2.1 Pretreatment Screening

Prior to initiating treatment with ADHANSIA 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 (5.2)].

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, and periodically re-evaluate the need for ADHANSIA XR use [see Boxed Warning, Warnings and Precautions (5.1), and Drug Abuse and Dependence (9)].

2.2 General Dosing Information

Administer ADHANSIA XR orally once daily in the morning with or without food.

The recommended starting dose of ADHANSIA XR for patients 6 years or older is 25 mg once daily. Titrate the dose in increments of 10 to 15 mg at intervals of no less than 5 days. Dosages higher than 100 mg daily in adults and 85 mg daily in pediatric patients have not been evaluated in clinical trials and are not recommended. Although efficacy was demonstrated in short-term controlled trials in adults at dosages of 100 mg daily, dosages above 85 mg daily were associated with a disproportionate increase in the incidence of certain adverse reactions. In short-term controlled trials in pediatric patients, efficacy was demonstrated at dosages of 70 mg daily, but dosages 70 mg daily and higher were associated with a disproportionate increase in the incidence of certain adverse reactions [see Adverse Reactions (6.1), Clinical Studies (14)]. Individualize dosage adjustments based upon assessment of clinical benefit and tolerability with careful consideration of the dose-related adverse reactions.

ADHANSIA XR may be taken whole or the capsule may be opened and the entire contents sprinkled onto a tablespoon of applesauce or yogurt. The entire mixture should be consumed immediately or within 10 minutes. If the mixture is not consumed within 10 minutes after mixing, it should be discarded and not stored. Patients should take the entire contents of the capsule sprinkled on the chosen food in its entirety, without chewing. The dose of a single capsule should not be divided. Patients should not take anything less than one capsule per day.

In the event of a missed dose, do not administer later in the day. Do not administer additional medication to make up for the missed dose [see Adverse Reactions (6.1), Clinical Studies (14)].

Pharmacological treatment of ADHD may be needed for extended periods. Periodically re-evaluate the long-term use of ADHANSIA XR, and adjust dosage as needed.

2.3 Dose Reduction and Discontinuation

If paradoxical aggravation of symptoms or other adverse reactions occur, reduce the dosage, or, if necessary, discontinue the drug. ADHANSIA XR should be periodically discontinued to assess the patient's condition. If improvement is not observed after appropriate dosage adjustment over a one-month period, discontinue ADHANSIA XR.

2.4 Switching from Other Methylphenidate Products

If switching from other methylphenidate products, discontinue that treatment, and titrate with ADHANSIA XR using the titration schedule above.

Do not substitute ADHANSIA XR for other methylphenidate products on a milligram-per-milligram basis because of different methylphenidate base compositions and differing pharmacokinetic profiles [see Description (11) and Clinical Pharmacology (12.3)].