Home » Drug Information » FDA Approved Drugs » 1995
Medical Areas: Endocrinology | Musculoskeletal | Obstetrics/Gynecology (Women’s Health) | Family Medicine
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Prempro & Premphase (conjugated estrogens/medroxyprogesterone acetate tablets)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved November 1995
Treatment Area: postmenopausal hormone replacement, postmenopausal osteoporosis
Both Prempro and Premphase are one-tablet hormone replacement
therapies available in convenient calendar packs marked with the
days of the week.
Although Prempro and Premphase contain the hormones estrogen and
progesterone, the dosage is different for each therapy. Prempro
contains a smaller amount of estrogen and progesterone (2.5 mg of
each); it should be taken on a daily basis throughout the year.
Premphase contains larger amounts of both hormones (5.0 mg of
each). Subjects taking Premphase alternate between a 14-day regimen
of just estrogen, followed by a 14 day regimen of estrogen and
Prempro and Premphase are the only one-tablet hormone
replacement therapies indicated to help prevent osteoporosis in
women at risk and to treat moderate to severe vasomotor symptoms
(such as hot flashes and night sweats) associated with
Most studies have not shown a higher risk of breast cancer in
women who have used estrogens. Some studies have reported that
breast cancer developed more often in women who used estrogens for
long periods of time or who used high doses for shorter time
periods. The effects of added progestins on the risk of breast
cancer are unknown. Some studies have reported a moderately
increased risk in those taking combination estrogen/progestin
therapy, even higher than the possible risk of taking estrogens
alone. Other studies have not shown this relationship. The addition
of progestin may have unfavorable effects on blood sugars and fats,
which might make a diabetic condition worse.
The most commonly reported side effects in the clinical study
were breast tenderness, headache, and abdominal pain. Rarely,
however, were these serious enough to cause women to stop
Previously, physicians have prescribed estrogen and progestin
for nonhysterectomized women needing hormone replacement therapy
(HRT) in a variety of different regimens. Until now, a woman taking
estrogen and progestin at different times throughout the month had
to keep track of where she was in her cycle and whether she needed
to take one tablet (estrogen alone), or two tablets (estrogen and
progestin) on any given day. As a result, many women found their
HRT regimens difficult to follow.
Some women should not take HRT. A woman should make sure her
doctor or health care provider is aware of her personal or family
health history before taking HRT. This history should include
instances of breast cancer, breast lumps, abnormal vaginal
bleeding, abnormal blood clotting, severe headache, dizziness, and
liver disease. Women who are pregnant should not take HRT.
Estrogens have been reported to increase the risk of cancer of the
uterus in postmenopausal women.