VAGIFEM- estradiol tablet, film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Physicians Total Care, Inc.

DCI (Dénomination commune internationale):

ESTRADIOL

Composition:

ESTRADIOL 10 ug

Mode d'administration:

VAGINAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Vagifem 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 deep vein thrombosis, pulmonary embolism or history of these conditions - Active arterial thromboembolic disease (for example, stroke, and myocardial infarction), or a history of these conditions - Known liver dysfunction or disease - Known or suspected pregnancy Vagifem 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. Vagifem should not be used during lactation. Estrogen administration to nursing women has been shown to decrease the quantity and quality of breast milk. Detectable amounts of estrogens have been identified in the breast milk of women receiving estrogen. Caution should be

Descriptif du produit:

Each Vagifem (estradiol vaginal tablets), 10 mcg is contained in a disposable, single-use applicator, packaged in a blister pack. Cartons contain 8 or 18 applicators with inset tablets. Vagifem 10 mcg 8 applicators: NDC 54868-6182-0 Keep out of reach of children Store at 25ºC (77ºF), excursions permitted to 15ºC-30ºC (59ºF-86ºF). Do not refrigerate. [See USP Controlled Room Temperature.]

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

VAGIFEM - ESTRADIOL TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VAGIFEM SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VAGIFEM.
VAGIFEM (ESTRADIOL VAGINAL TABLETS)
INITIAL U.S. APPROVAL: 1999
WARNING: CARDIOVASCULAR DISORDERS, ENDOMETRIAL CANCER, 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, AND MYOCARDIAL INFARCTION (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
Vagifem is an estrogen (estradiol) indicated for the treatment of
atrophic vaginitis due to menopause (1).
DOSAGE AND ADMINISTRATION
Vagifem should be administered intravaginally:
1 tablet daily for 2 weeks, followed by 1 tablet twice weekly (for
example, Tuesday and Friday) (2.2)
DOSAGE FORMS AND STRENGTHS
Vagifem 10 mcg tablet: One vaginal tablet contains 10.3 mcg of
estradiol hemihydrate equivalent to 10 mcg of estradiol
(3)
Vagifem 25 mcg tablet: On