Abstract
Background:
Children and adolescents are being treated increasingly for attention-deficit/hyperactivity disorder (ADHD) with a variety of stimulants in higher than Food and Drug Administration (FDA)–approved doses and in combination with other medications.
Objective:
We sought to determine methylphenidate (MPH) concentrations in children and adolescents treated with high-dose, extended-release osmotic release oral system (OROS) MPH plus concomitant medications, and to examine MPH concentrations with respect to the safety and tolerability of treatment.
Methods:
Plasma MPH concentrations were measured by liquid chromatography–mass spectrometry 4–5 hours after administration of medication in a sample of youths diagnosed with ADHD. These youths were treated naturalistically with higher than FDA-approved doses of OROS MPH in addition to their concomitant medications. Markers of safety and tolerability (e.g., measures of blood pressure and heart rate) were also examined.
Results:
Among the 17 patients (with a mean age of 16.2 ± 2 years and a mean number of concurrent medications of 2.23 ± 0.94), the mean plasma MPH concentration was 28 ± 9.1 ng/mL, despite a mean daily dose of OROS MPH of 169 ± 5 mg (3.0 ± 0.8 mg/kg per day). No patient had a plasma MPH level ≥50 ng/mL or clinical signs of stimulant toxicity. No correlation was found between plasma MPH concentrations and OROS MPH dose or changes in vital signs.
Conclusions:
High-dose OROS MPH, used in combination with other medications, was not associated with either unusually elevated plasma MPH concentrations or with clinically meaningful changes in vital signs. Study limitations include a single time-point sampling of MPH concentrations, a small sample size, and a lack of outcome measures to address treatment effectiveness.
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