"The US Food and Drug Administration (FDA) announced today it has approved a new label for Essure (Bayer) permanent contraception that includes a boxed warning about the risk for implant perforation, device migration, allergic reaction, p"...
(desogestrel and ethinyl estradiol) tablets USP
CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including Apri®, should not be used by women who are over 35 years of age and smoke.
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Apri® (desogestrel and ethinyl estradiol tablets USP) blister cards provide an oral contraceptive regimen of 21 rose-colored, round tablets each containing 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, USP (19-nor-17 alphapregna- 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 corn starch, stearic acid, titanium dioxide, and vitamin E.
Apri blister cards also contain 7 white “inactive” tablets for oral administration, containing the following inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch.
C22H30O M.W. 310.48
Ethinyl Estradiol, USP
C20H24O2 M.W. 296.40
The 21 rose-colored tablets meet USP Dissolution Test 2.
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...
Last reviewed on RxList: 10/3/2016
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.
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