"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.
(norgestimate and ethinyl estradiol) Tablets
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Sprintec™ (norgestimate and ethinyl estradiol tablets) Tablets are a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol.
Each blue tablet contains 0.250 mg of the progestational compound norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acety-loxy)-13-ethyl-, oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&C blue no. 2 aluminum lake, lactose monohydrate, magnesium stearate, and pregelatinized starch.
Each white tablet contains only inert ingredients as follows: anhydrous lactose, hydroxypropyl methylcellulose 2208, magnesium stearate, and microcrystalline cellulose.
The structural formula is as follows:
What are the possible side effects of birth control pills?
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 feeling;
- sudden cough, wheezing, rapid...
What are the precautions when taking norgestimate and ethinyl estradiol tablets (Sprintec)?
See also Warning section.
Before using this medication, tell your doctor or pharmacist if you are allergic to any estrogens (such as ethinyl estradiol, mestranol) or any progestins (such as norethindrone, desogestrel); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots (for example, in the legs, eyes, lungs), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, abnormal breast exam, cancer (especially endometrial or breast cancer), high cholesterol or triglyceride (blood fat) levels, depression,...
Last reviewed on RxList: 12/10/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Sprintec Information
Sprintec - User Reviews
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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