Overall Safety of Daytrana

Daytrana is Generally Well-tolerated

The Daytrana^® patch, as a methylphenidate product, shares the same Schedule II controlled substance warnings about drug dependence, diversion, and abuse as other methylphenidate products. It is important to educate parents and caregivers about tracking of drug use and proper disposal to help deter diversion and misuse. Patches should be folded (sticky sides together) when removed, and disposed of by flushing down the toilet or, for septic tanks, placing in a closed container.

The Daytrana patch should not be used by patients who:

• Have marked anxiety, tension, or agitation
• Have glaucoma
• Have motor tics or a diagnosis or a family history of Tourette's syndrome
• Are being treated (or within 14 days after treatment) with monoamine oxidase inhibitors (MAOIs)
• Have an allergy to methylphenidate, acrylic adhesive, or silicone adhesive (does not contain latex)
  • Some patients sensitized to Daytrana may not be able to take methylphenidate in any form

Daytrana is a safe and effective treatment option for ADHD. Its safety profile is generally similar to other methylphenidate formulations, with the addition of application site reactions.

• With transdermal administration and much less first-pass effect, a much lower dose of Daytrana on a mg/kg basis compared to oral dose, may still produce higher exposures of d-MPH and l-MPH
• Daytrana is a skin irritant. The majority of patients in clinical trials reported minimal to definite skin erythema at application sites
  • Erythema at application sites generally caused no or minimal discomfort. In the Daytrana group, 1.4% to 2.5% in each of the 3 pediatric studies and 2% in the adolescent study discontinued treatment due to an application site reaction
• Daytrana may be removed earlier than 9 hours if late-day side effects appear or a shorter duration of effect is desired
  • With the maximum 9-hour wear time, 26% of children and adolescents experienced decreased appetite and 13% of children and 6% of adolescents experienced insomnia