Estradiol instructions for administration

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Phone:617-525-6884

Instructions for administration

General instructions

For treatment of moderate to severe vasomotor symptoms, vulval and vaginal atrophy associated with the menopause

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

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

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

For prevention of osteoporosis

Lowest effective dose

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General instructions

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. 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. Return to top

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). Return to top

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. Return to top

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. Return to top

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. Return to top

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.Return to top

Lowest effective dose

The lowest effective dose of Estradiol has not been determined. Return to top

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The content of this page is taken from the FDA package insert for this drug and should not be edited.