ESTRADIOL insert

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

ESTRADIOL

Composition:

ESTRADIOL 10 ug

Administration route:

VAGINAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Estradiol vaginal inserts is contraindicated in women with any of the following conditions: - Undiagnosed abnormal genital bleeding [see Warnings and Precautions (5.3)]. - Breast cancer or a history of breast cancer [see Warnings and Precautions (5.3)]. - Estrogen-dependent neoplasia [see Warnings and Precautions (5.3)]. - Active DVT, PE, or history of these conditions [see Warnings and Precautions (5.2)]. - Active arterial thromboembolic disease (for example, stroke or MI), or a history of these conditions [see Warnings and Precautions (5.2)]. - Known anaphylactic reaction, or angioedema, or hypersensitivity to estradiol vaginal inserts [see Warnings and Precautions (5.16)]. - Hepatic impairment or disease. - Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Risk Summary Estradiol vaginal inserts are not indicated for use in pregnancy. There are no data with the use of estradiol vaginal inserts in pregnant women; however, epidemiologic studies and meta-analyses have

Product summary:

Estradiol vaginal inserts USP, 10 mcg, are white to off-white, round, film-coated, unscored, biconvex inserts, debossed with "TV " on one side and "T5 " on the other side. Each insert is contained in a disposable, single-use applicator, packaged in a blister pack. Cartons contain 8 or 18 applicators with inset inserts. Estradiol vaginal inserts USP, 10 mcg 8 applicators: NDC 0093-3223-08 18 applicators: NDC 0093-3223-97 Keep out of reach of children. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not refrigerate.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ESTRADIOL- ESTRADIOL INSERT
TEVA PHARMACEUTICALS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESTRADIOL VAGINAL
INSERTS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ESTRADIOL VAGINAL
INSERTS.
ESTRADIOL VAGINAL INSERTS
INITIAL U.S. APPROVAL: 1999
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR
DISORDERS, PROBABLE DEMENTIA, AND BREAST CANCER
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
ESTROGEN-ALONE THERAPY
THERE IS AN INCREASED RISK OF ENDOMETRIAL CANCER IN A WOMAN WITH A
UTERUS WHO USES
UNOPPOSED ESTROGENS (5.3)
THE WOMEN’S HEALTH INITIATIVE (WHI) ESTROGEN-ALONE SUBSTUDY REPORTED
INCREASED
RISKS OF STROKE AND DEEP VEIN THROMBOSIS (DVT) (5.2)
THE WHI MEMORY STUDY (WHIMS) ESTROGEN-ALONE ANCILLARY STUDY OF WHI
REPORTED AN
INCREASED RISK OF PROBABLE DEMENTIA IN POSTMENOPAUSAL WOMEN 65 YEARS
OF AGE AND
OLDER (5.4)
DO NOT USE ESTROGEN-ALONE THERAPY FOR THE PREVENTION OF CARDIOVASCULAR
DISEASE OR
DEMENTIA (5.2, 5.4)
ESTROGEN PLUS PROGESTIN THERAPY
THE WHI ESTROGEN PLUS PROGESTIN SUBSTUDY REPORTED INCREASED RISKS OF
PULMONARY
EMBOLISM (PE), DVT, STROKE, AND MYOCARDIAL INFARCTION (MI) (5.2)
THE WHI ESTROGEN PLUS PROGESTIN SUBSTUDY REPORTED INCREASED RISKS OF
INVASIVE
BREAST CANCER (5.3)
THE WHIMS ESTROGEN PLUS PROGESTIN ANCILLARY STUDY OF WHI REPORTED AN
INCREASED
RISK OF PROBABLE DEMENTIA IN POSTMENOPAUSAL WOMEN 65 YEARS OF AGE AND
OLDER
(5.4)
DO NOT USE ESTROGEN PLUS PROGESTOGEN THERAPY FOR THE PREVENTION OF
CARDIOVASCULAR
DISEASE OR DEMENTIA (5.2, 5.4)
INDICATIONS AND USAGE
Estradiol vaginal inserts are an estrogen indicated for the treatment
of atrophic vaginitis due to
menopause (1.1)
DOSAGE AND ADMINISTRATION
Administer estradiol vaginal inserts intravaginally:
1 insert daily for 2 weeks, followed by 1 insert twice weekly (for
example, Tuesday and Friday) (2.1)
DOSAGE FORMS AND STRENGTHS
Vaginal Insert: One 10 mcg vaginal insert contains 10.3 mcg of
estradiol hemihydrate equivalent to 10
mcg of estradiol (