ESTRADIOL tablet ESTRADIOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Direct Rx

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Estradiol Tablets USP are indicated in the: Treatment of moderate to severe vasomotor symptoms associated with the menopause. 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. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. (See CLINICAL PHARMACOLOGY, Clinical Studies.) The mainstays for decreasing the risk of

Product summary:

Estradiol Tablets USP are available as: 0.5 mg: White to off-white, oval, flat-faced, beveled-edge, scored tablet. Debossed with 899 / ½ on the scored side and stylized b on the other side, 1 mg: Light purple, oval, flat-faced, beveled-edge, scored tablet. Debossed with 886 / 1 on the scored side and stylized b on the other side, 2 mg: Green, oval, flat-faced, beveled-edge, scored tablet. Debossed with 887 / 2 on the scored side and stylized b on the other side, Store at 20° to 25° C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN Manufactured by: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Distributed by: Mayne Pharma Greenville, NC 27834 Rev. B 5/2018

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ESTRADIOL- ESTRADIOL TABLET
ESTRADIOL- ESTRADIOL TABLET
DIRECT RX
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ESTRADIOL
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 with or without 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 prescribed at th