MENEST esterified estrogens tablet film coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

ESTROGENS, ESTERIFIED (UNII: 3ASP8Q3768) (ESTROGENS, ESTERIFIED - UNII:3ASP8Q3768)

Disponible desde:

Avera McKennan Hospital

Designación común internacional (DCI):

ESTROGENS, ESTERIFIED

Composición:

ESTROGENS, ESTERIFIED 0.625 mg

tipo de receta:

PRESCRIPTION DRUG

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

MENEST- ESTERIFIED ESTROGENS TABLET, FILM COATED
AVERA MCKENNAN HOSPITAL
----------
MENEST
BRAND OF
ESTERIFIED ESTROGENS TABLETS, USP
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 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