SPL Set ID: 10fa1458-c8ed-4197-922a-1ba7271d2b02
1 drug(s) with this SPL Set ID
Norelgestromin and ethinyl estradiol transdermal system is a transdermal system with a contact surface area of 15.75 cm 2 . It contains 4.678 mg norelgestromin, USP (NGMN) and 0.53 mg ethinyl estradiol, USP (EE), and its delivery rate is approximately 150 mcg of NGMN and 35 mcg of EE per day. Systemic exposures (as measured by area under the curve [AUC] and steady state concentration [C ss ]) of NGMN and EE during use of norelgestromin and ethinyl estradiol transdermal system are higher and the C max is lower than those produced by an oral contraceptive containing NGM 250 mcg / EE 35 mcg. [See Boxed Warning and Clinical Pharmacology ( 12.3 ).] Norelgestromin and ethinyl estradiol transdermal system is a thin, matrix-type transdermal system consisting of three layers. The backing layer is composed of a peach flexible film consisting of a 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 crospovidone, lauryl lactate, polyisobutylene/polybutene adhesive and non-woven polyester fabric as inactive components. The active components in this layer are the hormones, NGMN and EE. 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 printed with "Norelgestromin and ethinyl estradiol 150/35 mcg per day" in red ink. Norelgestromin and ethinyl estradiol transdermal system is packaged with additional piece of protective film above the system within each pouch. This piece of protective film is removed and discarded at the time of use. The structural formulas of the components are: Molecular weight, NGMN: 327.47 Molecular weight, EE: 296.41 Chemical name for NGMN: 18, 19-dinorpregn-4-en-20-yn-3-one, 13-ethyl-, 17-hydroxy, 3-oxime, (17α)- Chemical name for EE: 19-Norpregna-1,3,5(10)-trien-20-yne-3, 17β-diol, (17α)- structure