Dosage and Administration
The recommended starting dose of Quillivant XRTM (methylphenidate HCl) is 20 mg once daily in the morning. The dose may be titrated weekly in increments of 10 to 20 mg. The maximum recommended dose is 60 mg/day. Quillivant XR must be shaken vigorously for at least 10 seconds before each use.
General Dosing Information
Quillivant XR™ (methylphenidate HCl) 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).
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.
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 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.
Product Reconstitution Instructions
Store reconstituted Quillivant XR at 25oC (77oF); excursions permitted from 15o to 30oC
(59o to 86oF). Dispense in original container, or other tight, light-resistant container. Quillivant XR is stable for up to 4 months after reconstitution.
*Terms and Conditions apply.
This co-pay card is not health insurance The co-pay card is available only at participating pharmacies. For any questions, please call 1-800-932-4371, or write: Pfizer, ATTN: Quillivant XR, PO Box 2049, Morrisville, PA 19067-8025
No membership fees required./ Average co-pay savings per patient per year is $X. The maximum limit is $900 per year or the amount of the co-pay you paid, whichever is less
IMPORTANT SAFETY INFORMATION
WARNING: ABUSE AND DEPENDENCE
CNS stimulants, including Quillivant XR, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.
- Quillivant XR is contraindicated:
- In patients known to be hypersensitive to methylphenidate or other components of Quillivant XR. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported.
- During treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with an MAOI because of the risk of hypertensive crisis.
- Stroke and myocardial infarction have occurred in adults treated with CNS stimulants at recommended doses. Sudden death has occurred in children and adolescents with structural cardiac abnormalities and other serious cardiac problems, and in adults taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during treatment with Quillivant XR.
- CNS stimulants cause an increase in blood pressure (mean increase approximately 2-4 mm Hg) and heart rate (mean increase approximately 3-6 bpm). Some individuals may have larger increases. Monitor all patients for hypertension and tachycardia.
- Use of stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychiatric illness. Evaluate for bipolar disorder prior to Quillivant XR use.
- Cases of painful and prolonged penile erections and priapism have been reported with methylphenidate products. Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or priapism are observed.
- Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Careful observation for digital changes is necessary during treatment with ADHD stimulants.
- CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Growth should be monitored during treatment with stimulants, including Quillivant XR. Patients who are not growing or gaining weight as expected may need to have their treatment interrupted.
- Based on accumulated data from other methylphenidate products, the most common (≥5% and twice the rate of placebo) adverse reactions are appetite decreased, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, and blood pressure increased. There is limited experience with Quillivant XR in controlled trials. Based on this limited experience, the adverse reaction profile of Quillivant XR appears similar to other methylphenidate extended-release products. The most common (≥2% in the Quillivant XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 45 ADHD patients (aged 6-12 years) were affect lability (9%), excoriation (4%), initial insomnia (2%), tic (2%), decreased appetite (2%), vomiting (2%), motion sickness (2%), eye pain (2%), and rash (2%).
- Based on animal data, use of Quillivant XR during pregnancy may cause fetal harm. Quillivant XR should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- Nursing mothers should be advised to discontinue drug or discontinue nursing, taking into consideration the importance of the drug to the mother because methylphenidate is present in human milk.
Quillivant XR is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The efficacy of Quillivant XR was established in a 2-week, placebo-controlled trial in children aged 6 to 12 years with a diagnosis of ADHD. Accumulated efficacy data from other methylphenidate products were also considered.
Please see full Prescribing Information and Medication Guide, including BOXED WARNING regarding Abuse and Dependence.
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