Academic productivity, interactions with peers and adults, and compliance during class improved with all dosages compared with placebo. Although most children removed the patch by 3:30 PM after 9 hours of use, parents reported that positive behavioral effects lasted into the evening.
As in the dose-ranging study, dose response diminished with higher dosages. Optimal effects were achieved on some measures with 12.5 cm2 of transdermal methylphenidate, which produces the same plasma drug level as 10 mg of oral methylphenidate.7
Multisite crossover study.5 Eighty children received transdermal methylphenidate—12.5, 18.75, 25, or 37.5 cm2 based on response to medication—over 5 weeks for 9 hours daily. Dosages were titrated by changing patch sizes until each child reached his or her optimal dosage. Children then received their optimal dosage or placebo for 1 week, then received the opposite treatment for another week. Results were measured in a simulated classroom.
Overall, children showed statistically significant improvement in Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Teacher Rating Scale scores while receiving their optimal dosage. Improvement was seen 2 hours after patches were applied and continued for 12 hours. Children also were more able to solve math problems during optimal dosage periods than while using placebo.
Nearly 80% of children were rated as significantly improved while receiving transdermal methylphenidate based on Clinical Global Impressions of Improvement scores. Roughly 12% of children showed significant improvement with placebo. Parents reported that their children were markedly less hyperactive and impulsive and more attentive during optimal dosage periods.
Tolerability
No serious side effects were reported during clinical trials of transdermal methylphenidate in children ages 6 to 12.5-7 Side effects commonly associated with oral methylphenidate—anorexia, decreased appetite, headache, insomnia, and abdominal pain—were most frequently reported with the patch.5
In one study,6 61% of children who wore the patch for 12 hours/day reported appetite loss and 47% reported insomnia. Insomnia prevalence diminished substantially when daily wear was limited to 9 hours.2,5 Loss of appetite was reported less often with lower-dose patches (12.5, 18.75 cm2) than with higher-dose patches (25, 37.5 cm2).
Although many children complained of erythema at the patch site,5-7 most reported minimal irritation or discomfort.5 Redness usually dissipated about 8 hours after the patch was removed.6
Despite concerns that youths with impulsive behaviors might remove the patches prematurely, very few children did so during clinical trials.5-7 Those who did had comorbid symptomatic conduct disturbances. Compliance with patch placement and maintenance was very high during dose optimization (98%) and analog classroom analysis (97%).5-7
Dosing
Start transdermal methylphenidate at 12.5 cm2 (10 mg) for children who have never taken methylphenidate or were previously stabilized on the drug. If the child does not respond after 1 week, switch to the 18.75 cm2 (15-mg) patch; keep switching to the next largest patch each week until optimal response is achieved. In clinical trials,5-7 18.75 or 25 cm2 (10 mg) of transdermal methylphenidate produced optimal response for most children.
Advise the child and parents to place the patch on the right and left hip on alternate days to minimize irritation. Counsel children to inform parents if the patch causes itching, burning, or irritation; tell parents to call you if they notice or the child complains of irritation. Children who experience intolerable skin sensitivity with the patch can resume taking oral methylphenidate the day after the patch is removed.
As with oral methylphenidate, the transdermal formulation may be discontinued without a taper and another formulation or medication may be started the next day. Ask the child and parents about side effects at each visit. See the child every 2 to 4 weeks during the titration period and monthly after symptoms are stabilized.
Consider trying a “drug holiday” for at least 2 weeks during the summer to see how the child behaves without methylphenidate, then evaluate the need for medication and determine the optimal dosage close to when the school year begins.
Related resources
- Transdermal methylphenidate Web site. www.daytrana.com.
- Greenhill LL, Pliszka S, Dulcan MK, et al. Practice parameter for the use of stimulant medications in the treatment of children, adolescents, and adults. J Am Acad Child Adolesc Psychiatry 2002;41:26S-49S.
Drug brand names
- Methylphenidate (oral) • Concerta, Ritalin, Metadate
- Methylphenidate (transdermal) • Daytrana
Disclosures
The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.