"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"...
(levonorgestrel and ethinyl estradiol)
SUPPLEMENTAL PATIENT MATERIAL
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Levora (levonorgestrel and ethinyl estradiol tablets) ® 0.15/30-28 Tablets provide an oral contraceptive regimen consisting of 21 white tablets containing levonorgestrel 0.15 mg and ethinyl estradiol 0.03 mg followed by 7 peach tablets containing inert ingredients.
Levonorgestrel is a totally synthetic progestogen with the chemical name (-)-13-Ethyl-17-hydroxy-18,19-dinor- 17α-pregn-4-en-20-yn-3-one. Ethinyl estradiol is an estrogen with the chemical name 19-Nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol. Their structural formulae follow:
The white Levora (levonorgestrel and ethinyl estradiol tablets) ® 0.15/30 tablets contain the following inactive ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, and povidone.
The inactive peach tablets in the 28-day regimen of Levora (levonorgestrel and ethinyl estradiol tablets) ® 0.15/30 contain the following inactive ingredients: FD&C Yellow No. 6 Lake, Lactose Anhydrous, Lactose Monohydrate, Magnesium Stearate and Microcrystalline Cellulose.
What are the possible side effects of ethinyl estradiol and levonorgestrel?
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,...
Last reviewed on RxList: 3/26/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Levora 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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