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Basic Drug Info
Drug Name:ESTRACE
Manufacturer:Bristol-Myers Squibb Co.
Other Info:

WHAT IS ESTRACE?ESTRACE (estradiol tablets, USP) is a medicine that contains estrogen hormones.WHAT IS ESTRACE USED FOR?ESTRACE is used to:reduce moderate to severe hot flashesEstrogens are hormones made by a woman's ovaries.

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).

Sometimes, 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 strong feelings of heat and sweating (“hot flashes” or “hot flushes”).

In some women, the symptoms are mild, and they will not need estrogens.

In other women, symptoms can be more severe.

You and your healthcare provider should talk regularly about whether you still need treatment with ESTRACE.Weight-bearing exercise, like walking or running, and taking calcium with vitamin D supplements may also lower your chances for getting postmenopausal osteoporosis.

It is important to talk about exercise and supplements with your healthcare provider before starting them.treat dryness, itching, and burning in or around the vagina, difficulty or burning on urination associated with menopauseYou and your healthcare provider should talk regularly about whether you still need treatment with ESTRACE to control these problems.

If you use ESTRACE only to treat your dryness, itching, and burning in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.treat certain conditions in which a young woman's ovaries do not produce enough estrogen naturallytreat certain types of abnormal vaginal bleeding due to hormonal imbalance when your doctor has found no serious cause of the bleedingtreat certain cancers in special situations, in men and womenprevent thinning of bonesOsteoporosis from menopause is a thinning of the bones that makes them weaker and easier to break.

If you use ESTRACE only to prevent osteoporosis from menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you.

You and your healthcare provider should talk regularly about whether you should continue with ESTRACE.WHO SHOULD NOT USE ESTRACE?Do not start taking ESTRACE if you:have unusual vaginal bleeding which has not been evaluated by your doctor (see BOXED WARNINGS)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.currently have or have had certain cancersEstrogens may increase the risk of certain types of cancer, including cancer of the breast or uterus.

If you have or had cancer, talk with your healthcare provider about whether you should take ESTRACE.(For certain patients with breast or prostate cancer, estrogens may help.)had a stroke or heart attack in the past yearcurrently have or have had blood clotshave or have had liver problemsare allergic to ESTRACE or any of its ingredientsSee the end of this leaflet for a list of ingredients in ESTRACE.ESTRACE 2 mg tablets contain tartrazine which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals.

Although the overall incidence of FD&C Yellow No.

5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.think you may be pregnantTell your healthcare provider:if you are breast feedingThe hormone in ESTRACE can pass into your milkabout all of your medical problemsYour healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.about all the medicines you takeThis includes prescription and nonprescription medicines, vitamins, and herbal supplements.

Some medicines may affect how ESTRACE works.

ESTRACE may also affect how your other medicines work.if you are going to have surgery or will be on bed restYou may need to stop taking estrogens.HOW SHOULD I TAKE ESTRACE?Start at the lowest dose and talk to your healthcare provider about how well that dose is working for you.Estrogens should be used at the lowest dose possible for your treatment only as long as needed.

You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are taking and whether you still need treatment with ESTRACE.WHAT ARE THE POSSIBLE SIDE EFFECTS OF ESTROGENS?Less common but serious side effects include:Breast cancerCancer of the uterusStrokeHeart attackBlood clotsDementiaGallbladder diseaseOvarian cancerThese are some of the warning signs of the serious side effects:Breast lumpsUnusual vaginal bleedingDizziness and faintnessChanges in speechSevere headachesChest painShortness of breathPains in your legsChanges in visionVomitingCall your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.Common side effects include:HeadacheBreast painIrregular vaginal bleeding or spottingStomach/abdominal cramps, bloatingNausea and vomitingHair lossOther side effects include:High blood pressureLiver problemsHigh blood sugarFluid retentionEnlargement of benign tumors ("fibroids") of the uterusA spotty darkening of the skin, particularly on the faceVaginal yeast infectionThese are not all the possible side effects of ESTRACE.

For more information, ask your healthcare provider or pharmacist.WHAT CAN I DO TO LOWER MY CHANCES OF A SERIOUS SIDE EFFECT WITH ESTRACE?If you use estrogens, you can reduce your risks by doing these things:Talk with your healthcare provider:While you are using estrogens, it is important to visit your doctor at least once a year for a check-up.If you have a uterus, talk to your healthcare provider about whether the addition of a progestin is right for you.See your healthcare provider right away if you have vaginal bleeding while taking ESTRACE.Have a breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else.

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.If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease.

Ask your healthcare provider for ways to lower your chances for getting heart disease.Talk with your healthcare provider regularly about whether you should continue taking ESTRACE.

You and your doctor should reevaluate whether or not you still need estrogens at least every six months.Be alert for signs of troubleIf 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, 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 show 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)GENERAL INFORMATION ABOUT SAFE AND EFFECTIVE USE OF ESTRACEMedicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.

Do not take ESTRACE for conditions for which it was not prescribed.

Do not give ESTRACE to other people, even if they have the same symptoms you have.

It may harm them.KEEP ESTRACE OUT OF THE REACH OF CHILDRENThis leaflet provides a summary of the most important information about ESTRACE.

