Ortho Evra

[NORELGESTROMIN - ETHINYL ESTRADIOL]

Drug Description
DESCRIPTION

*Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

ORTHO EVRA® is a combination transdermal contraceptive patch with a contact surface area of 20 cm2. It contains 6.00 mg norelgestromin and 0.75 mg ethinyl estradiol (EE), and releases 150 micrograms of norelgestromin and 20 micrograms of EE to the bloodstream per 24 hours.

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ORTHO EVRA® is a thin, matrix-type transdermal contraceptive patch consisting of three layers.

The backing layer is composed of a beige flexible film consisting of a low-density pigmented polyethylene outer layer and a polyester inner layer. It provides structural support and protects the middle adhesive layer from the environment.

The middle layer contains polyisobutylene/polybutene adhesive, crospovidone, non-woven polyester fabric and lauryl lactate as inactive components. The active components in this layer are the hormones, norelgestromin and ethinyl estradiol.

The third layer is the release liner, which protects the adhesive layer during storage and is removed just prior to application. It is a transparent polyethylene terephthalate (PET) film with a polydimethylsiloxane coating on the side that is in contact with the middle adhesive layer. The outside of the backing layer is heat-stamped “ORTHO EVRA® 150/20.”

The structural formulas of the components are:
norelgestromin ethinyl estradiol
Molecular weight, norelgestromin: 327.47
Molecular weight, ethinyl estradiol: 296.41
Chemical name for norelgestromin: 18, 19-dinorpregn-4-en-20-yn-3-one, 13-ethyl- 17-hydroxy-,
3-oxime, (17a)
Chemical name for ethinyl estradiol: 19-Norpregna-1, 3, 5 (10)-trien-20-yne-3, 17-diol, (17a)

HOW SUPPLIED

Each beige ORTHO EVRA® patch contains 6.0 mg norelgestromin and 0.75 mg EE, and releases 150 micrograms of norelgestromin and 20 micrograms of EE to the bloodstream per 24 hours. Each patch surface is heat stamped with ORTHO EVRA® 150/20. Each patch is packaged in a protective pouch.

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