Daytrana (Methylphenidate Transdermal) - Indications and Dosage

INDICATION AND USAGE

Attention Deficit Hyperactivity Disorder (ADHD)

Daytrana™ (methylphenidate transdermal system) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The efficacy of Daytrana™ was established in two controlled clinical trials in children with ADHD.

A diagnosis of ADHD (DSM-IV-TR®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.

Special Diagnostic Considerations

Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV-TR® characteristics.

Need for Comprehensive Treatment Program

Daytrana™ is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.

Long-Term Use

The effectiveness of Daytrana™ for long-term use, i.e., for more than 7 weeks, has not been systematically evaluated in controlled trials. The physician who elects to use Daytrana™ for extended periods should periodically re-evaluate the long-term usefulness of Daytrana™ for the individual patient (see DOSAGE AND ADMINISTRATION).

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 1 (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.

Application

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.

Maintenance/Extended Treatment

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.

HOW SUPPLIED

Daytrana™ (methylphenidate transdermal system) is supplied in a sealed tray containing 30 or 10 individually pouched patches. See the chart below for information regarding available strengths.

Nominal Dose Delivered (mg) Over 9 Hours	Dosage Rate 1 (mg/hr)	Patch Size (cm2)	Methylphenidate Content per Patch 2 (mg)	Patches Per Tray	NDC Number
10	1.1	12.5	27.5	30	54092-552-30
				10	54092-552-10
15	1.6	18.75	41.3	30	54092-553-30
				10	54092-553-10
20	2.2	25	55	30	54092-554-30
				10	54092-554-10
30	3.3	37.5	82.5	30	54092-555-30
				10	54092-555-10

Do not store patches unpouched. Store at 25° C (77° F); excursions permitted to 15-30° C (59-86° F) [see USP Controlled Room Temperature].

Once the tray is opened, use contents within 2 months. Apply the patch immediately upon removal from the protective pouch. Do not store patches unpouched. For transdermal use only.