Maximum Dose of Amlodipine
The maximum recommended dose of amlodipine is 10 mg once daily for adults in standard clinical practice, as established by FDA labeling and major cardiology guidelines. 1
Standard Adult Dosing
- The FDA-approved maximum dose is 10 mg once daily for hypertension, angina, and coronary artery disease. 1
- The American College of Cardiology recommends amlodipine at doses of 2.5-10 mg once daily for adults, confirming 10 mg as the upper limit for routine use. 2
- Initial dosing typically starts at 5 mg once daily, with titration to 10 mg if blood pressure goals are not achieved after 7-14 days. 1
Pediatric Maximum Dose
- For children aged 6-17 years, the maximum dose is 5 mg once daily. 3, 1
- The American Academy of Pediatrics explicitly states that doses exceeding 5 mg daily are not recommended in pediatric patients due to lack of safety and efficacy studies in this population. 3
- Amlodipine should not be used in children under 6 years of age. 3
Special Populations Requiring Lower Starting Doses
- Small, fragile, or elderly patients should start at 2.5 mg once daily, though they can still be titrated up to the standard 10 mg maximum if needed. 1
- Patients with hepatic insufficiency should also begin at 2.5 mg once daily, with careful upward titration as tolerated. 1
Off-Label Higher Dosing (Specialized Context Only)
- For idiopathic pulmonary arterial hypertension (IPAH) in vasoreactive patients, the European Society of Cardiology suggests doses up to 20 mg daily may be used, though this is off-label. 3
- This higher dosing is reserved exclusively for carefully selected IPAH patients who demonstrate positive acute vasodilator response during right heart catheterization. 3
- This is NOT applicable to routine hypertension or angina management.
Drug Interaction Considerations
- When coadministered with simvastatin or lovastatin, the American Heart Association advises that amlodipine doses should not exceed 20 mg daily due to increased statin exposure and myopathy risk. 3
- This represents a safety ceiling rather than a therapeutic recommendation for standard cardiovascular indications.
Clinical Efficacy Data Supporting Maximum Dose
- Dose-ranging studies demonstrate that 10 mg once daily achieves target blood pressure in approximately 73% of patients with mild to moderate hypertension, compared to 56% with 5 mg. 4
- For coronary artery disease and chronic stable angina, the majority of patients require 10 mg for adequate therapeutic effect. 1
- Research shows 83% of angina patients required dose escalation from 5 mg to 10 mg for optimal symptom control. 5
Important Caveats
- The long half-life of amlodipine (30-50 hours) supports true once-daily dosing and means steady-state is not reached for 7-14 days, so avoid premature dose escalation. 3, 2
- Titration should generally wait 7-14 days between dose adjustments to allow full pharmacodynamic effect, though more rapid titration is acceptable if clinically warranted with frequent patient assessment. 1