PATIENT INFORMATION
PATIENT PACKAGE
INSERT
Vaginal Cream, Oral Tablets, and Transdermal
System
This information describes when and how to use estrogens,
and the risks and benefits of estrogen treatment.
Estrogens have important benefits but also some risks.
You must decide, with your doctor, whether the risks to
you of estrogen use are acceptable because of their benefits.
If you use estrogens, check with your doctor to be sure
you are using the lowest possible dose that works, and
that you don't use them longer than necessary. How long
you need to use estrogens will depend on the reason for
use.
Additional Information for the Climara System:
The Climara system that your doctor has
prescribed for you releases small amounts of estradiol
through the skin in a continuous way. Estradiol is the
same hormone that your ovaries produce abundantly before
menopause. The dose of estradiol you require will depend
upon your individual response. The dose is adjusted by
the size of the Climara system used: the systems are avaialble
in 4 sizes.
Additional Information for Vaginal Cream:
NOTE: The number of doses per tube of estradiol vaginal
cream will vary with dosage requirements and patient handling.
Vaginal
Cream and Oral Tablets:
1. Estrogens Increase
the Risk of Cancer of the Uterus in Women Who Have
Had Their Menopause ("Change Of Life"):
If you are using
any estrogen-containing drug, it is important to visit
your doctor regularly and report any unusual vaginal
bleeding right away. Vaginal bleeding after menopause
may be a warning sign of uterine cancer. Your doctor
should evaluate any unusual vaginal bleeding to find
out the cause.
2. Estrogens Should
not be Used During Pregnancy: Estrogens
do not prevent miscarriage (spontaneous abortion)
and are not needed in the days following childbirth.
If you take estrogens during pregnancy, your unborn
child has a greater than usual chance of having
birth defects. The risk of developing these defects
is small, but clearly larger than the risk in children
whose mothers did not take estrogens during pregnancy.
These birth defects may affect the baby's urinary
system and sex organs. Daughters born to mothers
who took DES (an estrogen drug) have a higher than
usual chance of developing cancer of the vagina
or cervix when they become teenagers or young adults.
Sons may have a higher than usual chance of developing
cancer of the testicles when they become teenagers
or young adults.
|
Information About Climara
How the Cliamara System Works:
The Climara system contains 17b-estradiol. When applied
to the skin as directed below, the Climara system releases
17b-estradiol, which flows through the skin into the bloodstream.
How and Where to Apply the Climara System:
Each Climara system is individually sealed in a protective
pouch. To open the pouch, hold it vertically with the
Climara name facing you. Tear left to right using the
top tear notch. Tear from bottom to top using the side
tear notch. Pull the pouch open. The Climara patch is
the translucent plastic film attached to the clear, thicker
plastic backing. There is a silver-foil sticker securely
attached to the inside of the pouch. This contains a moisture
protectant (desiccant). Do not remove it. Carefully remove
the Climara patch. You'll notice that the patch is attached
to a thicker, hard-plastic backing and that the patch
itself is oval and transparent.
Apply the adhesive side of the Climara system to a clean,
dry area of the lower abdomen or the upper quadrant of
the buttock. Do not apply the Climara system to your breasts.
The sites of application must be rotated, with an interval
of at least 1 week allowed between applications to a particular
site. The area selected should not be oily, damaged, or
irritated. Avoid the waistline, since tight clothing may
rub and remove the system. Application to areas where
sitting would would dislodge the system should also be
avoided. Apply the system immediately after opening the
pouch and removing the protective liner. Press the system
firmly in place with the fingers for about 10 seconds,
making sure there is good contact, especially around the
edges.
The Climara system should be worn continuously for one
week. You may wish to experiment with different locations
when applying a new system, to find ones that are most
comfortable for you and where clothing will not rub on
the system.
When to Apply the Climara System:
The Climara system should be changed once weekly.
When changing the system, remove the used Climara system
and discard it. Any adhesive that might remain on your
skin can easily be rubbed off. Then place the new Climara
system on a different skin site. (The same skin site should
not be used again for at least one week after removal
of the system.)
Contact with water when you are bathing, swimming or
showering, may affect the system. In the unlikely event
that a system should fall off, a new system should be
applied for the remainder of the 7-day dosing interval.
