ESTRADIOL- estradiol gel 0.1% gel

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Xiromed, LLC

Toedieningsweg:

TOPICAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Estradiol gel 0.1% 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 history of these conditions [see Warnings and Precautions (5.1)] - Active arterial thromboembolic disease (e.g, stroke and MI), or a history of these conditions [see Warnings and Precautions (5.1)] - Known anaphylactic reaction, angioedema, or hypersensitivity to estradiol gel 0.1% - Hepatic impairment or disease - Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders Risk Summary Estradiol gel 0.1% is not indicated for use in pregnant women. There are no data with the use of estradiol gel 0.1% 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. Animal studies to evaluate embryo/fetal toxicity were not conducted with estradiol gel, 0.1%. 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 gel 0.1% and any potential adverse effects on the breastfed child from estradiol gel 0.1% or from the underlying maternal condition. Estradiol gel 0.1% is not indicated for use in pediatric patients. Clinical studies have not been conducted in the pediatric population. There have not been sufficient numbers of geriatric women involved in studies utilizing estradiol gel 0.1% to determine whether those over 65 years of age differ from younger subjects in their response to estradiol gel 0.1%. 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  (14.2)] . 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  (14.2)]. 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  (14.3)]. Since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women 8 [see Warnings and Precautions  (5.3), and Clinical Studies  (14.3)] .

Product samenvatting:

Estradiol gel 0.1% is a clear, colorless, smooth, opalescent gel supplied in single-dose foil packets of 0.25, 0.5, 0.75, 1.0 and 1.25 grams, corresponding to 0.25, 0.5, 0.75, 1.0 and 1.25 mg estradiol, respectively. NDC 70700-143-35, carton of 30 packets, 0.25 mg estradiol per single-dose foil packet NDC 70700-144-35, carton of 30 packets, 0.5 mg estradiol per single-dose foil packet NDC 70700-194-35, cartons of 30 packets, 0.75 mg estradiol per single-dose foil packet NDC 70700-145-35, carton of 30 packets, 1.0 mg estradiol per single-dose foil packet NDC 70700-195-35, cartons of 30 packets, 1.25 mg estradiol per single-dose foil packet Keep out of the reach of children. 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.]

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

ESTRADIOL- ESTRADIOL GEL 0.1% GEL
XIROMED, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESTRADIOL GEL 0.1% SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ESTRADIOL GEL
0.1%.
ESTRADIOL GEL, FOR TOPICAL USE
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)
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
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 STUDY 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)
RECENT MAJOR CHANGES
Boxed
Warning.........................................................................................12/2019
INDICATIONS AND USAGE
Estradiol gel 0.1% is an estrogen indicated for the treatment of
moderate to severe vasomotor symptoms
due to menopause (1.1). (1)
DOSAGE AND ADMINISTRATION
Daily administration of 0.25 to 1.25 grams of estradiol gel 0.1% to
the right or left upper thigh on
alternating days. Women should be started with the lowest