Overview
Amlodipine, initially approved by the FDA in 1987, is a popular antihypertensive drug belonging to the group of drugs called dihydropyridine calcium channel blockers. Due to their selectivity for the peripheral blood vessels, dihydropyridine calcium channel blockers are associated with a lower incidence of myocardial depression and cardiac conduction abnormalities than other calcium channel blockers . Amlodipine is commonly used in the treatment of high blood pressure and angina. Amlodipine has antioxidant properties and an ability to enhance the production of nitric oxide (NO), an important vasodilator that decreases blood pressure . The option for single daily dosing of amlodipine is an attractive feature of this drug .
Indication
Amlodipine may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of the following conditions : • Hypertension • Coronary artery disease • Chronic stable angina • Vasospastic angina (Prinzmetal’s or Variant angina) • Angiographically documented coronary artery disease in patients without heart failure or an ejection fraction < 40%
Associated Conditions
- Cardiovascular Events
- Chronic Stable Angina Pectoris
- Coronary Artery Disease (CAD)
- Homozygous Familial Hypercholesterolaemia (HoFH)
- Hypertension
- Hypertension, Essential Hypertension
- Mixed Dyslipidemias
- Primary Hypercholesterolemia
- Vasospastic Angina
Research Report
Comprehensive Analysis of Amlodipine (DB00381): A Foundational Cardiovascular Therapeutic
Executive Summary
Amlodipine is a third-generation dihydropyridine calcium channel blocker (CCB) that stands as a cornerstone therapy in cardiovascular medicine. Its clinical utility is anchored in its unique pharmacokinetic profile, characterized by a slow onset of action and a long elimination half-life, which translates to sustained, 24-hour blood pressure control with once-daily dosing and a favorable tolerability profile compared to earlier CCBs. It is approved by the U.S. Food and Drug Administration (FDA) for the treatment of hypertension, chronic stable angina, and vasospastic angina. Furthermore, it holds a specific indication for reducing the risk of hospitalization for angina and the need for coronary revascularization procedures in patients with documented coronary artery disease (CAD). Its versatility is further demonstrated by its extensive use as a foundational component in numerous fixed-dose combination therapies, targeting multiple facets of cardiovascular risk. This report provides an exhaustive analysis of Amlodipine's chemical properties, pharmacological mechanisms, clinical evidence base, safety profile, and its comparative position within the broader class of antihypertensive agents.
Section 1: Molecular Profile and Pharmaceutical Formulations
1.1 Chemical Identity and Nomenclature
Amlodipine is a small molecule drug classified chemically as a fully substituted dialkyl 1,4-dihydropyridine-3,5-dicarboxylate derivative.[1] Its identity is precisely defined by established chemical and regulatory identifiers.
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
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2009/07/13 | Phase 1 | Completed | |||
2009/07/09 | N/A | UNKNOWN | |||
2009/07/03 | Phase 1 | Completed | |||
2009/07/03 | Phase 1 | Completed | |||
2009/06/16 | Phase 4 | Completed | Gulhane School of Medicine | ||
2009/05/01 | Phase 3 | Completed | Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company | ||
2009/04/08 | Phase 3 | Completed | |||
2009/03/27 | Phase 1 | Completed | |||
2009/03/27 | Phase 1 | Completed | |||
2009/03/12 | Phase 3 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Bryant Ranch Prepack | 71335-0934 | ORAL | 5 mg in 1 1 | 9/28/2022 | |
Northwind Pharmaceuticals, LLC | 51655-291 | ORAL | 5 mg in 1 1 | 4/17/2023 | |
Zydus Pharmaceuticals (USA) Inc. | 68382-428 | ORAL | 5 mg in 1 1 | 10/31/2020 | |
Physicians Total Care, Inc. | 54868-5523 | ORAL | 10 mg in 1 1 | 11/30/2009 | |
Novartis Pharmaceuticals Corporation | 0078-0562 | ORAL | 10 mg in 1 1 | 6/12/2019 | |
Aidarex Pharmaceuticals LLC | 33261-826 | ORAL | 2.5 mg in 1 1 | 11/20/2013 | |
Lupin Pharmaceuticals, Inc. | 68180-755 | ORAL | 2.5 mg in 1 1 | 1/29/2024 | |
Mylan Pharmaceuticals Inc. | 0378-4515 | ORAL | 5 mg in 1 1 | 1/26/2022 | |
A-S Medication Solutions | 50090-1039 | ORAL | 5 mg in 1 1 | 11/10/2021 | |
RPK Pharmaceuticals, Inc. | 53002-1804 | ORAL | 10 mg in 1 1 | 11/10/2021 |
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