"The U.S. Food and Drug Administration today allowed marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old. When used as part of "...
QUILLIVANT XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The efficacy of QUILLIVANT XR was established in a 2-week, placebo-controlled, laboratory classroom, crossover study in children aged 6-12 years with a diagnosis of ADHD. Patients in the trial met DSM-IV® criteria for ADHD. Accumulated efficacy data from other methylphenidate products were also considered [see Clinical Studies].
DOSAGE AND ADMINISTRATION
General Dosing Information
QUILLIVANT XR should be orally administered once daily in the morning with or without food. The dose should be individualized according to the needs and responses of the patient. Before administering the dose, vigorously shake the bottle of QUILLIVANT XR for at least 10 seconds, to ensure that the proper dose is administered.
The recommended starting dose of QUILLIVANT XR for patients 6 years and above is 20 mg once daily in the morning. 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.
There is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with QUILLIVANT XR. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. The effectiveness of QUILLIVANT XR for longer-term use has not been systematically evaluated in controlled trials. The physician who elects to use QUILLIVANT XR for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with trials off medication to assess the patient's functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
Dose Reduction And Discontinuation
If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug. QUILLIVANT XR should be periodically discontinued to assess the child's condition. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
Important Information Prior To Initiating Treatment
Prior to treating children, adolescents, and adults with CNS stimulants including QUILLIVANT XR, assess for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see WARNINGS AND PRECAUTIONS].
Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically re-evaluate the need for QUILLIVANT XR use [see BOXED WARNING, WARNINGS AND PRECAUTIONS, and Drug Abuse and Dependence].
Reconstitution Instructions For The Pharmacist
QUILLIVANT XR is supplied as a powder for oral suspension which must be reconstituted with water prior to dispensing. Preparation instructions: Tap bottle until powder flows freely. Remove bottle cap, and add specified amount of water to the bottle (see Table 1 below). Insert bottle adapter into neck of bottle. Replace bottle cap. Shake with vigorous back and forth motion for at least 10 seconds to prepare suspension.
Table 1: Product Reconstitution Instructions
|Amount of drug in bottle||Amount of water to add to bottle||Final reconstituted volume (yield)|
|300 mg||53 mL||60 mL|
|600 mg||105 mL||120 mL|
|750 mg||131 mL||150 mL|
|900 mg||158 mL||180 mL|
Store reconstituted QUILLIVANT XR at 25°C (77°F); excursions permitted from 15° to 30°C (59° to 86°F). Dispense in original container. QUILLIVANT XR is stable for up to 4 months after reconstitution.
Dosage Forms And Strengths
Extended-release oral suspension (after reconstitution with water): 25 mg per 5 mL (5 mg per mL).
QUILLIVANT XR is supplied as powder that, after reconstitution with water, forms an extended-release oral suspension. The product is supplied in a carton. Each carton also contains one bottle, one oral dosing dispenser, and one bottle adapter.
The product must be reconstituted only by the pharmacist and not by the patient or caregiver. After reconstitution, the product is a light beige to tan viscous suspension containing 25 mg per 5 mL (5 mg per mL) of methylphenidate hydrochloride.
Bottles of 300 mg powder (to
prepare 60 mL suspension)…………. NDC 24478-190-10
Bottles of 600 mg powder (to prepare 120 mL suspension)………... NDC 24478-200-20
Bottles of 750 mg powder (to prepare 150 mL suspension)………... NDC 24478-205-25
Bottles of 900 mg powder (to prepare 180 mL suspension)………... NDC 24478-210-30
Storage And Handling
Store at 25°C (77°F); excursions permitted from 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Dispense in original container. Disposal Comply with laws and regulations on drug disposal. Use a medicine take-back program if available.
Distributed by: NextWave Pharmaceuticals, Inc., A subsidiary of Pfizer Inc., New York, NY 10017. Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852. Revised: Dec 2013
Last reviewed on RxList: 2/14/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Quillivant XR Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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