March 24, 2017
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Ogen

"Middle-aged women who exercise fewer than three times per week report more severe menopause symptoms than those who get more exercise, a study has shown. They are also significantly more likely to be obese, researchers report in an article publis"...

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Ogen




Indications
Dosage
How Supplied

INDICATIONS

OGEN therapy is indicated in the:

  1. Treatment of moderate to severe vasomotor symptoms due to menopause.
  2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
  3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
  4. 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 non-estrogen medications should be carefully considered.

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 per 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 per day may also be required to ensure adequate daily intake in postmenopausal women.

DOSAGE AND ADMINISTRATION

When estrogen therapy 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 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. Patients should be reevaluated periodically as clinically appropriate (for example at 3-month to 6-month intervals) to determine if treatment is still necessary. Adequate diagnostic measures, such as directed or random endometrial sampling, when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.

  1. For the treatment of moderate to severe vasomotor symptoms and/or moderate to severe vulvar and vaginal atrophy due to 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 3-month 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. Vulvar 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. When prescribing solely for the treatment of moderate to severe vulvar and vaginal atrophy, topical vaginal products should be considered.
  2. For the treatment of female hypoestrogenism 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 therapy necessary to produce bleeding may vary depending on the responsiveness of the endometrium. If satisfactory withdrawal bleeding does not occur, an oral progestogen may be given in addition to estrogen 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.
  3. For the prevention of postmenopausal osteoporosis. A daily dose of one OGEN .625 (0.75 mg estropipate) tablet for 25 days of a 31-day cycle per month. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should be considered only for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.

HOW SUPPLIED

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 are available in bottles of 100.

Recommended storage: Store below 77°F (25°C)

Distributed by: Pharamacia & Upjohn Company, Divsion of Pfizer Inc., NY, NY 10017. Revised: Jul 2016.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 1/9/2017

Indications
Dosage
How Supplied

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