ESTRADIOL tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Golden State Medical Supply, Inc.

INN (Medzinárodný Name):

ESTRADIOL

Zloženie:

ESTRADIOL 0.5 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 d

Prehľad produktov:

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 (NDC 60429-833-01). 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 (NDC 60429-834-01) and 500 (NDC 60429-834-05). 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 (NDC 60429-835-01) and 500 (NDC 60429-835-05). Store at 20° to 25° C (68° to 77°F) [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 Manufactured by: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Distributed by: Mayne Pharma Greenville, NC 27834 Marketed/Packaged by: GSMS, Inc. Camarillo, CA USA 93012 Rev. B 5/2018

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

ESTRADIOL- ESTRADIOL TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
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ESTRADIOL TABLETS USP
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 prescr