ESTRADIOL tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Asclemed USA, Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 decreasi

Dettagli prodotto:

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 76420-021-10 in bottles of 100 (relabeled from NDC 42806-087-01) 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 76420-022-10 in bottles of 100 (relabeled from NDC 42806-088-01) 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 76420-023-10 in bottles of 100 (relabeled from NDC 42806-089-01) 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. Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

ESTRADIOL- ESTRADIOL TABLET
ASCLEMED USA, 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 lo