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ActivellaŽ
(estradiol/norethindrone acetate tablets)
1mg/0.5mg
See:
Estradiol Evista
Mircette Alora
Climara Pro
CombiPatch Delestrogen
Esclim Estraderm
Estring Estrace Tablets
Evamist Vagifem Vivelle-Dot
Activella is used for treating certain moderate
to severe symptoms of menopause (eg, hot flashes; dryness, itching, or burning
in or around the vagina). It is also used to prevent osteoporosis (weakened
bones) in certain women after menopause. It may also be used for other
conditions as determined by your doctor.
Activella is a combination of estrogen and progestin hormones. It works by
replacing natural progestin and estrogen in women who can no longer produce
enough of these hormones.
All of these products are used to reduce symptoms
of menopause, including feelings of warmth in the face, neck, and chest; the
sudden intense episodes of heat and sweating known as "hot flashes"; dry, itchy
external genitals; and vaginal irritation. They are also prescribed for other
conditions that cause low levels of estrogen, and some doctors prescribe them
for teenagers who fail to mature at the usual rate.
Along with diet, calcium supplements, and exercise, Alora, Estraderm, Climara,
Vivelle, and Vivelle-Dot are prescribed to prevent osteoporosis, a condition in
which the bones become brittle and easily broken.
ActivellaŽ is a single tablet containing an
estrogen, estradiol (E2), and a progestin, norethindrone acetate (NETA), for
oral administration. Each tablet contains 1 mg estradiol and 0.5 mg
norethindrone acetate and the following excipients: lactose monohydrate, starch
(corn), copovidone, talc, magnesium stearate, hypromellose and triacetin.
Estradiol (E2) is a white or almost white crystalline powder. Its chemical name
is estra-1, 3 ,5 (10)-triene-3, 17b-diol hemihydrate with the empirical formula
of C18H24O2, ˝ H2O and a molecular weight of 281.4.
Norethindrone acetate (NETA) is a white or yellowish-white crystalline powder.
Its chemical name is:
17b -acetoxy-19-nor-17a -pregn-4-en-20-yn-3-one
with the empirical formula of C22H28O3 and
molecular weight of 340.5.
WARNING
Estrogens and 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 estrogens (CE 0.625 mg) combined with
medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. (See CLINICAL
PHARMACOLOGY, Clinical Studies and 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 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 and 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 trials, 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.
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