Vaginal Cream, Oral Tablets, and Transdermal
System
Uses of Estrogen
Not every estrogen drug is approved for every use listed
in this section. If you want to know which of these possible
uses are approved for the medicine prescribed for you,
ask your doctor or pharmacist to wshow you the product
information. Generic drugs carry virtually the same labeling
information as their name brand versions.
To Reduce Moderate or Severe Menopausal Symptoms: Estrogens
are hormones made by the ovaries of normal women. Between
ages 45 and 55, the ovaries normally stop making estrogens.
This leads to a drop in body estrogen levels which causes
the "change of life" or menopause (the end of
monthly menstrual periods). If both ovaries are removed
during an operation before natural menopause takes place,
the sudden drop in estrogen levels causes "surgical
menopause."
When the estrogen levels begin dropping, some women develop
very uncomfortable symptoms, such as feelings of warmth
in the face, neck and chest, or sudden intense episodes
of heat and sweating ("hot flashes or "hot flushes").
Using estrogen drugs can help the body adjust to lower
estrogen levels and reduce these symptoms. Most women
have only mild menopausal symptoms or none at all and
do not need to use estrogen drugs for these symptoms.
Others may need to take estrogens for a few months while
their bodies adjust to lower estrogen levels. The majority
of women do not need estrogen replacement for longer than
6 months for these symptoms.
To Treat Vulval and Vaginal Atrophy: (Itching,
burning, dryness in or around the vagina, difficulty or
burning on urination) associated with menopause.
To treat certain conditions in which a young
woman's ovaries do not produce enough estrogen naturally.
To treat certain types of abnormal vaginal bleeding
due to hormonal imbalance when your doctor has found no
serious cause of the bleeding.
To treat certain cancers in special situations,
in men and women.
To Prevent Thinning of Bones:
Osteoporosis is a thinning of the bones that makes them
weaker and allows them to break more easily. The bones
of the spine, wrists and hips break most often in osteoporosis.
Both men and women start to lose bone mass after about
age 40, but women lose bone mass faster after the menopause.
Using estrogens after the menopause slows down bone thinning
and may prevent bones from breaking. Lifelong adequate
calcium intake, either in the diet (such as dairy products)
or by calcium supplements (to reach a total daily intake
of 1000 milligrams per day before menopause or 1500 milligrams
per day after menopause), may help to prevent osteoporosis.
Regular weight-bearing exercise (like walking and running
for an hour, two or three times a week) may also help
to prevent osteoporosis. Before you change your calcium
intake or exercise habits, it is important to discuss
these lifestyle changes with your doctor to find out if
they are safe for you.
Since estrogen use has some risks, only women who are
likely to develop osteoporosis should use estrogens for
prevention. Women who are likely to develop osteoporosis
often have the following characteristics: White or Asian
race, slim, cigarette smokers, and a family history of
osteoporosis in a mother, sister, or aunt. Women who have
relatively early menopause, often because their ovaries
were removed during an operation ("surgical menopause")
are more likely to develop osteoporosis than women whose
menopause happens at the average age.
Who Should Not Use Estrogens
Estrogens should not be used:
- During Pregnancy: See BOXED WARNING,
Vaginal Cream; BOXED WARNING, Oral Tablets; or BOXED
WARNING, Transdermal. If you think you may be pregnant,
do not use any form of estrogen-containing drug. Using
estrogens while you are pregnant may cause your unborn
child to have birth defects. Estrogens do not prevent
miscarriage.
- If You Have Unusual Vaginal Bleeding Which Has
not Been Evaluated by Your Doctor: See BOXED
WARNING, Vaginal Cream; BOXED WARNING, Oral Tablets;
or BOXED WARNING, Transdermal. Unusual vaginal bleeding
can be a warning sign of cancer of the uterus, especially
if it happens after menopause. Your doctor must find
out the cause of the bleeding so that he or she can
recommend the proper treatment. Taking estrogens without
visiting your doctor can cause you serious harm if your
vaginal bleeding is caused by cancer of the uterus.
