Quillivant XR (methylphenidate hydrochloride)

Company
NextWave Pharmaceuticals

Approval Status
Approved September 2012

Treatment for
Attention Deficit Hyperactivity Disorder

Areas
Neurology & Nervous System , Pediatrics , Psychiatry / Psychiatric

Quillivant XR is a once daily, extended-release liquid formulation of methylphenidate HCL, a central nervous system stimulant.

Quillivant XR is specifically approved for the treatment of Attention Deficit Hyperactivity Disorder in children.

Quillivant XR is supplied as a liquid solution designed for oral administration. The recommended dose of Quillivant XR for patients 6 years and above is 20 mg orally once daily in the morning with or without food. The dose may be titrated weekly in increments of 10 mg to 20 mg. Daily doses above 60 mg have not been studied and are not recommended. Before administering the dose, vigorously shake the bottle of Quillivant XR for at least 10 seconds, to ensure that the proper dose is administered.

FDA Approval
The FDA approval of Quillivant XR was based on a randomized, double-blind, placebo-controlled, crossover, multicenter, laboratory classroom study of 45 pediatrics (ages 6 to 12 years) with ADHD. There was an open-label dose optimization period (four to six weeks) with an initial 20mg dose of Quillivant XR once daily in the morning. The dose was titrated weekly in 10 or 20mg increments until an optimal dose or maximum dose of 60mg per day was reached. Subjects then entered a two-week double-blind, crossover treatment of the individually optimized dose of Quillivant XR or placebo. At the end of each week, the attention and behavior of the patients in a laboratory classroom were evaluated using the SKAMP rating scale. Quillivant XR significantly improved ADHD symptoms compared to placebo at the primary endpoint of four hours post-dose, and in a secondary analysis, showed significant improvement at every time point measured, from 45 minutes to 12 hours after dosing.

Adverse effects associated with the use of Quillivant XR may include, but are not limited to, the following:

  • appetite decreased
  • insomnia
  • nausea
  • vomiting
  • dyspepsia
  • abdominal pain
  • weight decreased
  • anxiety
  • dizziness
  • irritability
  • affect lability
  • tachycardia
  • blood pressure increased

Quillivant XR is a once daily, extended-release liquid formulation of methylphenidate HCL, a central nervous system stimulant. The exact mechanism of action in ADHD is unknown. The drug 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.

For additional information regarding Quillivant XR or ADHD, please visit the Quillivant XR web page.

Quillivant XR (methylphenidate hydrochloride) Drug Information

The Quillivant XR (methylphenidate hydrochloride) drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.

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