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Estrace

"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.

Dyspareunia"...

Estrace

Estrace

INDICATIONS

ESTRACE (estradiol tablets, USP) is indicated in the:

  1. Treatment of moderate to severe vasomotor symptoms associated with the menopause.
  2. 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.
  3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
  4. Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.
  5. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).
  6. Prevention of 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 medications are not considered to be appropriate. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
    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 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 theindividual 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 for the indication.

  1. 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 3-month to 6-month intervals. The usual initial dosage range is 1 to 2 mg daily of estradiol adjusted as necessary to control presenting symptoms. The minimal effective dose for maintenance therapy should be determined by titration. Administration should be cyclic (e.g., 3 weeks on and 1 week off).
  2. For treatment of female hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.
    Treatment is usually initiated with a dose of 1 to 2 mg daily of estradiol, adjusted as necessary to control presenting symptoms; the minimal effective dose for maintenance therapy should be determined by titration.
  3. For treatment of breast cancer, for palliation only, in appropriately selected women and men with metastatic disease.
    Suggested dosage is 10 mg three times daily for a period of at least three months.
  4. For treatment of advanced androgen-dependent carcinoma of the prostate, for palliation only.
    Suggested dosage is 1 to 2 mg three times daily. The effectiveness of therapy can be judged by phosphatase determinations as well as by symptomatic improvement of the patient.
  5. For prevention of osteoporosis.
    When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should be considered only for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. The lowest effective dose of ESTRACE (estradiol) has not been determined.

HOW SUPPLIED

ESTRACE® (estradiol tablets, USP) are available as:

0.5 mg: White to off-white, oval, flat-faced, beveled-edge, scored tablet. Debossed with 720 / ½ on the scored side and WC on the other side. Available in bottles of: 100 Tablets NDC 0430-0720-24

1 mg: Light purple, oval, flat-faced, beveled-edge, scored tablet. Debossed with 721 / 1 on the scored side and WC on the other side. Available in bottles of: 100 Tablets NDC 0430-0721-24

2 mg: Green, oval, flat-faced, beveled-edge, scored tablet. Debossed with 722 / 2 on the scored side and WC on the other side. Available in bottles of: 100 Tablets NDC 0430-0722-24

Store at 20° to 25° C (68° to 77°F) [See USP Controlled Room Temperature].Dispense with a child-resistant closure in a tight, light-resistant container.

Manufactured by: BARR LABORATORIES, INC. POMONA, NY 10970. Marketed by: Warner Chilcott (US), LLC Rockaway, NJ 07866. 1-800-521-8813. Revised MARCH 2008. FDA revision date: 1/25/2001

Last reviewed on RxList: 10/3/2008
This monograph has been modified to include the generic and brand name in many instances.

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