Amlodipine Dosing in Children
For pediatric hypertension, start amlodipine at 2.5 mg once daily in children aged 6-17 years, with a maximum dose of 5 mg once daily, as doses exceeding 5 mg daily have not been studied in this population. 1
FDA-Approved Dosing
The FDA label provides clear guidance for pediatric patients:
- Age range: 6 to 17 years 1
- Starting dose: 2.5 mg once daily 1
- Maximum dose: 5 mg once daily 1
- Important limitation: Doses exceeding 5 mg daily have not been studied in pediatric patients 1
Weight-Based Dosing from Clinical Guidelines
For children requiring weight-based calculations, the American Heart Association and American Thoracic Society guidelines for pediatric pulmonary hypertension provide alternative dosing:
- Starting dose: 0.1-0.3 mg/kg/day orally 2
- Dose range: 2.5-7.5 mg/day orally 2
- Maximum adult dose: 10 mg/day orally 2
- Key principle: Always uptitrate from a lower dose 2
The 2011 Pediatrics guidelines for cardiovascular health recommend similar dosing for hypertension:
- Starting dose: 2.5 mg/day in children 6-17 years 3
- Maximum dose: 5 mg/day 3
- Dosing frequency: Once daily 3
- Important note: Doses up to 10 mg of amlodipine have been evaluated in children, though this exceeds FDA-approved dosing 3
Age-Specific Considerations
Younger children require higher weight-adjusted doses than older children. 4, 5, 6 This is due to significantly greater weight-adjusted clearance and volume of distribution in younger patients 5. Research demonstrates:
- Children <13 years required mean doses of 0.29±0.11 mg/kg/day 4
- Children ≥13 years required mean doses of 0.16±0.11 mg/kg/day 4
- An inverse relationship exists between patient age and required amlodipine dose 6
Dosing Frequency
Once-daily dosing is standard, though twice-daily dosing may be required in some children to achieve blood pressure control. 7, 6 Studies show:
- 55% of patients required twice-daily dosing for adequate control 6
- Amlodipine concentrations were similar in subjects dosed once or twice daily 5
- Dosing frequency did not appear to affect amlodipine concentrations 5
Formulation Options
Amlodipine can be compounded into stable extemporaneous suspensions for children unable to swallow tablets. 3 This is particularly useful for younger children who cannot take solid dosage forms 6.
Common Pitfalls to Avoid
- Do not exceed 5 mg daily in children 6-17 years without clear justification, as this exceeds FDA-studied doses 1
- Do not use adult starting doses (5 mg) in small or young children—begin at 2.5 mg 1
- Monitor for peripheral edema, headache, fatigue, and dizziness, which are the most common adverse effects 2, 4, 7
- Expect dose adjustments in younger children, who metabolize the drug more rapidly 5
- Wait 7-14 days between dose titrations to assess response, though more rapid titration is acceptable with frequent monitoring 1
Safety Profile
Amlodipine demonstrates an acceptable safety profile in children with adverse effects including:
- Fatigue (most common) 4, 7
- Headache 4
- Facial flushing 4
- Dizziness 4, 7, 6
- Peripheral edema 4, 7, 6
- Bradycardia and decreased cardiac output (less common) 2
Discontinuation due to adverse effects is rare, occurring in only 3-12.5% of patients in clinical studies 7, 6.