"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
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
- Patient Information:
Details with Side Effects
Apri (desogestrel and ethinyl estradiol tablets) 28 Day Regimen blister cards for desogestrel and ethinyl estradiol tablets provide an oral contraceptive regimen of 21 round rose-colored tablets. Each rose-colored "active" desogestrel and ethinyl estradiol tablet for oral administration contains 0.15 mg desogestrel (13-ethyl-11- methylene-18,19-dinor-17 alpha-pregn-4-en- 20-yn-17-ol) and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Inactive ingredients include colloidal silicon dioxide, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl methylcellulose, lactose monohydrate, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide, and vitamin E.
Apri (desogestrel and ethinyl estradiol tablets) 28 Day Regimen blister cards also contain 7 white "inactive" tablets for oral administration, containing the following inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized starch.
DESOGESTREL C22H30O M.W.: 310.48
ETHINYL ESTRADIOL C20H24O2 M.W.: 296.41
What are the possible side effects of ethinyl estradiol and desogestrel?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have any of these serious side effects:
- sudden numbness or weakness, especially on one side of the body;
- sudden headache, confusion, problems with vision, speech, or balance;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- a change in the pattern or...
Last reviewed on RxList: 3/19/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Apri Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.