Focalin XR Starting Dose for an 8-Year-Old
For an 8-year-old child who is new to methylphenidate treatment, start with Focalin XR 5 mg once daily in the morning. 1
Dosing Based on Prior Methylphenidate Exposure
For Patients New to Methylphenidate (Most Relevant for Your Question)
- Pediatric patients should start with 5 mg orally once daily in the morning, with or without food 1
- This is the FDA-approved starting dose for children not currently taking any methylphenidate formulation 1
For Patients Currently on Methylphenidate
- If the child is already taking racemic methylphenidate (e.g., Ritalin), the starting dose of Focalin XR should be half (1/2) the total daily dose of the racemic methylphenidate 1
- If switching from immediate-release dexmethylphenidate (Focalin IR), use the same total daily dose as Focalin XR 1
Titration and Maximum Dosing
- Titrate weekly in increments of 5 mg based on clinical response and tolerability 1
- Maximum recommended daily dose in pediatric patients is 30 mg 1
- Doses above 30 mg in children have not been studied and are not recommended 1
Administration Considerations
- Administer once daily in the morning 1
- The capsule may be swallowed whole or opened and sprinkled on applesauce for children who cannot swallow capsules 1
- If using the sprinkle method, the applesauce should be consumed immediately without chewing the beads 1
- Do not divide the contents of a single capsule—the entire capsule contents must be taken 1
Clinical Efficacy Evidence
The 5 mg starting dose has demonstrated efficacy in clinical trials:
- In a fixed-dose study of children with ADHD, 10 mg once daily (which would be reached after one titration from the 5 mg starting dose) showed significant improvement in ADHD symptoms compared to placebo 2
- The bimodal release formulation provides two distinct plasma concentration peaks, mimicking twice-daily dosing with a single morning administration 3, 4
- Duration of effect ranges from 6-7.5 hours based on teacher and parent assessments 5
Important Pretreatment Screening
Before initiating Focalin XR, assess for:
- Cardiac disease through careful history, family history of sudden death or ventricular arrhythmia, and physical examination 1
- Family history of tics or Tourette's syndrome 1
Common Pitfall to Avoid
Do not start with 10 mg in pediatric patients—this is the adult starting dose. The FDA label clearly distinguishes that pediatric patients should start at 5 mg, while adults start at 10 mg 1. Starting too high increases the risk of adverse effects such as decreased appetite, insomnia, and irritability without improving efficacy 2.