ENJUVIA- synthetic conjugated estrogens, b tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

ESTROGENS, CONJUGATED SYNTHETIC B (UNII: 8L6LAK9BTR) (ESTROGENS, CONJUGATED SYNTHETIC B - UNII:8L6LAK9BTR)

Tilgjengelig fra:

Physicians Total Care, Inc.

INN (International Name):

ESTROGENS, CONJUGATED SYNTHETIC B

Sammensetning:

ESTROGENS, CONJUGATED SYNTHETIC B 0.9 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

ENJUVIA tablets are indicated in the: - Treatment of moderate to severe vasomotor symptoms associated with menopause. - Treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause. When prescribing solely for the treatment of moderate to severe vaginal dryness and pain with intercourse, topical vaginal products should be considered. ENJUVIA tablets should not be used in women with any of the following conditions: - Undiagnosed abnormal genital bleeding. - Known, suspected, or history of cancer of the breast. - Known or suspected estrogen-dependent neoplasia. - Active deep vein thrombosis, pulmonary embolism or a history of these conditions. - Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). - Liver dysfunction or disease. - Known hypersensitivity to the ingredients of ENJUVIA Tablets. - Known or suspected pregnancy. There is no indication for ENJUVIA in pregnancy

Produkt oppsummering:

ENJUVIA® (synthetic conjugated estrogens, B) Tablets 0.3 mg: The tablets are oval, white, film-coated, and debossed with “E” on one side and “1” on the reverse and are available in bottles of: The tablets are oval, pink, film-coated, and debossed with “E” on one side and “3” on the reverse and are available in bottles of: 0.9 mg: The tablets are oval, light blue-green, film-coated, and debossed with “E” on one side and “5” on the reverse and are available in bottles of: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep this and all drugs out of the reach of children. Dispense in a tight container with a child-resistant closure. Pharmacist: Include one “Patient Information” leaflet with each prescription. Iss. 3/2010

Autorisasjon status:

New Drug Application

Preparatomtale

ENJUVIA - SYNTHETIC CONJUGATED ESTROGENS, B TABLET
PHYSICIANS TOTAL CARE, INC.
----------
ENJUVIA®
(SYNTHETIC CONJUGATED ESTROGENS, B) TABLETS
11001651
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 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 oral
conjugated estrogens (CE 0.625 mg)
alone per day, relative to placebo. (See CLINICAL STUDIES and
WARNINGS,
CARDIOVASCULAR DISORDERS.)
The estrogen-plus-progestin substudy of the WHI 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 5.6 years of
treatment with oral conjugated
estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA
2.5 mg) per day,
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 study, reported
increased risk of developing probable dementia in postmenopausal women
65 years of age or
older during 5.2 years of treatment with CE 0.625 mg alone and durin