Description
Estrogens (ES-troe-jenz)
are female hormones. They are produced by the
body and are necessary for the normal sexual development of the female and
for the regulation of the menstrual cycle during the childbearing years.
The ovaries begin to produce less estrogen after menopause (the change
of life). This medicine is prescribed to make up for the lower amount of estrogen.
Estrogens help relieve signs of menopause, such as hot flashes and unusual
sweating, chills, faintness, or dizziness.
Estrogens are prescribed for several reasons:
-
to provide additional hormone when the body does not produce enough
of its own, such as during menopause or when female puberty (development of
female sexual organs) does not occur on time. Other conditions include a genital
skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis),
or ovary problems (female hypogonadism or failure or removal of both ovaries).
-
to help prevent weakening of bones (osteoporosis) in women past menopause.
-
in the treatment of selected cases of breast cancer in men and women.
-
in the treatment of cancer of the prostate in men.
Estrogens may also be used for other conditions as determined by your doctor.
There is no
medical evidence to support the
belief that the use of estrogens will keep the patient feeling young, keep
the skin soft, or delay the appearance of wrinkles. Nor has it been proven
that the use of estrogens during menopause will relieve emotional and nervous
symptoms, unless these symptoms are caused by other menopausal symptoms, such
as hot flashes or hot flushes.
Estrogens are available only with your doctor's prescription, in the following
dosage forms:
Oral
-
Conjugated Estrogens
-
Tablets (U.S. and Canada)
-
Diethylstilbestrol
-
Tablets (U.S. and Canada)
-
Esterified Estrogens
-
Tablets (U.S. and Canada)
-
Estradiol
-
Tablets (U.S. and Canada)
-
Estropipate
-
Tablets (U.S. and Canada)
-
Ethinyl Estradiol
-
Tablets (U.S. and Canada)
Parenteral
-
Conjugated Estrogens
-
Injection (U.S. and Canada)
-
Diethylstilbestrol
-
Injection (U.S. and Canada)
-
Estradiol
-
Injection (U.S. and Canada)
-
Estrone
Topical
-
Estradiol
-
Transdermal system (skin patch) (U.S. and Canada)
Before Using This Medicine
In deciding to use a medicine,
the risks of taking the medicine must be weighed against the good it will
do. This is a decision you and your doctor will make. For estrogens, the following
should be considered:
Allergies--Tell your doctor if you have ever had any unusual or
allergic reaction to estrogens. Also tell your health care professional if
you are allergic to any other substances, such as foods, preservatives, or
dyes.
Pregnancy--Estrogens are not recommended for use during pregnancy
or right after giving birth. Becoming pregnant or maintaining a pregnancy
is not likely to occur around the time of menopause.
Certain estrogens have been shown to cause serious birth defects in humans
and animals. Some daughters of women who took diethylstilbestrol (DES) during
pregnancy have developed reproductive (genital) tract problems and, rarely,
cancer of the vagina or cervix (opening to the uterus) when they reached childbearing
age. Some sons of women who took DES during pregnancy have developed urinary-genital
tract problems.
Breast-feeding--Use of this medicine is not recommended in nursing
mothers. Estrogens pass into the breast milk and their possible effect on
the baby is not known.
Older adults--This medicine has been tested and has not been shown
to cause different side effects or problems in older women than it does in
younger women.
