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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:
JHP Pharmaceuticals

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:

Breast or estrogen-dependent carcinoma. Undiagnosed abnormal vaginal bleeding. Thromboembolic disorders (eg, stroke or MI within one year, DVT, pulmonary embolism). Thrombophlebitis. Liver dysfunction or disease. Pregnancy (Cat.X).

Warnings/Precautions:

Increased risk of cardiovascular events (eg, MI, stroke, VTE); discontinue if occurs. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Endometrial hyperplasia. Gallbladder disease. Familial hypercholesterolemia. Hypercoagulability. Hypothyroidism. Hypocalcemia. Bone disease associated with hypercalcemia. Do initial complete physical (include BP, mammogram, PAP smear) and repeat annually. Conditions aggravated by fluid retention. Discontinue if visual disturbances or jaundice occurs and during immobilization, or at least 4–6 weeks before surgery associated with thromboembolism. May aggravate asthma, diabetes, epilepsy, migraine, porphyria, SLE, hepatic hemangiomas. May interfere with lab tests (eg, thyroid, PT, glucose tolerance, HDL-C/LDL-C). Nursing mothers.

Pharmacological Class:

Estrogen.

Adverse Reactions:

GI upset, abdominal pain, irregular bleeding, vaginitis, dysmenorrhea, headache, edema, hypertension, mastodynia, chloasma, visual abnormalities (reevaluate if occur), leg cramps, hypertriglyceridemia. Long-term use may increase risk of estrogen-dependent cancers (eg, breast and/or endometrial), dementia, others. Increased risk of thromboembolic disorders, gallbladder disease.

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).

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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