"April 10, 2012 -- Birth control pills that contain the hormone drospirenone must now carry a warning that they may increase the risk for potentially fatal blood clots, according to the FDA.
Drospirenone is a synthetic version of the f"...
(drospirenone/ethinyl estradiol) Tablets, for Oral Use
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke [see CONTRAINDICATIONS].
Yasmin (drospirenone/ethinyl estradiol) tablets provide an oral contraceptive regimen consisting of 28 film-coated tablets that contain the ingredients specified for each tablet below:
- 21 yellow tablets each containing 3 mg DRSP and 0.03 mg EE
- 7 inert white tablets
The inactive ingredients in the yellow tablets are lactose monohydrate NF, corn starch NF, pregelatinized starch NF, povidone 25000 NF, magnesium stearate NF, hypromellose USP, macrogol 6000 NF, titanium dioxide USP, talc USP, and ferric oxide pigment, yellow NF. The white inert film-coated tablets contain lactose monohydrate NF, corn starch NF, povidone 25000 NF, magnesium stearate NF, hypromellose USP, talc USP, and titanium dioxide USP.
Drospirenone (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-l,3',4',6,6a,7,8,9,10,ll,12,13, 14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16] cyclopenta[a]phenanthrene-17,2'(5H)-furan]-3,5'(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3.
Ethinyl estradiol (19-nor-17α-pregna l,3,5(10)-triene-20-yne-3,17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2.
The structural formulas are as follows:
What are the possible side effects of drospirenone and ethinyl estradiol (Ocella, Yasmin, Yaz)?
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, confusion, pain behind the eyes, 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 severity of migraine...
What are the precautions when taking drospirenone and ethinyl estradiol (Yasmin)?
See also Warning section.
Before using this medication, tell your doctor or pharmacist if you are allergic to ethinyl estradiol or drospirenone; or to other estrogens or progestins; 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 product, tell your doctor or pharmacist your medical history, especially of: adrenal gland problems, stroke, blood clots (such as in the legs, eyes, lungs), untreated/uncontrolled high blood pressure, abnormal breast exam, cancer (especially endometrial or breast cancer), blood clotting disorders (such as protein C or protein S deficiency), diabetes that has caused kidney/eye/nerve/blood vessel...
Last reviewed on RxList: 4/23/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Yasmin Information
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