Methylphenidatedosage

Administer once daily in the morning with or without food. Swallow whole with liquid. Do not chew, divide, or crush. Recommended dosage for patients new to methylphenidate: Pediatric patients 6 to 17 years Starting dosage is 18 mg once daily. Dosage may be increased by 18 mg once per day at weekly intervals. Maximum dosage for pediatric patients 6 to 12 years: 54 mg once daily. Maximum dosage for pediatric patients 13 to 17 years: 72 mg once daily. Adults (up to 65 years) Starting dosage is 18 mg or 36 mg once daily. Dosage may be increased by 18 mg once daily at weekly intervals.

Maximum dosage: 72 mg once daily.

2.1 Pretreatment

Screening Prior to treating patients 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). the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating RELEXXII.

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.

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 Patient Population RELEXXII Recommended Starting Dosage RELEXXII Dosage Range Pediatric patients 6 to 12 years 18 mg once daily 18 mg to 54 mg once daily 13 to 17 years 18 mg once daily 18 mg to 72 mg once daily (not to exceed 2 mg/kg/day) Adults 18 (up to 65 years) 18 mg or 36 mg once daily 18 mg to 72 mg once daily

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 Current Methylphenidate Daily Dosage Recommended Starting Dosage of RELEXXII 5 mg methylphenidate twice daily or three times daily 18 mg once daily in the morning 10 mg methylphenidate twice daily or three times daily 36 mg once daily in the morning 15 mg methylphenidate twice daily or three times daily 54 mg once daily in the morning 20 mg methylphenidate twice daily or three times daily 72 mg once daily in the morning

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 Dosage Reduction and

Discontinuation If paradoxical aggravation of symptoms or other adverse reaction 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.