ESTRADIOL tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

REMEDYREPACK INC.

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Estradiol tablets 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 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: - Undiagnosed abnormal genital bleeding. - Known, suspected or history of cancer of the breast except in appropriately selected patients being treated for metastatic disease. - Known or suspected estrogen-dependent neoplasia. - Active deep vein thrombosis, pulmonary embolism or history of these conditions. - Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). - Liver dysfunction or disease. - Estradiol tablets should not be used in patients with known hypersensitivity to its ingredients. - Known or suspected pregnancy. There is no indication for estradiol tablets in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy (See PRECAUTIONS).

Toote kokkuvõte:

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: 70518-2829-00 NDC: 70518-2829-01 PACKAGING: 100 in 1 BOX PACKAGING: 1 in 1 POUCH 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

ESTRADIOL- ESTRADIOL TABLET
REMEDYREPACK INC.
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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 low