ESTRING- estradiol ring

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)

Saadav alates:

U.S. Pharmaceuticals

INN (Rahvusvaheline Nimetus):

estradiol

Koostis:

estradiol 2 mg

Manustamisviis:

VAGINAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

ESTRING is indicated for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. ESTRING is contraindicated 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 DVT, PE, or a history of these conditions. - Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions. - Known anaphylactic reaction or angioedema or hypersensitivity to ESTRING. - Known liver impairment or disease. - Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. - Known or suspected pregnancy. How should I use ESTRING? ESTRING is a local estrogen therapy used after menopause to treat moderate to severe menopausal changes in and around the vagina. ESTRING PROVIDES RELIEF OF LOCAL SYMPTOMS OF MENOPAUSE ONLY. Estrogens should be used only as long as needed. You and your healthcare p

Toote kokkuvõte:

Each ESTRING (estradiol vaginal ring) is individually packaged in a heat-sealed rectangular pouch consisting of three layers, from outside to inside: polyester, aluminum foil, and low density polyethylene, respectively. The pouch is provided with a tear-off notch on one side. NDC 0013-2150-36 ESTRING (estradiol vaginal ring) 2 mg - available in single packs. Store at controlled room temperature 15° to 25 °C (59 °F to 77 °F).

Volitamisolek:

New Drug Application

Toote omadused

ESTRING- ESTRADIOL RING
U.S. PHARMACEUTICALS
----------
ESTRING
(ESTRADIOL VAGINAL RING)
PHYSICIAN'S LEAFLET
®
WARNINGS: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS,
BREAST CANCER AND PROBABLE DEMENTIA
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
and random
endometrial sampling when indicated, should be undertaken to rule out
malignancy
in all cases of 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 PROBABLE 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]-alone, relative to placebo. (See CLINICAL STUDIES and
WARNINGS, CARDIOVASCULAR DISORDERS.)
The WHI Memory Study (WHIMS)estrogen-alone ancillary study of the 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 CLINICAL STUDIES and WARNINGS,
PROBABLE 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