FEMRING- estradiol acetate ring

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

ESTRADIOL ACETATE (UNII: 5R97F5H93P) (ESTRADIOL - UNII:4TI98Z838E)

Dostopno od:

Physicians Total Care, Inc.

INN (mednarodno ime):

ESTRADIOL ACETATE

Sestava:

ESTRADIOL ACETATE 0.1 mg in 24 [USP'U]

Pot uporabe:

VAGINAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Femring therapy is indicated in the: 1. Treatment of moderate to severe vasomotor symptoms due to menopause. 2. Treatment of moderate to severe vulvar and vaginal atrophy due to menopause. Femring should not be used in women with any of the following conditions: - Undiagnosed abnormal genital bleeding. - Known, suspected, or history of breast cancer. - Known or suspected estrogen-dependent neoplasia. - Active deep vein thrombosis, pulmonary embolism or history of these conditions. - Active arterial thromboembolic disease (for example, stroke and myocardial infarction) or a history of these conditions. - Known liver dysfunction or disease. - Known or suspected pregnancy.

Povzetek izdelek:

Each Femring® (estradiol acetate vaginal ring) is individually packaged in a pouch consisting of one side medical grade paper and the other side polyester/polyethylene laminate. NDC 54868-6030-0 Femring® 0.10 mg/day (estradiol acetate vaginal ring) is available in single units. Relabeling of "Additional Barcode" by Physicians Total Care, Inc. Tulsa, OK    74146

Status dovoljenje:

New Drug Application

Lastnosti izdelka

FEMRING - ESTRADIOL ACETATE RING
PHYSICIANS TOTAL CARE, INC.
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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, MALIGNANT
NEOPLASMS, _ENDOMETRIAL_
_CANCER_.)
CARDIOVASCULAR DISORDERS AND PROBABLE DEMENTIA
Estrogen-alone therapy should not be used for the prevention of
cardiovascular disease or
dementia. (See CLINICAL STUDIES and WARNINGS, CARDIOVASCULAR DISORDERS
and
DEMENTIA.)
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
CLINICAL STUDIES and WARNINGS, CARDIOVASCULAR DISORDERS.)
The Women’s Health Initiative Memory Study (WHIMS) estrogen-alone
ancillary study of the
WHI reported 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 CLINICAL
STUDIES and WARNINGS, DEMENTIA and PRECAUTIONS, GERIATRIC USE.)
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