Jornay PM Dosage

Pretreatment Screening

Prior to treating patients with JORNAY PM, 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)].
• the family history and clinically evaluate patients for motor or verbal tics or Tourette's syndrome [see Warnings and Precautions (5.10)].

Recommended Dosage

The recommended starting dosage of JORNAY PM in patients 6 years and older is 20 mg once daily orally in the evening. Do not take JORNAY PM in the morning. The dose may be titrated weekly in increments of 20 mg. A daily dosage above 100 mg has not been studied and is not recommended.

Initiate dosing at 8:00 p.m. Adjust the timing of administration between 6:30 p.m. and 9:30 p.m. to optimize the tolerability and efficacy the next morning and throughout the day. In clinical trials of patients aged 6 to 12 years, the most common dosing time (>70% of patients) was 8:00 p.m., with an allowed range between 6:30 p.m. and 9:30 p.m. Following determination of the optimal administration time, advise patients to maintain a consistent dosing time.

Advise patients to take JORNAY PM consistently, either with food or without food.

Patients who miss their dose of JORNAY PM at the regularly scheduled time should take it as soon as they remember that same evening. If a patient remembers the missed dose the following morning, they should skip the missed dose and wait until their next scheduled evening administration.

Administration Instructions

JORNAY PM may be taken whole, or the capsule may be opened, and the entire contents sprinkled onto applesauce. If the patient is using the sprinkled administration method, the sprinkled applesauce should be consumed immediately; it should not be stored. Patients should take the applesauce with sprinkled beads in its entirety without chewing. The dose of a single capsule should not be divided. The contents of the entire capsule should be taken at the same time.

Switching from Other Methylphenidate Products

If switching from other methylphenidate products, discontinue that treatment, and titrate with JORNAY PM using the titration schedule described above.

Do not substitute JORNAY PM for other methylphenidate products on a milligram-per-milligram basis because these products have different pharmacokinetic profiles from JORNAY PM and may have different methylphenidate base composition [see Description (11) and Clinical Pharmacology (12.3)].

Dosage Reduction and Discontinuation

If paradoxical aggravation of symptoms or other adverse reactions occur, reduce dosage or, if necessary, discontinue JORNAY PM. If improvement is not observed after appropriate dosage adjustment over a one-month period, discontinue JORNAY PM.