ESTRADIOL tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

Estradiol (UNII: 4TI98Z838E) (estradiol - UNII:4TI98Z838E)

Mevcut itibaren:

Stat Rx USA

INN (International Adı):

Estradiol

Kompozisyon:

Estradiol 0.5 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Estradiol Tablets, USP 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

Ürün özeti:

Estradiol Tablets, USP are available as: Store at 20º to 25º C (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense with a child-resistant closure in a tight, light-resistant container.                               

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

ESTRADIOL - ESTRADIOL TABLET
STAT RX USA
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ESTRADIOL (ESTRADIOL) TABLET
DESCRIPTION:
Estradiol Tablets, USP for oral administration contains 0.5, 1 or 2 mg
of micronized estradiol per tablet.
Estradiol (17β-estradiol) is a white, crystalline solid, chemically
described as estra-1,3,5,(10)-triene-3,
17β-diol. The structural formula is:
INACTIVE INGREDIENTS: Colloidal silicon dioxide, corn starch, dibasic
calcium phosphate, lactose
monohydrate, magnesium stearate, and sodium starch glycolate. In
addition, the 1 mg also contains FD
and C blue no. 1 aluminum lake and D and C red no. 27 aluminum lake.
The 2 mg also contains FD and C
blue no. 1 aluminum lake and FD and C yellow no. 5 (tartrazine)
aluminum lake.
CLINICAL PHARMACOLOGY
Endogenous estrogens are largely responsible for the development and
maintenance of the female
reproductive system and secondary sexual characteristics. Although
circulating estrogens exist in a
dynamic equilibrium of metabolic interconversions, estradiol is the
principal intracellular human
estrogen and is substantially more potent than its metabolites,
estrone and estriol at the receptor level.
The primary source of estrogen in normally cycling adult women is the
ovarian follicle, which secretes
70 to 500 mcg of estradiol daily, depending on the phase of the
menstrual cycle. After menopause, most
endogenous estrogen is produced by conversion of androstenedione,
secreted by the adrenal cortex, to
estrone by peripheral tissues. Thus, estrone and the
sulfate-conjugated form, estrone sulfate, are the
most abundant circulating estrogens in postmenopausal women.
Estrogens act through binding to nuclear receptors in
estrogen-responsive tissues. To date, two
estrogen receptors have been identified. These vary in proportion from
tissue to tissue.
Circulating estrogens modulate the pituitary secretion of the
gonadotropins, luteinizing hormone (LH)
and follicle-stimulating hormone (FSH), through a negative feedback
mechanism. Estrogens act to
reduce the elevated levels of these hormones s