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Amlodipine

Generic Name
Amlodipine
Brand Names
Amlobenz, Azor, Caduet, Dafiro, Exforge, Exforge Hct, Katerzia, Lotrel, Norliqva, Norvasc, Prestalia, Tribenzor, Twynsta, Viacoram
Drug Type
Small Molecule
Chemical Formula
C20H25ClN2O5
CAS Number
88150-42-9
Unique Ingredient Identifier
1J444QC288

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 .

Background

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

FDA Approved Products

olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Manufacturer:Par Pharmaceutical, Inc.
Route:ORAL
Strength:10 mg in 1 1
Approved: 2023/10/10
NDC:49884-790
Amlodipine Besylate
Manufacturer:REMEDYREPACK INC.
Route:ORAL
Strength:2.5 mg in 1 1
Approved: 2024/02/02
NDC:70518-1971
AMLODIPINE BESYLATE 5 mg
Manufacturer:Bi‐Coastal Pharma International LLC
Route:ORAL
Strength:5 mg in 1 1
Approved: 2019/01/09
NDC:42582-314
AMLODIPINE BESYLATE
Manufacturer:REMEDYREPACK INC.
Route:ORAL
Strength:10 mg in 1 1
Approved: 2023/12/12
NDC:70518-0297
AMLODIPINE BESYLATE 2.5 mg
Manufacturer:Bi‐Coastal Pharma International LLC
Route:ORAL
Strength:2.5 mg in 1 1
Approved: 2019/01/09
NDC:42582-313

Singapore Approved Products

AMLOPIN TABLET 10MG
Manufacturer:Intas Pharmaceuticals Limited
Form:TABLET
Strength:10mg
Online:Yes
Approved: 2018/05/28
Approval:SIN15497P
SWAMLO TABLETS 5MG
Manufacturer:Ind-Swift Limited
Form:TABLET
Strength:5mg
Online:Yes
Approved: 2012/07/04
Approval:SIN14186P
Azoren Film-Coated Tablet 20mg/5mg
Manufacturer:Daiichi Sankyo Europe GmbH, Pfizer Manufacturing Deutschland GmbH (primary and secondary packager)
Form:TABLET, FILM COATED
Strength:5mg
Online:Yes
Approved: 2011/06/06
Approval:SIN13964P
Azoren Film-Coated Tablet 40mg/5mg
Manufacturer:Daiichi Sankyo Europe GmbH, Pfizer Manufacturing Deutschland GmbH (primary and secondary packager)
Form:TABLET, FILM COATED
Strength:5mg
Online:Yes
Approved: 2011/06/06
Approval:SIN13965P
Azoren Film-Coated Tablet 40mg/10mg
Manufacturer:Daiichi Sankyo Europe GmbH, Pfizer Manufacturing Deutschland GmbH (primary and secondary packager)
Form:TABLET, FILM COATED
Strength:10mg
Online:Yes
Approved: 2011/06/06
Approval:SIN13966P

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