Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)
Physicians Total Care, Inc.
ESTRADIOL
ESTRADIOL 10 ug
VAGINAL
PRESCRIPTION DRUG
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
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.]
New Drug Application
VAGIFEM - ESTRADIOL TABLET, FILM COATED PHYSICIANS TOTAL CARE, INC. ---------- 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 Lesen Sie das vollständige Dokument