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Depo-estradiol Generic Name & Formulations
Legal Class
Rx
General Description
Estradiol cypionate 5mg/mL (contains chlorobutanol anhydrous 5.4mg in cottonseed oil 913mg); soln for IM inj.
Pharmacological Class
Estrogen.
How Supplied
Vials (5mL)—1
Manufacturer
Depo-estradiol Indications
Indications
Moderate-to-severe vasomotor symptoms of menopause. Hypoestrogenism due to hypogonadism.
Depo-estradiol Dosage and Administration
Adult
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.
Children
Not applicable.
Depo-estradiol Contraindications
Contraindications
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.
Depo-estradiol Boxed Warnings
Boxed Warning
Estrogens increase the risk of endometrial cancer. Cardiovascular and other risks.
Depo-estradiol Warnings/Precautions
Warnings/Precautions
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.
Depo-estradiol Pharmacokinetics
See Literature
Depo-estradiol Interactions
Interactions
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).
Depo-estradiol Adverse Reactions
Adverse Reactions
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.
Depo-estradiol Clinical Trials
See Literature
Depo-estradiol Note
Not Applicable
Depo-estradiol Patient Counseling
See Literature
