Estradiol Cypionate
Generic Name: estradiol cypionate
Brand Names:
Depo-estradiol
DESCRIPTION DEPO-Estradiol Injection contains estradiol cypionate for intramuscular use. Each mL contains: 5 mg/mL—5 mg estradiol cypionate, 5.4 mg chlorobutanol anhydrous (chloral derivative) added as preservative; in 913 mg cottonseed oil. Warning: Chlorobutanol may be habit forming. The structural formula is represented below: DEPO-Estradiol contains an oil soluble ester of estradiol 17β. The chemical name for estradiol cypionate is estradiol 17-cyclopentanepropionate. Chemical Structure
Overview
DESCRIPTION DEPO-Estradiol Injection contains estradiol cypionate for intramuscular use. Each mL contains: 5 mg/mL—5 mg estradiol cypionate, 5.4 mg chlorobutanol anhydrous (chloral derivative) added as preservative; in 913 mg cottonseed oil. Warning: Chlorobutanol may be habit forming. The structural formula is represented below: DEPO-Estradiol contains an oil soluble ester of estradiol 17β. The chemical name for estradiol cypionate is estradiol 17-cyclopentanepropionate. Chemical Structure
Uses
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
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.
Side Effects
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.
Warnings
WARNINGS ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures including endometrial sampling, when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. 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. 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.
Pregnancy
F. PREGNANCY DEPO-Estradiol should not be used during pregnancy. See CONTRAINDICATIONS and Boxed WARNINGS .
Storage
Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP].
Frequently Asked Questions
What is Estradiol Cypionate used for?▼
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.
What are the side effects of Estradiol Cypionate?▼
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.
Can I take Estradiol Cypionate during pregnancy?▼
F. PREGNANCY DEPO-Estradiol should not be used during pregnancy. See CONTRAINDICATIONS and Boxed WARNINGS .
What are the important warnings for Estradiol Cypionate?▼
WARNINGS ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures including endometrial sampling, when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. 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. 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.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.