ESTRADIOL tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Direct_Rx

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 pos

Podsumowanie produktu:

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, packaged in bottles of 100 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 100 and 500 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, packaged in bottles of 100 and 500 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 Rev. B 5/2018

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

ESTRADIOL- ESTRADIOL TABLET
DIRECT_RX
----------
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 the
lowest effective doses and