ESTRADIOL TRANSDERMAL SYSTEM- estradiol patch

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Alvogen, Inc.

INN (Nome Internazionale):

ESTRADIOL

Composizione:

ESTRADIOL 0.025 mg in 1 d

Via di somministrazione:

TRANSDERMAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

    When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered.     When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered. The Estradiol Transdermal System is contraindicated in women with any of the following conditions: The Estradiol Transdermal System should not be used during pregnancy [see Contraindications (4)] . There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as oral contraceptives inadvertently during early pregnancy. The Estradiol Transdermal System should not be used during lactation. Estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. Detectable amounts of estrogens have been identified in the b

Dettagli prodotto:

Store at 20°C to 25°C (66°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Do not store above 86°F (30°C). 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.

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

ESTRADIOL TRANSDERMAL SYSTEM- ESTRADIOL PATCH
ALVOGEN, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE THE
ESTRADIOL TRANSDERMAL SYSTEM
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR THE
ESTRADIOL TRANSDERMAL SYSTEM.
ESTRADIOL TRANSDERMAL SYSTEM (ESTRADIOL TRANSDERMAL SYSTEM)
INITIAL U.S. APPROVAL: 1975
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER
AND
PROBABLE DEMENTIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
•
Estrogen Plus Progestin Therapy
•
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions, Malignant Neoplasms (5.2) 8/2017
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
Estrogen-Alone Therapy
There is an increased risk of endometrial cancer in a woman with a
uterus who uses unopposed estrogens (5.2)
Estrogen-alone therapy should not be used for the prevention of
cardiovascular disease or dementia (5.1, 5.3)
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)
ESTROGEN PLUS PROGESTIN THERAPY SHOULD NOT BE USED 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)
• Start therapy with the Estradiol Transdermal System 0.025 mg per
day applied to the skin once-weekly. Dosage
adjustment should be guided by the clinical response ( 2.1 )
• The Estradiol Transdermal System should b