"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.
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DOSAGE AND ADMINISTRATION
When estrogen is prescribed for a postmenopausal woman with a uterus, progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need 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. Patients should be re-evaluated periodically as clinically appropriate (e.g., at 3-month to 6-month intervals) to determine if treatment is still necessary (see BOXED WARNINGS and WARNINGS). For women with a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
For the treatment of moderate to severe vasomotor symptoms associated with the menopause, the single approved dose of Estrasorb is 3,48 grams daily. The lowest effective dose of Estrasorb for this indication has not been determined. (See BOXED WARNINGS and WARNINGS.)
Instructions lor daily application of two 1.74-gram (oil-laminated pouches
1. Estrasorb should be applied in a comfortable sitting position to clean, dry skin on both legs each morning. Each foil-laminated pouch of Estrasorb should be opened individually.
2. Cut or tear the first foil-laminated pouch at the notches indicated near the top of the pouch.
3. Apply the emulsion in the pouch to the top of the left thigh, being careful to push the entire contents from the bottom through the neck of the pouch.
4. Using one hand or both hands rub the emulsion into the entire left thigh and left calf for three minutes or until thoroughly absorbed. Rub any excess material remaining on both hands on the buttocks.
5. Cut or tear the second foil-laminated pouch at the notches indicated near the top of the pouch. Apply the emulsion in the pouch to the top of the right thigh, being careful to push the entire contents from the bottom through the neck of the pouch. Using one hand or both hands rub the emulsion into the entire right thigh and right calf for three minutes until thoroughly absorbed. Rub any excess material remaining on both hands on the buttocks. Estrasorb absorption was not studied on other parts of the body.
6. Allow the application areas to dry completely before covering with clothing to avoid transfer to other individuals.
7. On completion of Estrasorb application, both hands should be washed with soap and water to remove any residual estradiol.
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, packaged in a 1-month supply carton of 56 pouches. NDC 15456-325-56
Store at 20-25°C (68-77°F); excursions permitted to 15-3°C (59-86°F) [see USP Controlled Room Temperature]
Distributed by: Graceway Pharmaceuticals, LLC, Bristol, TN 37620. Issued-March 2008
Last reviewed on RxList: 7/22/2011
This monograph has been modified to include the generic and brand name in many instances.
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