Estrogens and Progestins Combined DROSPIRENONE/ESTRADIOL Rx Angeliq
(Berlex) Tablets: 0.5 mg drospirenone and 1 mg
estradiol Lactose. (CK). Pink. Film coated. In blister pack 28s. DROSPIRENONE/ESTRADIOL WARNING Do not use estrogens with or without progestins for the prevention
of cardiovascular disease or dementia. Cardiovascular risks The Womens Health Initiative (WHI) study
reported increased risks of myocardial infarction, stroke, invasive
breast cancer, pulmonary emboli, and deep vein thrombosis in post-
menopausal women (50 to 79 years of age) during 5 years of treat-
ment with oral conjugated equine estrogens (0.625 mg) combined
with medroxyprogesterone acetate (2.5 mg) relative to placebo.
Dementia The Womens 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 nding applies to younger postmenopausal women.
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, prescribe estrogens with or without
progestins at the lowest effective doses and for the shortest duration
consistent with treatment goals and risks for the individual woman. Indications Drospirenone/Estradiol is indicated in women who have a uterus for: Moderate to severe vasomotor symptoms: Treatment of moderate to severe vasomotor symptoms associated with menopause. Moderate to severe vulvar and vaginal atrophy: Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated
with menopause. When prescribing solely for the treatment of symp-
toms of vulvar and vaginal atrophy, consider topical vaginal products. Administration and Dosage Moderate to severe vasomotor symptoms and moderate to severe vulvar and vaginal atrophy: Dosage is 1 tablet daily. Women who are already using a product containing estrogen should stop taking
that product before starting drospirenone/estradiol.
Use of estrogen alone or in combination with a progestin should be lim-
ited to the lowest effective dose available and for the shortest duration
consistent with treatment goals and risks for the individual woman.
Patients should be reevaluated periodically as clinically appropriate
(eg, 3- to 6-month intervals) to determine if treatment is still necessary
(see Black Box Warning). For women who have a uterus, adequate
diagnostic measures such as endometrial sampling, when indicated,
should be undertaken to rule out malignancy in cases of undiagnosed
persistent or recurring abnormal vaginal bleeding.
The lowest effective dose has not been determined. Storage/Stability: Store at 25