- PROGYNON (estradiol valerate)
-
- Estradiol is a form of estrogen. Estrogen is
a female sex hormone necessary for many processes in the body.
Estradiol is used to treat symptoms of menopause; deficiency in ovary function (including
underdevelopment of female sexual characteristics and some types of infertility); Turner's
syndrome; some types of breast cancer in men and in postmenopausal women; degeneration of
the vagina and urethra; and prostate cancer. In addition, estradiol is used to prevent
osteoporosis.
Estradiol may also be used for purposes other than those listed in this medication guide.
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
- Estradiol
- Tablets (U.S. and Canada)
- Ethinyl Estradiol
- Tablets (U.S. and Canada)
Parenteral
- Estradiol ( Progynon )
- Injection (U.S. and Canada)
Topical
- Estradiol ( Progynon )
- 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.
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 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
( Progynon ):
- 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 Estradiol ( Progynon
)
- 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 Estradiol ( Progynon
) valerate ( Progynon )
- 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 ethinyl Estradiol (
Progynon )
- 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 (
Progynon ) and norethindrone
- For oral dosage form (tablets):
- For treating symptoms of menopause:
- Adults—1 tablet (5 mcg ethinyl Estradiol
( Progynon ) and 1 mg of norethindrone) each day
- To prevent loss of bone (osteoporosis):
- Adults—1 tablet (5 mcg ethinyl Estradiol
( Progynon ) 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 ( Progynon ): 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
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 womenTherefore, 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
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:
ˇ 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.
ˇ 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:
More common
Breast pain (in females and
males); increased breast size (in females and males); swelling of feet and
lower legs; weight gain (rapid)
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:
More common
Bloating of stomach;
cramps of lower stomach; loss of appetite; nausea; skin
irritation or redness where skin patch was worn
Less common
Diarrhea (mild);
dizziness (mild); headaches (mild); migraine headaches ; problems
in wearing contact lenses; unusual decrease in sexual desire (in males);
unusual increase in sexual desire (in females); vomiting (usually with high
doses)
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.