- If You Have Had Cancer: Since estrogens
increase the risk of certain types of cancer, you should
not use estrogens if you have ever had cancer of the
breast or uterus, unless your doctor recommends that
the drug may help in cancer treatment. (For certain
patients with breast or prostate cancer, estrogens may
help.)
- If You Have any Circulation Problems:
Estrogen drugs should not be used except in unusually
special situations in which your doctor judges that
you need estrogen therapy so much that the risks are
acceptable. Men and women with abnormal blood clotting
conditions should avoid estrogen use (see Dangers of
Estrogens).
- When They do not Work: During menopause,
some women develop nervous symptoms or depression. Estrogens
do not relieve these symptoms. You may have heard that
taking estrogens for years after menopause will keep
your skin soft and supple and keep you feeling young.
There is no evidence for these claims and such long-term
estrogen use may have serious risks.
- After Childbirth or When Breastfeeding a Baby:
Estrogens should not be used to try to stop the breasts
from filling with milk after a baby is born. Such treatment
may increase the risk of developing blood clots (see
Dangers of Estrogens).
If you are breastfeeding, you should avoid using any
drugs because many drugs pass through to the baby in the
milk. While nursing a baby, you should take drugs only
on the advice of your health care provider.
Dangers of Estrogens
Cancer of the Uterus: Your
risk of developing cancer of the uterus gets higher the
longer you use estrogens and the larger doses you use.
One study showed that after women stop taking estrogens,
this higher cancer risk quickly returns to the usual level
of risk (as if you had never used estrogen therapy). Three
other studies showed that the cancer risk stayed high
for 8 to more than 15 years after stopping estrogen treatment.
Because of this risk, IT IS IMPORTANT TO TAKE THE LOWEST
DOSE THAT WORKS AND TO TAKE IT ONLY AS LONG AS YOU NEED
IT.
Using progestin therapy together with estrogen therapy
may reduce the higher risk of uterine cancer related to
estrogen use (but see Other Information).
If you have had your uterus removed (total hysterectomy),
there is no danger of developing cancer of the uterus.
Cancer of the Breast: Most
studies have not shown a higher risk of breast cancer
in women who have ever used estrogens. However, some studies
have reported that breast cancer developed more often
(up to twice the usual rate) in women who used estrogens
for long periods of time (especially more than 10 years),
or who used higher doses for shorter time periods.
Regular breast examinations by a health professional
and monthly self-examination are recommended for all women.
Gallbladder Disease: Women
who use estrogens after menopause are more likely to develop
gallbladder disease needing surgery than women who do
not use estrogens.
Abnormal Blood Clotting: Taking
estrogens may cause changes in your blood clotting system.
These changes allow the blood to clot more easily, possibly
allowing clots to form in your bloodstream. If blood clots
do form in your bloodstream, they can cut off the blood
supply to vital organs, causing serious problems. These
problems may include a stroke (by cutting off blood to
the brain), a heart attack (by cutting off blood to the
heart), a pulmonary embolus (by cutting off blood to the
lungs), or other problems. Any of these conditions may
cause death or serious long term disability. However,
most studies of low dose estrogen usage by women do not
wshow an increased risk of these complications.
Side Effects
In addition to th
- Nausea and vomiting.
- Breast tenderness or enlargement.
- Enlargement of benign tumors ("fibroids")
of the uterus.
- Retention of excess fluid. This may make some conditions
worsen, such as asthma, epilepsy, migraine, heart disease,
or kidney disease.
- A spotty darkening of the skin, particularly of the
face.
Reducing Risk of Estrogen Use
If you use estrogens, you can reduce your risks by doing
these things:
See Your Doctor Regularly:
While you are using estrogens, it is important to visit
your doctor at least once a year for a check-up. If you
develop vaginal bleeding while taking estrogens, you may
need further evaluation. If members of your family have
had breast cancer or if you have ever had breast lumps
or an abnormal mammogram (breast x-ray), you may need
to have more frequent breast examinations.
Reassess Your Need for Estrogens:
You and your doctor should reevaluate whether or not you
still need estrogens at least every six months.
Be Alert for Signs of Trouble: If
any of these warning signals (or any other unusual symptoms)
happen while you are using estrogens, call your doctor
immediately:
- Abnormal bleeding from the vagina (possible uterine
cancer).
