What it's for (Indications)
- Used for the treatment of moderate to severe vasomotor symptoms due to menopause, moderate to severe symptoms of vulvar and vaginal atrophy, and as a component in certain oral contraceptive formulations.
Dosage Information
| Type | Guideline |
|---|---|
| Standard | When prescribing estrogen for a postmenopausal woman with a uterus, consider adding a progestogen to mitigate the risk of endometrial cancer; a woman without a uterus generally does not require a progestogen, though those with a history of endometriosis may. Administer estrogen-alone or in combination with a progestogen at the lowest effective dose for the shortest duration consistent with treatment goals and individual risks. Postmenopausal women should be periodically reevaluated to determine the continued necessity of treatment. An example for transdermal application for vasomotor symptoms or vulvar/vaginal atrophy is 0.0375 mg/day applied twice weekly. |
Safety & Warnings
Common Side Effects
- Common side effects may include nausea, vomiting, weight gain, breast tenderness and enlargement, headache, nasopharyngitis, sinusitis, sinus headache, upper respiratory tract infection, back pain, depression, and irregular vaginal bleeding or spotting.
- Patients experiencing these symptoms should consult a healthcare professional.
Serious Warnings
- Black Box Warning: WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, and BREAST CANCER. Estrogen-alone therapy increases the risk of endometrial cancer in women with a uterus. Adding a progestogen reduces this risk. Estrogen-alone and estrogen plus progestin therapies increase the risk of cardiovascular events and breast cancer. Estrogen-alone therapy also increases the risk of probable dementia in postmenopausal women 65 years or older.
- Patients should consult a healthcare professional as a precaution if they have hypertension, asthma, chloasma (skin condition), or a predisposition to thrombophlebitis, thromboembolic disorder, or cerebrovascular disease.
- Furthermore, estrogen therapy is associated with increased risks, including cardiovascular disorders, malignant neoplasms, and probable dementia (especially in postmenopausal women 65 years or older).
- For women with an intact uterus, adding a progestogen to estrogen therapy is crucial to reduce the risk of endometrial hyperplasia and cancer.
- Adequate diagnostic measures, including endometrial sampling, should be performed if clinically indicated to rule out endometrial pathology.
How it Works (Mechanism of Action)
Endogenous estrogens, with estradiol being the principal intracellular human estrogen, are responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Estrogens act by binding to nuclear receptors in estrogen-responsive tissues. In normally cycling women, the ovarian follicle is the primary source; post-menopause, most endogenous estrogen is produced by conversion of androstenedione to estrone in peripheral tissues.
Commercial Brands (Alternatives)
No other brands found for this formula.