ESTRADIOL (Page 5 of 6)

OVERDOSAGE

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

DOSAGE AND ADMINISTRATION

When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (see BOXED WARNINGS and WARNINGS). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

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

1. For treatment of moderate to severe vasomotor symptoms, vulval and vaginal atrophy associated with the menopause, the lowest dose and regimen that will control symptoms should be chosen and medication should be discontinued as promptly as possible.

Attempts to discontinue or taper medication should be made at 3-month to 6-month intervals. 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. Administration should be cyclic (e.g., 3 weeks on and 1 week off).

2. 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.

3. 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.

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

Suggested dosage is 1 to 2 mg three times daily. The effectiveness of therapy can be judged by phosphatase determinations as well as by symptomatic improvement of the patient.

5. 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.

HOW SUPPLIED

Product: 50090-5494

NDC: 50090-5494-1 90 TABLET in a BOTTLE

NDC: 50090-5494-0 30 TABLET in a BOTTLE

Patient Information

Estradiol Tablets, USP

Rx Only

Read this PATIENT INFORMATION before you start taking estradiol and read what you get each time you refill estradiol tablets. 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 THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ESTRADIOL TABLETS (AN ESTROGEN HORMONE)?

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.

WHAT ARE ESTRADIOL TABLETS?

Estradiol tablets are medicine that contains estrogen hormones.

WHAT IS ESTRADIOL USED FOR?

Estradiol is used to:

reduce moderate to severe hot flashes

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.

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 menopause

You and your healthcare provider should talk regularly about whether you still need treatment with estradiol to control these problems. If you use estradiol 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 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 is a thinning of the bones that makes them weaker and easier to break. If you use estradiol 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.

WHO SHOULD NOT USE ESTRADIOL?

Do not start taking estradiol 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 cancers

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.

(For certain patients with breast or prostate cancer, estrogens may help.)

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

See the end of this leaflet for a list of ingredients in estradiol tablets.

think you may be pregnant

Tell your healthcare provider:

if you are breast feeding

The hormone in estradiol can pass into your milk

about all of your medical problems

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.

about all the medicines you take

This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how estradiol tablets work. Estradiol tablets may also affect how your other medicines work.

if you are going to have surgery or will be on bed rest

You may need to stop taking estrogens.

HOW SHOULD I TAKE ESTRADIOL TABLETS?

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.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF ESTROGENS?

Less common but serious side effects 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

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:

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

These are not all the possible side effects of estradiol tablets. For more information, ask your healthcare provider or pharmacist.

WHAT CAN I DO TO LOWER MY CHANCES OF A SERIOUS SIDE EFFECT WITH ESTRADIOL?

If you use estrogens, you can reduce your risks by doing these things:

Talk with your healthcare provider:
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.
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. 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, 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)

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

GENERAL INFORMATION ABOUT SAFE AND EFFECTIVE USE OF ESTRADIOL TABLETS

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.

Do not take estradiol tablets for conditions for which they were not prescribed. Do not give estradiol tablets to other people, even if they have the same symptoms you have. They may harm them.

KEEP ESTRADIOL TABLETS OUT OF THE REACH OF CHILDREN

This leaflet provides a summary of the most important information about estradiol tablets. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about estradiol tablets that is written for health professionals. For more information about estradiol call Epic Pharma, LLC at 1-888-374-2791.

WHAT ARE THE INGREDIENTS IN ESTRADIOL TABLETS?

Estradiol Tablets USP for oral administration contains 0.5, 1 or 2 mg of estradiol, USP.

In addition, each tablet for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Distributed by:

Epic Pharma, LLC

Laurelton, NY 11413

Manufactured in USA

Rev. 09-2018-00

OE1616

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.