"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"...
(norgestrel and ethinyl estradiol) Tablets USP, 0.3 mg/0.03 mg
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
ORAL CONTRACEPTIVE AGENTS
Low-Ogestrel® Tablets (norgestrel and ethinyl estradiol tablets USP, 0.3 mg/0.03 mg) provide an oral contraceptive regimen consisting of 21 white tablets followed by 7 peach tablets.
Each white tablet, for oral administration contains 0.3 mg of norgestrel and 0.03 mg ethinyl estradiol and the following inactive ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, and povidone.
Each inactive peach tablet, for oral administration, in the 28 day regimen contains the following inactive ingredients: anhydrous lactose, FD&C Yellow No. 6 Lake, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.
Norgestrel is a totally s ynthetic progestogen, insoluble in water, freely soluble in chloroform, sparingly soluble in alcohol with the chemical name (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one. Ethinyl estradiol is an estrogen, insoluble in water, soluble in alcohol, in chloroform, in ether, in vegetable oils, and in solutions of fixed alkali hydroxides with the chemical name 19-nor-17α;-pregna-1,3,5(10)-trien-20-yne-3,17-diol. Their structural formulae follow:
Therapeutic class: Oral contraceptive.
Last reviewed on RxList: 12/23/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Low-Ogestrel Information
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