"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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OGEN (estropipate) is indicated in the:
- Treatment of moderate to severe vasomotor symptoms associated with the menopause.
- Treatment of moderate to severe symptoms of vulval and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
- Treatment of hypoestrogen (estropipate) ism due to hypogonadism, castration or primary ovarian failure.
- Prevention of postmenopausal osteoporosis. When
prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant
risk of osteoporosis and for whom non-estrogen (estropipate) medications are not considered to be appropriate.
The mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400–800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
DOSAGE AND ADMINISTRATION
When estrogen (estropipate) is prescribed for a 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 (estropipate) , 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. Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (See BOXED WARNINGS and WARNINGS.) For women who have 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 treatment of moderate to severe vasomotor symptoms,
vulval and vaginal atrophy associated with the menopause, the lowest dose and regimen that will control symptoms should be chosen
and medication should be discontinued as promptly as possible. Attempts to discontinue or taper medication should be made
at 3month to 6-month intervals. Usual dosage ranges:
Vasomotor symptoms—One OGEN .625 (0.75 mg estropipate) tablet to two OGEN 2.5 (3 mg estropipate) tablets per day. The lowest dose that will control symptoms should be chosen. If the patient has not menstruated within the last two months or more, cyclic administration is started arbitrarily. If the patient is menstruating, cyclic administration is started on day 5 of bleeding.
Vulval and vaginal atrophy—One OGEN .625 (0.75 mg estropipate) tablet to two OGEN 2.5 (3 mg estropipate) tablets daily, depending upon the tissue response of the individual patient. The lowest dose that will control symptoms should be chosen. Administer cyclically.
- For treatment of female hypoestrogen (estropipate) ism due to
hypogonadism, castration, or primary ovarian failure. Usual dosage ranges: Female hypogonadism—A daily dose of one OGEN 1.25 (1.5 mg
estropipate) tablet to three OGEN 2.5 (3 mg estropipate) tablets may be given for the first three weeks of a
theoretical cycle, followed by a rest period of eight to ten days. The lowest
dose that will control symptoms should be chosen. If bleeding
does not occur by the end of this period, the same dosage schedule is repeated. The number of courses of estrogen (estropipate) therapy
necessary to produce bleeding may vary depending on the responsiveness of the endometrium. If satisfactory withdrawal bleeding does
not occur, an oral progestogen (estropipate) may be given in addition to estrogen (estropipate) during the third week of the cycle.
Female castration or primary ovarian failure—A daily dose of one OGEN 1.25 (1.5 mg estropipate) tablet to three OGEN 2.5 (3 mg estropipate) tablets may be given for the first three weeks of a theoretical cycle, followed by a rest period of eight to ten days. Adjust dosage upward or downward according to severity of symptoms and response of the patient. For maintenance, adjust dosage to lowest level that will provide effective control.
Treated patients with an intact uterus should be monitored closely for signs of endometrial cancer and appropriate diagnostic measures should be taken to rule out malignancy in the event of persistent or recurring abnormal vaginal bleeding.
- For prevention of osteoporosis. A daily dose of one OGEN .625 (0.75 mg estropipate) tablet for 25 days of a 31-day cycle per month.
OGEN (estropipate tablets, USP) is supplied as OGEN .625 (0.75 mg estropipate; calculated as sodium estrone sulfate 0.625 mg), yellow, scored tablets, imprinted U 3772, NDC 0009-3772-01; OGEN 1.25 (1.5 mg estropipate; calculated as sodium estrone sulfate 1.25 mg), peach-colored, scored tablets, imprinted U 3773, NDC 0009-3773-01; and OGEN 2.5 (3 mg estropipate; calculated as sodium estrone sulfate 2.5 mg), blue, scored tablets, imprinted U 3774, NDC 0009-3774-01. Tablets of all three dosage levels are standardized to provide uniform estrone activity and are scored to provide dosage flexibility. All tablet sizes of OGEN (estropipate) are available in bottles of 100.
Recommended storage: Store below 77°F (25°C)
Distributed by : Pharmacia & Upjohn Company, Division of Pfizer Inc, NY, NY 10017. July 2006.
Last reviewed on RxList: 4/30/2009
This monograph has been modified to include the generic and brand name in many instances.
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