ESTRADIOL tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

EPIC PHARMA, LLC

Designació comuna internacional (DCI):

ESTRADIOL

Composición:

ESTRADIOL 0.5 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Estradiol tablets are indicated in the: The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400 to 800 IU/day may also be required to ensure adequate daily intake in postmenopausal women. Estrogens should not be used in individuals with any of the following conditions:

Resumen del producto:

Estradiol Tablets, USP, 0.5 mg are white to off-white, round, convex, bisected tablets, debossed “Є ” above the bisect and “87” below the bisect on one side, and plain on the other side. NDC 42806-087-01 in bottles of 100 NDC 42806-087-05 in bottles of 500 Estradiol Tablets, USP, 1 mg are white to off-white, round, convex, bisected tablets, debossed “Є ” above the bisect and “88” below the bisect on one side and plain on the other side. NDC 42806-088-01 in bottles of 100 NDC 42806-088-05 in bottles of 500 Estradiol Tablets, USP, 2 mg are white to off-white, round, convex, bisected tablets, debossed “Є ” above the bisect and “89” below the bisect on one side and plain on the other side. NDC 42806-089-09 in bottles of 90 NDC 42806-089-01 in bottles of 100 NDC 42806-089-05 in bottles of 500 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense contents 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. Distributed by: Epic Pharma, LLC Laurelton, NY 11413 Manufactured in USA Rev. 09-2018-00 MF087REV09/18 OE1609

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

ESTRADIOL- ESTRADIOL TABLET
EPIC PHARMA, LLC
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ESTRADIOL TABLETS, USP
BOXED WARNING
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 lowe