ESTRADIOL cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ESTRADIOL HEMIHYDRATE (UNII: CXY7B3Q98Z) (ESTRADIOL - UNII:4TI98Z838E)

Available from:

Alvogen Inc.

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: - Undiagnosed abnormal genital bleeding. - Known, suspected, or history of cancer of the breast. - Known or suspected estrogen-dependent neoplasia. - Active DVT, PE or history of these conditions. - Active arterial thromboembolic disease (for example, stroke, MI) or a history of these conditions. - Known anaphylactic reaction or angioedema to Estradiol Vaginal Cream 0.01%. - Known liver dysfunction or disease. - Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. - Known or suspected pregnancy.

Product summary:

Estradiol Vaginal Cream, USP 0.01% NDC 47781-104-44: Tube containing 1 ½ oz (42.5 grams) with a calibrated plastic applicator for delivery of 1 gram, 2 grams, 3 grams, or 4 grams. Store at 25°C (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. Protect from temperatures in excess of 40°C (104°F). Keep Estradiol Vaginal Cream 0.01% out of the reach of children. Estradiol vaginal cream, USP 0.01% is supplied as a tube containing 1 ½ oz (42.5 grams) of cream with a calibrated plastic applicator for delivery of 1 gram, 2 grams, 3 grams, or 4 grams. Store at 25°C (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. Protect from temperatures in excess of 40°C (104°F). Product of Germany Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA Revised: February 2018 PL104-01

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ESTRADIOL- ESTRADIOL CREAM
ALVOGEN INC.
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ESTRADIOL VAGINAL CREAM, USP 0.01%
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 shortest duration consistent with treatment goals