Overview
Aminophylline is a drug combination that contains theophylline and ethylenediamine in a 2:1 ratio. Once in the body, theophylline is released and acts as a phosphodiesterase inhibitor, adenosine receptor blocker, and histone deacetylase activator. Similar to other theophyllines, aminophylline is indicated for the treatment of lung diseases such as asthma, chronic bronchitis, and COPD. The majority of aminophylline medications are discontinued and the remaining medications on the market are in short supply.
Indication
For the treatment of bronchospasm due to asthma, emphysema and chronic bronchitis.
Associated Conditions
- Acute Exacerbation of Chronic Bronchitis (AECB)
- Asthma
- Bronchial Asthma
- Bronchospasm
- Chronic Bronchitis
- Exacerbation of asthma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/02/22 | N/A | Not yet recruiting | |||
2024/01/09 | Phase 2 | Not yet recruiting | |||
2023/11/18 | N/A | Completed | University of Padova | ||
2023/10/24 | N/A | Completed | University of Padova | ||
2023/07/06 | Phase 2 | Recruiting | |||
2023/02/21 | Not Applicable | Completed | |||
2023/01/30 | Not Applicable | Completed | |||
2022/12/27 | Phase 4 | Withdrawn | |||
2022/12/19 | Phase 4 | Recruiting | |||
2022/09/23 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1204 | INTRAVENOUS | 25 mg in 1 mL | 1/8/2024 | |
| Medical Purchasing Solutions, LLC | 71872-7060 | INTRAVENOUS | 25 mg in 1 mL | 5/30/2023 | |
| Hospira, Inc. | 0409-5922 | INTRAVENOUS | 25 mg in 1 mL | 11/29/2022 | |
| Hospira, Inc. | 0409-5921 | INTRAVENOUS | 25 mg in 1 mL | 11/29/2022 | |
| Medical Purchasing Solutions, LLC | 71872-7121 | INTRAVENOUS | 25 mg in 1 mL | 1/24/2020 | |
| Henry Schein, Inc. | 0404-9814 | INTRAVENOUS | 25 mg in 1 mL | 1/8/2022 | |
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1341 | INTRAVENOUS | 25 mg in 1 mL | 2/1/2024 | |
| Henry Schein, Inc. | 0404-9813 | INTRAVENOUS | 25 mg in 1 mL | 1/8/2022 |
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 |
|---|---|---|---|---|---|
| AMINOPHYLLINE INJECTION 0.25 g/10 ml | ATLANTIC LABORATORIES CORPN LTD | SIN03471P | INJECTION | 0.25 g/10 ml | 6/21/1989 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Aminophylline Oral Solution | 国药准字H20140008 | 化学药品 | 口服溶液剂 | 8/23/2023 | |
| Aminophylline For Injection | 国药准字H20052480 | 化学药品 | 注射剂 | 5/18/2020 | |
| Aminophylline For Injection | 国药准字H20052479 | 化学药品 | 注射剂 | 5/18/2020 | |
| Aminophylline For Injection | 国药准字H20051832 | 化学药品 | 注射剂 | 9/29/2020 | |
| Aminophylline For Injection | 国药准字H20051831 | 化学药品 | 注射剂 | 9/29/2020 | |
| Aminophylline For Injection | 国药准字H20050415 | 化学药品 | 注射剂(冻干粉针剂 ) | 4/2/2020 | |
| Aminophylline Sustained-release Tablets | 国药准字H22021080 | 化学药品 | 片剂(缓释) | 1/9/2020 | |
| Aminophylline Sustained-release Tablets | 国药准字H23020256 | 化学药品 | 片剂(缓释) | 4/17/2020 | |
| Aminophylline Sustained-release Tablets | 国药准字H22021461 | 化学药品 | 片剂 | 2/17/2020 | |
| Aminophylline Sustained-release Tablets | 国药准字H20094197 | 化学药品 | 片剂 | 11/25/2019 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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