May 25, 2017
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"A new study finds that women who experience frequent hot flashes in younger midlife (age 40 - 53 years) may be more likely to have poor vascular function regardless of cardiovascular disease (CVD) risk factors or estradiol levels. These findings "...



How Supplied


Treatment Of Atrophic Vaginitis Due To Menopause


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].

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.

Treatment Of Atrophic Vaginitis Due To Menopause

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.

Each Vagifem (estradiol vaginal inserts), 10 mcg and 25 mcg, is contained in a disposable, single-use applicator, packaged in a blister pack. Cartons contain 8 or 18 applicators with inset tablets.

Vagifem 25 mcg

8 applicators: NDC 0169-5173-03
18 applicators: NDC 0169-5173-04

Vagifem 10 mcg

8 applicators: NDC 0169-5176-03
18 applicators: NDC 0169-5176-04

Keep out of reach of children

Storage And Handling

Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Do not refrigerate. [See USP Controlled Room Temperature.]

Manufactured by: Novo Nordisk A/S, 2880 Bagsvaerd, Denmark. Date of Issue: 7/2016, For information contact: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, USA, 1-888-824-4336. Revised: July 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 8/1/2016

How Supplied

Vagifem - User Reviews

Vagifem User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Vagifem sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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