2.1 Pretreatment Screening
Prior to initiating treatment with central nervous system (CNS) stimulants, including Ritalin LA, assess for the presence of cardiac disease (i.e., perform a careful history, including family history of sudden death or ventricular arrhythmia, and physical examination) [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, monitor for signs of abuse and overdose, and periodically reevaluate the need for Ritalin LA use [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2, 9.3)].
2.2 General Dosing Information
The recommended starting dose for Ritalin LA is 20 mg once daily. Increase dosage gradually, in increments of 10 mg weekly. Daily dosage above 60 mg is not recommended. When a lower initial dose is appropriate, patients may begin treatment with 10 mg.
Administer Ritalin LA orally once daily in the morning. Ritalin LA may be swallowed as whole capsules or may be administered by sprinkling the capsule contents on a small amount of applesauce (see specific instructions below). Ritalin LA and/or their contents should not be crushed, chewed, or divided.
The capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The applesauce should not be warm because it could affect the modified release properties of this formulation. The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use.
Pharmacological treatment of ADHD may be needed for extended periods. Periodically reevaluate the long-term use of Ritalin and Ritalin-SR, and adjust dosage as needed.
2.3 Patients Currently Using Ritalin or Ritalin-SR
The recommended dose of Ritalin LA for patients currently taking Ritalin twice daily or Ritalin extended-release (SR) is provided below.
Table 1: Recommended Dose Conversion From Ritalin or Ritalin-SR
| Previous Ritalin or Ritalin-SR Dose |
Recommended Ritalin LA Dose |
| 5 mg Ritalin twice daily |
10 mg once daily |
| 10 mg Ritalin twice daily or 20 mg Ritalin-SR |
20 mg once daily |
| 15 mg Ritalin twice daily |
30 mg once daily |
| 20 mg Ritalin twice daily or 40 mg Ritalin-SR |
40 mg once daily |
| 30 mg Ritalin twice daily or 60 mg Ritalin-SR |
60 mg once daily |
2.4 Switching From Other Methylphenidate Products
If switching from other methylphenidate products, discontinue that treatment, and titrate with Ritalin LA using the titration schedule.
Do not substitute for other methylphenidate products on a milligram-per-milligram basis, because different methylphenidate base compositions and differing pharmacokinetic profiles [see Description (11), Clinical Pharmacology (12.3)].
Clinical judgment should be used when selecting the starting dose. Daily dosage above 60 mg is not recommended.
2.5 Dose Reduction and Discontinuation
If paradoxical worsening of symptoms or other adverse reactions occur, reduce the dosage, or, if necessary, discontinue Ritalin LA. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
