ESTRACE *

THE FOLLOWING IS FROM ESTRACE'S PACKAGE INSERT:

INTRODUCTION
This leaflet 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.

WARNINGS
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.

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' 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
(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 show you the professional labeling. You can also look up the specific estrogen product in a book called the "Physicians' Desk Reference", which is available in many book stores and public libraries. Generic drugs carry virtually the same labeling information as their brand name 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 six months for these symptoms.

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:

WHEN THEY DO NOT WORK.

DANGERS OF ESTROGENS

SIDE EFFECTS
In addition to the risks listed above, the following side effects have been reported with estrogen use:

REDUCING RISK OF ESTROGEN USE
If you use estrogens, you can reduce your risks by doing these things:

If any of these warning signals (or any other unusual symptoms) happen while you are using estrogens, call your doctor immediately:

OTHER INFORMATION
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 estrogens lower the risk of developing this condition. Therefore, if your uterus has not been removed, your doctor may prescribe a progestin for you to take together with the estrogen.

You should know, however, that taking estrogens with progestins may have additional risks. These include: (a) unhealthy effects on blood fats (especially the lowering of HDL blood cholesterol, the "good" blood fat which protects against heart disease); (b) unhealthy effects on blood sugar (which might make a diabetic condition worse); and (c) 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 be associated with a reduced risk for 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.

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 part 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.

This leaflet provides a summary of the most important information about estrogens. If you want more information, ask your doctor or pharmacist to show you the professional labeling. The professional labeling is also published in a book called the "Physicians' Desk Reference," which is available in book stores and public libraries. Generic drugs carry virtually the same labeling information as their brand name versions.

HOW SUPPLIED
ESTRACE® (ESTRADIOL VAGINAL CREAM, USP, 0.01%).

NDC 0087-0754-42: Tube containing 1 ½ oz (42.5 g) with a calibrated plastic applicator for delivery of 1, 2, 3, or 4 g.

NOTE: The number of doses per tube will vary with dosage requirements and patient handling.

Store at room temperature. Protect from temperatures in excess of 40°C (104°F).

Bristol-Myers
Squibb Company
Princeton, New Jersey 08543
USA
Revised: April 1998 J4-503E


Copyright © 2006, Gilbert Manso, MD - The Whole Health Center