"The U.S. Food and Drug Administration on Wednesday approved a request by Danco Laboratories to expand authorized use of its abortion pill Mifeprex (mifepristone), formerly known as RU-486, to 70 days of gestation from 49 days.
(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.
What are the possible side effects of birth control pills (Cryselle 28, Lo/Ovral-28, Low-Ogestrel, Ogestrel-28)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using birth control pills and call your doctor at once if you have a serious side effect such as:
- sudden numbness or weakness, especially on one side of the body;
- sudden and severe headache, confusion, problems with vision, speech, or balance;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill...
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
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.
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