Usual Adult Dose for Postmenopausal Symptoms

1.25 mg orally once a day; administer cyclically (e.g., 3 weeks on and 1 week off)

Comments:

• A progestin should be prescribed for postmenopausal women with a uterus to reduce the risk of endometrial cancer.
• For women who are menstruating, cyclic administration is started on day 5 of bleeding; the start date can be any day for women who have not menstruated within the last 2 months.
• Treatment should be at the lowest effective dose for the shortest duration consistent with goals and risks for the individual women.

Use: For the treatment of moderate to severe vasomotor symptoms associated with menopause.

Usual Adult Dose for Atrophic Urethritis

Initial dose: 0.3 mg to 1.25 mg orally once a day; administer cyclically (e.g., 3 weeks on and 1 week off)
Maintenance dose: Adjust dose depending on tissue response; treatment should be at the lowest effective dose for the shortest duration consistent with goals and risks

Comments:

• Topical vaginal products should be considered when use is solely for the treatment of vulvar and vaginal atrophy.
• A progestin should be prescribed for postmenopausal women with a uterus to reduce the risk of endometrial cancer.
• For women who are menstruating, cyclic administration is started on day 5 of bleeding; the start date can be any day for women who have not menstruated within the last 2 months.

Use: For the treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause.

Usual Adult Dose for Atrophic Vaginitis

Initial dose: 0.3 mg to 1.25 mg orally once a day; administer cyclically (e.g., 3 weeks on and 1 week off)
Maintenance dose: Adjust dose depending on tissue response; treatment should be at the lowest effective dose for the shortest duration consistent with goals and risks

Comments:

• Topical vaginal products should be considered when use is solely for the treatment of vulvar and vaginal atrophy.
• A progestin should be prescribed for postmenopausal women with a uterus to reduce the risk of endometrial cancer.
• For women who are menstruating, cyclic administration is started on day 5 of bleeding; the start date can be any day for women who have not menstruated within the last 2 months.

Use: For the treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause.

Usual Adult Dose for Hypoestrogenism

Single course: 2.5 mg to 7.5 mg orally once a day in divided doses for 20 days, then 10 day rest period (drug-free)

For Patients Who Do Not Bleed After 1 Course:

• Repeat course; the number of courses required to produce bleeding may vary depending on responsiveness of the endometrium

For Patients Who Bleed Before the End of 1 Course:

• Begin estrogen-progestin cyclic regimen: 2.5 to 7.5 mg orally once a day in divided doses for 20 days (administer oral progestin during last 5 days of estrogen therapy), then 10-day rest period, repeat

Comments:

• If bleeding occurs before one course of therapy is finished, discontinue and resume regimen on the fifth day of bleeding.

Use: For the treatment of female hypogonadism.

Usual Adult Dose for Oophorectomy

Initial dose: 1.25 mg orally once a day; administer cyclically (e.g., 3 weeks on and 1 week off)

• Adjust dosage according to severity of symptoms and patient response

Maintenance dose: Lowest level that provides effective control

Uses: For the treatment of female castration and primary ovarian failure.

Usual Adult Dose for Primary Ovarian Failure

Initial dose: 1.25 mg orally once a day; administer cyclically (e.g., 3 weeks on and 1 week off)

• Adjust dosage according to severity of symptoms and patient response

Maintenance dose: Lowest level that provides effective control

Uses: For the treatment of female castration and primary ovarian failure.

Usual Adult Dose for Breast Cancer

10 mg orally 3 times a day for at least 3 months

Comments:

• Patients with an intact uterus should be monitored closely for signs of endometrial cancer and appropriate diagnostic measures should be taken to rule out malignancy in the event of persistent or recurring abnormal vaginal bleeding.

Use: For the palliative treatment of inoperable breast cancer in select postmenopausal women and men with metastatic disease.

Usual Adult Dose for Prostate Cancer

1.25 mg to 2.5 mg orally 3 times a day

Comments:

• The effectiveness of therapy can be judged by phosphatase determinations as well as by symptomatic improvement of the patient.

Use: For the treatment of inoperable prostatic cancer.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Contraindicated in patients with liver dysfunction or disease

Precautions

US BOXED WARNINGS: ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER, CARDIOVASCULAR AND OTHER RISKS

• ENDOMETRIAL CANCER: Estrogens increase the risk of endometrial cancer. Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of "natural" estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses.
• CARDIOVASCULAR: Estrogen with or without progestins should not be used for prevention of cardiovascular disease. The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg), relative to placebo.
• DEMENTIA: The WHI Memory Study (WHIMS) study, a substudy of WHI, reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens/medroxyprogesterone relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or women taking estrogen alone therapy.
• Other doses of conjugated estrogens with medroxyprogesterone, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Due to these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

CONTRAINDICATIONS:

• Undiagnosed abnormal genital bleeding
• Known, suspected, or a history of breast cancer except in appropriately selected patients being treated for metastatic disease
• Known or suspected estrogen-dependent neoplasia
• Active or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE)
• Active, or within last year, arterial thromboembolic disease (e.g., stroke and MI)
• Liver disease or dysfunction
• Hypersensitivity to the active component or any of the ingredients
• Known or suspected pregnancy

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
Take orally, generally cyclically

Missed dose: If a dose is missed, take as soon as possible, however, if it is almost time for the next dose, skip the missed dose and resume regular schedule; do not take 2 doses at the same time

General:

• For postmenopausal woman with a uterus, a progestin should be added to reduce the risk of endometrial cancer.
• This drug should be given at the lowest effective dose and for the shortest duration necessary; periodically reevaluate if treatment is still necessary.

Monitoring:

• Monitor blood pressure
• Monitor thyroid function in patients receiving thyroid replacement
• Monitor glycemic control in patients with diabetes

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Patient Information).
• Patients should be instructed to immediately report any unusual vaginal bleeding, breast lumps, signs or symptoms of stroke, myocardial infarction, severe headaches/migraines, or changes in vision.