Generic Name and Formulations:
Estradiol cypionate 5mg/mL (contains chlorobutanol anhydrous 5.4mg in cottonseed oil 913mg); soln for IM inj.
Indications for DEPO-ESTRADIOL:
Moderate-to-severe vasomotor symptoms of menopause. Hypoestrogenism due to hypogonadism.
Give by IM inj only. Vasomotor symptoms, vulval, vaginal atrophy: usually 1–5mg every 3–4 weeks; attempts to discontinue or taper should be made at 3- to 6-month intervals. Hypoestrogenism: 1.5–2mg at monthly intervals. Reevaluate periodically.
Undiagnosed abnormal genital bleeding. Known or suspected breast cancer. Known or suspected estrogen-dependent neoplasia. Active or history of DVT, PE. Active or recent arterial thromboembolic disease (eg, stroke, MI). Hepatic dysfunction or disease. Known or suspected pregnancy.
Estrogens increase the risk of endometrial cancer. Cardiovascular and other risks.
Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Increased risk of cardiovascular events (eg, MI, stroke, VTE); discontinue if occurs. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Breast cancer. Risk of probable dementia in women >65yrs of age. Gallbladder disease. Bone disease associated with hypercalcemia. Visual abnormalities. Hypertriglyceridemia. Hepatic impairment. Hypothyroidism. Hypocalcemia. Conditions aggravated by fluid retention. Endometriosis. May aggravate asthma, diabetes, epilepsy, migraine, porphyria, SLE, hepatic hemangiomas. Do initial complete physical; repeat annually (include BP, mammogram, PAP smear). Discontinue if cardiac events, visual disturbances, or jaundice occurs; and during prolonged immobilization, or at least 4–6 weeks before surgery associated with an increased risk of thromboembolism. Nursing mothers.
May be antagonized by CYP3A4 inducers (eg, St. John’s Wort, phenobarbital, carbamazepine, rifampin). May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). May interfere with lab tests (eg, thyroid, PT, binding proteins, glucose tolerance, HDL-C/LDL-C).
See full labeling. Nausea, vomiting, abdominal cramps, bloating, gallbladder disease, jaundice, irregular bleeding, vaginitis, dysmenorrhea, tender breasts, headache, dizziness, mood disturbances, edema, weight fluctuations, chloasma, melasma, leg cramps; visual abnormalities, hypertriglyceridemia, thromboembolic disorders, estrogen-dependent cancers (eg, breast, ovarian, endometrial), dementia, others.
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