Amlodipine besylate

(Norvasc®)

Norvasc®

Drug updated on 9/4/2024

Dosage FormTablet (oral: 2.5 mg, 5 mg, 10 mg)
Drug ClassCalcium channel blockers
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • For the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
  • For the treatment of 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%.

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Summary
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  • Norvasc (amlodipine besylate) is indicated for the treatment of hypertension to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It is also indicated for the treatment of coronary artery disease, chronic stable angina, vasospastic angina (Prinzmetal's or variant angina), and angiographically documented coronary artery disease in patients without heart failure or with an ejection fraction less than 40%.
  • This summary is based on the review of eight systematic review(s)/meta-analysis(es). [1-8]
  • Perindopril/Amlodipine FDC and Hypertension: The combination therapy significantly reduced systolic and diastolic blood pressure, pulse pressure, mean blood pressure, and heart rate, with efficacy increasing at higher doses. This combination also improved patient adherence with minimal side effects, outperforming monotherapy and placebo in blood pressure response and normalization.
  • Amlodipine for Vasospastic Angina (VSA): Amlodipine reduced VSA episodes by 17% to 33% after 6 weeks of treatment.
  • ARB-Amlodipine Combinations in Hypertension: Various ARB-amlodipine combinations were more effective in achieving treatment response compared to amlodipine monotherapy, with azilsartan-amlodipine showing the most favorable response.
  • Perindopril/Amlodipine Fixed-Dose Combination (FDC): Mild adverse reactions were observed in a small subset of participants; however, no detailed breakdown of specific adverse effects was provided.
  • Dihydropyridine Calcium Channel Blockers (DHPCCBs): Peripheral edema was commonly observed, particularly with nifedipine. Combining DHPCCBs with renin-angiotensin system blockers reduced this risk. Nifedipine had the highest rank for inducing peripheral edema, while lacidipine had the least.
  • ARB-Amlodipine Combinations: These combinations generally had safety profiles comparable to amlodipine monotherapy, with telmisartan-amlodipine showing significantly lower odds of treatment-emergent adverse events.
  • The studies primarily focused on hypertensive patients, with a particular emphasis on the Asian population for ARB-amlodipine combinations. Higher doses of the perindopril-amlodipine combination were associated with increased efficacy in blood pressure control. There is no additional subgroup information related to age, gender, or comorbid conditions available.

Product Monograph / Prescribing Information

Document TitleYearSource
Norvasc (amlodipine besylate) Prescribing Information.2019Pfizer Labs, Div of Pfizer Inc., NY

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines