Estradiol Cypionate (5 brand names, 1 dosage form, 2 routes)
Available dosage forms: INJECTABLE.
Routes of administration: INJECTION, INTRAMUSCULAR.
Brand Names
- DEPO-ESTRADIOL
- DEPO-TESTADIOL
- ESTRADIOL CYPIONATE
- LUNELLE
- TESTOSTERONE CYPIONATE-ESTRADIOL CYPIONATE
Boxed Warning
Estrogens increase the chances of getting cancer of the uterus. Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterine (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. You and your healthcare provider should talk regularly about whether you still need treatment with DEPO-Estradiol.
Indications and Usage
DEPO-Estradiol Injection is indicated in the treatment of: 1.Moderate to severe vasomotor symptoms associated with the menopause. 2.Hypoestrogenism due to hypogonadism.
Dosage and Administration
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Warming and shaking the vial should redissolve any crystals that may have formed during storage at temperatures lower than recommended. DEPO-Estradiol INJECTION IS FOR INTRAMUSCULAR USE ONLY. When estrogen is prescribed for a woman with a uterus, progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary. (See BOXED WARNINGS and WARNINGS .) For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding. 1.Short-term cyclic use for treatment of moderate to severe vasomotor symptoms, vulval and vaginal atrophy associated with the menopause, the lowest dose and regimen that will control symptoms should be chosen and medication should be discontinued as promptly as possible. Attempts to discontinue or taper medication should be made at 3- to 6-month intervals. The usual dosage range is 1 to 5 mg injected every 3 to 4 weeks. 2.For treatment of female hypoestrogenism due to hypogonadism 1.5 to 2 mg injected at monthly intervals.
Contraindications
Estrogens should not be used in individuals with any of the following conditions: 1.Undiagnosed abnormal genital bleeding. 2.Known or suspected cancer of the breast. 3.Known or suspected estrogen-dependent neoplasia. 4.Active deep vein thrombosis, pulmonary embolism or history of these conditions. 5.Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). 6.Liver dysfunction or disease. 7.DEPO-Estradiol should not be used in patients with known hypersensitivity to its ingredients. 8.Known or suspected pregnancy. There is no indication for DEPO-Estradiol in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy. (See PRECAUTIONS.)
Adverse Reactions
See BOXED WARNINGS, WARNINGS and PRECAUTIONS. The following additional adverse reactions have been reported with estrogens and/or progestin therapy. 1. Genitourinary system Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding, spotting; dysmenorrhea; increase in size of uterine leiomyomata; vaginitis including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer. 2. Breasts Tenderness, enlargement pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer. 3. Cardiovascular Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure. 4. Gastrointestinal Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis, enlargement of hepatic hemangiomas. 5. Skin Chloasma or melasma that may persist when drug is discontinued. Erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash. 6. Eyes Retinal vascular thrombosis; steepening of corneal curvature; intolerance to contact lenses. 7. Central nervous system Headache, migraine, dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia. 8. Miscellaneous Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; changes in libido; arthralgias; leg cramps; anaphylactoid/anaphylactic reactions including urticaria and angioedema; hypocalcemia; exacerbation of asthma; increased triglycerides.
Overdosage
Serious ill effects have not been reported following acute ingestion of large doses of estrogen-containing oral contraceptives by young children. Overdosage of estrogen may cause nausea and vomiting, and withdrawal bleeding may occur in females.