- Pains in the calves or chest, sudden shortness of
breath, or coughing blood (possible clot in the legs,
heart or lungs).
- Severe headache or vomiting, dizziness, faintness,
changes in vision or speech, weakness or numbness of
an arm or leg (possible clot in the brain or eye).
- Breast lumps (possible breast cancer; ask your doctor
or health professional to wshow you how to examine your
breasts monthly).
- Yellowing of the skin or eyes (possible liver problem).
- Pain, swelling, or tenderness in the abdomen (possible
gallbladder problem).
Other Information
Your doctor has prescribed this drug for you and you
alone. Do not give the drug to anyone else.
If you will be taking calcium supplements as party of
the treatment to help prevent osteoporosis, check with
your doctor about how much to take.
Keep this and all drugs out of the reach of children.
In case of overdose, call your doctor, hospital or poison
control center immediately.
Vaginal Cream and Oral Tablets
Some doctors may choose to prescribe a progestin, a different
hormonal drug, for you to take together with your estrogen
treatment. Progestins lower your risk of developing endometrial
hyperplasia (a possible pre-cancerous condition of the
uterus) while using estrogens. Taking estrogens and progestins
together may also protect you from the higher risk of
uterine cancer, but this has not been clearly established.
Combined use of progestin and estrogen treatment may have
additional risks, however, the possible risks include
unhealthy effects on blood fats (especially a lowering
of HDL cholesterol, the “good” blood fat which
protects against heart disease risk), unhealthy effects
on blood sugar (which might worsen a diabetic condition),
and a possible further increase in the breast cancer risk
which may be associated with long-term estrogen use. The
type of progestin drug used and its dosage schedule may
be important in minimizing these effects.
Transdermal System
Estrogens increase the risk of developing a condition
(endometrial hyperplasia) that may lead to cancer of the
lining of the uterus. Taking progestins, another hormone
drug, with estrogen lowers the risk of developing this
condition. Therefore, if your uterus has not been removed,
your doctors may prescribe a progestin for you to take
together with your estrogen.
You should know, however, that taking estrogens with
progestins may have additional risks. These include: Unhealthy
effects on blood fats (especially a lowering of HDL blood
cholestrol, the "good" blood fat which protects
against heart disease); unhealthy effects on blood sugar
(which might make a diabetic condition worse); and a possible
further increase in breast cancer risk which may be associated
with long term estrogen use.
Some research has shown that estrogens taken without
progestins may protect women against developing heart
disease. However, this is not certain. The protection
shown may have been caused by the characteristics of the
estrogen-treated women, and not by the estrogen treatment
itself. In general, treated women were slimmer, more physically
active, and were less likely to have diabetes than the
untreated women. These characteristics are known to protect
against heart disease.
You are cautioned to discuss very carefully with your
doctor or health care provider, all the possible risks
and benefits of long-term estrogen and progestin treatment
as they affect you personally.
Do not store above 86°F (30°C). Do not store
unpouched. Apply immediately upon removal from the protective
pouch.
Vaginal Ring
Introduction
This information describes when and how to use Estring
vaginal ring, and the risks and benefits of estrogen treatment.
Please read this information carefully before starting
treatment.
Estrogens have important benefits but also some risks. You
must decide, with your doctor, whether the risks to you
of estrogen use are acceptable because of their benefits.
If you use estrogens, check with your doctor to be sure
you are using the dose that is appropriate for you, and
that you don't use them longer than necessary. How long
you need to use estrogens should be decided by you and your
doctor.
| 1. Estrogens
Increase the Risk of Cancer of the Uterus in Women
Who Have Had Their Menopause (“Change of Life”):
If you use any estrogen-containing drug, it is important
to visit your doctor regularly and report any unusual
vaginal bleeding right away. Vaginal bleeding after
menopause may be a warning sign of uterine cancer.
Your doctor should evaluate any unusual vaginal bleeding
to find out the cause.
2.
Estrogens Should Not be Used During Pregnancy:Estrogens
do not prevent miscarriage (spontaneous abortion)
and are not needed in the days following childbirth.