Other medicines--Although certain medicines should not be used
together at all, in other cases two different medicines may be used together
even if an interaction might occur. In these cases, your doctor may want to
change the dose, or other precautions may be necessary. When you are taking
estrogens, it is especially important that your health care professional know
if you are taking any of the following:
-
Acetaminophen (e.g., Tylenol) (with long-term, high-dose use) or
-
Amiodarone (e.g., Cordarone) or
-
Anabolic steroids (nandrolone [e.g., Anabolin], oxandrolone [e.g.,
Anavar], oxymetholone [e.g., Anadrol], stanozolol [e.g., Winstrol]) or
-
Androgens (male hormones) or
-
Anti-infectives by mouth or by injection (medicine for infection)
or
-
Antithyroid agents (medicine for overactive thyroid) or
-
Carbamazepine (e.g., Tegretol) or
-
Carmustine (e.g., BiCNU) or
-
Chloroquine (e.g., Aralen) or
-
Dantrolene (e.g., Dantrium) or
-
Daunorubicin (e.g., Cerubidine) or
-
Disulfiram (e.g., Antabuse) or
-
Divalproex (e.g., Depakote) or
-
Etretinate (e.g., Tegison) or
-
Gold salts (medicine for arthritis) or
-
Hydroxychloroquine (e.g., Plaquenil) or
-
Isoniazid or
-
Mercaptopurine (e.g., Purinethol) or
-
Methotrexate (e.g., Mexate) or
-
Methyldopa (e.g., Aldomet) or
-
Naltrexone (e.g., Trexan) (with long-term, high-dose use) or
-
Oral contraceptives (birth control pills) containing estrogen or
-
Phenothiazines (acetophenazine [e.g., Tindal], chlorpromazine [e.g.,
Thorazine], fluphenazine [e.g., Prolixin], mesoridazine [e.g., Serentil],
perphenazine [e.g., Trilafon], prochlorperazine [e.g., Compazine], promazine
[e.g., Sparine], promethazine [e.g., Phenergan], thioridazine [e.g., Mellaril],
trifluoperazine [e.g., Stelazine], triflupromazine [e.g., Vesprin], trimeprazine
[e.g., Temaril]) or
-
Phenytoin (e.g., Dilantin) or
-
Plicamycin (e.g., Mithracin) or
-
Valproic acid (e.g., Depakene)--Use of these medicines with
estrogens may increase the chance of problems occurring that affect the liver
-
Cyclosporine (e.g., Sandimmune)--Estrogens can prevent cyclosporine's
removal from the body; this can lead to cyclosporine causing kidney or liver
problems
-
Protease inhibitors, such as ritonavir (e.g., Norvir)--May decrease
the effect of estrogens
Other medical problems--The presence of other medical
problems may affect the use of estrogens. Make sure you tell your doctor if
you have any other medical problems, especially:
For all patients
-
Blood clotting problems (or history of during previous estrogen therapy)--Estrogens
usually are not used until blood clotting problems stop; using estrogens is
not a problem for most patients without a history of blood clotting problems
due to estrogen use
-
Breast cancer or
-
Bone cancer or
-
Cancer of the uterus or
-
Fibroid tumors of the uterus--Estrogens may interfere with the
treatment of breast or bone cancer or worsen cancer of the uterus when these
conditions are present
-
Changes in genital or vaginal bleeding of unknown causes--Use
of estrogens may delay diagnosis or worsen condition. The reason for the bleeding
should be determined before estrogens are used
-
Endometriosis or
-
High cholesterol or triglycerides (or history of) or
-
Gallbladder disease or gallstones (or history of) or
-
Liver disease (or history of) or
-
Pancreatitis (inflammation of pancreas)--Estrogens may worsen
these conditions. Although estrogens can improve blood cholesterol, they can
worsen blood triglycerides for some people
For males treated for breast or prostate cancer
-
Blood clots or
-
Heart or circulation disease or
-
Stroke--Males with these medical problems may be more likely
to have clotting problems while taking estrogens; the high doses of estrogens
used to treat male breast or prostate cancer have been shown to increase the
chances of heart attack, phlebitis (inflamed veins) caused by a blood clot,
or blood clots in the lungs
Proper Use of This Medicine
Estrogens
usually come with patient information or directions. Read them carefully before
taking this medicine.
Take this medicine only as directed by your doctor.
Do not take more of it and do not take or use it for a longer time than your
doctor ordered
. For patients taking any of the estrogens by mouth,
try to take the medicine at the same time each day to reduce the possibility
of side effects and to allow it to work better.
For patients taking any of the estrogens by mouth or by injection:
-
Nausea may occur during the first few weeks after you start taking
estrogens. This effect usually disappears with continued use. If the nausea
is bothersome, it can usually be prevented or reduced by taking each dose
with food or immediately after food.
For patients using the transdermal (skin patch) form of estradiol:
-
Wash and dry your hands thoroughly before and after handling the
patch.
-
Apply the patch to a clean, dry, nonoily skin area of your lower
abdomen, hips below the waist, or buttocks that has little or no hair and
is free of cuts or irritation. The manufacturer of the 0.025-mg patch recommends
that its patch be applied to the buttocks only. Furthermore, each new patch
should be applied to a new site of application. For instance, if the old patch
is taken off the left buttock, then apply the new patch to the right buttock.
-
Do not apply to the breasts
. Also, do
not apply to the waistline or anywhere else where tight clothes may rub the
patch loose.
-
Press the patch firmly in place with the palm of your hand for about
10 seconds. Make sure there is good contact, especially around the edges.
-
If a patch becomes loose or falls off, you may reapply it or discard
it and apply a new patch.
-
Each dose is best applied to a different area of skin on your lower
abdomen, hips below the waist, or buttocks so that at least 1 week goes by
before the same area is used again. This will help prevent skin irritation.
