"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
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: 04/2012
Last reviewed on RxList: 5/3/2012
This monograph has been modified to include the generic and brand name in many instances.
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