Estradiol (medication)

What is Estradiol (medication)?

• Estradiol (E2) Estradiol is a medicine that contains estrogen hormones.
• It is an estrogen and is used mainly in menopausal hormone therapy and to treat low sex hormone levels in women.
• It is also used in hormonal birth control for women, in hormone therapy for transgender women, and in the treatment of hormone-sensitive cancers like prostate cancer in men and breast cancer in women, among other uses.
• Estradiol can be taken by mouth, held and dissolved under the tongue, as a gel or patch that is applied to the skin, in through the vagina, by injection into muscle or fat, or through the use of an implant that is placed into fat, among other routes.

Estradiol

Estradiol 3D ball

Estradiol 3D spacefill

What are the uses of this medicine?

Estradiol (E2), is used to:

• reduce moderate to severe hot flashes
• treat dryness, itching, and burning in or around the vagina, difficulty or burning on urination associated with menopause
• treat certain conditions in which a young woman's ovaries do not produce enough estrogen naturally
• treat certain types of abnormal vaginal bleeding due to hormonal imbalance when your doctor has found no serious cause of the bleeding
• treat certain cancers in special situations, in men and women
• prevent thinning of bones (Osteoporosis from menopause)

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have unusual vaginal bleeding which has not been evaluated by your doctor.
• currently have or have had certain cancers.
• had a stroke or heart attack in the past year
• currently have or have had blood clots
• have or have had liver problems
• are allergic to Estradiol Tablets or any of its ingredients

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• St. John's wort

Is this medicine FDA approved?

• Yes, it was FDA approved.

How should this medicine be used?

Recommended dosage:

• Patients should be started at the lowest dose for the indication.

For treatment of moderate to severe vasomotor symptoms:

• The usual initial dosage range is 1 to 2 mg daily of estradiol adjusted as necessary to control presenting symptoms. The minimal effective dose for maintenance therapy should be determined by titration.

For treatment of female hypoestrogenism due to hypogonadism, castration, or primary ovarian failure:

• Treatment is usually initiated with a dose of 1 to 2 mg daily of estradiol, adjusted as necessary to control presenting symptoms; the minimal effective dose for maintenance therapy should be determined by titration.

For treatment of breast cancer, for palliation only, in appropriately selected women and men with metastatic disease:

• Suggested dosage is 10 mg three times daily for a period of at least three months.

For treatment of advanced androgen-dependent carcinoma of the prostate, for palliation only.

• Suggested dosage is 1 to 2 mg three times daily.

For prevention of osteoporosis:

• When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should be considered only for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate.
• The lowest effective dose of estradiol has not been determined.

Administration:

• 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 estradiol.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol per tablet.

This medicine is available in fallowing brand namesː

• Estradiol Tablets

What side effects can this medication cause?

The most common side effects of this medicine include:

• Headache
• Breast pain
• Irregular vaginal bleeding or spotting
• Stomach/abdominal cramps, bloating
• Nausea and vomiting
• Hair loss

Other side effects include:

• High blood pressure
• Liver problems
• High blood sugar
• Fluid retention
• Enlargement of benign tumors (“fibroids”) of the uterus
• A spotty darkening of the skin, particularly on the face
• Vaginal yeast infection

Less common, but serious side effects may include:

• Breast cancer
• Cancer of the uterus
• Stroke
• Heart attack
• Blood clots
• Dementia
• Gallbladder disease
• Ovarian cancer

These are some of the warning signs of the serious side effects:

• Breast lumps
• Unusual vaginal bleeding
• Dizziness and faintness
• Changes in speech
• Severe headaches
• Chest pain
• Shortness of breath
• Pains in your legs
• Changes in vision
• Vomiting

What special precautions should I follow?

• Estrogens increase the chances of getting cancer of the uterus. Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
• Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia. You and your healthcare provider should talk regularly about whether you still need treatment with estradiol tablets.
• 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 estradiol tablets. You and your doctor should reevaluate whether or not you still need estrogens at least every six months.
• In a small number of case reports, substantial increases in blood pressure have been attributed to idiosyncratic reactions to estrogens. Blood pressure should be monitored at regular intervals with estrogen use.
• In patients with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis and other complications.
• Estrogen administration leads to increased thyroid-binding globulin (TBG) levels. Patients dependent on thyroid hormone replacement therapy who are also receiving estrogens may require increased doses of their thyroid replacement therapy.
• Estrogens should be used with caution in individuals with severe hypocalcemia.
• Endometriosis may be exacerbated with administration of estrogens.
• Estrogens may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine or porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
• Estrogen administration to nursing mothers has been shown to decrease the quantity and quality of the milk. Caution should be exercised when estradiol is administered to a nursing woman.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• nausea and vomiting, and withdrawal bleeding may occur in females.
• Serious ill effects have not been reported following acute ingestion of large doses of estrogen-containing oral contraceptives by young children.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pregnancy Category X.
• Estradiol Tablets should not be used during pregnancy.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Inactive Ingredients: Colloidal silicon dioxide, corn starch, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and FD&C yellow no. 5 (tartrazine) aluminum lake.
• Active Ingredients: micronized estradiol

Who manufactures and distributes this medicine?

Manufactured by:

• Barr laboratories, inc.
• pomona,NY.

What should I know about storage and disposal of this medication?

• Store at 20º to 25º C (68º to 77ºF).
• Dispense with a child-resistant closure in a tight, light-resistant container.

• Dailymed label info on Estradiol (medication)
• FDA Estradiol (medication)

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