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Vagifem (Estradiol Vaginal) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Treatment of Atrophic Vaginitis due to Menopause

DOSAGE AND ADMINISTRATION

General Dosing Information

Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer.

A woman without a uterus does not need a progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin [see Warnings and Precautions , 5.15) ].

Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.

Recommended Dosing

Vagifem should be administered intravaginally using the supplied applicator: 1 tablet daily for 2 weeks, followed by 1 tablet twice weekly (for example, Tuesday and Friday). Generally, women should be started at the 10 mcg dosage strength.

DOSAGE FORMS AND STRENGTHS

Vagifem is a small, white, round, film-coated, bi-convex vaginal tablet containing 10 mcg or 25 mcg of estradiol. Each vaginal tablet is 6 mm in diameter and is administered in a disposable applicator.

HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Each Vagifem (estradiol vaginal tablets), 10 mcg is contained in a disposable, single-use applicator, packaged in a blister pack. Cartons contain 8 or 18 applicators with inset tablets.

Vagifem 10 mcg

8 applicators: NDC 54868-6182-0

Keep out of reach of children

Storage and Handling

Store at 25ºC (77ºF), excursions permitted to 15ºC-30ºC (59ºF-86ºF). Do not refrigerate.

[See USP Controlled Room Temperature.]

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