If you take estrogens during pregnancy, your unborn
child has a greater than usual chance of having
birth defects. The risk of developing these defects
is small, but clearly larger than the risk in children
whose mothers did not take estrogens during pregnancy.
These birth defects may affect the baby's urinary
system and sex organs. Daughters born to mothers
who took DES (an estrogen drug) have a higher than
usual chance of developing cancer of the vagina
or cervix when they become teenagers or young adults.
Sons may have a higher than usual chance of developing
cancer of the testicles when they become teenagers
or young adults. |
Uses of Estrogen
Estrogens are hormones made by the ovaries of women during
their reproductive years. Between ages 45 and 55, the
ovaries normally stop making estrogens. This leads to
a drop in body estrogen levels which causes the “change
of life” or menopause (the end of monthly menstrual
periods). If both ovaries are removed during an operation
before natural menopause takes place, the sudden drop
in estrogen levels results in what is known as “surgically
induced menopause”.
When the estrogen levels begin dropping, some women develop
very uncomfortable symptoms, such as feelings of warmth
in the face, neck, and chest, or sudden intense episodes
of heat and sweating (“hot flashes” or “hot
flushes”). Using estrogen drugs can help the body
adjust to lower estrogen levels and reduce these symptoms.
ESTRING DOES NOT PROVIDE ENOUGH ESTROGEN TO REDUCE THESE
SYMPTOMS.
The declining estrogen levels associated with advancing
age after menopause may also result in thinning and drying
of the tissue in the urinary tract and vagina (urogenital
atrophy). Vaginal symptoms of this condition include dryness
in the vagina (atrophic vaginitis), genital itching and
burning, and pain with intercourse. Urinary symptoms may
include urinary urgency and pain on urination. Small amounts
of estrogen delivered directly to the local tissue can
be used to help reduce these symptoms.
Use of Estring Vaginal Ring
Estring is a local estrogen therapy designed to relieve
vaginal and urinary symptoms of postmenopausal estrogen
deficiency for a full 90 days. Estring exerts its effect
locally in the lower urogenital tract and has not been
shown to have significant effects in other estrogen-sensitive
organs or tissues of the body. Consequently, ESTRING VAGINAL
RING PROVIDES RELIEF OF LOCAL SYMPTOMS OF MENOPAUSE ONLY.
Description
Estring contains a drug reservoir of 2 mg of the estrogen,
estradiol, in its core. Estring releases estradiol into
the vagina in a consistent, stable manner for 90 days.
The soft, flexible ring is placed in the upper third of
the vagina (by the physician or the patient) and worn
continuously for 90 days, then removed and replaced if
continuation of therapy is indicated.
Who Should Not Use Estring
Estring Should Not Be Used:
During pregnancy. See BOXED
WARNING. Women who are definitely postmenopausal cannot
become pregnant. Women who believe they are postmenopausal
because their menstrual cycles have recently stopped should
confirm that they are not pregnant before using any form
of estrogen-containing drug. Using estrogens while pregnant
may cause the unborn child to have birth defects. Estrogens
do not prevent miscarriage.
In the presence of unusual vaginal bleeding which has
not been evaluated by a doctor. See BOXED WARNING. Unusual
vaginal bleeding after menopause can be a warning sign
of cancer of the uterus. Estrogens may increase the risk
of cancer of the uterus in women who have had their menopause
(“change of life”). If you use any estrogen-containing
drug, it is important to visit your doctor regularly and
report any unusual vaginal bleeding right away. Your doctor
should evaluate any unusual vaginal bleeding to find out
the cause.
If there is a history of certain types of cancer. Estrogens
may increase the risk of certain types of cancer. In general,
Estring should not be used in women who have ever had
cancer of the breast or uterus.
During treatment for vaginal infection with vaginal antimicrobial
therapy. It is recommended that Estring be discontinued
while other vaginal medications are being used to treat
a vaginal infection. Use of Estring can be resumed after
termination of the other vaginal medication, and after
first consulting with a physician.
After childbirth or when breastfeeding a baby. Estring
should not be used to try to stop the breasts from filling
with milk after a baby is born. Women who are breast-feeding
should avoid using any drugs because many drugs pass through
to the baby in the milk. While nursing a baby, drugs should
only be taken on the advice of your healthcare giver.
