ESTRADIOL patch

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Mylan Pharmaceuticals Inc.

Designación común internacional (DCI):

ESTRADIOL

Composición:

ESTRADIOL 0.025 mg in 1 d

Vía de administración:

TRANSDERMAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Estradiol transdermal system continuous delivery (once-weekly) is indicated for:     When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products.       When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis. Estradiol transdermal system continuous delivery (once-weekly) is contraindicated in women with any of the following conditions: Estradiol transdermal system continuous delivery (once-weekly) is not indicated for use in pregnancy. There are no data with the use of estradiol transdermal system continuous delivery (once-weekly) in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined

Resumen del producto:

Estradiol Transdermal System, USP Continuous Delivery (Once-Weekly) is available as 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.06 mg/day, 0.075 mg/day or 0.1 mg/day of estradiol. The 0.025 mg/day is available as a 7.75 cm2 system containing estradiol, USP hemihydrate equivalent to 0.97 mg of estradiol for a nominal in vivo delivery of 0.025 mg of estradiol per day. Each patch consists of a round inner disk centered on a round peach color outer disk with “Estradiol 0.025 mg/day (Once-Weekly)” printed on the outer disk in brown. Each patch is contained in a square, notched pouch with printed paper on both sides. The pouch is imprinted with the lot number and expiration date. They are available as follows: NDC 0378-3349-99 carton containing 4 transdermal systems The 0.0375 mg/day is available as an 11.625 cm2 system containing estradiol, USP hemihydrate equivalent to 1.46 mg of estradiol for a nominal in vivo delivery of 0.0375 mg of estradiol per day. Each patch consists of a round inner disk centered on a round peach color outer disk with “Estradiol 0.0375 mg/day (Once-Weekly)” printed on the outer disk in brown. Each patch is contained in a square, notched pouch with printed paper on both sides. The pouch is imprinted with the lot number and expiration date. NDC 0378-3360-99 carton containing 4 transdermal systems The 0.05 mg/day is available as a 15.5 cm2 system containing estradiol, USP hemihydrate equivalent to 1.94 mg of estradiol for a nominal in vivo delivery of 0.05 mg of estradiol per day. Each patch consists of a round inner disk centered on a round peach color outer disk with “Estradiol 0.05 mg/day (Once-Weekly)” printed on the outer disk in brown. Each patch is contained in a square, notched pouch with printed paper on both sides. The pouch is imprinted with the lot number and expiration date. NDC 0378-3350-99 carton containing 4 transdermal systems The 0.06 mg/day is available as an 18.6 cm2 system containing estradiol, USP hemihydrate equivalent to 2.33 mg of estradiol for a nominal in vivo delivery of 0.06 mg of estradiol per day. Each patch consists of a round inner disk centered on a round peach color outer disk with “Estradiol 0.06 mg/day (Once-Weekly)” printed on the outer disk in brown. Each patch is contained in a square, notched pouch with printed paper on both sides. The pouch is imprinted with the lot number and expiration date. NDC 0378-3361-99 carton containing 4 transdermal systems The 0.075 mg/day is available as a 23.25 cm2 system containing estradiol, USP hemihydrate equivalent to 2.91 mg of estradiol for a nominal in vivo delivery of 0.075 mg of estradiol per day. Each patch consists of a round inner disk centered on a round peach color outer disk with “Estradiol 0.075 mg/day (Once-Weekly)” printed on the outer disk in brown. Each patch is contained in a square, notched pouch with printed paper on both sides. The pouch is imprinted with the lot number and expiration date. NDC 0378-3351-99 carton containing 4 transdermal systems The 0.1 mg/day is available as a 31 cm2 system containing estradiol, USP hemihydrate equivalent to 3.88 mg of estradiol for a nominal in vivo delivery of 0.1 mg of estradiol per day. Each patch consists of a round inner disk centered on a round peach color outer disk with “Estradiol 0.1 mg/day (Once-Weekly)” printed on the outer disk in brown. Each patch is contained in a square, notched pouch with printed paper on both sides. The pouch is imprinted with the lot number and expiration date. NDC 0378-3352-99 carton containing 4 transdermal systems Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not store unpouched. Apply immediately upon removal from the protective pouch. Used transdermal systems still contain active hormone. To discard, fold the sticky side of the transdermal system together, place it in a sturdy child-proof container, and place this container in the trash. Used transdermal systems should not be flushed in the toilet.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

ESTRADIOL- ESTRADIOL PATCH
MYLAN PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESTRADIOL
TRANSDERMAL SYSTEM CONTINUOUS DELIVERY (ONCE-WEEKLY) SAFELY AND
EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR ESTRADIOL TRANSDERMAL SYSTEM
CONTINUOUS DELIVERY
(ONCE-WEEKLY).
ESTRADIOL TRANSDERMAL SYSTEM CONTINUOUS DELIVERY (ONCE-WEEKLY)
INITIAL U.S. APPROVAL: 1975
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE
DEMENTIA, AND BREAST CANCER
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ESTROGEN-ALONE THERAPY
•
•
•
•
ESTROGEN PLUS PROGESTIN THERAPY
•
•
•
•
•
RECENT MAJOR CHANGES
Boxed Warning 09/2021
INDICATIONS AND USAGE
Estradiol transdermal system continuous delivery (once-weekly) is an
estrogen indicated for:
•
•
•
•
DOSAGE AND ADMINISTRATION
•
THERE IS AN INCREASED RISK OF ENDOMETRIAL CANCER IN A WOMAN WITH A
UTERUS WHO
USES UNOPPOSED ESTROGENS (5.2)
THE WOMEN’S HEALTH INITIATIVE (WHI) ESTROGEN-ALONE SUBSTUDY REPORTED
INCREASED
RISKS OF STROKE AND DEEP VEIN THROMBOSIS (DVT) (5.1)
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 (5.3)
DO NOT USE ESTROGEN-ALONE THERAPY FOR THE PREVENTION OF CARDIOVASCULAR
DISEASE OR
DEMENTIA (5.1, 5.3)
THE WHI ESTROGEN PLUS PROGESTIN SUBSTUDY REPORTED INCREASED RISKS OF
STROKE, DVT,
PULMONARY EMBOLISM (PE), AND MYOCARDIAL INFARCTION (MI) (5.1)
THE WHI ESTROGEN PLUS PROGESTIN SUBSTUDY REPORTED INCREASED RISKS OF
INVASIVE
BREAST CANCER (5.2)
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 (5.3)
DO NOT USE ESTROGEN PLUS PROGESTOGEN THERAPY FOR THE PREVENTION OF
CARDIOVASCULAR DISEASE OR DEMENTIA (5.1, 5.3)
Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
(1.1)
Treatment of Moderate to Severe Symptoms of