Dosing--The dose of these medicines will be different
for different patients. Follow your doctor's orders or
the directions on the label
. The following information includes only
the average doses of these medicines. If your dose is
different, do not change it
unless your doctor tells you to do so.
The number of tablets that you take or the amount of injection you use
depends on the strength of the medicine. Also, the number
of doses you take or use each day or patches you apply each week, the time
allowed between doses, and the length of time you take or use the medicine
depend on the medical problem for which you are taking, using, or applying
estrogen
.
For conjugated estrogens
-
For oral
dosage form (tablets):
-
For treating breast cancer in women after menopause and in men:
-
Adults--10 milligrams (mg) three times a day for at least three
months.
-
For treating a genital skin condition (vulvar atrophy), inflammation
of the vagina (atrophic vaginitis), or symptoms of menopause:
-
Adults--0.3 to 1.25 mg a day. Your doctor may want you to take
the medicine each day or only on certain days of the month.
-
To prevent loss of bone (osteoporosis):
-
Adults--0.625 mg a day. Your doctor may want you to take the
medicine each day or only on certain days of the month.
-
For treating ovary problems (female hypogonadism or for starting
puberty):
-
Adults and teenagers--2.5 to 7.5 mg a day. This dose is divided
up and taken in smaller doses. Your doctor may want you to take the medicine
only on certain days of the month.
-
For treating ovary problems (failure or removal of both ovaries):
-
Adults--1.25 mg a day. Your doctor may want you to take the
medicine each day or only on certain days of the month.
-
For treating prostate cancer:
-
Adults--1.25 to 2.5 mg three times a day.
-
For injection
dosage form:
-
For controlling abnormal bleeding of the uterus:
-
Adults--25 mg injected into a muscle or vein. This may be repeated
in six to twelve hours if needed.
For diethylstilbestrol
-
For oral
dosage form (tablets):
-
For treating prostate cancer:
-
Adults--At first, 1 to 3 milligrams (mg) a day. Later, your
doctor may decrease your dose to 1 mg a day.
For diethylstilbestrol diphosphate
-
For oral
dosage form (tablets):
-
For treating prostate cancer:
-
Adults--50 to 200 milligrams (mg) three times a day.
-
For injection
dosage form:
-
For treating prostate cancer:
-
Adults--At first, 500 mg is mixed in solution with sodium chloride
or dextrose injection and injected slowly into a vein. Your doctor may increase
your dose to 1 gram a day for five or more straight days as needed. Then,
your doctor may lower your dose to between 250 and 500 mg one or two times
a week.
For esterified estrogens
-
For oral
dosage form (tablets):
-
For treating breast cancer in women after menopause and in men:
-
Adults--10 milligrams (mg) three times a day for at least three
months.
-
For treating a genital skin condition (vulvar atrophy) or inflammation
of the vagina (atrophic vaginitis), or to prevent loss of bone (osteoporosis):
-
Adults--0.3 to 1.25 mg a day. Your doctor may want you to take
the medicine each day or only on certain days of the month.
-
For treating ovary problems (failure or removal of both ovaries):
-
Adults--1.25 mg a day. Your doctor may want you to take the
medicine each day or only on certain days of the month.
-
For treating ovary problems (female hypogonadism):
-
Adults--2.5 to 7.5 mg a day. This dose may be divided up and
taken in smaller doses. Your doctor may want you to take the medicine each
day or only on certain days of the month.
-
For treating symptoms of menopause:
-
Adults--0.625 to 1.25 mg a day. Your doctor may want you to
take the medicine each day or only on certain days of the month.
-
For treating prostate cancer:
-
Adults--1.25 to 2.5 mg three times a day.
For estradiol
-
For oral
dosage form (tablets):
-
For treating breast cancer in women after menopause and in men:
-
Adults--10 milligrams (mg) three times a day for at least three
months.
-
For treating a genital skin condition (vulvar atrophy), inflammation
of the vagina (atrophic vaginitis), ovary problems (female hypogonadism or
failure or removal of both ovaries), or symptoms of menopause:
-
Adults--0.5 to 2 mg a day. Your doctor may want you to take
the medicine each day or only on certain days of the month.
-
For treating prostate cancer:
-
Adults--1 to 2 mg three times a day.
-
To prevent loss of bone (osteoporosis):
-
Adults--0.5 mg a day. Your doctor may want you to take the medicine
each day or only on certain days of the month.
