ESTROPIPATE tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

ESTROPIPATE (UNII: SVI38UY019) (ESTROPIPATE - UNII:SVI38UY019)

Saadav alates:

Physicians Total Care, Inc.

INN (Rahvusvaheline Nimetus):

ESTROPIPATE

Koostis:

ESTROPIPATE 0.75 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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 con

Toote kokkuvõte:

Estropipate tablets USP are supplied as follows:

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

ESTROPIPATE - ESTROPIPATE TABLET
PHYSICIANS TOTAL CARE, INC.
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WARNINGSESTROGENS 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
SHOULD BE PRESCRIBED
AT THE LOWEST EFFECTIVE D