ESTRADIOL VAGINAL- estradiol cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals of New York LLC

INN (International Name):

ESTRADIOL

Composition:

ESTRADIOL 0.1 mg in 1 g

Administration route:

VAGINAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Estradiol Vaginal Cream, 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Estradiol Vaginal Cream, 0.01% 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 DVT, PE or history of these conditions. 5. Active arterial thromboembolic disease (for example, stroke, MI) or a history of these conditions. 6. Known anaphylactic reaction or angioedema to Estradiol Vaginal Cream, 0.01%. 7. Known liver dysfunction or disease. 8. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. 9. Known or suspected pregnancy.

Product summary:

Estradiol Vaginal Cream USP, 0.01% NDC 0115-1518-66: Tube containing 1½ oz (42.5 g) with a calibrated plastic applicator for delivery of 1, 2, 3, or 4 g. Store at room temperature 20° to 25°C (59° to 77°F). Protect from temperatures in excess of 40°C (104°F). Keep Estradiol Vaginal Cream, 0.01% out of the reach of children. REFERENCES 1. Jackson RD, et al. Effects of Conjugated Equine Estrogen on Risk of Fractures and BMD in Postmenopausal Women With Hysterectomy: Results From the Women’s Health Initiative Randomized Trial. J Bone Miner Res . 2006;21:817-828. 2. Hendrix SL, et al. Effects of Conjugated Equine Estrogen on Stroke in the Women’s Health Initiative. Circulation . 2006;113:2425-2434. 3. Rossouw JE, et al. Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years Since Menopause. JAMA . 2007;297:1465-1477. 4. Hsia J, et al. Conjugated Equine Estrogens and Coronary Heart Disease. Arch Int Med . 2006;166:357-365. 5. Curb JD, et al. Venous Thrombosis and Conjugated Equine Estrogen in Women Without a Uterus. Arch Int Med . 2006;166:772-780. 6. Cushman M, et al. Estrogen Plus Progestin and Risk of Venous Thrombosis. JAMA . 2004;292:1573-1580. 7. Stefanick ML, et al. Effects of Conjugated Equine Estrogens on Breast Cancer and Mammography Screening in Postmenopausal Women With Hysterectomy. JAMA . 2006;295:1647-1657. 8. Chlebowski RT, et al. Influence of Estrogen Plus Progestin on Breast Cancer and Mammography in Healthy Postmenopausal Women. JAMA . 2003;289:3234-3253. 9. Anderson GL, et al. Effects of Estrogen Plus Progestin on Gynecologic Cancers and Associated Diagnostic Procedures. JAMA . 2003;290:1739-1748. 10. Shumaker SA, et al. Conjugated Equine Estrogens and Incidence of Probable Dementia and Mild Cognitive Impairment in Postmenopausal Women. JAMA . 2004;291:2947-2958.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ESTRADIOL VAGINAL- ESTRADIOL CREAM
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
ESTRADIOL VAGINAL CREAM USP, 0.01%
RX ONLY
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS,
BREAST CANCER AND PROBABLE DEMENTIA
ESTROGEN-ALONE THERAPY
ENDOMETRIAL CANCER
There is an increased risk of endometrial cancer in a woman with a
uterus who
uses unopposed estrogens. Adding a progestin to estrogen therapy has
been
shown to reduce the risk of endometrial hyperplasia, which may be a
precursor to
endometrial cancer. Adequate diagnostic measures, including directed
or random
endometrial sampling when indicated, should be undertaken to rule out
malignancy
in postmenopausal women with undiagnosed persistent or recurring
abnormal
genital bleeding [see WARNINGS, MALIGNANT NEOPLASMS, ENDOMETRIAL
CANCER].
CARDIOVASCULAR DISORDERS AND PROBABLE DEMENTIA
Estrogen-alone therapy should not be used for the prevention of
cardiovascular
disease or dementia [see CLINICAL STUDIES and WARNINGS, CARDIOVASCULAR
DISORDERS, and PROBABLE DEMENTIA].
The Women’s Health Initiative (WHI) estrogen-alone substudy reported
increased
risks of stroke and deep vein thrombosis (DVT) in postmenopausal women
(50 to
79 years of age) during 7.1 years of treatment with daily oral
conjugated estrogens
(CE) [0.625 mg]-alone, relative to placebo [see CLINICAL STUDIES and
WARNINGS, CARDIOVASCULAR DISORDERS].
The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI
reported
an increased risk of developing probable dementia in postmenopausal
women 65
years of age or older during 5.2 years of treatment with daily CE
(0.625 mg) -alone,
relative to placebo. It is unknown whether this finding applies to
younger
postmenopausal women [see CLINICAL STUDIES and WARNINGS, PROBABLE
DEMENTIA and PRECAUTIONS, GERIATRIC USE].
In the absence of comparable data, these risks should be assumed to be
similar for
other doses of CE and other dosage forms of estrogens.
Estrogens with or without progestins should be prescribed at the
lowest effective
doses and for the shorte