-
For transdermal
dosage form (skin patches):
-
For treating a genital skin condition (vulvar atrophy), inflammation
of the vagina (atrophic vaginitis), symptoms of menopause, ovary problems
(female hypogonadism or failure or removal of both ovaries), or to prevent
loss of bone (osteoporosis):
For the Climara or FemPatch patches
-
Adults--0.025 to 0.1 milligram (mg) (one patch) applied to the
skin and worn for one week. Then, remove that patch and apply a new one. A
new patch should be applied once a week for three weeks. During the fourth
week, you may or may not wear a patch. Your health care professional will
tell you what you should do for this fourth week. After the fourth week, you
will repeat the cycle.
For the Alora, Estraderm, or Vivelle patches
-
Adults--0.025 to 0.1 mg (one patch) applied to the skin and
worn for one half of a week. Then, remove that patch and apply and wear a
new patch for the rest of the week. A new patch should be applied two times
a week for three weeks. During the fourth week, you may or may not apply new
patches. Your health care professional will tell you what you should do for
this fourth week. After the fourth week, you will repeat the cycle.
For estradiol cypionate
-
For injection
dosage form:
-
For treating ovary problems (female hypogonadism):
-
Adults--1.5 to 2 milligrams (mg) injected into a muscle once
a month.
-
For treating symptoms of menopause:
-
Adults--1 to 5 mg injected into a muscle every three to four
weeks.
For estradiol valerate
-
For injection
dosage form:
-
For treating a genital skin condition (vulvar atrophy), inflammation
of the vagina (atrophic vaginitis), symptoms of menopause, or ovary problems
(female hypogonadism or failure or removal of both ovaries):
-
Adults--10 to 20 milligrams (mg) injected into a muscle every
four weeks as needed.
-
For treating prostate cancer:
-
Adults--30 mg injected into a muscle every one or two weeks.
For estrone
-
For injection
dosage form:
-
For controlling abnormal bleeding of the uterus:
-
Adults--2 to 5 milligrams (mg) a day, injected into a muscle
for several days.
-
For treating a genital skin condition (vulvar atrophy), inflammation
of the vagina (atrophic vaginitis), or symptoms of menopause:
-
Adults--0.1 to 0.5 mg injected into a muscle two or three times
a week. Your doctor may want you to receive the medicine each week or only
during certain weeks of the month.
-
For treating ovary problems (female hypogonadism or failure or removal
of both ovaries):
-
Adults--0.1 to 1 mg a week. This is injected into a muscle as
a single dose or divided into more than one dose. Your doctor may want you
to receive the medicine each week or only during certain weeks of the month.
-
For treating prostate cancer:
-
Adults--2 to 4 mg injected into a muscle two or three times
a week.
For estropipate
-
For oral dosage form (tablets):
-
For treating a genital skin condition (vulvar atrophy), inflammation
of the vagina (atrophic vaginitis), or symptoms of menopause:
-
Adults--0.75 to 6 milligrams (mg) a day. Your doctor may want
you to take the medicine each day or only on certain days of the month.
-
For treating ovary problems (female hypogonadism or failure or removal
of both ovaries):
-
Adults--1.5 to 9 mg a day. Your doctor may want you to take
the medicine each day or only on certain days of the month.
-
To prevent loss of bone (osteoporosis):
-
Adults--0.75 mg a day. Your doctor may want you to take the
medicine each day for twenty-five days of a thirty-one-day cycle.
For ethinyl estradiol
-
For oral
dosage form (tablets):
-
For treating breast cancer in women after menopause and in men:
-
Adults--1 milligram (mg) three times a day.
-
For treating ovary problems (female hypogonadism or failure or removal
of both ovaries):
-
Adults--0.05 mg one to three times a day for three to six months.
Your doctor may want you to take the medicine each day or only on certain
days of the month.
-
For treating prostate cancer:
-
Adults--0.15 to 3 mg a day.
-
For treating symptoms of menopause:
-
Adults--0.02 to 0.05 mg a day. Your doctor may want you to take
the medicine each day or only on certain days of the month.
For ethinyl estradiol and norethindrone
-
For oral
dosage form (tablets):
-
For treating symptoms of menopause:
-
Adults--1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone)
each day
-
To prevent loss of bone (osteoporosis):
-
Adults--1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone)
each day
Missed dose--
-
For patients taking any of the estrogens by mouth: If you miss a
dose of this medicine, take it as soon as possible. However, if it is almost
time for your next dose, skip the missed dose and go back to your regular
dosing schedule. Do not double doses.
-
For patients using the transdermal (skin patch) form of estradiol:
If you forget to apply a new patch when you are supposed to, apply it as soon
as possible. However, if it is almost time for the next patch, skip the missed
one and go back to your regular schedule. Always remove the old patch before
applying a new one. Do not apply more than one patch at a time.
