Overview
Terbutaline was first synthesized in 1966 and described in the literature in the late 1960s and early 1970s. It is a selective beta-2 adrenergic agonist used as a bronchodilator in asthmatic patients. Terbutaline was granted FDA approval on 25 March 1974.
Indication
Terbutaline is indicated for prevention and reversal of bronchospasm in patients at least 12 years old, with asthma and reversible bronchospasm associated with bronchitis and emphysema.
Associated Conditions
- Asthma
- Bronchospasm
- Chronic Cough (CC)
- Chronic Obstructive Pulmonary Disease (COPD)
- Cough
- Premature Labour
- Productive cough
Research Report
A Comprehensive Monograph on Terbutaline (DB00871)
1. Terbutaline: An Overview and Summary of Key Properties
1.1. Introduction
Terbutaline is a synthetic sympathomimetic amine belonging to the phenylethanolamine chemical class.[1] Pharmacologically, it is classified as a selective, short-acting beta-2 (
β2) adrenergic receptor agonist (SABA).[2] Its primary and approved therapeutic function is as a bronchodilator for the prevention and reversal of bronchospasm in patients with reversible obstructive airway diseases, including asthma, chronic bronchitis, and emphysema.[5] By selectively targeting
β2 receptors in the bronchial smooth muscle, terbutaline provides rapid relief from symptoms such as wheezing, shortness of breath, and chest tightness, making it a cornerstone of "reliever" or "rescue" therapy in respiratory medicine.[3]
1.2. Executive Summary
This report provides an exhaustive analysis of terbutaline, synthesizing its chemical, pharmacological, clinical, and safety profiles. The clinical narrative of terbutaline is defined by a profound duality. On one hand, it is a well-established, effective, and widely used bronchodilator for a common set of respiratory conditions.[5] On the other hand, its off-label use as a tocolytic agent to manage preterm labor has been associated with significant risks, leading to severe regulatory actions.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/10/04 | Phase 3 | Completed | Muhammad Aamir Latif | ||
2022/08/09 | Phase 2 | UNKNOWN | |||
2022/04/13 | Not Applicable | Completed | |||
2022/01/18 | Not Applicable | Recruiting | |||
2021/07/22 | Phase 2 | Suspended | Kanecia Obie Zimmerman | ||
2021/01/12 | Phase 3 | Terminated | |||
2020/07/22 | Phase 2 | UNKNOWN | |||
2020/07/13 | N/A | Completed | |||
2018/06/21 | Not Applicable | UNKNOWN | Morten Hostrup, PhD | ||
2017/04/10 | Phase 4 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Marlex Pharmaceuticals Inc | 10135-580 | ORAL | 5 mg in 1 1 | 1/6/2020 | |
Lannett Company, Inc. | 0527-1318 | ORAL | 2.5 mg in 1 1 | 7/27/2022 | |
Rebel Distributors Corp | 21695-121 | ORAL | 5 mg in 1 1 | 3/21/2008 | |
Medical Purchasing Solutions. LLC | 71872-7080 | SUBCUTANEOUS | 1 mg in 1 mL | 5/23/2023 | |
Lannett Company, Inc. | 0527-1311 | ORAL | 5 mg in 1 1 | 7/27/2022 | |
UBI Pharma Inc. | 72843-101 | SUBCUTANEOUS | 1 mg in 1 mL | 2/15/2019 | |
Amneal Pharmaceuticals of New York LLC | 0115-2622 | ORAL | 5 mg in 1 1 | 1/25/2020 | |
Henry Schein, Inc. | 0404-9962 | SUBCUTANEOUS | 1 mg in 1 mL | 1/12/2022 | |
ANI Pharmaceuticals, Inc. | 62559-722 | ORAL | 5 mg in 1 1 | 10/16/2018 | |
Chartwell RX, LLC. | 62135-525 | ORAL | 5 mg in 1 1 | 3/2/2023 |
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 |
---|---|---|---|---|---|
BUTYLIN SYRUP 1.5 mg/5 ml | SIN08075P | SYRUP | 1.5 mg/5 ml | 3/18/1995 | |
ASMALIN TABLET 2.5 mg | SIN06420P | TABLET | 2.5 mg | 7/8/1991 | |
ASMALIN SYRUP 1.5 mg/5 ml | SIN07055P | SYRUP | 1.5 mg/5 ml | 6/12/1992 |
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 |
---|---|---|---|---|---|
BUCANIN SYRUP 1.5MG/5ML | N/A | synco (h.k.) limited | N/A | N/A | 9/1/1995 |
BUCANIN SYRUP 3MG/5ML | N/A | N/A | N/A | 9/1/1995 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
Bricanyl 0.5mg/1mL injection ampoule | 12068 | Medicine | A | 8/13/1991 | |
BRICANYL TURBUHALER terbutaline sulfate 400 microgram powder for inhalation dry powder inhaler | 315075 | Medicine | A | 4/9/2020 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
BRICANYL TAB 5 MG | astrazeneca canada inc | 00335363 | Tablet - Oral | 5 MG | 12/31/1975 |
BRICANYL TAB 2.5 MG | astrazeneca canada inc | 00335355 | Tablet - Oral | 2.5 MG | 12/31/1978 |
BRICANYL TURBUHALER | astrazeneca canada inc | 00786616 | Powder - Inhalation | 0.5 MG / DOSE | 12/31/1990 |
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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