2.1 Pretreatment Screening

Prior to initiating treatment with RELEXXII, 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 RELEXXII use [see Boxed Warning, Warning and Precautions (5.1), Drug Abuse and Dependence (9)].

2.2 General Administration Information

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

Swallow RELEXXII whole with liquid. Do not chew, divide, or crush [see Warnings and Precautions (5.8)].

2.3 Dosage Recommendations for Patients New to Methylphenidate

Table 1 includes the starting dosage and dosage recommendations for RELEXXII in pediatric patients 6 to 17 years and adults who are not currently taking methylphenidate or other stimulants.

Table 1: Dosage Recommendations for RELEXXII in Pediatric Patients 6 to 17 years and Adults

Pharmacological treatment of ADHD may be needed for extended periods. Periodically reevaluate the long-term use of RELEXXII and adjust dosage as needed.

2.4 Dosage Recommendations for Patients Currently Using Methylphenidate

The recommended starting dosage of RELEXXII for patients who are currently taking methylphenidate twice daily or three times daily at doses of 10 mg to 60 mg daily is provided in Table 2.

Table 2. Recommended Starting Dosage when Converting from Methylphenidate Regimens to RELEXXII

2.5 Dose Titration

Doses may be increased in 18 mg increments at weekly intervals for patients who have not achieved clinical response at a lower dose. Daily dosages above 54 mg in pediatric patients 6 to 12 years and above 72 mg in pediatric patients 13 to 17 years have not been studied and are not recommended. Daily dosages above 72 mg are not recommended in adults.

Dosage strengths of 27 mg, 45 mg, and 63 mg are available for additional titration options based on clinical response.

2.6 Dose Reduction and Discontinuation

If paradoxical aggravation of symptoms or other adverse effects occur, reduce the dosage, or, if necessary, discontinue RELEXXII.

If improvement is not observed after appropriate dosage adjustment over a one-month period, discontinue RELEXXII.