Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2282
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
Premarin (Cream)
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| dailymed-instance:activeIng... | |
| dailymed-instance:genericDr... | |
| dailymed-instance:boxedWarn... |
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS
AND PROBABLE DEMENTIA FOR ESTROGEN-ALONE THERAPY ENDOMETRIAL CANCER There is an increased risk of endometrial cancer
in a woman with a uterus who uses unopposed estrogens. Adding a progestin
to estrogen therapy has been shown to reduce the risk of endometrial
hyperplasia, which may be a precursor to endometrial cancer. Adequate
diagnostic measures, including directed or random endometrial sampling
when indicated, should be undertaken to rule out malignancy in postmenopausal
women with undiagnosed persistent or recurring abnormal genital bleeding [see Warnings and Precautions (5.3)]. CARDIOVASCULAR DISORDERS AND PROBABLE DEMENTIA Estrogen-alone
therapy should not be used for the prevention of cardiovascular disease
or dementia [see Warnings and Precautions (5.2, 5.4),
and Clinical Studies (14.2, 14.3)]. The
Women's Health Initiative (WHI) estrogen-alone substudy reported
increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal
women (50 to 79 years of age) during 7.1 years of treatment with daily
oral conjugated estrogens (CE) [0.625 mg], relative to placebo [see Warnings and Precautions (5.2), and Clinical Studies (14.2)]. The
Women's Health Initiative Memory Study (WHIMS) estrogen-alone
ancillary study of WHI reported an increased risk of developing probable
dementia in postmenopausal women 65 years of age or older during 5.2
years of treatment with daily CE (0.625 mg) alone, relative to placebo.
It is unknown whether this finding applies to younger postmenopausal
women [see Warnings and Precautions (5.4), Use in Specific Populations (8.5), and Clinical Studies (14.3)]. In
the absence of comparable data, these risks should be assumed to be
similar for other doses of CE and other dosage forms of estrogens. Estrogens
with or without progestins should be prescribed at the lowest effective
doses and for the shortest duration consistent with treatment goals
and risks for the individual woman. WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER
AND PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY Estrogen
plus progestin therapy should not be used for the prevention of cardiovascular
disease or dementia [see Warnings and Precautions (5.2, 5.4),
and Clinical Studies (14.2, 14.3)]. The
WHI estrogen plus progestin substudy reported increased risks of DVT,
pulmonary embolism, stroke and myocardial infarction in postmenopausal
women (50 to 79 years of age) during 5.6 years of treatment with daily
oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA)
[2.5 mg], relative to placebo [see Warnings and Precautions (5.2), and Clinical Studies (14.2)]. The
WHI estrogen plus progestin substudy also demonstrated an increased
risk of invasive breast cancer [see Warnings and Precautions (5.3), and Clinical Studies (14.2)]. The
WHIMS estrogen plus progestin ancillary study of the WHI, reported
an increased risk of developing probable dementia in postmenopausalwomen 65 years of age or older during 4 years of treatment with daily
CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It
is unknown whether this finding applies to younger postmenopausal
women [see Warnings and Precautions (5.4), Use in Specific Populations (8.5), and Clinical Studies (14.3)]. In
the absence of comparable data, these risks should be assumed to be
similar for other doses of CE and MPA, and other combinations and
dosage forms of estrogens and progestins. Estrogens with or without progestins should be prescribed
at the lowest effective doses and for the shortest duration consistent
with treatment goals and risks for the individual woman.
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| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... |
dailymed-ingredient:benzyl_alcohol,
dailymed-ingredient:cetyl_alcohol,
dailymed-ingredient:cetyl_esters_wax,
dailymed-ingredient:glycerin,
dailymed-ingredient:glyceryl_monostearate,
dailymed-ingredient:methyl_stearate,
dailymed-ingredient:mineral_oil,
dailymed-ingredient:propylene_glycol_monostearate,
dailymed-ingredient:sodium_lauryl_sulfate,
dailymed-ingredient:white_wax
|
| dailymed-instance:possibleD... | |
| dailymed-instance:genericMe... |
Conjugated Estrogens
|
| dailymed-instance:fullName |
Premarin (Cream)
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| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Premarin
|