What are the guidelines for amlodipine (calcium channel blocker) therapy?

From the Guidelines

Amlodipine should be used as a first-line calcium channel blocker for the management of hypertension, at an initial dose of 5 mg once daily, with a maximum dose of 10 mg daily, as recommended by the most recent guidelines 1.

Key Considerations for Amlodipine Use

• The medication should be taken at the same time each day with or without food, and patients should not abruptly discontinue use.
• Common side effects include peripheral edema, dizziness, flushing, and headache.
• Patients should monitor for severe side effects such as significant hypotension, worsening chest pain, or allergic reactions.
• Amlodipine works by blocking calcium channels in blood vessels, causing them to relax and widen, which reduces blood pressure and improves blood flow.

Special Populations

• For elderly patients or those with hepatic impairment, starting at 2.5 mg daily is recommended.
• Amlodipine may be considered in the management of hypertension or ischemic heart disease in patients with heart failure because it is generally well tolerated and had neutral effects on morbidity and mortality in large RCTs 1.

Monitoring and Lifestyle Modifications

• Regular blood pressure monitoring is essential to ensure the medication is effectively controlling hypertension.
• Patients should continue other prescribed heart-healthy measures like diet, exercise, and smoking cessation while taking amlodipine.
• It may take 1-2 weeks to see initial effects, with maximum benefit occurring after 2-4 weeks of consistent use.

Guideline Recommendations

• The use of amlodipine as a first-line calcium channel blocker is supported by the 2021 guideline-driven management of hypertension update 1.
• The guidelines recommend using fixed-dose combinations, substituting long-acting chlorthalidone for hydrochlorothiazide, and using long-acting amlodipine as a first-line calcium channel blocker.

From the FDA Drug Label

The effectiveness of 5 to 10 mg/day of amlodipine in exercise-induced angina has been evaluated in 8 placebo-controlled, double-blind clinical trials of up to 6 weeks duration involving 1038 patients (684 amlodipine, 354 placebo) with chronic stable angina In 5 of the 8 studies, significant increases in exercise time (bicycle or treadmill) were seen with the 10 mg dose. Amlodipine has been evaluated for safety in more than 11,000 patients in U. S. and foreign clinical trials. In general, treatment with amlodipine was well-tolerated at doses up to 10 mg daily.

Guidelines for Amlodipine:

• The recommended dose for amlodipine is 5 to 10 mg/day for the treatment of exercise-induced angina.
• Amlodipine has been shown to be effective in increasing exercise time and reducing angina attacks.
• The most common adverse reactions reported with amlodipine are edema, dizziness, flushing, and palpitations.
• Amlodipine is generally well-tolerated, but may cause adverse reactions such as peripheral edema, fatigue, and nausea.
• The incidence of adverse reactions may be higher in women than men, particularly for edema, flushing, and palpitations.
• Amlodipine has not been associated with clinically significant changes in routine laboratory tests. 2 2

From the Research

Guidelines for Amlodipine

• Amlodipine is a dihydropyridine calcium channel blocker that has been widely used for the treatment of hypertension 3.
• The use of amlodipine in combination with other antihypertensive agents, such as perindopril, has been shown to be effective in reducing blood pressure and cardiovascular complications 4, 5.
• Amlodipine has been found to be at least as efficacious as other classes of antihypertensive agents in reducing systolic and diastolic blood pressure 6.
• The efficacy of amlodipine is increased by increasing the dose, as shown in a meta-regression analysis 4.
• Amlodipine should be considered a first-line antihypertensive agent due to its good efficacy and safety profile, as well as strong evidence from large randomized controlled trials for cardiovascular event reduction 3.

Safety Evaluation

• The most common adverse effects of amlodipine are peripheral edema, cough, dizziness, and hypotension 7.
• The incidence of adverse effects reported in clinical trials is lower than expected, likely due to exclusion of subjects previously exposed to its components 7.
• Amlodipine can cause dose-dependent hyperkalemia, impairment of renal function, angioedema, and teratogenicity, although these effects are rare 7.

Combination Therapy

• The combination of perindopril and amlodipine has been shown to be effective in reducing blood pressure and cardiovascular complications, and is a useful option for the treatment of hypertension 4, 5.
• The fixed-dose combination of perindopril arginine and amlodipine besylate is a novel formulation that has been approved for the treatment of hypertension, and has been shown to be safe and effective 5, 7.