ESTRADIOL patch

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Mylan Pharmaceuticals Inc.

Laluan pentadbiran:

TRANSDERMAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Estradiol transdermal system (twice-weekly) is indicated for:   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 (estrogens and progestins) before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to

Ringkasan produk:

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 0378-4619-26 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 0378-4620-26 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 0378-4621-26 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 0378-4622-26 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 0378-4623-26 carton containing 8 systems [*see DESCRIPTION] 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.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

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: 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 10/2021
INDICATIONS AND USAGE
Estradiol transdermal system (twice-weekly) is an estrogen indicated
for:
•
•
DOSAGE AND ADMINISTRATION
Start therapy with estradiol transdermal system (twice-weekly) 0.0375
mg per day applied to the skin twice
weekly for the treatment of moderate to severe vasomotor symptoms due
to menopause. Dosage
adjustment should be guided by the clinical response (2.1)
Start therapy with estradiol transdermal system (twice-weekly) 0.025
mg per day applied to the skin twice
weekly for the prevention of postmenopausal osteoporosis. The dose may
be adjusted as necessary (2.2)
Place estradiol transdermal system (twice-weekly) on a clean, dry area
on the lower abdomen (below the
umbilicus) or buttocks. Do not apply estradiol transdermal system
(twice-weekly) to the breasts (2.3)
DOSAGE FORMS AND STRENGTHS
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 PROGEST