Drug Catalog - Product Detail
ESTRADIOL VAGINAL TABLETS TB 10MCG 18
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 65162-0226-23 | AMNEAL PHARMACEUTICALS | 18 | 10MCG | TABLET |
PACKAGE FILES
Generic Name
ESTRADIOL
Substance Name
ESTRADIOL
Product Type
HUMAN PRESCRIPTION DRUG
Route
VAGINAL
Application Number
ANDA205256
Description
11 DESCRIPTION Yuvafem (estradiol vaginal inserts, USP), 10 mcg, are small, white, film-coated inserts containing 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol, USP. Each insert of Yuvafem, 10 mcg contains the following excipients: corn starch, hypromellose, lactose monohydrate and magnesium stearate. The film coating contains hypromellose and polyethylene glycol. Each Yuvafem vaginal insert is 6 mm in diameter and is placed in a disposable applicator. Each insert-filled applicator is packaged separately in a blister pack. Yuvafem are used intravaginally. When the insert comes in contact with the vaginal mucosa, estradiol, USP is released into the vagina. Estradiol hemihydrate is a white, almost white or colorless crystalline solid, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The chemical formula is C 18 H 24 O 2 • ½ H 2 O with a molecular weight of 281.4. The structural formula is: formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Yuvafem, 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 Yuvafem, 10 mcg , is contained in a disposable, single-use applicator, packaged in a blister pack. Cartons contain 8 or 18 applicators with inset inserts. Yuvafem, 10 mcg 8 applicators: NDC 65162-226-21 18 applicators: NDC 65162-226-23 Keep out of reach of children. 16.2 Storage and Handling 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.
Indications & Usage
1 INDICATIONS AND USAGE Yuvafem is an estrogen (estradiol) indicated for the treatment of atrophic vaginitis due to menopause ( 1.1 ) 1.1 Treatment of Atrophic Vaginitis due to Menopause
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, consider addition of a progestogen to reduce the risk of endometrial cancer. Generally, a woman without a uterus does not need to use a progestogen in addition to her estrogen therapy. In some cases, however, hysterectomized women with a history of endometriosis may need a progestogen [see Warnings and Precautions (5.3 , 5.15) ] . Use of estrogen-alone, or in combination with a progestogen, at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Reevaluate postmenopausal women periodically as clinically appropriate to determine if treatment is still necessary. Administer Yuvafem intravaginally: 1 insert daily for 2 weeks, followed by 1 insert twice weekly (for example, Tuesday and Friday) (2.1) 2.1 Treatment of Atrophic Vaginitis due to Menopause Administer Yuvafem intravaginally using the supplied applicator: 1 insert daily for 2 weeks, followed by 1 insert twice weekly (for example, Tuesday and Friday).