"NEW YORK (Reuters Health) - The combination of conjugated estrogens with bazedoxifene (CE/BZA) significantly improves bone mineral density (BMD) and bone turnover, according to pooled results from the SMART-1 and SMART-5 trials.
DOSAGE AND ADMINISTRATION
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 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/1/2016
Additional Vagifem Information
Vagifem - User Reviews
Vagifem User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
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.
Find out what women really need.