BXdosage

Prior to initiating Methylphenidate HCl Extended-Release Tablets treatment assess for: the presence of cardiac disease for family history of tics or Tourette’s syndrome and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome Administer once daily in the morning with or without food. Swallow whole with liquids; do not chew, divide, or crush. Recommended dosage in pediatric patients 6 to 17 years of age new to methylphenidate: starting dosage is 18 mg once daily. May be increased weekly in 18 mg increments. Maximum dosage for pediatric patients: 6 to 12 years: 54 mg once daily 13 to 17 years: 72 mg once daily Recommended dosage in adults (up to 65 years of age) new to methylphenidate: starting dosage is 18 mg or 36 mg once daily. May be increased weekly in 18 mg increments, up to 72 mg once daily. Patients currently using immediate-release methylphenidate: starting Methylphenidate HCl Extended-Release Tablets dosage is based on current dosage regimen.

2.1 Pretreatment

Screening Prior to treating patients with Methylphenidate HCl Extended-Release Tablets, assess: For the presence of cardiac disease (e.g., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam). The family history for tics or Tourette’s syndrome and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome.

2.2 Important

Administration Instructions Administer Methylphenidate HCl Extended-Release Tablets orally once daily in the morning with or without food. Swallow Methylphenidate HCl Extended-Release Tablets whole with liquids. Do not split, crush, or chew the extended-release tablets because doing so will compromise the extended-release characteristics of Methylphenidate HCl Extended-Release Tablets and may compromise the effectiveness or safety of Methylphenidate HCl Extended-Release Tablets.

2.3 Recommended

Methylphenidate HCl Extended-Release Tablets Dosage in Patients New to Methylphenidate See Table 1 for the recommended once-daily dosage of Methylphenidate HCl Extended-Release Tablets in patients who were not taking a methylphenidate product. In patients who have not achieved an optimal response at a lower dosage, increase the Methylphenidate HCl Extended-Release Tablets dosage in 18 mg increments at weekly intervals. However, if a slower titration is recommended for patients who have not achieved an optimal response taking 18 mg of Methylphenidate HCl Extended-Release Tablets once daily, increase their daily dosage to 27 mg once per day.

Table 1: Recommended Methylphenidate HCl Extended-Release Tablets Dosage in Patients New to Methylphenidate Patient Population Recommended Starting Dosage Dosage Range Pediatric patients 6 to 12 years of age 18 mg once daily 18 mg to 54 mg once daily Pediatric patients 13 to 17 years of age 18 mg once daily 18 mg to 72 mg once daily (not to exceed 2 mg/kg/day) Adults 18 to 65 years of age 18 or 36 mg once daily 18 mg to 72 mg once daily

2.4 Recommended

Methylphenidate HCl Extended-Release Tablets Dosage in Patients Switching from Another Methylphenidate Product See Table 2 for the recommended starting dosage of Methylphenidate HCl Extended-Release Tablets in patients switching from an immediate-release methylphenidate product administered twice daily or three times daily (total daily dosage of 10 to 60 mg/day).

Table 2: Recommended Starting Dosage in Patients Switching from Another Methylphenidate Product Previous Immediate-release Methylphenidate Daily Dosage Recommended Methylphenidate HCl Extended-Release Tablets StartingDosage 5 mg twice daily or three times daily 18 mg every morning 10 mg twice daily or three times daily 36 mg every morning 15 mg twice daily or three times daily 54 mg every morning 20 mg twice daily or three times daily 72 mg every morning* * Only for patients 13-65 years of age. In patients who have not achieved an optimal response at a lower dosage, increase the Methylphenidate HCl Extended-Release Tablets dosage in 18 mg increments at weekly intervals. The maximum recommended dosage in pediatric patients 6 to 12 years of age is 54 mg/day, and the maximum recommended dosage in patients 13-65 years old is 72 mg/day.

2.5 Dosage Reduction and

Discontinuation If paradoxical aggravation of ADHD symptoms or Methylphenidate HCl Extended-Release Tablets-associated adverse reactions occur, reduce the Methylphenidate HCl Extended-Release Tablets dosage or, if necessary, discontinue Methylphenidate HCl Extended-Release Tablets. If ADHD improvement is not observed after appropriate dosage modification over a one-month period, discontinue Methylphenidate HCl Extended-Release Tablets.