If you would like more information, talk with your healthcare provider or pharmacist.

You can ask for information about ESTRACE that is written for health professionals.

You can get more information by calling the toll free number 1-800-521-8813.WHAT ARE THE INGREDIENTS IN ESTRACE?ESTRACE tablets, 0.5 mg, contain 0.5 mg estradiol and the following inactive ingredients: acacia, dibasic calcium phosphate, lactose, magnesium stearate, colloidal silicon dioxide, starch (corn), and talc.ESTRACE tablets, 1 mg, contain 1 mg estradiol and the following inactive ingredients: acacia, D&C Red No.

27 (aluminum lake), dibasic calcium phosphate, FD&C Blue No.

1 (aluminum lake), lactose, magnesium stearate, colloidal silicon dioxide, starch (corn), and talc.ESTRACE tablets, 2 mg, contain 2 mg estradiol and the following inactive ingredients: acacia, dibasic calcium phosphate, FD&C Blue No.

1 (aluminum lake), FD&C Yellow No.

5 (tartrazine) (aluminum lake), lactose, magnesium stearate, colloidal silicon dioxide, starch (corn), and talc.Manufactured by: Bristol-Myers Squibb Co.Princeton, NJ 08543Marketed by: Warner Chilcott, Inc.Rockaway, NJ 07866002141I-30021G0231145058A2March 2005



Clinical Trials:


Indications and Usage

ESTRACE (estradiol tablets, USP) is indicated in the:Treatment of moderate to severe vasomotor symptoms associated with the menopause.Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause.

When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).Prevention of osteoporosis.

When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate.

(See CLINICAL PHARMACOLOGY, Clinical Studies.)The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy.

Postmenopausal women require an average of 1500 mg/day of elemental calcium.

Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake.

Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
Symptoms -- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.

Hypogonadism -- Condition resulting from deficient gonadal functions, such as GAMETOGENESIS and the production of GONADAL STEROID HORMONES. It is characterized by delay in GROWTH, germ cell maturation, and development of secondary sex characteristics. Hypogonadism can be due to a deficiency of GONADOTROPINS (hypogonadotropic hypogonadism) or due to primary gonadal failure (hypergonadotropic hypogonadism).

Breast Carcinoma -- (brest KAN-ser) Cancer that forms in tissues of the breast, usually the ducts (tubes that carry milk to the nipple) and lobules (glands that make milk). It occurs in both men and women, although male breast cancer is rare.

Malignant neoplasm of breast -- A primary or metastatic malignant neoplasm involving the breast. The vast majority of cases are carcinomas arising from the breast parenchyma or the nipple. Malignant breast neoplasms occur more frequently in females than in males. -- 2003

Neoplasm Metastasis -- The transfer of a neoplasm from one organ or part of the body to another remote from the primary site.

Carcinoma -- A malignant neoplasm made up of epithelial cells tending to infiltrate the surrounding tissues and give rise to metastases. It is a histological type of neoplasm but is often wrongly used as a synonym for "cancer." (From Dorland, 27th ed)

Osteoporosis -- Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.

Osteoporosis, Postmenopausal -- Metabolic disorder associated with fractures of the femoral neck, vertebrae, and distal forearm. It occurs commonly in women within 15-20 years after menopause, and is caused by factors associated with menopause including estrogen deficiency.

Contraindications

Estrogens should not be used in individuals with any of the following conditions:Undiagnosed abnormal genital bleeding.Known, suspected or history of cancer of the breast except in appropriately selected patients being treated for metastatic disease.Known or suspected estrogen-dependent neoplasia.Active deep vein thrombosis, pulmonary embolism or history of these conditions.Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction).Liver dysfunction or disease.ESTRACE should not be used in patients with known hypersensitivity to its ingredients.

ESTRACE (estradiol tablets, USP), 2 mg, contain FD&C Yellow No.

5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals.

Although the overall incidence of FD&C Yellow No.

5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.Known or suspected pregnancy.

There is no indication for ESTRACE in pregnancy.

There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy.

(See PRECAUTIONS.)
Malignant Neoplasms -- A term for diseases in which abnormal cells divide without control. Cancer cells can invade nearby tissues and can spread through the bloodstream and lymphatic system to other parts of the body.

Primary malignant neoplasm --

Neoplasm Metastasis -- The transfer of a neoplasm from one organ or part of the body to another remote from the primary site.

Deep Vein Thrombosis -- A blood clot (thrombus) in a deep vein in the thigh or leg.

Deep vein thrombosis of lower limb --

Pulmonary Embolism -- Blocking of the PULMONARY ARTERY or one of its branches by an EMBOLUS.

Thromboembolism -- Obstruction of a blood vessel (embolism) by a blood clot (THROMBUS) in the blood stream.

Arteriopathic disease -- An impairment of the structure or function of the blood vessels which carry blood away from the heart.

Cerebrovascular accident -- sudden neurologic impairment due to a cerebrovascular disorder, either an arterial occlusion or an intracranial hemorrhage.

Liver Dysfunction --

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Allergic Reaction --

Asthma -- A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL).

Little's Disease --

Warnings
See BOXED WARNINGS.

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