PREMARIN- conjugated estrogens 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:

State of Florida DOH Central Pharmacy

INN (International Name):

ESTROGENS, CONJUGATED

Sammensetning:

ESTROGENS, CONJUGATED 0.625 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

PREMARIN therapy is indicated in the: - Treatment of moderate to severe vasomotor symptoms due to menopause. - Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to 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 breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. - Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). - Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. (See CLINICAL STUDIES .) The mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exe

Produkt oppsummering:

PREMARIN® (conjugated estrogens tablets, USP) — Each oval green tablet contains 0.3 mg. — Each oval blue tablet contains 0.45 mg. — Each oval maroon tablet contains 0.625 mg. — Each oval white tablet contains 0.9 mg. — Each oval yellow tablet contains 1.25 mg. The appearance of these tablets is a trademark of Wyeth Pharmaceuticals. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in a well-closed container, as defined in the USP.

Autorisasjon status:

New Drug Application

Preparatomtale

PREMARIN - CONJUGATED ESTROGENS TABLET, FILM COATED
STATE OF FLORIDA DOH CENTRAL PHARMACY
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PREMARIN
(CONJUGATED ESTROGENS TABLETS, USP)
RX ONLY
WARNINGS
ENDOMETRIAL CANCER
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. (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 or dementia. (See CLINICAL STUDIES and WARNINGS,
CARDIOVASCULAR DISORDERS
and DEMENTIA.)
The estrogen alone substudy of the Women's Health Initiative (WHI)
reported increased risks of
stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to
79 years of age) during
6.8 years and 7.1 years, respectively, of treatment with daily oral
conjugated estrogens
(CE 0.625 mg), relative to placebo. (See CLINICAL STUDIES and
WARNINGS,
CARDIOVASCULAR DISORDERS.)
The estrogen plus progestin substudy of WHI reported increased risks
of myocardial infarction,
stroke, invasive breast cancer, pulmonary emboli, and DVT in
postmenopausal women (50 to 79
years of age) during 5.6 years of treatment with daily CE 0.625 mg
combined with
medroxyprogesterone acetate (MPA 2.5 mg), relative to placebo. (See
CLINICAL STUDIES
and WARNINGS, CARDIOVASCULAR DISORDERS and MALIGNANT NEOPLASMS, BREAST
CANCER.)
The Women's Health Initiative Memory Study (WHIMS), a substudy 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 and
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 CLINICAL
STUDIES and
WARNINGS, DEMENTIA and PRECAUTIONS, GERIATRIC USE.)
In the absence of comparable data, these risks should be assumed to be
similar for ot