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

 

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 Dose for DELESTROGEN:

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's Dose for DELESTROGEN:

Not applicable.

Pharmacological Class:

Estrogen.

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:

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. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. 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.

Adverse Reactions:

GI upset, abdominal pain, irregular bleeding, vaginitis, dysmenorrhea, headache, edema, hypertension, mastodynia, chloasma, visual abnormalities (reeva luate 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