Adderal XR

[Amphetamine Mixed Salts]

Food does not affect the extent of absorption of ADDERALL XRª capsules, but prolongs T max by 2.5 hours (from 5.2 hrs at fasted state to 7.7 hrs after a high-fat meal). Opening the capsule and sprinkling the contents on applesauce results in comparable absorption to the intact capsule taken in the fasted state.

Special Populations

Pediatric

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Patients Children eliminated amphetamine faster than adults. The elimination half-life (t1/ 2) is approximately 1 hour shorter for d-amphetamine and 2 hours shorter for l-amphetamine in children than in adults. However, children had higher systemic exposure to amphetamine (C max and AUC) than adults for a given dose of ADDERALL XRª, which was attributed to the higher dose administered to children on a mg/ kg body weight basis compared to adults. Upon dose normalization on a mg/ kg basis, children showed 30% less systemic exposure compared to adults.

Gender

Systemic exposure to amphetamine was 20-30% higher in women (N= 20) than in men (N= 20) due to the higher dose administered to women on a mg/ kg body weight basis. When the exposure parameters (C max and AUC) were normalized by dose (mg/ kg), these differences diminished.

Race

Formal pharmacokinetic studies for race have not been conducted. However, amphetamine pharmacokinetics appeared to be comparable among Caucasians (N= 33), Blacks (N= 8) and Hispanics (N= 10).

Clinical Trials

A double-blind, randomized, placebo-controlled, parallel-group study was conducted in children aged 6-12 (N= 584) who met DSM-IV criteria for ADHD (either the combined type or the hyperactive-impulsive type).

Patients were randomized to fixed dose treatment groups receiving final doses of 10, 20, or 30 mg of ADDERALL XRª or placebo once daily in the morning for three weeks. Significant improvements in patient behavior, based upon teacher ratings of attention and hyperactivity, were observed for all ADDERALL XRª doses compared to patients who received placebo, for all three weeks, including the first week of treatment, when all ADDERALL XRª subjects were receiving a dose of 10 mg/ day. Patients who received ADDERALL XRª showed behavioral improvements in both morning and afternoon assessments compared to patients on placebo.

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