Generic Name and Formulations:
Synthetic conjugated estrogens, B, 0.3mg, 0.45mg, 0.625mg, 0.9mg, 1.25mg; tabs.
Indications for ENJUVIA:
Moderate-to-severe vasomotor symptoms of menopause. Moderate-to-severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, due to menopause.
Use lowest effective dose for shortest duration. Initially 0.3mg once daily. Reevaluate periodically.
Undiagnosed abnormal uterine bleeding. Known, suspected or history of breast cancer. Known or suspected estrogen-dependent neoplasia. Active DVT, PE or history of. Active arterial thromboembolic disease or history of. Hepatic impairment. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Pregnancy.
Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular disorders (eg, stroke, DVT, VTE); discontinue if occurs or suspected. Manage risk factors for CVD and VTE appropriately. Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Risk of probable dementia in women ≥65yrs of age. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Breast or ovarian cancer. Gallbladder disease. Bone disease associated hypercalcemia. Visual abnormalities. Hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, loss of vision, or hypercalcemia occurs. Hypothyroidism. Conditions aggravated by fluid retention (eg, cardiac or renal impairment). Hypoparathyroidism. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical (include BP, mammogram, PAP smear) and repeat annually. Nursing mothers.
May be antagonized by CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John’s wort). May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). May interfere with lab tests (eg, PT, thyroid, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding proteins).
Abdominal pain, headache, pain, nausea, mastodynia, irregular bleeding, vaginitis, dysmenorrhea, paresthesia, breast tenderness, back pain, edema, hypertension, visual abnormalities, hypertriglyceridemia, dementia.
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