ESTRADIOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

ESTRADIOL

Composition:

ESTRADIOL 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Estradiol tablets are indicated in the: Estrogens should not be used in individuals with any of the following conditions:

Product summary:

Estradiol Tablets USP are available as: 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, packaged in bottles of 30 (NDC 63187-741-30), 60 (63187-741-60 and 90 (NDC 63187-741-90). Store at 20º to 25º C (68º to 77ºF) [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 TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Repackaged by: Proficient Rx LP. Thousand Oaks, CA 91320 Rev. A 5/2016

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ESTRADIOL- ESTRADIOL TABLET
PROFICIENT RX LP
----------
ESTRADIOL TABLETS USP
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 the lowest effect