"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.
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. (See Boxed Warnings and WARNINGS.)
Two doses of Femring (estradiol acetate) are available, 0.05 mg/day and 0.10 mg/day, for the treatment of moderate to severe vasomotor symptoms and/or vulvar and vaginal atrophy due to menopause.
Patients should be started at the lowest dose. The lowest effective dose of Femring (estradiol acetate) has not been determined.
Instructions for Use
Hands should be thoroughly washed before and after ring insertion.
Femring (estradiol acetate) Insertion
Insert upon removal from the protective pouch.
The opposite sides of the vaginal ring should be pressed together and inserted into the vagina. The exact position is not critical to its function. When Femring (estradiol acetate) is in place, the patient should not feel anything. If the patient feels discomfort, the vaginal ring is probably not far enough inside the vagina. Gently push Femring (estradiol acetate) further into the vagina.
Femring (estradiol acetate) Use
Femring (estradiol acetate) should remain in place for 3 months and then be replaced by a new Femring (estradiol acetate) .
The patient should not feel Femring (estradiol acetate) when it is in place and it should not interfere with sexual intercourse. Straining upon bowel movement may make Femring (estradiol acetate) move down in the lower part of the vagina. If so, it may be repositioned with a finger.
If Femring (estradiol acetate) is expelled totally from the vagina, it should be rinsed in lukewarm water and reinserted by the patient (or healthcare provider if necessary).
Femring (estradiol acetate) Removal
Femring (estradiol acetate) may be removed by looping a finger through the ring and pulling it out.
For patient instructions, see PATIENT INFORMATION
Each Femring® (estradiol acetate) (estradiol acetate vaginal ring) is individually packaged in a pouch consisting of one side medical grade paper and the other side polyester/polyethylene laminate.
NDC 0430-6201-40 Femring® 0.05 mg/day (estradiol acetate vaginal ring) is available in single units.
NDC 0430-6202-40 Femring® 0.10 mg/day (estradiol acetate vaginal ring) is available in single units.
Store at 25° C (77° F); excursions permitted to 15° - 30° C (59° - 86° F) [see USP Controlled Room Temperature].
Manufactured by: Warner Chilcott UK, Ltd., Larne, Northern Ireland, UK Marketed by: Warner Chilcott (US), LLC, Rockaway, NJ 07866. 1-800-521-8813. REVISED May 2009
Last reviewed on RxList: 6/15/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Femring Information
Femring - User Reviews
Femring User Reviews
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