ESTRADIOL VAGINAL INSERTS- estradiol tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Glenmark Pharmaceuticals Inc., USA

Podání:

VAGINAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

    ●Estradiol is contraindicated in women with any of the following conditions: ● Undiagnosed abnormal genital bleeding [see Warnings and Precautions (5.3)]. ● Breast cancer or a history of breast cancer [see Warnings and Precautions (5.3)]. ● Estrogen-dependent neoplasia [see Warnings and Precautions (5.3)]. ● Active DVT, PE, or history of these conditions [see Warnings and Precautions (5.2)]. ● Active arterial thromboembolic disease (for example, stroke or MI), or a history of these conditions [see Warnings and Precautions (5.2)]. ● Known anaphylactic reaction, or angioedema, or hypersensitivity to estradiol [see Warnings and Precautions (5.16)] . Hepatic impairment or disease. ● Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Risk Summary Estradiol vaginal inserts is not indicated for use in pregnancy. There are no data with the use of estradiol vaginal inserts 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 females. 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 vaginal inserts and any potential adverse effects on the breastfed child from estradiol or from the underlying maternal condition. Estradiol vaginal inserts are 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 clinical studies utilizing estradiol vaginal inserts to determine whether those over 65 years of age differ from younger subjects in their response to estradiol vaginal inserts. 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 (5.4), 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 women8  [see Warnings and Precautions (5.4), and Clinical Studies (14.3)].

Přehled produktů:

Estradiol vaginal inserts, USP 10 mcg are supplied as white to off-white, round, biconvex, film-coated insert debossed with ‘G’ on one side and ‘94’ on the other side. Estradiol vaginal inserts, USP 10 mcg are contained in a disposable, single-use applicator, packaged in a blister pack. Cartons contain 8 or 18 applicators with inset inserts. Estradiol Vaginal Inserts, USP 10 mcg 8 applicators:                                            NDC 68462-711-71 18 applicators:                                          NDC 68462-711-88 Keep out of reach of children. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not refrigerate.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

ESTRADIOL VAGINAL INSERTS- ESTRADIOL TABLET, FILM COATED
GLENMARK PHARMACEUTICALS INC., USA
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESTRADIOL VAGINAL
INSERTS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ESTRADIOL VAGINAL
INSERTS.
ESTRADIOL VAGINAL INSERTS
INITIAL U.S. APPROVAL: 1999
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 (5.3)
●THE WOMEN'S HEALTH INITIATIVE (WHI) ESTROGEN-ALONE SUBSTUDY
REPORTED INCREASED
RISKS OF STROKE AND DEEP VEIN THROMBOSIS (DVT) (5.2)
●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 (5.4)
●DO NOT USE ESTROGEN-ALONE THERAPY FOR THE PREVENTION OF
CARDIOVASCULAR DISEASE OR
DEMENTIA (5.2, 5.4)
ESTROGEN PLUS PROGESTIN THERAPY
●THE WHI ESTROGEN PLUS PROGESTIN SUBSTUDY REPORTED INCREASED RISKS
OF PULMONARY
EMBOLISM (PE), DVT,STROKE, AND MYOCARDIAL INFARCTION (MI) (5.2)
●THE WHI ESTROGEN PLUS PROGESTIN SUBSTUDY REPORTED INCREASED RISKS
OF INVASIVE
BREAST CANCER (5.3)
●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
(5.4)
●DO NOT USE ESTROGEN PLUS PROGESTOGEN THERAPY FOR THE PREVENTION OF
CARDIOVASCULAR
DISEASE OR DEMENTIA (5.2, 5.4)
RECENT MAJOR CHANGES
•
INDICATIONS AND USAGE
•
DOSAGE AND ADMINISTRATION
Administer estradiol vaginal inserts intravaginally:
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
●Undiagnosed abnormal genital bleeding (4,5.3)
● Breast cancer or a history of breast cancer (4, 5.3)
● Estrogen-dependent neoplasia (4, 5.3)
● Active DVT, PE, or history of these conditions (4, 5.2)
Warnings and Precau