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ESTRACE
Breast cancer
Menopause and HRT
Prostate and other male cancers
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Drug Name:

ESTRACE Rx

Generic Name and Formulations:
Estradiol 0.5mg, 1mg, 2mg+; scored tabs; +contains tartrazine.

Company:
Allergan

Therapeutic Use:

Indications for ESTRACE:

Palliative treatment of metastatic breast cancer in select patients (see full labeling).

Adult:

10mg 3 times daily for at least 3 months.

Children:

Not applicable.

Contraindications:

Thrombophlebitis. Thromboembolic disorders. Cerebrovascular disorders. Abnormal undiagnosed genital bleeding. Estrogen-depended neoplasias. Liver dysfunction or disease. Pregnancy (Cat. X).

Warnings/Precautions:

Asthma (2mg tabs). Hepatic dysfunction. Conditions aggravated by fluid retention. Cardiovascular disorders, arterial vascular disease, and risks factors (eg, hypertension, diabetes, obesity, SLE). Familial hyperlipoprotenemia. Monitor BP. Discontinue if jaundice occurs and before prolonged immobilization (eg, surgery). Nursing mothers.

Pharmacological Class:

Estrogen.

Adverse Reactions:

See full labeling. GI upset, headache, hypertension, edema, hypercalcemia, gallbladder or thromboembolic disease, gynecomastia, impotence, impaired glucose tolerance.

Generic Availability:

YES

How Supplied:

Tabs—100

Indications for ESTRACE:

Moderate-to-severe vasomotor symptoms of menopause. Atrophic vaginitis. Hypoestrogenism. Osteoporosis prevention.

Adult:

Menopause, hypoestrogenism: 1–2mg daily, given cyclically (3 weeks on, 1 week off). Osteoporosis prevention (begin therapy soon after menopause): 0.5mg daily for 3 weeks, then stop for 1 week, then recycle; adjust. Reevaluate periodically.

Children:

Not applicable.

Contraindications:

Breast or estrogen-dependent cancer. Thrombophlebitis. Thromboembolic disorders. Undiagnosed abnormal genital bleeding. Pregnancy (Cat.X).

Warnings/Precautions:

Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Increased risk of cardiovascular events (eg, MI, stroke, VTE); discontinue if occurs. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Breast cancer. Risk of probable dementia in women >65yrs of age. Asthma (2mg tabs). Hepatic dysfunction. Conditions aggravated by fluid retention. Familial hyperlipoproteinemia. Do initial complete physical examination and repeat annually (include BP, mammogram, and PAP smear). Discontinue if jaundice occurs. Nursing mothers.

Pharmacological Class:

Estrogen.

Adverse Reactions:

See full labeling. Mastodynia, breast secretion, uterine bleeding, dysmenorrhea, amenorrhea, GI upset, headache, hypertension, edema, hypercalcemia, gallbladder or thromboembolic disease, skin changes.

Generic Availability:

YES

How Supplied:

Tabs—100

Indications for ESTRACE:

Palliative treatment of androgen-dependent advanced prostate cancer.

Adult:

1–2mg 3 times daily.

Children:

Not applicable.

Contraindications:

Thrombophlebitis. Thromboembolic disorders. Cerebrovascular disorders. Abnormal undiagnosed genital bleeding. Estrogen-depended neoplasias. Liver dysfunction or disease. Pregnancy (Cat. X).

Warnings/Precautions:

Asthma (2mg tabs). Hepatic dysfunction. Conditions aggravated by fluid retention. Cardiovascular disorders, arterial vascular disease, and risks factors (eg, hypertension, diabetes, obesity, SLE). Familial hyperlipoprotenemia. Monitor BP. Discontinue if jaundice occurs and before prolonged immobilization (eg, surgery). Nursing mothers.

Pharmacological Class:

Estrogen.

Adverse Reactions:

See full labeling. GI upset, headache, hypertension, edema, hypercalcemia, gallbladder or thromboembolic disease, gynecomastia, impotence, impaired glucose tolerance.

Generic Availability:

YES

How Supplied:

Tabs—100

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