ESTRADIOL VALERATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ESTRADIOL VALERATE (UNII: OKG364O896) (ESTRADIOL - UNII:4TI98Z838E)

Available from:

Perrigo Company

INN (International Name):

ESTRADIOL VALERATE

Composition:

ESTRADIOL VALERATE 20 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Estradiol Valerate Injection is indicated in the: 1.    Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2.    Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause.  When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3.    Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4.    Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). Estradiol Valerate Injection should not be used in women with any of the following conditions: 1.    Undiagnosed abnormal genital bleeding. 2.    Known, suspected, or history of cancer of the breast. 3.    Known or suspected estrogen-dependent neoplasia. 4.    Active deep vein thrombosis, pulmonary embolism or a history of these conditions. 5.    Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial i

Product summary:

Estradiol Valerate Injection, USP Multiple Dose Vials NDC 0574-0870-05          20 mg/mL (5 mL) NDC 0574-0872-05          40 mg/mL (5 mL) Store at 20° to 25°C (68° to 77°F) [see Controlled USP Room Temperature]. Keep out of reach of children. PROTECT FROM LIGHT. Store vial in carton until used.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ESTRADIOL VALERATE- ESTRADIOL VALERATE INJECTION, SOLUTION
PERRIGO COMPANY
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ESTRADIOL VALERATE INJECTION, USP
RX ONLY
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. There
is no evidence that the use of "natural" estrogens results in a
different endometrial risk profile
than synthetic estrogens at equivalent estrogen doses. (See WARNINGS,
MALIGNANT NEOPLASMS,
ENDOMETRIAL CANCER_._)
CARDIOVASCULAR AND OTHER RISKS
Estrogens and progestins should not be used for the prevention of
cardiovascular disease. (See
WARNINGS, CARDIOVASCULAR DISORDERS.)
The Women's Health Initiative (WHI) study reported increased risks of
myocardial infarction,
stroke, invasive breast cancer, pulmonary emboli, and deep vein
thrombosis in postmenopausal
women (50 to 79 years of age) during 5 years of treatment with oral
conjugated estrogens (CE
0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg)
relative to placebo. (See
CLINICAL PHARMACOLOGY, CLINICAL STUDIES. )
The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI,
reported increased
risk of developing probable dementia in postmenopausal women 65 years
of age or older during 4
years of treatment with oral conjugated estrogens plus
medroxyprogesterone acetate relative to
placebo. It is unknown whether this finding applies to younger
postmenopausal women or to
women taking estrogen alone therapy. (See CLINICAL PHARMACOLOGY,
CLINICAL STUDIES.)
Other doses of oral conjugated estrogens with medroxyprogesterone
acetate, and other
combinations and dosage forms of estrogens and progestins were not
studied in the WHI clinical
trials and, in the absence of comparable data, these risks should be
assumed to be similar. Because
of these risks, estrogens with or without progestins should be
prescr