YUVAFEM- estradiol tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ESTRADIOL HEMIHYDRATE (UNII: CXY7B3Q98Z) (ESTRADIOL - UNII:4TI98Z838E)

Available from:

Amneal Pharmaceuticals NY LLC

INN (International Name):

ESTRADIOL HEMIHYDRATE

Composition:

ESTRADIOL 10 ug

Administration route:

VAGINAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Yuvafem should not be used 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 history of these conditions - Active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions - Known anaphylactic reaction or angioedema to  Yuvafem - Known liver impairment or disease - Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders - Known or suspected pregnancy Yuvafem should not be used during pregnancy [see Contraindications (4)] . There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy. Yuvafem should not be used during lactation. Estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast m

Product summary:

Yuvafem™ (estradiol vaginal inserts), 10 mcg , is contained in a disposable, single-use applicator, packaged in a blister pack. Cartons contain 8 or 18 applicators with inset inserts. Yuvafem™ 10 mcg   8 applicators:             NDC 69238-1524-7 18 applicators:             NDC 69238-1524-8 Keep out of reach of children Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Do not refrigerate.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

YUVAFEM- ESTRADIOL TABLET
AMNEAL PHARMACEUTICALS NY LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
YUVAFEM SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR YUVAFEM.
YUVAFEM (ESTRADIOL VAGINAL INSERTS)
INITIAL U.S. APPROVAL: 1999
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR
DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA
_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)
ESTROGEN-ALONE THERAPY SHOULD NOT BE USED FOR THE PREVENTION OF
CARDIOVASCULAR DISEASE OR DEMENTIA
(5.2, 5.4)
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)
ESTROGEN PLUS PROGESTIN THERAPY
ESTROGEN PLUS PROGESTIN THERAPY SHOULD NOT BE USED FOR THE PREVENTION
OF CARDIOVASCULAR DISEASE OR
DEMENTIA (5.2, 5.4)
THE WHI ESTROGEN PLUS PROGESTIN SUBSTUDY REPORTED INCREASED RISKS OF
STROKE, DVT, PULMONARY
EMBOLISM (PE) 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)
INDICATIONS AND USAGE
Yuvafem is an estrogen (estradiol) indicated for the treatment of
atrophic vaginitis due to menopause (1.1)
DOSAGE AND ADMINISTRATION
Yuvafem should be administered intravaginally:
1 insert daily for 2 weeks, followed by 1 insert twice weekly (for
example, Tuesday and Friday) (2.1)
DOSAGE FORMS AND STRENGTHS
Yuvafem, 10 mcg: One vaginal insert contains 10.3 mcg of estradiol
hemihydrate, USP equivalent to 10 mcg of
estradiol, USP (3)
CONTRAINDICATIONS
Undia