DOSAGE AND ADMINISTRATION
It is recommended that Daytrana™ be applied to the hip area 2 hours before an effect is needed and should be removed 9 hours after application. Dosage should be titrated to effect. The recommended dose titration schedule is shown in the table below. Dose titration, final dosage, and wear time should be individualized according to the needs and response of the patient.
TABLE 2 Daytrana™ - Recommended Titration Schedule (Patients New to Methylphenidate)
| Upward Titration, if Response is Not Maximized|
| Patch Size|| Week 1|| Week 2|| Week 3|| Week 4|
| 12.5 cm2|| 18.75 cm2|| 25 cm2|| 37.5 cm2|
| Nominal Delivered Dose
(mg/9 hours)|| 10 mg|| 15 mg|| 20 mg|| 30 mg|
| Delivery Rate*|| (1.1 mg/hr)4|| (1.6 mg/hr)4|| (2.2 mg/hr)4|| (3.3 mg/hr)4|
Patients converting from another formulation of methylphenidate should follow the above titration schedule due to differences in bioavailability of Daytrana™ compared to other products.
The parent or caregiver should be encouraged to use the administration chart included with each carton of Daytrana™ to monitor application and removal time, and method of disposal. The patient information included at the end of this insert also includes a timetable to calculate when to remove Daytrana™, based on the 9-hour application time.
The adhesive side of Daytrana™ should be placed on a clean, dry area of the hip. The area selected should not be oily, damaged, or irritated. Apply patch to the hip area. Avoid the waistline, since clothing may cause the patch to rub off. When applying the patch the next morning, place on the opposite hip at a new site if possible.
Daytrana™ should be applied immediately after opening the pouch and removing the protective liner. Do not use if the pouch seal is broken. The patch should then be pressed firmly in place with the palm of the hand for approximately 30 seconds, making sure that there is good contact of the patch with the skin, especially around the edges. After proper application, bathing, swimming, or showering have not been shown to affect patch adherence. In the unlikely event that a patch should fall off, a new patch may be applied at a different site, but the total recommended wear time for that day should remain 9 hours.
Disposal of Daytrana™
Upon removal of Daytrana™, used patches should be folded so that the adhesive side of the patch adheres to itself and should be flushed down the toilet or disposed of in an appropriate lidded container. If the patient stops using the prescription, each unused patch should be removed from its pouch, separated from the protective liner, folded onto itself, and flushed down the toilet or disposed of in an appropriate lidded container.
The parent should be encouraged to record on the administration chart included with each carton the time that each patch was applied and removed. If a patch was removed without the parent or caregiver's knowledge, or if a patch is missing from the tray, the parent or caregiver should be encouraged to ask the child when and how the patch was removed.
There is no body of evidence available from controlled clinical trials to indicate how long the patient with ADHD should be treated with Daytrana™. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use Daytrana™ for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with periods off medication to assess the patient's functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
Dose/Wear Time Reduction and Discontinuation
Daytrana™ may be removed earlier than 9 hours if a shorter duration of effect is desired or late day side effects appear. Plasma concentrations of d-methylphenidate generally begin declining when the patch is removed, although absorption may continue for several hours. Individualization of wear time may help manage some of the side effects caused by methylphenidate. If aggravation of symptoms or other adverse events occur, the dosage or wear time should be reduced, or, if necessary, the drug should be discontinued. Residual methylphenidate remains in used patches when worn as recommended.