ESTRADIOL insert

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals of New York LLC

INN (International Name):

ESTRADIOL

Composition:

ESTRADIOL 10 ug

Administration route:

VAGINAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Estradiol is contraindicated in women with any of the following conditions: - Undiagnosed abnormal genital bleeding [see Warnings and Precautions (5.3)] . - Breast cancer or 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 is not indicated for use in pregnancy. There are no data with the use of estradiol 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 and any potential adverse effects on the breastfed child from estradiol or from the underlying maternal condition. Estradiol 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 clinical studies utilizing estradiol to determine whether those over 65 years of age differ from younger subjects in their response to estradiol. 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) ] . Estradiol (ess-tra-DYE-ole) Vaginal Inserts Read this Instructions for Use before you start using estradiol vaginal inserts 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. How should I use estradiol vaginal inserts? - Estradiol vaginal insert is an insert for use only in the vagina. Do not take by mouth. - Wash and dry your hands well before handling estradiol vaginal insert. Step 1: Tear off 1 applicator. Step 2: Pull apart the plastic wrap and remove the applicator (see Figure A). If after opening the package you see that the estradiol vaginal insert has come out of the applicator but has not fallen out of the package, carefully put the insert back into the applicator for insertion. Figure A Step 3: Hold the applicator between your thumb and middle finger. Leave your index (pointer) finger free to press the applicator plunger (see Figure B). Figure B Step 4: Select the best position for vaginal insertion of estradiol vaginal inserts that is most comfortable for you. For insertion in the lying down position, see Figure C. For insertion in the standing position, see Figure D Figure C Figure D Step 5: Gently insert the end of the applicator into your vagina as far as it will comfortably go or until half of the applicator is inside your vagina, whichever is less. Do not use force. If the insert falls out of the applicator before insertion, throw away (dispose of) the insert and applicator. Get a new applicator. Step 6: While holding the applicator in place, gently press the applicator plunger with your index (pointer) finger until it stops, to release the insert into your vagina. The insert will dissolve. Step 7: Gently remove the applicator from your vagina and throw away (dispose of) after use. Insertion may be done at any time of the day. It is advisable to use the same time daily for all applications of estradiol vaginal inserts. If you have any questions, please ask your healthcare provider or pharmacist. How should I store estradiol vaginal inserts? - Store estradiol vaginal inserts at room temperature between 68ºF to 77ºF (20ºC to 25ºC). - Do not refrigerate. Keep estradiol vaginal inserts and all medicines out of the reach of children. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured by: Amneal Pharmaceuticals of New York, LLC Brookhaven, NY 11719 Rev. 01-2024-01

Product summary:

Estradiol vaginal inserts USP, 10 mcg , are supplied as white to off-white, round biconvex, film-coated unscored inserts debossed with “276” on obverse and “AN” on the reverse. Each estradiol vaginal insert USP, 10 mcg , is 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 53746-226-21 18 applicators:             NDC 53746-226-23 Keep out of reach of children. Store at 20º to 25ºC (68º to 77ºF), excursions permitted between 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Do not refrigerate.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ESTRADIOL- ESTRADIOL INSERT
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
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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).
INDICATIONS AND USAGE
Estradiol vaginal inserts are an estrogen indicated for the treatment
of atrophic vaginitis due to
menopause (1.1)
DOSAGE AND ADMINISTRATION
Administer estradiol vaginal inserts intravaginally:
1 insert daily for 2 weeks, followed by 1 insert twice weekly (for
example, Tuesday and Friday) (2.1)
DOSAGE FORMS AND STRENGTHS
Vaginal insert: One 10 mcg vaginal insert contains 10.3 mcg of
estradiol hemihydrate equivalent to 10
mcg of e