ESTRADIOL patch, extended release

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Sandoz Inc

INN (International ime):

ESTRADIOL

Sastav:

ESTRADIOL 0.025 mg in 1 d

Administracija rute:

TRANSDERMAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Estradiol transdermal system is indicated for:   Limitations of Use: When prescribing solely for the treatment of moderate to severe symptoms of vulvar and 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. Estradiol transdermal system is contraindicated in women with any of the following conditions: 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 (estrogen 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. 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 maturation 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 Warnings and Precautions (5.1), and 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 [seeWarnings and Precautions (5.1), and 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)].

Proizvod sažetak:

Estradiol transdermal system, 0.025 mg per day – each 2.5 cm2 system contains 0.39 mg of estradiol USP for nominal* delivery of 0.025 mg of estradiol per day. Patient Calendar Pack of 8 Systems.........................................................................NDC 0781-7129-83 Package of 24 Systems (3 Patient Calendar Packs of 8 Systems)............................ NDC 0781-7129-40 Estradiol transdermal system, 0.0375 mg per day – each 3.75 cm2 system contains 0.585 mg of estradiol USP for nominal* delivery of 0.0375 mg of estradiol per day. Patient Calendar Pack of 8 Systems......................................................................... NDC 0781-7138-83 Package of 24 Systems (3 Patient Calendar Packs of 8 Systems)............................ NDC 0781-7138-40 Estradiol transdermal system, 0.05 mg per day – each 5.0 cm2 system contains 0.78 mg of estradiol USP for nominal* delivery of 0.05 mg of estradiol per day. Patient Calendar Pack of 8 Systems......................................................................... NDC 0781-7144-83 Package of 24 Systems (3 Patient Calendar Packs of 8 Systems)............................ NDC 0781-7144-40 Estradiol transdermal system, 0.075 mg per day – each 7.5 cm2 system contains 1.17 mg of estradiol USP for nominal* delivery of 0.075 mg of estradiol per day. Patient Calendar Pack of 8 Systems......................................................................... NDC 0781-7156-83 Package of 24 Systems (3 Patient Calendar Packs of 8 Systems)............................ NDC 0781-7156-40 Estradiol transdermal system, 0.1 mg per day – each 10.0 cm2 system contains 1.56 mg of estradiol USP for nominal* delivery of 0.1 mg of estradiol per day. Patient Calendar Pack of 8 Systems......................................................................... NDC 0781-7167-83 Package of 24 Systems (3 Patient Calendar Packs of 8 Systems)............................ NDC 0781-7167-40 [*see DESCRIPTION (11)] Store at 20 to 25°C (68 to 77°F). Excursions permitted to 15 to 30°C (59 to 86°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 autorizacije:

New Drug Application Authorized Generic

Svojstava lijeka

ESTRADIOL- ESTRADIOL PATCH, EXTENDED RELEASE
SANDOZ INC
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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: 1996
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE
DEMENTIA, AND BREAST CANCER
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ESTROGEN-ALONE THERAPY
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ESTROGEN PLUS PROGESTIN THERAPY
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RECENT MAJOR CHANGES
Warnings and Precautions, Malignant Neoplasms (5.2) 11/2023
INDICATIONS AND USAGE
Estradiol transdermal system is an estrogen indicated for:
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DOSAGE AND ADMINISTRATION
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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 OF DEVELOPING 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 vulvar and vaginal atrophy
due to menopause (1.2)
Limitations of Use
When presc