ESTRING- estradiol ring

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Pfizer Laboratories Div Pfizer Inc

INN (International Name):

ESTRADIOL

Composition:

ESTRADIOL 2 mg

Administration route:

VAGINAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: 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 provider should talk regularly (for example, every 3 to 6 months) about whether you still need treatment with ESTRING. ESTRING INSERTION ESTRING can be inserted and removed by you or your doctor or healthcare provider. To insert ESTRING yourself, choose the position that is most comfortable for you: standing with one leg up, squatting, or lying down. ESTRING PLACEMENT The exact position of ESTRING is not critical, as long as it is placed in the upper third of the vagina. When ESTRING is in place, you should not feel anything. If you fee

Product summary:

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).

Authorization status:

New Drug Application

Summary of Product characteristics

ESTRING- ESTRADIOL RING
PFIZER LABORATORIES DIV PFIZER INC
----------
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 durati