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
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2005/09/15 | Phase 4 | Completed | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | ||
2005/09/15 | Phase 4 | Completed | |||
2005/09/12 | Phase 1 | Completed | |||
2005/09/12 | Phase 4 | Completed | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | ||
2005/09/12 | Phase 4 | Completed | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | ||
2005/09/09 | Phase 2 | Terminated | Rennes University Hospital | ||
2005/09/02 | Phase 4 | Completed | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | ||
2005/08/31 | Phase 4 | Completed | |||
2005/08/29 | Phase 4 | Completed | |||
2005/08/29 | Phase 4 | Completed |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Unichem Pharmaceuticals (USA), Inc. | 29300-398 | ORAL | 10 mg in 1 1 | 12/5/2022 | |
Daiichi Sankyo, Inc. | 65597-114 | ORAL | 5 mg in 1 1 | 6/7/2022 | |
Proficient Rx LP | 71205-596 | ORAL | 5 mg in 1 1 | 6/1/2022 | |
NuCare Pharmaceuticals,Inc. | 68071-4870 | ORAL | 5 mg in 1 1 | 4/25/2019 | |
Lupin Pharmaceuticals, Inc. | 68180-721 | ORAL | 10 mg in 1 1 | 1/12/2024 | |
NuCare Pharmaceuticals,Inc. | 68071-2312 | ORAL | 5 mg in 1 1 | 9/7/2022 | |
Zydus Lifesciences Limited | 65841-621 | ORAL | 5 mg in 1 1 | 9/18/2023 | |
Legacy Pharmaceutical Packaging, LLC | 68645-516 | ORAL | 10 mg in 1 1 | 12/8/2023 | |
Zydus Pharmaceuticals (USA) Inc. | 68382-432 | ORAL | 10 mg in 1 1 | 10/31/2020 | |
Apotex Corp. | 60505-3488 | ORAL | 5 mg in 1 1 | 2/24/2023 |
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Help Us Improve
Your feedback helps us provide better drug information and insights.