Possible Risks From Treatment With Estrogens
The Following Risk Factors Apply to Estrogens
in General:
Cancer of the uterus. Estrogens
increase the risk of developing a condition (endometrial
hyperplasia) that may lead to cancer of the lining of
the uterus (endometrial cancer). The risk of endometrial
cancer is greater in estrogen users than nonusers. Studies
have shown that this increased risk depends on estrogen
dose, duration of treatment, and treatment regimen. If
the uterus has been removed (total hysterectomy), there
is no danger of developing cancer of the uterus.
Cancer of the breast. Most
studies have not shown a higher risk of breast cancer
in women who have ever used estrogens. However, some studies
have reported that breast cancer developed more often
(up to twice the usual rate) in women who used estrogens
for long periods of time (especially more than 10 years),
or who used higher doses for shorter time periods. Regular
breast examinations by a health professional and monthly
self-examination are recommended for all women.
Gallbladder disease and abnormal
blood clotting. Gallbladder disease and abnormal blood
clotting are risk factors associated with medium to high
doses of estrogen. Most studies of low dose estrogen usage
by women do not wshow an increased risk of these complications,
and to date have not been seen with Estring treatment.
Side Effects
Like all medications, Estring may cause side effects.
The most frequently reported side effect is increased
vaginal secretions. Many of these vaginal secretions are
like those that occur normally prior to menopause and
indicate that Estring is working. Vaginal secretions that
are associated with a bad odor, vaginal itching, or other
signs of vaginal infection are NOT normal and may indicate
a risk or a cause for concern. Other side effects may
include vaginal discomfort, abdominal pain, or genital
itching.
Estrogens in General
In Addition to the Risks Listed Above, the Following
Side Effects Have Been Reported With Estrogen Use:
- Nausea and vomiting.
- Breast tenderness or enlargement.
- Enlargement of benign tumors (“fibroids”) of the uterus.
- Retention of excess fluid. This may worsen some conditions,
such as asthma, epilepsy, migraine, heart disease, or
kidney disease.
- Spotty darkening of the skin, particularly on the
face.
Reducing Risk of Estrogen Use
If You Use Estrogens, You May Reduce Your
Risks By Doing These Things:
See Your Doctor Regularly:
While you are using estrogens, it is important to visit
your doctor at least once a year for a check-up. If you
develop vaginal bleeding while taking estrogens, call
your doctor¾you may need further evaluation. If
members of your family have had breast cancer or if you
have ever had breast lumps or an abnormal mammogram (breast
X-ray), you may need to have more frequent breast examinations.
Reassess Your Need for Estrogens:
You and your doctor should reevaluate whether or not you
still need estrogens at least every 6 months.
Be Alert for Warning Signs: If
any of these warning signals (or any other unusual symptoms)
happen while you are using estrogens, call your doctor
immediately:
- Abnormal bleeding from the vagina (possible uterine
cancer).
- Pains in the calves or chest, sudden shortness of
breath, or coughing blood (possible clot in the legs,
heart, or lungs).
- Severe headache or vomiting, dizziness, faintness,
changes in vision or speech, weakness or numbness of
an arm or leg (possible clot in the brain or eye).
- Breast lumps (possible breast cancer; ask your doctor
or health professional to wshow you how to examine your
breasts monthly).
- Yellowing of skin or eyes (possible liver problem).
- Pain, swelling, or tenderness in the abdomen (possible
gallbladder problem).
Other Information
Estrogens increase the risk of developing a condition
(endometrial hyperplasia) that may lead to cancer of the
lining of the uterus. Progestin, another hormone drug,
is usually prescribed with higher-dose estrogen preparations
to lower the risk of developing endometrial hyperplasia.
Progestins are not usually needed for women using Estring
alone.
Some women have experienced moving or sliding of Estring
within the vagina. If this happens, Estring can be gently
pushed back into position with a clean finger. Instances
of Estring slipping out of the vagina have been infrequent
and were usually associated with moving the bowels, straining,
or constipation within the first few weeks of treatment.
