ESTRING- estradiol ring

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Physicians Total Care, Inc.

INN (Rahvusvaheline Nimetus):

ESTRADIOL

Koostis:

ESTRADIOL 2 mg

Manustamisviis:

VAGINAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

ESTRING (estradiol vaginal ring) is an estrogen indicated for the treatment of moderate to severe urogenital symptoms due to postmenopausal atrophy of the vagina (such as dryness, burning, pruritus and dyspareunia) and/or the lower urinary tract (urinary urgency and dysuria). ESTRING vaginal ring 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 (within the past year) arterial thromboembolic disease (for example, stroke and myocardial infarction). - Known liver dysfunction or disease. - Known hypersensitivity to any of the ingredients in ESTRING. - Known or suspected pregnancy.

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 54868-5538-0   ESTRING (estradiol vaginal ring) 2 mg - available in single packs. Store at controlled room temperature 15° to 30° C (59° to 86° F).

Volitamisolek:

New Drug Application

Toote omadused

ESTRING - ESTRADIOL RING
PHYSICIANS TOTAL CARE, INC.
----------
ESTRING
(ESTRADIOL VAGINAL RING)
PHYSICIAN'S LEAFLET
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 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 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 WHI substudy 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 oral 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 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 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 other doses of
CE and MPA and other combinat