"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
(desogestrel and ethinyl estradiol) Tablets USP, 0.15 mg/0.02 mg and (ethinyl estradiol) Tablets USP, 0.01 mg
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
VIORELE (desogestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP) provides an oral contraceptive regimen of 21 white tablets each containing 0.15 mg desogestrel (13-ethyl-11- methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include vitamin E, potato starch, povidone, isopropyl alcohol, colloidal silicon dioxide, magnesium stearate, lactose, hypromellose, titanium dioxide, macrogol, talc, followed by 2 green tablets with following inactive ingredients: lactose, starch, magnesium stearate, hypromellose, titanium dioxide, macrogol, talc, iron oxide yellow, FD&C blue No. 2 indigo carmine aluminum lake. VIORELE also contains 5 yellow tablets containing 0.01 mg ethinyl estradiol USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3, 17-diol) and inactive ingredients which include vitamin E, lactose, potato starch, povidone, isopropyl alcohol, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, macrogol, talc, iron oxide yellow. The molecular weights for desogestrel and ethinyl estradiol USP are 310.48 and 296.40 respectively. The structural formulas are as follows:
1. Hatcher RA, Trussell J, Stewart F et al. Contraceptive Technology: Seventeenth Revised Edition, New York: Irvington Publishers, 1998, in press.
Last reviewed on RxList: 6/1/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Viorele Information
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