Information for professionals: The new label: Ortho Evra (norelgestromin/ethinyl estradiol) information 

(20 January 2008: VIDYYA MEDICAL NEWS SERVICE) -- FDA has approved changes to the Ortho Evra label to include the results of an additional epidemiology study designed to evaluate the risk of developing serious blood clots, also known as venous thromboembolism (VTE), among women aged 15-44 when using Ortho Evra.

Since the patch is applied transdermally, first-pass metabolism (via the gastrointestinal tract and/or liver) of NGMN and EE that would be expected with oral administration is avoided. Hepatic metabolism of NGMN occurs and metabolites include norgestrel, which is highly bound to SHBG, and various hydroxylated and conjugated metabolites. Ethinyl estradiol is also metabolized to various hydroxylated products and their glucuronide and sulfate conjugates.

Download the entire label here: http://www.vidyya.com/11pdfs/021180s026lbl.pdf

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