"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"...
(levonorgestrel and ethinyl estradiol)
SUPPLEMENTAL PATIENT MATERIAL
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Levora (levonorgestrel and ethinyl estradiol tablets) ® 0.15/30-28 Tablets provide an oral contraceptive regimen consisting of 21 white tablets containing levonorgestrel 0.15 mg and ethinyl estradiol 0.03 mg followed by 7 peach tablets containing inert ingredients.
Levonorgestrel is a totally synthetic progestogen with the chemical name (-)-13-Ethyl-17-hydroxy-18,19-dinor- 17α-pregn-4-en-20-yn-3-one. Ethinyl estradiol is an estrogen with the chemical name 19-Nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol. Their structural formulae follow:
The white Levora (levonorgestrel and ethinyl estradiol tablets) ® 0.15/30 tablets contain the following inactive ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, and povidone.
The inactive peach tablets in the 28-day regimen of Levora (levonorgestrel and ethinyl estradiol tablets) ® 0.15/30 contain the following inactive ingredients: FD&C Yellow No. 6 Lake, Lactose Anhydrous, Lactose Monohydrate, Magnesium Stearate and Microcrystalline Cellulose.
Last reviewed on RxList: 3/26/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Levora Information
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