"The U.S. Food and Drug Administration today approved Brisdelle (paroxetine)to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause. Brisdelle, which contains the selective serotonin reuptake inhibitor paroxetine mes"...
DOSAGE AND ADMINISTRATION
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 tablets), 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.]
For information contact: Novo Nordisk Inc. 100 College Road West Princeton, NJ 08540, USA 1-888-824-4336 .Manufactured by: Novo Nordisk A/S 2880 Bagsvaerd, Denmark. Revised: 04/2012This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/3/2012
Additional Vagifem Information
Vagifem - User Reviews
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