QUILLIVANT XR CII

Indication(s):

Attention deficit hyperactivity disorder (ADHD).

Pharmacology:

Methylphenidate is a racemic mixture comprised of the d-and l-isomers. The d-isomer is more pharmacologically active than the l-isomer. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

Clinical Trials:

The efficacy of Quillivant XR was evaluated in a laboratory classroom study conducted in 45 pediatric patients (ages 6–12 years) with ADHD. The study began with an open-label dose optimization period (4–6 weeks) with an initial Quillivant XR dose of 20mg once daily in the morning. The dose could be titrated weekly in increments of 10 or 20mg until an optimal dose or the maximum dose of 60mg/day was reached. Subjects then entered a 2-week randomized, double-blind, crossover treatment with the individually optimized dose of Quillivant XR or placebo. At the end of each week, school teachers and raters evaluated the attention and behavior of the subjects in a laboratory classroom using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale. The primary efficacy endpoint was the SKAMP-Combined score at 4 hours post-dosing. The key secondary efficacy endpoints were the SKAMP-Combined scores at 0.75, 2, 8, 10, and 12 hours post-dosing. Results from the first double-blind, placebo-controlled week of the study demonstrated that the SKAMP-Combined scores were statistically significantly lower (improved) at all time points (0.75, 2, 4, 8, 10, 12 hours) post- dosing with Quillivant XR compared to placebo.

Legal Classification:

CII

Contraindication(s):

During or within 14 days of MAOIs.

Adults & Children:

<6yrs: not established. ≥6yrs: Individualize. Shake bottle for 10 secs before use. Initially 20mg once daily in the morning. May increase by 10–20mg per week if needed; max 60mg daily.

Warnings/Precautions:

Risk of potential abuse and dependence; monitor. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, and other cardiac problems; evaluate if chest pain, unexplained syncope, or arrhythmias develop. Monitor for hypertension and tachycardia. May exacerbate behavior disturbances, thought disorders in pre-existing psychotic disorder. Depression. Bipolar disorder. History of suicide. Monitor growth (esp. children). Reduce dose or discontinue if paradoxical aggravation occurs. Reassess periodically. Neonates. Pregnancy (Cat. C). Nursing mothers: not recommended.

Interaction(s)

See Contraindications. Concomitant MAOIs can cause hypertensive crisis.

Adverse Reaction(s)

Appetite decreased, insomnia, GI upset, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, blood pressure increased; hypersensitivity reactions.

How Supplied:

Bottles (w. oral dosing dispenser)—60mL, 120mL, 180mL

LAST UPDATED:

1/30/2013