Pretreatment Screening

Prior to initiating treatment with COTEMPLA XR-ODT, 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)] .

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, and periodically re-evaluate the need for COTEMPLA XR-ODT use [see Boxed Warning, Warnings and Precautions (5.1), and Drug Abuse and Dependence (9)].

General Dosing Information

COTEMPLA XR-ODT is given orally once daily in the morning.

Advise patients to take COTEMPLA XR-ODT consistently either with food or without food [see Clinical Pharmacology (12.3)] .

The recommended starting dose of COTEMPLA XR-ODT for patients 6 to 17 years of age is 17.3 mg once daily in the morning. The dose may be titrated weekly in increments of 8.6 mg to 17.3 mg. Daily doses above 51.8 mg have not been studied and are not recommended.

The dose should be individualized according to the needs and responses of the patient.

Pharmacological treatment of ADHD may be needed for extended periods. Periodically re-evaluate the long-term use of COTEMPLA XR-ODT and adjust dosage as needed.

Dose Reduction and Discontinuation

If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug. COTEMPLA XR-ODT should be periodically discontinued to assess the child's condition. If improvement is not observed after appropriate dosage adjustment over a one-month period, discontinue the drug.

COTEMPLA XR-ODT Administration

Instruct the patient or caregiver on the following administration instructions:

• Do not remove the tablet from the blister pack until just prior to dosing. Take the tablet immediately after opening the blister pack. Do not store the tablet for future use.
• Use dry hands when opening the blister pack.
• Remove the tablet by peeling back the foil on the blister pack. Do not push the tablet through the foil.
• As soon as the blister is opened, remove the tablet and place on the patient's tongue.
• Place the whole tablet on the tongue and allow it to disintegrate without chewing or crushing.
• The tablet will disintegrate in saliva so that it can be swallowed. No liquid is needed to take the tablet.