ESTRADIOL - estradiol tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)

Available from:

Heritage Pharmaceuticals Inc

INN (International Name):

ESTRADIOL

Composition:

ESTRADIOL 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Estradiol Tablets, USP is indicated in the: 1.Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2.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. 3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4. Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. 5. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). 6. 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 postmeno

Product summary:

Estradiol Tablets, USP are available as: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense with a child-resistant closure in a tight, light-resistant container. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured for: Heritage Pharmaceuticals Inc. Edison, NJ 08837 1.866.901.DRUG(3784) Manufactured by: ANDAPharm L.L.C. Ft. Lauderdale, FL 33309 Iss. 08/09 PATIENT INFORMATION INTRODUCTION: Read this PATIENT INFORMATION before you start taking Estradiol Tablets, USP and read what you get each time you refill Estradiol Tablets, USP. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. WHAT IS ESTRADIOL TABLETS, USP? Estradiol Tablets, USP is a medicine that contains estrogen hormones. WHAT IS ESTRADIOL TABLETS, USP USED FOR? Estradiol Tablets, USP is used to: Estrogens 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 Estradiol Tablets, USP. 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. You and your healthcare provider should talk regularly about whether you still need treatment with Estradiol Tablets, USP to control these problems.  If you use Estradiol Tablets, USP 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. Osteoporosis from menopause is a thinning of the bones that makes them weaker and easier to break. If you use Estradiol Tablets, USP 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 Estradiol Tablets, USP. WHO SHOULD NOT USE ESTRADIOL TABLETS, USP? Do not start taking Estradiol Tablets, USP if you: 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. Estrogens 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 Estradiol Tablets, USP. (For certain patients with breast or prostate cancer, estrogens may help.) See the end of this leaflet for a list of ingredients in Estradiol Tablets, USP. Tell your healthcare provider: The hormone in Estradiol Tablets, USP can pass into your milk Your 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. This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Estradiol Tablets, USP works. Estradiol Tablets, USP may also affect how your other medicines work. You may need to stop taking estrogens. HOW SHOULD I TAKE ESTRADIOL TABLETS, USP? 1.Start at the lowest dose and talk to your healthcare provider about how well that dose is working for you. 2.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 Estradiol Tablets, USP. WHAT ARE THE POSSIBLE SIDE EFFECTS OF ESTROGENS? Less common but serious side effects include: These are some of the warning signs of the serious side effects: Call 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: Other side effects include: These are not all the possible side effects of Estradiol Tablets, USP.  For more information, ask your healthcare provider or pharmacist. WHAT CAN I DO TO LOWER MY CHANCES OF A SERIOUS SIDE EFFECT WITH ESTRADIOL TABLETS, USP? If you use estrogens, you can reduce your risks by doing these things: 1. While you are using estrogens, it is important to visit your doctor at least once a year for a check-up. 2. If you have a uterus, talk to your healthcare provider about whether the addition of a progestin is right for you. 3. See your healthcare provider right away if you have vaginal bleeding while taking Estradiol Tablets, USP. 4. 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. 5. 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. 6. Talk with your healthcare provider regularly about whether you should continue taking Estradiol Tablets, USP. You and your doctor should reevaluate whether or not you still need estrogens at least every six months. 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, 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 ESTRADIOL TABLETS, USP Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.  Do not take Estradiol Tablets, USP for conditions for which it was not prescribed.  Do not give Estradiol Tablets, USP to other people, even if they have the same symptoms you have.  It may harm them. KEEP ESTRADIOL TABLETS, USP OUT OF THE REACH OF CHILDREN This leaflet provides a summary of the most important information about Estradiol Tablets, USP.  If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Estradiol Tablets, USP that is written for health professionals. You can get more information by calling the toll free number 1-866-901-DRUG(3784). WHAT ARE THE INGREDIENTS IN ESTRADIOL TABLETS, USP? Inactive Ingredients:   Lactose monohydrate, microcrystalline c

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ESTRADIOL - ESTRADIOL TABLET
HERITAGE PHARMACEUTICALS INC
----------
ESTRADIOL TABLETS, USP
RX ONLY
BOXED WARNING
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is
important. Adequate diagnostic
measures, including endometrial sampling when indicated, should be
undertaken to rule out
malignancy in all cases of undiagnosed persistent or recurring
abnormal vaginal bleeding. There
is no evidence that the use of "natural" estrogens results in a
different endometrial risk profile
than "synthetic" estrogens at equivalent estrogen doses. (See
WARNINGS, Malignant neoplasms,
Endometrial cancer.)
CARDIOVASCULAR AND OTHER RISKS
Estrogens with or without progestins should not be used for the
prevention of cardiovascular
disease. (See WARNINGS, Cardiovascular disorders.)
The Women’s Health Initiative (WHI) study reported increased risks
of myocardial infarction,
stroke, invasive breast cancer, pulmonary emboli, and deep vein
thrombosis in postmenopausal
women (50 to 79 years of age) during 5 years of treatment with oral
conjugated estrogens (CE
0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg)
relative to placebo. (See
CLINICAL PHARMACOLOGY, Clinical Studies.)
The Women’s Health Initiative Memory Study (WHIMS), a substudy of
WHI, reported increased
risk of developing probable dementia in postmenopausal women 65 years
of age or older during 4
years of treatment with oral conjugated estrogens plus
medroxyprogesterone acetate relative to
placebo. It is unknown whether this finding applies to younger
postmenopausal women or to
women taking estrogen alone therapy. (See CLINICAL PHARMACOLOGY,
Clinical Studies.)
Other doses of oral conjugated estrogens with medroxyprogesterone
acetate, and other
combinations and dosage forms of estrogens and progestins were not
studied in the WHI clinical
trials and, in the absence of comparable data, these risks should be
assumed to be similar. Because
of these risks, estrogens with or without progestins should be
presc