ESTRADIOL tablet

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Preferred Pharmaceuticals, Inc.

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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:

Резиме производа:

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 68788-7567-03 in bottles of 30 NDC 68788-7567-06 in bottles of 60 NDC 68788-7567-09 in bottles of 90 NDC 68788-7567-01 in bottles of 100 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 Repackaged by Preferred Pharmaceuticals, Inc.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

ESTRADIOL- ESTRADIOL TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
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
prescri