Daytrana

Daytrana is a transdermal patch developed and marketed by Noven Pharmaceuticals, Inc. that was approved in the US by the Food and Drug Administration (FDA) in April 2006. In the literature, Daytrana is most commonly referred to as methylphenidate transdermal system (MTS).

Daytrana is approved by the FDA as a once daily treatment in children — ages 6 to 17 — with attention deficit hyperactivity disorder (ADHD). It is mainly prescribed as a second-line treatment for ADHD when traditional oral forms are not well-tolerated or if patients have difficulty with compliance.

Noven's original FDA submission indicated that it should be used for 12 hours. When the FDA rejected the submission they requested evidence that a shorter time period was safe and effective, Noven provided such evidence and Daytrana was approved for the aforementioned indication over a 9-hour period.[1]

Transdermal versus oral administration

Orally administered methylphenidate is subject to first-pass metabolism, by which the levo-isomer is extensively metabolized. By circumventing this first-pass metabolism, the relative concentrations of l-threo-methylphenidate are much higher with transdermal administration (50-60% of those of dexmethylphenidate instead of about 14-27%).[2]

Pharmacokinetics

In patients using Daytrana, a 39 nanograms/mL peak serum concentration of methylphenidate be has been found to occur between 7.5 and 10.5 hours after administration.[3] However the onset to peak effect is 2 hours and the clinical effects remain up to 2 hours after patch has been removed.

The absorption of Daytrana is increased when the transdermal patch is applied onto inflamed skin or skin that has been exposed to heat. The absorption lasts for approximately 9 hours after application (onto normal, unexposed to heat and uninflamed skin). 90% of the medication is excreted in the urine as metabolites and unchanged drug.[3]

In pregnancy

The FDA has labeled Daytrana as a Category C medication in pregnancy.[4]

Footnotes
  1. https://www.fda.gov/ohrms/dockets/AC/05/briefing/2005-4195B1_01_04-Noven-Appendix-3.pdf
  2. Heal DJ, Pierce DM (2006). "Methylphenidate and its isomers: their role in the treatment of attention-deficit hyperactivity disorder using a transdermal delivery system". CNS Drugs. 20 (9): 713–738 (Page:730). doi:10.2165/00023210-200620090-00002. PMID 16953648.
    - Anderson Vanessa R.; Lesley J. Scott (2006). "Methylphenidate Transdermal System In Attention-Deficit Hyperactivity Disorder in Children". Drugs. 66 (8): 1117–1126. doi:10.2165/00003495-200666080-00007. PMID 16789796.
  3. "Product Information: DAYTRANA(R) transdermal patch, methylphenidate transdermal patch" (PDF). 2010. Archived from the original (PDF) on 2014-08-01.
  4. Methylphenidate Use During Pregnancy and Breastfeeding. Drugs.com. Retrieved on 30 April 2011.
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