ESTRADIOL patch

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Mylan Pharmaceuticals Inc.

INN (International Adı):

ESTRADIOL

Kompozisyon:

ESTRADIOL 0.025 mg in 1 d

Uygulama yolu:

TRANSDERMAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Estradiol transdermal system (twice-weekly) is indicated for:       When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, 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 (twice-weekly) is contraindicated in women with any of the following conditions: Estradiol transdermal system (twice-weekly) is not indicated for use in pregnancy. There are no data with the use of estradiol transdermal system (twice-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 hormonal contraceptives (estrogen and progestins) before conception or during early pregna

Ürün özeti:

Estradiol Transdermal System, USP (Twice-Weekly) is available as 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day or 0.1 mg/day of estradiol. Each strength is supplied in a Patient Calendar Pack containing 8 individually packaged systems. The 0.025 mg per day is available as a 2.5 cm2 system containing estradiol, USP hemihydrate equivalent to 0.41 mg of estradiol, for nominal* delivery of 0.025 mg of estradiol per day. Each rectangular patch with rounded corners consists of an opaque, white to cream adhesive layer, matte film backing randomly printed with “Estradiol 0.025 mg/day” in brown ink, and a clear release liner. The patch is contained in a square, flat, notched, pouch. The pouch is imprinted with the lot number and expiration date. They are available as follows: NDC 0378-4644-26 carton containing 8 systems The 0.0375 mg per day is available as a 3.75 cm2 system containing estradiol, USP hemihydrate equivalent to 0.62 mg of estradiol for nominal* delivery of 0.0375 mg of estradiol per day. Each rectangular patch with rounded corners consists of an opaque, white to cream adhesive layer, matte film backing randomly printed with “Estradiol 0.0375 mg/day” in brown ink, and a clear release liner. The patch is contained in a square, flat, notched, pouch. The pouch is imprinted with the lot number and expiration date. They are available as follows: NDC 0378-4643-26 carton containing 8 systems The 0.05 mg per day is available as a 5.0 cm2 system containing estradiol, USP hemihydrate equivalent to 0.82 mg of estradiol for nominal* delivery of 0.05 mg of estradiol per day. Each rectangular patch with rounded corners consists of an opaque, white to cream adhesive layer, matte film backing randomly printed with “Estradiol 0.05 mg/day” in brown ink, and a clear release liner. The patch is contained in a square, flat, notched, pouch. The pouch is imprinted with the lot number and expiration date. They are available as follows: NDC 0378-4642-26 carton containing 8 systems The 0.075 mg per day is available as a 7.5 cm2 system containing estradiol, USP hemihydrate equivalent to 1.23 mg of estradiol for nominal* delivery of 0.075 mg of estradiol per day. Each rectangular patch with rounded corners consists of an opaque, white to cream adhesive layer, matte film backing randomly printed with “Estradiol 0.075 mg/day” in brown ink, and a clear release liner. The patch is contained in a square, flat, notched, pouch. The pouch is imprinted with the lot number and expiration date. They are available as follows: NDC 0378-4641-26 carton containing 8 systems The 0.1 mg per day is available as a 10.0 cm2 system containing estradiol, USP hemihydrate equivalent to 1.64 mg of estradiol for nominal* delivery of 0.1 mg of estradiol per day. Each rectangular patch with rounded corners consists of an opaque, white to cream adhesive layer, matte film backing randomly printed with “Estradiol 0.1 mg/day” in brown ink, and a clear release liner. The patch is contained in a square, flat, notched, pouch. The pouch is imprinted with the lot number and expiration date. They are available as follows: NDC 0378-4640-26 carton containing 8 systems [*see DESCRIPTION (11)] 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.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

ESTRADIOL- ESTRADIOL PATCH
MYLAN PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESTRADIOL
TRANSDERMAL SYSTEM (TWICE-WEEKLY) SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR ESTRADIOL TRANSDERMAL SYSTEM (TWICE-WEEKLY).
ESTRADIOL TRANSDERMAL SYSTEM (TWICE-WEEKLY)
INITIAL U.S. APPROVAL: 1996
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 10/2021
INDICATIONS AND USAGE
Estradiol transdermal system (twice-weekly) is an estrogen indicated
for:
•
•
Limitations of Use: When prescribing solely for the treatment of
moderate to severe vaginal atrophy, first
consider the use of topical vaginal products.
•
•
Limitations of Use: 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.
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 DEVELOPING 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
DVT,
PULMONARY EMBOLISM (PE), STROKE 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