Focalin Dosage

2.1 Pretreatment Screening

​Prior to treating patients with Focalin, assess:

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​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)].

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​the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating Focalin [see Warnings and Precautions (5.10)].

2.2 Recommended Dosage

​Patients New to Methylphenidate

​The recommended starting dose of Focalin for pediatric patients who are not currently taking racemic methylphenidate, or for patients who are on stimulants other than methylphenidate, is 5 mg daily (2.5 mg twice daily) with or without food.

​Patients Currently on Methylphenidate

​The recommended starting dose of Focalin for pediatric patients currently using methylphenidate is half (1/2) the total daily dose of racemic methylphenidate.

​Titration Schedule

​The dose may be titrated weekly in increments of 2.5 mg to 5 mg to a maximum of 20 mg daily (10 mg twice daily). The dose should be individualized according to the needs and response of the patient.

2.3 Administration Instructions

Focalin is administered orally twice daily, at least 4 hours apart.

2.4 Dosage Reduction and Discontinuation

If paradoxical aggravation of symptoms or other adverse reactions occur, reduce the dosage, or if necessary, discontinue Focalin. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.