ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE tablet film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

ESTROGENS, CONJUGATED (UNII: IU5QR144QX) (ESTROGENS, CONJUGATED - UNII:IU5QR144QX)

Tilgjengelig fra:

Seton Pharmaceuticals

INN (International Name):

ESTROGENS, CONJUGATED

Sammensetning:

ESTROGENS, CONJUGATED 0.625 mg

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

unapproved drug other

Preparatomtale

ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE- ESTERIFIED ESTROGENS AND
METHYLTESTOSTERONE TABLET, FILM COATED
SETON PHARMACEUTICALS
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLETS CIII
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
a