Depo-Estradiol 5 mg/mL
estradiol cypionate · INJECTION · Pharmacia & Upjohn Company LLC
Depo-Estradiol is an estrogen medication given as an intramuscular injection that is used to treat symptoms of menopause and hormone deficiency in women. It works by replacing or supplementing estrogen levels in the body.
Key Facts
- Brand Name
- Depo-Estradiol
- Generic Name
- estradiol cypionate
- NDC Code (Product)
0009-0271- Manufacturer
- Pharmacia & Upjohn Company LLC
- Strength
- 5 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAMUSCULAR
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- ANDA085470
- Drug Class
- Estradiol Congeners [CS]; Estrogen Receptor Agonists [MoA]
- Marketing Start
- 08/15/1979
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 & Administration
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 t…
Warnings
WARNINGS See BOXED WARNINGS 1. Cardiovascular disorders Estrogen and estrogen/progestin therapy have been associated with an increased risk of cardiovascular events such as myocardial infarction and stroke, as well as venous thrombosis and pulmonary embolism (venous thromboembolism or VTE). Should any of these occur or be suspected, estrogens should be discontinued immediately. Risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately. a. Coronary heart disease and stroke In the Women's Health Initiative (WHI) study, an increase in the number of myocardial infarctions and strokes has been observed in women receiving CE compared to placebo. These observations are preliminary, and the study is continuing. (See CLINICAL PHARMACOLOGY, Clinical Studies .) In the CE/MPA substudy of WHI, an increased risk of coronary heart disease (CHD) events (defined as nonfatal myocardial infarction and CHD death) was observed in women receiving CE/MPA compared to women receivin…
Contraindications
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
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…
Frequently Asked Questions
What is Depo-Estradiol used for?
Depo-Estradiol is an estrogen medication given as an intramuscular injection that is used to treat symptoms of menopause and hormone deficiency in women. It works by replacing or supplementing estrogen levels in the body.
Is Depo-Estradiol a controlled substance?
Depo-Estradiol is not classified as a controlled substance by the DEA.
What is the generic name for Depo-Estradiol?
The generic name for Depo-Estradiol is estradiol cypionate. There are no other listed brand versions of estradiol cypionate.
What is the NDC code for Depo-Estradiol 5 mg/mL?
The NDC (National Drug Code) for Depo-Estradiol 5 mg/mL is 0009-0271, listed by Pharmacia & Upjohn Company LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)