ESTRADIOL patch

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Zydus Pharmaceuticals USA Inc.

Manustamisviis:

TRANSDERMAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Estradiol Transdermal System is indicated for: Limitation of Use 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. Limitation 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. Estradiol Transdermal System is contraindicated in women with any of the following conditions: - Undiagnosed abnormal genital bleeding [see Warnings and Precautions (5.2)] - Breast cancer or history of breast cancer [see Warnings and Precautions (5.2)] - Estrogen-dependent neoplasia [see Warnings and Precautions (5.2)] - Active DVT, PE, or a history of these conditions [see Warnings and Precautions (5.1)] - Active arterial thromboembolic disease (for example, stroke or MI), or a history of these conditions [see Warnings and Precautions (5.1)] - Known anaphylactic reaction, or angioedema, or hypersensitivity to Estradiol Transdermal System - Hepatic impairment or disease - Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders Risk Summary Estradiol Transdermal System is not indicated for use in pregnancy. There are no data with the use of Estradiol Transdermal System 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 20%, respectively. Risk Summary Estrogens are present in human milk and can reduce milk production in breast-feeding women. This reduction can occur at any time but is less likely to occur once breast-feeding is well-established. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Estradiol Transdermal System and any potential adverse effects on the breastfed child from Estradiol Transdermal System or from the underlying maternal condition. In general, Estradiol Transdermal System is not indicated for use in pediatric patients. Clinical studies have not been conducted in the pediatric population. If estrogen is administered to patients whose bone growth is not complete, periodic monitoring of bone metabolism and effects on epiphyseal centers is recommended during estrogen administration. There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Estradiol Transdermal System to determine whether those over 65 years of age differ from younger subjects in their response to Estradiol Transdermal System. The Women's Health Initiative Studies In the WHI estrogen-alone substudy (daily CE [0.625 mg]-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see Clinical Studies (14.3)] . In the WHI estrogen plus progestin substudy (daily CE [0.625 mg] plus MPA [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see Clinical Studies (14.3)] . The Women's Health Initiative Memory Study In the WHIMS ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen-alone or estrogen plus progestin when compared to placebo [see Warnings and Precautions (5.3), and Clinical Studies (14.4)] . Since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women8 [see Warnings and Precautions (5.3), and Clinical Studies (14.4)] .

Toote kokkuvõte:

Estradiol Transdermal System, USP, 0.025 mg / day — each 7.5 cm2 system contains 1.888 mg of estradiol USP Individual Carton of 4 systems………………NDC 68382-324-04 Estradiol Transdermal System, USP, 0.0375 mg / day — each 11.25 cm2 system contains 2.832 mg of estradiol USP Individual Carton of 4 systems………………NDC 68382-325-04 Estradiol Transdermal System, USP, 0.05 mg / day — each 15 cm2 system contains 3.777 mg of estradiol USP Individual Carton of 4 systems………………NDC 68382-326-04 Estradiol Transdermal System, USP, 0.06 mg / day — each 18 cm2 system contains 4.532 mg of estradiol USP Individual Carton of 4 systems………………NDC 68382-327-04 Estradiol Transdermal System, USP, 0.075 mg / day — each 22.5 cm2 system contains 5.665 mg of estradiol USP Individual Carton of 4 systems………………NDC 68382-328-04 Estradiol Transdermal System, USP, 0.1 mg / day — each 30 cm2 system contains 7.553 mg of estradiol USP Individual Carton of 4 systems………………NDC 68382-329-04 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP for Controlled Room Temperature]. Do not store unpouched. Do not store above 86°F (30°C). 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.

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

ESTRADIOL- ESTRADIOL PATCH
Zydus Pharmaceuticals USA Inc.
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PATIENT INFORMATION
Estradiol Transdermal System, USP
(es" tra dye' ol)
Rx only
Read this Patient Information before you start using Estradiol
Transdermal System and each time you get
a refill. There may be new information. This information does not take
the place of talking to your
healthcare provider about your menopausal symptoms or your treatment.
What is the most important information I should know about Estradiol
Transdermal System (an estrogen
hormone)?
• Using estrogen-alone may increase your chance of getting cancer of
the uterus (womb).
• Report any unusual vaginal bleeding right away while you are using
Estradiol Transdermal System.
Vaginal bleeding after menopause may be a warning sign of cancer of
the uterus (womb). Your
healthcare provider should check any unusual vaginal bleeding to find
out the cause.
• Do not use estrogen-alone to prevent heart disease, heart attacks,
strokes, or dementia (decline in brain
function).
• Using estrogen-alone may increase your chances of getting strokes
or blood clots.
• Using estrogen-alone may increase your chance of getting dementia,
based on a study of women age
65 years of age and older.
• Do not use estrogens with progestogens to prevent heart disease,
heart attacks, strokes or dementia.
• Using estrogens with progestogens may increase your chances of
getting heart attacks, strokes, breast
cancer, or blood clots.
• Using estrogens with progestogens may increase your chance of
getting dementia, based on a study of
women age 65 years of age and older.
• Only one estrogen-alone product and dose have been shown to
increase your chances of getting
strokes, blood clots, and dementia. Only one estrogen with progestogen
product and dose have been
shown to increase your chances of getting heart attacks, strokes,
breast cancer, blood clots, and dementia.
Because other products and doses have not been studied in the same
way, it is not known how the use of
Estradiol Transdermal System

Toote omadused

ESTRADIOL- ESTRADIOL PATCH
ZYDUS PHARMACEUTICALS USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESTRADIOL
TRANSDERMAL SYSTEM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
ESTRADIOL TRANSDERMAL SYSTEM.
ESTRADIOL TRANSDERMAL SYSTEM
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
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)
ESTROGEN PLUS PROGESTIN THERAPY
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)
RECENT MAJOR CHANGES
Warnings and Precautions (5.2)
12/2023
INDICATIONS AND USAGE
Estradiol Transdermal System, USP is an estrogen indicated for:
Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
(1.1)
Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy
due to Menopause (1.2)
Limitations of Use
When prescribing solely for the treatment of moderate to severe
symptoms of vulvar and vaginal atrophy
due to menopause, first