Country: United States
Language: English
Source: NLM (National Library of Medicine)
ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)
Teva Pharmaceuticals USA, Inc.
ESTRADIOL
ESTRADIOL 10 ug
VAGINAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
ESTRADIOL- ESTRADIOL INSERT TEVA PHARMACEUTICALS USA, INC. ---------- 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 ( Read the complete document