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Estrace (estradiol)


Estrogens increase the risk of endometrial cancer. Perform adequate diagnostic measures, including endometrial sampling, to rule out malignancy w/ undiagnosed persistent or recurrent abnormal vaginal bleeding. Should not be used for the prevention of cardiovascular disease. Increased risk of MI, stroke, invasive breast cancer, pulmonary embolism (PE), and DVT in postmenopausal women (50-79 yrs of age) reported. Increased risk of developing probable dementia in postmenopausal women ≥65 yrs of age reported. Should be prescribed at the lowest effective dose and for the shortest duration consistent w/ treatment goals and risks.






(Cre) Treatment of vulvar and vaginal atrophy. (Tab) Treatment of moderate to severe vasomotor symptoms associated w/ menopause. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated w/ menopause. Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure. Palliative treatment of breast cancer in appropriately selected women and men w/ metastatic disease, and advanced androgen-dependent prostate carcinoma. Prevention of osteoporosis.


Menopausal Vasomotor Symptoms

Moderate to Severe:
Initial: 1-2mg/day
Maint: Minimal effective dose should be determined by titration; Administer cyclically (eg, 3 weeks on and 1 week off)

Use the lowest effective dose for the shortest duration; reevaluate at 3- to 6-month intervals

Menopausal Vulvar/Vaginal Atrophy

Usual: 2-4g/day for 1-2 weeks; then gradually reduce to 1/2 initial dose for a similar period
Maint: 1g 1-3X/week

Moderate to Severe:
Initial: 1-2mg/day
Maint: Minimal effective dose should be determined by titration; Administer cyclically (eg, 3 weeks on and 1 week off)

Use the lowest effective dose for the shortest duration; reevaluate at 3- to 6-month intervals


Due to Hypogonadism, Castration, or Primary Ovarian Failure:
Initial: 1-2mg/day
Titrate: Adjust as necessary to control presenting symptoms
Maint: Minimal effective dose should be determined by titration

Breast Cancer

Palliative Treatment in Appropriately Selected Women and Men w/ Metastatic Disease:
10mg tid for at least 3 months

Prostate Carcinoma

Palliative Treatment of Advanced Androgen-Dependent Carcinoma:
1-2mg tid


Consider therapy for women at risk of osteoporosis and for whom non-estrogen medications are not appropriate, when used solely for prevention of postmenopausal osteoporosis


Intravaginal route

Oral route


Cre: 0.01% [42.5g]; Tab: 0.5mg*, 1mg*, 2mg* *scored


Undiagnosed abnormal genital bleeding, known/suspected/history of breast cancer, known/suspected estrogen-dependent neoplasia, active/history of DVT/PE, active or recent arterial thromboembolic disease (eg, stroke, MI), liver dysfunction or disease, known/suspected pregnancy.


D/C immediately if stroke, DVT, PE, or MI occur or is suspected. Caution in patients w/ risk factors for arterial vascular disease and/or venous thromboembolism. If feasible, d/c at least 4-6 weeks before surgery of the type associated w/ an increased risk of thromboembolism, or during periods of prolonged immobilization. May increase the risk of gallbladder disease and ovarian cancer. May lead to severe hypercalcemia in patients w/ breast cancer and bone metastases; d/c and take appropriate measures if hypercalcemia occurs. Retinal vascular thrombosis reported; d/c pending exam if sudden partial/complete loss of vision, or sudden onset of proptosis, diplopia, or migraine occurs. D/C permanently if exam reveals papilledema or retinal vascular lesions. Consider addition of progestin for women w/ a uterus or w/ residual endometriosis post-hysterectomy. May elevate BP and thyroid-binding globulin levels. May elevate plasma TGs leading to pancreatitis in patients w/ preexisting hypertriglyceridemia. Caution w/ impaired liver function, and history of cholestatic jaundice associated w/ past estrogen use or w/ pregnancy; d/c in case of recurrence. May cause fluid retention; caution w/ cardiac/renal impairment. Caution w/ severe hypocalcemia. May exacerbate endometriosis, asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas; use w/ caution. May affect certain endocrine and blood components in lab tests. (Tab) 2mg tab contains tartrazine, which may cause allergic-type reactions (eg, bronchial asthma) in certain susceptible individuals.


Vaginal bleeding pattern changes, vaginitis, breast tenderness, galactorrhea, N/V, thrombophlebitis, melasma, abdominal cramps, headache, mental depression, weight changes, edema, libido changes, MI, PE.


CYP3A4 inducers (eg, St. John's wort preparations, phenobarbital, carbamazepine, rifampin) may decrease levels, which may decrease therapeutic effects and/or change uterine bleeding profile. CYP3A4 inhibitors (eg, erythromycin, ketoconazole, ritonavir, grapefruit juice) may increase levels, which may result in side effects. Patients concomitantly receiving thyroid replacement therapy and estrogens may require increased doses of thyroid replacement therapy; monitor thyroid function.


(Cre) Contraindicated in pregnancy, (Tab) Category X; caution in nursing.


Estrogen; binds to nuclear receptors in estrogen-responsive tissues. Circulating estrogens modulate pituitary secretion of gonadotropins, luteinizing hormone and follicle-stimulating hormone, through a (-) feedback mechanism. Reduces elevated levels of these hormones in postmenopausal women.


Absorption: (Cre) Absorbed through skin, mucous membranes, and GI tract. Distribution: Largely bound to sex hormone-binding globulin and albumin; found in breast milk. Metabolism: Liver to estrone (metabolite); estriol (major urinary metabolite); sulfate and glucuronide conjugation (liver); biliary secretion of conjugates into the intestine; hydrolysis (gut); reabsorption; CYP3A4 (partial metabolism). Elimination: Urine (parent compound and metabolites).


Assess for undiagnosed abnormal genital bleeding, presence/history of breast cancer, estrogen-dependent neoplasia, active/history of DVT/PE/arterial thromboembolic disease, liver impairment/disease, history of cholestatic jaundice, drug hypersensitivity, pregnancy/nursing status, any other conditions where treatment is contraindicated or cautioned, need for progestin therapy, and possible drug interactions.


Monitor for signs/symptoms of CV events, malignant neoplasms, dementia, gallbladder disease, hypercalcemia, visual abnormalities, BP and serum TG elevations, pancreatitis, fluid retention, cholestatic jaundice, exacerbation of endometriosis and other conditions, and other adverse reactions. Perform annual breast exam; schedule mammography based on age, risk factors, and prior mammogram results. Monitor thyroid function in patients on thyroid hormone replacement therapy. Periodically evaluate (every 3-6 months) to determine need for therapy. In cases of undiagnosed, persistent, or recurrent abnormal vaginal bleeding, perform adequate diagnostic measures (eg, endometrial sampling) to rule out malignancy.


Inform of the risks/benefits of therapy. Inform that medication increases risk for breast/uterine cancer. Advise to contact physician if breast lumps, unusual vaginal bleeding, dizziness or faintness, changes in speech, severe headaches, chest pain, SOB, leg pain, visual changes, or vomiting occur. Advise to have yearly breast exams by a physician and perform monthly breast self-exams. Advise to notify physician if pregnant/nursing.


(Cre) Room temperature. Protect from temperatures in excess of 40°C (104°F). (Tab) 20-25°C (68-77°F).


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