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Estradiol / Progesterone Dosage

Medically reviewed by Drugs.com. Last updated on Feb 18, 2019.

Applies to the following strengths: 1 mg-100 mg

Usual Adult Dose for Postmenopausal Symptoms

1 capsule (estradiol 1 mg/progesterone 100 mg) orally once a day in the evening with food

Comments:
-Hormone replacement therapy should be limited to the shortest duration consistent with treatment goals and risks for the individual women.
-Reevaluate periodically to determine if treatment is still necessary.

Use: Treatment of moderate to severe vasomotor symptoms due to menopause.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Liver impairment or disease: Use is Contraindicated

Precautions

US BOXED WARNINGS: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER, and PROBABLE DEMENTIA:
Estrogen Plus Progestin Therapy:
-Cardiovascular Disorders and Probable Dementia: Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. The Women's Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens 0.625 mg combined with medroxyprogesterone acetate 2.5 mg, relative to placebo. The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age of older during 4 years of treatment with daily conjugated estrogens 0.625 mg combined with medroxyprogesterone acetate 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
-Breast Cancer: The WHI estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer. In the absence of comparable data, these risks should be assumed to be similar for other doses of conjugated estrogens and medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins. 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.
Estrogen-Alone Therapy:
-Endometrial Cancer There is an increased risk of endometrial cancer in a woman with a uterus who use unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.
-Cardiovascular Disorders and Probable Dementia: Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia. The WHI estrogen-alone substudy reported increased risks of stroke and DVT in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogen 0.625 mg alone, relative to placebo. The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily conjugated estrogen alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. In the absence of comparable data, these risks should be assumed to be similar for other doses of conjugated estrogens and other dosage forms of estrogens. 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
-Known or suspected estrogen-dependent neoplasia
-Active or history of DVT or PE
-Active or history of arterial thromboembolic disease (e.g., stroke, MI)
-Known anaphylactic reaction, angioedema, or hypersensitivity to active substance or any product ingredients
-Liver impairment or disease
-Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders

Safety and efficacy have not been established in premenopausal women.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Take orally once a day in the evening with food

Missed dose: If a dose is missed, it may be taken as soon as remembered with food; if it is within 2 hours of the next dose, the dose should be skipped

General:
-Due to risks of cardiovascular disorders, breast cancer, endometrial cancer, and probable dementia, estrogens with or without progestins should be prescribed at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman.

Monitoring:
-Monitor thyroid function in women on thyroid hormone replacement therapy

Patient advice:
Read the US FDA-approved patient labeling (Patient Information).
-Women should be instructed to report abnormal vaginal bleeding to their healthcare provider as soon as possible.
-Women should understand the serious risks of therapy including cardiovascular disorders, malignant neoplasms, and dementia.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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