02988P | SOLUTION | 0.5% w/v | 5/26/1989 | |
VENDEROL TABLET 2 mg | SIN02687P | TABLET | 2 mg | 4/28/1989 | |
ZENMOLIN SYRUP 2 mg/5 ml | SIN00022P | SYRUP | 2 mg/5 ml | 2/2/1988 | |
BUVENTOL EASYHALER 100 mcg/inhalation dose | SIN08676P | POWDER, METERED | 100 mcg/dose | 4/24/1996 | |
SALBUAIR CFC-FREE INHALER 100 mcg/dose | SIN12458P | AEROSOL, SPRAY | 100 mcg/dose | 10/30/2003 | |
COMBIVENT UNIT DOSE VIAL FOR INHALATION | SIN09558P | SOLUTION | 2.500 mg/2.5 ml | 11/28/1997 | |
ASMOL SYRUP 2 mg/5 ml | SIN02461P | SYRUP | 2 mg/5 ml | 2/27/1989 | |
ASMOL TABLET 4 mg | SIN02913P | TABLET | 4 mg | 5/22/1989 | |
SALBUTAMOL SYRUP 2 mg/5 ml | SIN10339P | SYRUP | 2mg/5ml | 11/4/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
VENTOLIN NEBULES 5MG | 12534 | Medicine | A | 8/13/1991 | |
SALBUTAMOL CIPLA salbutamol 2.5mg/2.5mL (as sulfate) inhalation ampoules | 115652 | Medicine | A | 10/18/2006 | |
VENTOLIN SYRUP salbutamol 2mg/5mL (as sulfate) sugar free oral liquid bottle | 92339 | Medicine | A | 1/28/2003 | |
ASMOL CFC-FREE INHALER Salbutamol 100 microgram (as sulfate) pressurised inhaler metered dose (with counter) | 335970 | Medicine | A | 5/7/2020 | |
ZEMPREON CFC-FREE INHALER Salbutamol 100 microgram (as sulfate) pressurised inhaler metered dose (with counter) | 335999 | Medicine | A | 5/7/2020 | |
VENTOLIN NEBULES 2.5MG | 12533 | Medicine | A | 8/13/1991 | |
VENTOLIN INHALER CFC-Free Salbutamol 100 microgram (as sulfate) pressurised inhaler metered dose | 62695 | Medicine | A | 6/30/1998 | |
AIROMIR INHALER salbutamol (as sulfate) 100 microgram/metered dose inhalation aerosol can | 64799 | Medicine | A | 8/19/1998 | |
SALBUTAMOL CIPLA salbutamol 5mg/2.5mL (as sulfate) inhalation ampoules | 115657 | Medicine | A | 10/18/2006 | |
Salbutamol/Bromhexine Liquid | 149333 | Medicine | A | 1/21/2008 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
VENTOLIN IM INJ 0.5MG/ML | glaxo canada inc | 00894249 | Liquid - Intramuscular | .5 MG / ML | 12/31/1992 |
COMBIVENT INHALATION AEROSOL | boehringer ingelheim (canada) ltd ltee | 02163721 | Metered-Dose Aerosol - Inhalation
,
Oral | 120 MCG / ACT | 12/31/1995 |
VENTOLIN TAB 4MG | glaxo canada inc | 01932691 | Tablet - Oral | 4 MG / TAB | 12/31/1993 |
SABULIN INHALER 100MCG/METERED DOSE AEROSOL | genpharm ulc | 00812463 | Metered-Dose Aerosol - Inhalation | 100 MCG / ACT | 12/31/1989 |
NOVO-SALMOL INHALER 100MCG/AEM | novopharm limited | 00874086 | Metered-Dose Aerosol - Oral | 100 MCG / ACT | 12/31/1991 |
APO-SALVENT AEM 100MCG | 00790419 | Metered-Dose Aerosol - Inhalation | 100 MCG / ACT | 12/31/1989 | |
RATIO-SALBUTAMOL | ratiopharm inc division of teva canada limited | 00851841 | Metered-Dose Aerosol - Inhalation | 100 MCG / ACT | 12/31/1989 |
VENTOLIN INHALER 100MCG/AEM | glaxo canada inc | 00867179 | Metered-Dose Aerosol - Inhalation | 100 MCG / ACT | 12/31/1972 |
VENTOLIN INHALER | 02213478 | Metered-Dose Aerosol - Inhalation | 100 MCG / ACT | 9/30/1997 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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