"Dec. 9, 2011 -- An FDA panel has voted 15-11 that the benefits of newer oral contraceptives outweigh their risks of dangerous blood clots.
But the panel voted 21-5 that the contraceptives' labels don't adequately reflect that risk/ben"...
(drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets)
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].
Safyral (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) provides an oral contraceptive regimen consisting of 28 film-coated tablets that contain the active ingredients specified for each tablet below:
- 21 orange tablets each containing 3 mg DRSP, 0.03 mg EE as betadex clathrate, and 0.451 mg levomefolate calcium
- 7 light orange tablets each containing 0.451 mg levomefolate calcium
The inactive ingredients in the orange tablets are lactose monohydrate NF, microcrystalline cellulose NF, croscarmellose sodium NF, hydroxypropyl cellulose USP, magnesium stearate NF, hypromellose USP, titanium dioxide USP, talc USP, polyethylene glycol NF, ferric oxide pigment, yellow NF, and ferric oxide pigment, red NF. The light orange film-coated tablets contain 0.451 mg of levomefolate calcium. The inactive ingredients in the light orange tablets are lactose monohydrate NF, microcrystalline cellulose NF, croscarmellose sodium NF, hydroxypropyl cellulose NF, magnesium stearate NF, hypromellose USP, titanium dioxide USP, talc USP, polyethylene glycol NF and ferric oxide pigment, yellow NF, and ferric oxide pigment, red NF.
Drospirenone (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3',4',6,6a,7,8,9,10,11,12,13, 14,15,15a,16-hexadecahydro10,13-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 1,3,5(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.
Levomefolate calcium (N-[4-[[(2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-(6S)-pteridinyl)methyl]amino]benzoyl]L-glutamic acid, calcium salt) is a synthetic calcium salt of L-5-methyltetrahydrofolate (L-5-methyl-THF), which is a metabolite of vitamin B9 and has a molecular weight of 497.5 and a molecular formula of C20H23CaN7O6.
The structural formulas are as follows:
What are the possible side effects of drospirenone, ethinyl estradiol, and levomefolate (Beyaz, Safyral)?
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 medicine and call your doctor at once if you have a serious side effect such as:
- 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...
What are the precautions when taking drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate (Safyral)?
See also Warning section.
Before taking this medication, tell your doctor or pharmacist if you are allergic to drospirenone, ethinyl estradiol, or folate supplements; 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), diabetes that has caused kidney/eye/nerve/blood vessel disease, severe headaches/migraines, heart disease (such as heart attack, chest pain),...
Last reviewed on RxList: 4/20/2012
This monograph has been modified to include the generic and brand name in many instances.
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