If this occurs, Estring can be washed with lukewarm (NOT
hot) water and reinserted. If this happens repeatedly,
you should consult with your doctor or healthcare giver
and determine whether continued treatment is appropriate
for you.
Estring may not be suitable for women with narrow, short,
or stenosed (constricted) vaginas. A narrow vagina, vaginal
stenosis (constriction), significant prolapse, and vaginal
infections are conditions that make the vagina more susceptible
to irritation or ulceration caused by Estring. Women with
signs or symptoms of vaginal irritation should alert their
doctor or healthcare giver.
Vaginal infection is generally more common in postmenopausal
women. Vaginal infections should be treated with appropriate
antimicrobial therapy before initiation of Estring. If
a vaginal infection develops during use of Estring, then
Estring should be removed and reinserted only after the
infection has been appropriately treated. See your doctor
or healthcare giver if you have vaginal discomfort or
suspect you have a vaginal infection.
Your doctor has prescribed this drug for you and you
alone. Do not give the drug to anyone else.
Keep this and all drugs out of the reach of children.
How Supplied
Storage: Store at controlled
room temperature 15-30° C (59-86° F).
Estring Insertion
Estring can be inserted and removed by you or your doctor.
To insert Estring yourself, choose the position that is
most comfortable for you: standing with one leg up, squatting,
or lying down.
1. After washing and drying your hands,
remove Estring from its pouch using the tear-off notch
on the side. (Since the ring becomes slippery when wet,
be sure your hands are dry before handling it.)
2. Hold Estring between your thumb and
index finger and press the opposite sides of the ring
together as shown.
3. Gently push the compressed ring into
your vagina as far as you can.
Estring Placement
The exact position of Estring is not critical, as long
as it is placed in the upper third of the vagina.
When Estring is in place, you should not feel anything.
If you feel uncomfortable, Estring is probably not far
enough inside. Use your finger to gently push Estring
further into your vagina.
There is no danger of Estring being pushed too far up
in the vagina or getting lost. Estring can only be inserted
as far as the end of the vagina, where the cervix (the
narrow, lower end of the uterus) will block Estring from
going any further.
Estring Use
Once inserted, Estring should remain in place in the
vagina for 90 days.
Most women and their partners experience no discomfort
with Estring in place during intercourse, so it is NOT
necessary that the ring be removed. If Estring should
cause you or your partner any discomfort, you may remove
it prior to intercourse (see Estring Removal). Be sure
to reinsert Estring as soon as possible afterwards.
Estring may slide down into the lower party of the vagina
as a result of the abdominal pressure or straining that
sometimes accompanies constipation. If this should happen,
gently guide Estring back into place with your finger.
There have been rare reports of Estring falling out in
some women following intense straining or coughing. If
this should occur, simply wash Estring with lukewarm (NOT
hot) water and reinsert it.
Estring Drug Delivery
Once in the vagina, Estring begins to release Estring
immediately. Estring will continue to release a low, continuous
dose of estradiol for the full 90 days it remains in place.
It will take about 2 to 3 weeks to restore the tissue
of the vagina and urinary tract to a healthier condition
and to feel the full effect of Estring in relieving vaginal
and urinary symptoms. If your symptoms persist for more
than a few weeks after beginning Estring therapy, contact
your doctor.
One of the most frequently reported effects associated
with the use of Estring is an increase in vaginal secretions.
These secretions are like those that occur normally prior
to menopause and indicate that Estring is working. However,
if the secretions are associated with a bad odor or vaginal
itching or discomfort, be sure to contact your doctor.
Estring Removal
After 90 days there will no longer be enough estradiol
in the ring to maintain its full effect in relieving your
vaginal or urinary symptoms. Estring should be removed
at that time and replaced with a new Estring, if your
doctor determines that you need to continue your therapy.
To remove Estring:
1. Wash and dry your hands thoroughly.
2. Assume a comfortable position, either
standing with one leg up, squatting, or lying down.
3. Loop your finger through the ring
and gently pull it out.
4. Discard the used ring in a waste
receptacle. (Do not flush Estring).
If you have any additional questions about removing Estring,
contact your doctor or healthcare giver.
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