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DELESTROGEN
Menopause and HRT
Prostate and other male cancers
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Drug Name:

DELESTROGEN Rx

Generic Name and Formulations:
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.

Company:
Par Pharmaceutical, Inc.

Therapeutic Use:

Indications for DELESTROGEN:

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.

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.

Contraindications:

Undiagnosed abnormal genital bleeding. Breast or other estrogen-dependent neoplasms. Thromboembolic disorders (eg, DVT, PE, stroke, MI). Hepatic disease. Pregnancy.

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.

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).

Pharmacological Class:

Estrogen.

Adverse Reactions:

Nausea, vomiting, irregular bleeding, vaginitis, dysmenorrhea, headache, dizziness, edema, hypertension, mastodynia, chloasma, weight changes, intolerance to contact lenses; hypercoagulability, thromboembolism, neoplasms.

How Supplied:

Multi-dose vials (5mL)—1

Indications for DELESTROGEN:

Advanced androgen-dependent carcinoma of the prostate (for palliation only).

Adult:

Give by deep IM inj into upper, outer quadrant of gluteal muscle. 30mg or more every 1 or 2 weeks.

Children:

Not applicable.

Contraindications:

Thrombophlebitis. Thromboembolic disorders. Cerebrovascular disorders. Abnormal undiagnosed genital bleeding. Estrogen-depended neoplasias. Liver dysfunction or disease. Pregnancy (Cat.X).

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).

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).

Pharmacological Class:

Estrogen.

Adverse Reactions:

See full labeling. GI upset, headache, hypertension, edema, hypercalcemia, gallbladder or thromboembolic disease, gynecomastia, impotence, impaired glucose tolerance.

How Supplied:

Multi-dose vials (5mL)—1

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