Storage--To store this medicine:
-
Keep out of the reach of children.
-
Store away from heat and direct light.
-
Do not store in the bathroom medicine cabinet because the heat or
moisture may cause the medicine to break down.
-
Keep the injection form of this medicine from freezing.
-
Do not keep outdated medicine or medicine no longer needed. Be sure
that any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
It is very important that your doctor check your progress at
regular visits to make sure this medicine does not cause unwanted effects
. These visits will usually be every year, but some doctors require
them more often.
In some patients using estrogens, tenderness, swelling, or bleeding of
the gums may occur. Brushing and flossing your teeth carefully and regularly
and massaging your gums may help prevent this. See your dentist regularly
to have your teeth cleaned. Check with your medical doctor or dentist if you
have any questions about how to take care of your teeth and gums, or if you
notice any tenderness, swelling, or bleeding of your gums.
It is not yet known whether the use of estrogens increases
the risk of breast cancer in women
. Therefore,
it is very important that you regularly check your breasts for any unusual
lumps or discharge. Report any problems to your doctor
. You should
also have a mammogram (x-ray pictures of the breasts) done if your doctor
recommends it. Because breast cancer has occurred in men taking estrogens,
regular breast self-exams and exams by your doctor for any unusual lumps or
discharge should be done.
If your menstrual periods have stopped, they may start
again
. This effect will continue for as long as the medicine is taken.
However, if taking the continuous treatment (0.625 mg conjugated estrogens
and 2.5 mg medroxyprogesterone once a day), monthly bleeding usually stops
within 10 months.
Also, vaginal bleeding between your regular menstrual periods may occur
during the first 3 months of use. Do not stop taking your medicine. Check with your doctor if bleeding continues for an unusually
long time, if your period has not started within 45 days of your last period,
or if you think you are pregnant
.
Tell the doctor in charge that you are taking this medicine before having
any laboratory test because some results may be affected.
Side Effects of This Medicine
Women rarely have severe side effects from taking estrogens to replace
estrogen. Discuss these possible effects with your doctor:
-
The prolonged use of estrogens has been reported to increase the
risk of endometrial cancer (cancer of the lining of the uterus) in women after
menopause. This risk seems to increase as the dose and the length of use increase.
When estrogens are used in low doses for less than 1 year, there is less risk.
The risk is also reduced if a progestin (another female hormone) is added
to, or replaces part of, your estrogen dose. If the uterus has been removed
by surgery (total hysterectomy), there is no risk of endometrial cancer.
-
It is not yet known whether the use of estrogens increases the risk
of breast cancer in women. Although some large studies show an increased risk,
most studies and information gathered to date do not support this idea. Breast
cancer has been reported in men taking estrogens.
The following side effects may be caused by
blood clots, which could lead to stroke, heart attack, or death. These side
effects occur rarely, and, when they do occur, they occur in men treated for
cancer using high doses of estrogens. Get emergency help
immediately
if any of the following side effects occur:
Rare--for males being treated for breast or prostate cancer only
Headache (sudden or severe); loss of
coordination (sudden); loss of vision or change of
vision (sudden); pains in chest, groin, or leg, especially
in calf of leg; shortness of breath (sudden and unexplained); slurring of speech (sudden); weakness or numbness in arm or leg
Also, check with your doctor as soon as possible
if any of the following side effects occur:
Less common or rare
Changes in vaginal bleeding (spotting, breakthrough bleeding,
prolonged or heavier bleeding, or complete stoppage of bleeding); lumps in, or discharge from, breast (in females and males); pains in stomach, side, or abdomen; yellow eyes or skin
Other side effects may occur that usually do
not need medical attention. These side effects may go away during treatment
as your body adjusts to the medicine. However, check with your doctor if any
of the following side effects continue or are bothersome:
Also,
many women who are taking estrogens with a progestin (another female hormone)
will start having monthly vaginal bleeding, similar to menstrual periods,
again. This effect will continue for as long as the medicine is taken. However,
monthly bleeding will not occur in women who have had the uterus removed by
surgery (total hysterectomy).
Other side effects not listed above may also occur in
some patients. If you notice any other effects, check with your doctor.
Additional Information
Once a medicine has been approved
for marketing for a certain use, experience may show that it is also useful
for other medical problems. Although these uses are not included in product
labeling, estrogen is used in certain patients with the following medical
conditions:
-
Osteoporosis caused by lack of estrogen before menopause
-
Atherosclerotic disease (hardening of the arteries)
-
Turner's syndrome (a genetic disorder)
Other than the above information, there is no additional information relating
to proper use, precautions, or side effects for these uses.
