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(drospirenone and estradiol) Tablets 0.5 mg/1 mg
Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. (See WARNINGS, Cardiovascular disorders and Dementia.)
The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated equine estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo (see CLINICAL PHARMACOLOGY, Clinical Studiesand WARNINGS, Cardiovascular disorders and Malignant neoplasms, Breast cancer.)
The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with conjugated estrogens alone and during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL PHARMACOLOGY, Clinical Studies, WARNINGS, Dementia and PRECAUTIONS, Geriatric Use.)
Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials, and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
ANGELIQ (drospirenone and estradiol) TABLETS provide a hormone regimen consisting of film coated tablets each containing 0.5 mg of drospirenone and 1 mg of estradiol. The inactive ingredients are lactose monohydrate NF, corn starch NF, modified starch NF, povidone 25000 USP, magnesium stearate NF, hydroxylpropylmethyl cellulose USP, macrogol 6000 NF, talc USP, titanium dioxide USP, and ferric oxide pigment 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-hexadecahydro-10,13- dimethylspiro-[17H-dicyclopropa[6,7:15,16]cyclopenta [a]phenanthrene-17,2´(5H)-furan]-3,5´(2H)-dione (CAS) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3.
Estradiol USP, (Estra–1,3,5(10)–triene–3,17–diol,17β), has a molecular weight of 272.39 and the molecular formula is C18H24O2. The structural formulas are as follows:
What are the possible side effects of drospirenone and estradiol (Angeliq)?
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:
- chest pain;
- shortness of breath;
- sudden numbness or weakness, especially on one side of the body;
- sudden headache, confusion, problems with vision, speech, or balance;
- unusual vaginal bleeding;
- stomach pain, swelling, or tenderness;
What are the precautions when taking drospirenone and estradiol (Angeliq)?
Before taking this medication, tell your doctor or pharmacist if you are allergic to drospirenone or estradiol; or to spironolactone; 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.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: vaginal bleeding of unknown cause, certain types of cancer (breast, ovary, uterus), blood clotting disorders (such as protein C or protein S deficiency), current/history of blood clots (such as in the legs, eyes, lungs), history of stroke or heart attack, liver disease, kidney disease, adrenal gland problems.
Last reviewed on RxList: 1/16/2009
This monograph has been modified to include the generic and brand name in many instances.
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