Adult Dosing
Moderate to severe symptoms of vulvar and vaginal atrophy due to menopause
- Start 1 g PV qd x 1 wk followed by 1 g PV x 2/wk
Notes:- In postmenopausal women with uterus, add progestin to the therapy to reduce the risk of endometrial cancer
- Use lowest effective dose of estrogen/progestin combination for shortest duration
Pediatric Dosing
[Outline]
See Supplemental Patient Information
- Estrogen conjugated vaginal cream is absorbed systemically; hence, the warnings, precautions, and adverse reactions associated with oral synthetic conjugated estrogen should be taken into account
- Estrogen alone or in combination with progestin therapy increases the risk of stroke, DVT, pulmonary embolism, and myocardial infarction [US Black Box Warning]. Discontinue therapy immediately if any of these symptoms occur
- Risk factors for arterial vascular disease and/or venous thromboembolism should be managed appropriately
- Estrogen alone or in combination with progestin therapy increases the risk of venous thromboembolism. Discontinue estrogen therapy 4-6 wks before surgery associated with an increased risk of thromboembolism or during periods of prolonged immobilization
- Use of unopposed estrogens in women with intact uteri increases the risk of endometrial cancer 2-12 times greater than in non-users [US Black Box warning]
- Use of estrogens and progestins in postmenopausal women has been reported to increase the risk of breast cancer. Perform regular breast examinations and mammograms based on patient age, risk factors, and prior mammogram results [US Black Box warning]. Advise patients to perform breast self-examinations every month
- Prolonged use of estrogen-plus progestin and estrogen-only therapy has been associated with an increased risk of ovarian cancer
- Estrogen and estrogen/progestin therapy has been reported to increase the risk of dementia in postmenopausal women 65 years of age and older [US Black Box warning]
- Increased risk of gallbladder disease by 2 to 4 fold has been reported in postmenopausal women receiving estrogen therapy
- Estrogen therapy may cause severe hypercalcemia in women with breast cancer and bone metastases. Discontinue therapy and provide appropriate measures if hypercalcemia occurs
- Retinal vascular thrombosis may occur in women receiving estrogens. Discontinue the drug if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia or migraine. Permanently discontinue therapy if papilledema or retinal vascular lesions are seen on examination
- Use of progestin with estrogen in a continuous regimen may lower the incidence of endometrial hyperplasia than would be induced by estrogen-alone treatment. However, there is possible increased risk of breast cancer, adverse effects on lipoprotein metabolism and impairment of glucose tolerance with the use of progestins along with estrogens compared to estrogen-alone regimens
- Estrogen use may cause substantial increases in blood pressure; monitor BP at regular intervals
- Estrogen therapy may elevate plasma triglycerides in women with preexisting hypertriglyceridemia, leading to pancreatitis and other complications; discontinue therapy if pancreatitis occurs
- Use cautiously in patients with a history of cholestatic jaundice associated with past estrogen use or with pregnancy; discontinue the drug in case of recurrence
- Estrogen administration may cause increased thyroid-binding globulin (TBG) levels. Patients on thyroid hormone replacement therapy receiving estrogens may require increased doses of their thyroid replacement therapy. Monitor thyroid function regularly to maintain free thyroid hormone levels in an acceptable range
- Estrogen plus progestins may cause fluid retention; use cautiously in patients with conditions like asthma, epilepsy, migraine, and cardiac or renal dysfunction
- Administration of estrogen therapy in women treated post-hysterectomy may exacerbate endometriosis; consider adding progestin to the therapy for women known to have residual endometriosis post-hysterectomy
- Estrogen-induced hypocalcemia may occur in women with hypoparathyroidism
Cautions: Use cautiously in
- Risk of cardiovascular disease
- Hypertension
- Hypertriglyceridemia
- History of cholestatic jaundice with estrogens or pregnancy
- Gallbladder disease
- Hypothyroidism
- Hypoparathyroidism
- Severe hypocalcemia
- Diabetes mellitus
- Surgery or prolonged immobilization
- Porphyria
- Systemic lupus erythematosus
- Hepatic hemangiomas
- Endometriosis
- Smoking
- Obesity
- Chorea
- Seizure disorder
- Geriatric patients >65 yrs
- Latex or rubber contraceptive use
Supplemental Patient Information
- Explain postmenopausal women of the importance of reporting abnormal vaginal bleeding to their physician as early as possible
- Inform postmenopausal women of possible serious and common adverse reactions of estrogen plus progestin therapy such as cardiovascular disorders, malignant neoplasms, probable dementia, headache, breast tenderness, nausea and vomiting
Pregnancy Category:X
Breastfeeding: Estrogen administration during breastfeeding interferes with lactation by decreasing the quantity and quality of the milk. Detectable amounts of estrogens have been secreted in breast milk. Manufacturer advises caution.
US Trade Name(s)
US Availability
estrogen conjugated A (Synthetic) (generic)
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
65 years of age during 5.2 and 4 years of treatment respectively, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women