ESTROPIPATE- estropipate tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

ESTROPIPATE (UNII: SVI38UY019) (ESTRONE - UNII:2DI9HA706A)

제공처:

Actavis Pharma, Inc.

INN (국제 이름):

ESTROPIPATE

구성:

ESTROPIPATE 1.5 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Estropipate tablets are indicated in the: - Treatment of moderate to severe vasomotor symptoms associated with the menopause. Treatment of moderate to severe vasomotor symptoms associated with the menopause. - Treatment of moderate to severe symptoms of vulval 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 moderate to severe symptoms of vulval 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 hypoestrogenism due to hypogonadism, castration or primary ovarian failure. - Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for

제품 요약:

Estropipate tablets, USP are supplied as follows:

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

ESTROPIPATE- ESTROPIPATE TABLET
ACTAVIS PHARMA, INC.
----------
ESTROPIPATE TABLETS, USP
REVISED: MAY 2016 RX ONLY
WARNINGS:
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 result 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 and 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 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