ESTRADIOL cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

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:

Product summary:

Estradiol Vaginal Cream USP, 0.01% contains estradiol, USP hemihydrate equivalent to 0.1 mg estradiol in a nonliquefying base. The opaque, white to off white cream is available in a tube containing 1.5 oz (42.5 g) with a calibrated plastic applicator for delivery of 1 g, 2 g, 3 g, or 4 g. It is available as follows: NDC 0378-8770-35 carton containing one 1.5 oz (42.5 g) tube Store at 20° to 25°C (68° to 77°F). [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. PHARMACIST: Dispense the Patient Information Leaflet with each prescription.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ESTRADIOL- ESTRADIOL CREAM
MYLAN PHARMACEUTICALS INC.
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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 and risks for
the in