"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.
Menest (estrogens) is indicated in the:
- Treatment of moderate to severe vasomotor symptoms associated with the menopause.
- Treatment of moderate to severe symptoms of vulvar 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.
- Female castration.
- Primary ovarian failure.
- Breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.
- Prostatic carcinoma - palliative therapy of advanced disease.
DOSAGE AND ADMINISTRATION
When estrogen is prescribed for a postmenopausal woman with a uterus, a 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 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.
Patients should be started at the lowest dose.
1. Given cyclically for short term use only:
For treatment of moderate to severe vasomotor symptoms, or moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause.
Administration should be cyclic (e.g.,3 weeks on and 1 week off).
USUAL DOSAGE RANGES:
Vasomotor symptoms – 1.25 mg daily.If the patient has not menstruated within the last 2 months or more,cyclic administration is started arbitrarily.If the patient is menstruating,cyclic administration is started on day 5 of bleeding.
Moderate to severe symptoms of vulvar and vaginal atrophy – 0.3 mg to 1.25 mg or more daily, depending upon the tissue response of the individual patient.Administer cyclically.
2. Given cyclically: Female hypogonadism; female castration; primary ovarian failure.
USUAL DOSAGE RANGES:
Female hypogonadism – 2.5 to 7.5 mg daily,in divided doses for 20 days, followed by a rest period of 10 days' duration. If bleeding does not occur by the end of this period, the same dosage schedule is repeated. The number of courses of estrogen therapy necessary to produce bleeding may vary depending on responsiveness of the endometrium.
If bleeding occurs before the end of the 10 day period, begin a 20 day estrogen-progestin cyclic regimen with Menest (esterified estrogens tablets), 2.5 to 7.5 mg daily in divided doses, for 20 days.During the last 5 days of estrogen therapy, give an oral progestin. If bleeding occurs before this regimen is concluded, therapy is discontinued and may be resumed on the fifth day of bleeding.
Female castration and primary ovarian failure — 1.25 mg daily, cyclically. 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.
3. Given chronically: Inoperable progressing prostatic cancer —1.25 to 2.5 mg three times daily.The effectiveness of therapy can be judged by phosphatase determinations as well as by symptomatic improvement of the patient.
Inoperable progressing breast cancer in appropriately selected men and postmenopausal women. (See INDICATIONS) – Suggested dosage is 10 mg three times daily for a period of at least 3 months.
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.
The lowest effective dose of Menest (estrogens) has not been determined.
0.3 mg yellow,film-coated oblong tablet imprinted with M72
100's: NDC 61570-072-01
0.625 mg orange, film-coated oblong tablet imprinted with M73
100's: NDC 61570-073-01
500's: NDC 61570-073-05
1.25 mg green,film-coated oblong tablet imprinted with M74
100's: NDC 61570-074-01
2.5 mg pink,film-coated oblong tablet imprinted with M75
50's: NDC 61570-075-50
Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620. (A wholly owned subsidiary of King Pharmaceuticals, Inc.) Manufactured by: King Pharmaceuticals, Inc.,Bristol, TN 37620. FDA rev date: 4/28/2000This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/28/2008
Additional Menest Information
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