RVP

Drug Catalog - Product Detail

ESTRADIOL TB 1MG 500

NDC Mfr Size Str Form
00378-1454-05 MYLAN 500 1MG TABLET
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Description
DESCRIPTION Estradiol tablets, USP for oral administration contains 0.5 mg, 1 mg or 2 mg of micronized estradiol per tablet. Estradiol (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5(10)-triene-3,17β-diol. It has a molecular formula of C 18 H 24 O 2 and molecular weight of 272.39. The structural formula is: In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The 1 mg tablet also contains FD&C Red No. 40 Aluminum Lake and the 2 mg tablet also contains FD&C Blue No. 1 Aluminum Lake. Structural Formula
How Supplied
HOW SUPPLIED Estradiol Tablets, USP are available containing 0.5 mg, 1 mg or 2 mg of estradiol, USP. The 0.5 mg tablets are white to off-white, round, scored tablets debossed with E to the left of the score and 3 to the right of the score on one side of the tablet and M on the other side. They are available as follows: NDC 0378-1452-01 bottles of 100 tablets NDC 0378-1452-05 bottles of 500 tablets The 1 mg tablets are pink, round, scored tablets debossed with E to the left of the score and 4 to the right of the score on one side of the tablet and M on the other side. They are available as follows: NDC 0378-1454-01 bottles of 100 tablets NDC 0378-1454-05 bottles of 500 tablets The 2 mg tablets are pale blue, round, scored tablets debossed with E to the left of the score and 5 to the right of the score on one side of the tablet and M on the other side. They are available as follows: NDC 0378-1458-77 bottles of 90 tablets NDC 0378-1458-01 bottles of 100 tablets NDC 0378-1458-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Patient Information Leaflet with each prescription.
Indications & Usage
INDICATIONS AND USAGE Estradiol tablets are 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. • Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. • Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. • Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). • 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 to 800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
Dosage and Administration
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 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 mg 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 mg 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 3 months. 4. For treatment of advanced androgen-dependent carcinoma of the prostate, for palliation only. Suggested dosage is 1 mg 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 estradiol tablets has not been determined.