"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
For topical use only. ESTRASORB is not for ophthalmic, oral, or intravaginal use. ESTRASORB should not be applied to the face or breasts.
Generally, when estrogen therapy 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 women. Postmenopausal women should be re-evaluated periodically as clinically appropriate.
Treatment Of Moderate To Severe Vasomotor Symptoms Due To Menopause
The single approved dose of ESTRASORB is 3.48 grams daily. Apply one pouch (1.74 grams) to the left thigh and calf and one pouch (1.74 grams) to the right thigh and calf each morning. Attempts to taper or discontinue the medication should be made at 3 to 6 month intervals.
The lowest effective dose of ESTRASORB for this indication has not been determined.
Dosage Forms And Strengths
Each gram of ESTRASORB contains 2.5 mg of estradiol hemihydrate. Each pouch contains 1.74 grams of ESTRASORB.
ESTRASORB (estradiol topical emulsion), nominal 0.05 mg/day: ESTRASORB is packaged in foil-laminated pouches. A daily dose of ESTRASORB is two foil-laminated pouches.
Each pouch contains 1.74-grams. Each 1.74-gram, foil-laminated pouch contains 4.35 mg of estradiol hemihydrate USP, EP. Each box of ESTRASORB contains fourteen 1.74-gram, foil-laminated pouches.
1-month supply carton of 56 pouches, NDC 99207-190-56
Storage And Handling
Store at 20-25°C (68-77°F); excursions permitted to 15-40°C (59-104°F).
Manufactured for: Medicis Pharmaceuticals, A Division of Valeant Pharmaceuticals North America Bridgewater, NJ 08807. Manufactured by: Ei Inc. Kannapolis, NC 28083 Estrasorb is a registered trademark of Medicis Pharmaceutical Corporation. Revised: March 2015
Last reviewed on RxList: 3/23/2015
This monograph has been modified to include the generic and brand name in many instances.
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