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Delestrogen Generic Name & Formulations
Legal Class
Rx
General Description
Estradiol valerate 10mg/mL (in a vehicle containing chlorobutanol 5mg and sesame oil), 20mg/mL (in a vehicle containing benzyl benzoate 224mg, benzyl alcohol 20mg, and castor oil), 40mg/mL (in a vehicle containing benzyl benzoate 447mg, benzyl alcohol 20mg, and castor oil); soln for IM inj.
Pharmacological Class
Estrogen.
How Supplied
Multi-dose vials (5mL)—1
Manufacturer
Delestrogen Indications
Indications
Moderate to severe vasomotor symptoms of menopause. Moderate to severe symptoms of vulvar and vaginal atrophy of menopause. Hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
Delestrogen Dosage and Administration
Adult
Give by deep IM inj into upper, outer quadrant of gluteal muscle. Vasomotor symptoms, vulvar, vaginal atrophy: 10–20mg every 4 weeks; attempts to discontinue or taper should be made at 3-month to 6-month intervals. Hypoestrogenism: 10–20mg every 4 weeks.
Children
Not applicable.
Delestrogen Contraindications
Contraindications
Undiagnosed abnormal genital bleeding. Breast or other estrogen-dependent neoplasms. Thromboembolic disorders (eg, DVT, PE, stroke, MI). Hepatic disease. Pregnancy.
Delestrogen Boxed Warnings
Boxed Warning
Estrogens increase the risk of endometrial cancer. Cardiovascular disease and other risks.
Delestrogen Warnings/Precautions
Warnings/Precautions
Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular events (eg, MI, stroke, VTE); discontinue if occurs. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Increased risk of breast or ovarian cancer. Risk of probable dementia in women >65yrs of age. Gallbladder disease. Severe hypercalcemia in breast cancer or bone metastases. Visual abnormalities. History of hypertriglyceridemia. Discontinue if cholestatic jaundice, hypercalcemia, or retinal vascular lesions occur. Monitor thyroid function. Conditions aggravated by fluid retention. Endometriosis. Severe hypocalcemia. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical and repeat annually (include Pap smear, mammogram, and BP). Reevaluate periodically. Nursing mothers.
Delestrogen Pharmacokinetics
See Literature
Delestrogen Interactions
Interactions
Concomitant thyroid replacement; may need to increase thyroid dose. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).
Delestrogen Adverse Reactions
Adverse Reactions
Nausea, vomiting, irregular bleeding, vaginitis, dysmenorrhea, headache, dizziness, edema, hypertension, mastodynia, chloasma, weight changes, intolerance to contact lenses; hypercoagulability, thromboembolism, neoplasms.
Delestrogen Clinical Trials
See Literature
Delestrogen Note
Not Applicable
Delestrogen Patient Counseling
See Literature
Delestrogen Generic Name & Formulations
Legal Class
Rx
General Description
Estradiol valerate 10mg/mL (in a vehicle containing chlorobutanol 5mg and sesame oil), 20mg/mL (in a vehicle containing benzyl benzoate 224mg, benzyl alcohol 20mg, and castor oil), 40mg/mL (in a vehicle containing benzyl benzoate 447mg, benzyl alcohol 20mg, and castor oil); soln for IM inj.
Pharmacological Class
Estrogen.
How Supplied
Multi-dose vials (5mL)—1
Manufacturer
Delestrogen Indications
Indications
Advanced androgen-dependent carcinoma of the prostate (for palliation only).
Delestrogen Dosage and Administration
Adult
Give by deep IM inj into upper, outer quadrant of gluteal muscle. 30mg or more every 1 or 2 weeks.
Children
Not applicable.
Delestrogen Contraindications
Contraindications
Thrombophlebitis. Thromboembolic disorders. Cerebrovascular disorders. Abnormal undiagnosed genital bleeding. Estrogen-depended neoplasias. Liver dysfunction or disease. Pregnancy (Cat.X).
Delestrogen Boxed Warnings
Boxed Warning
Estrogens increase the risk of endometrial cancer. Cardiovascular disease and other risks.
Delestrogen Warnings/Precautions
Warnings/Precautions
Hepatic dysfunction. Conditions aggravated by fluid retention. Cardiovascular disorders, arterial vascular disease, and risks factors (eg, hypertension, diabetes, obesity, SLE). Familial hyperlipoprotenemia. Monitor BP. Discontinue if jaundice occurs and before prolonged immobilization (eg, surgery).
Delestrogen Pharmacokinetics
See Literature
Delestrogen Interactions
Interactions
Concomitant thyroid replacement; may need to increase thyroid dose. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).
Delestrogen Adverse Reactions
Adverse Reactions
See full labeling. GI upset, headache, hypertension, edema, hypercalcemia, gallbladder or thromboembolic disease, gynecomastia, impotence, impaired glucose tolerance.
Delestrogen Clinical Trials
See Literature
Delestrogen Note
Not Applicable
Delestrogen Patient Counseling
See Literature
