MENEST- estrogens, esterified tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Physicians Total Care, Inc.

INN (International Name):

ESTROGENS, ESTERIFIED

Sammensetning:

ESTROGENS, ESTERIFIED 0.3 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Menest is 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 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 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. - Female hypogonadism. Female hypogonadism. - Female castration. Female castration. - Primary ovarian failure. Primary ovarian failure. - Breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. Breast cancer (for palliation only) in appropriately selected women and men with metastatic disease

Produkt oppsummering:

Tablets: 0.3 mg yellow, film-coated oblong tablet imprinted with M72 0.625 mg orange, film-coated oblong tablet imprinted with M73 1.25 mg green, film-coated oblong tablet imprinted with M74

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

MENEST - ESTROGENS, ESTERIFIED TABLET
PHYSICIANS TOTAL CARE, INC.
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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 be prescribed at the lowest effective doses and