|Manufacturer:||Wyeth Pharmaceuticals, Inc.|
PREMARIN contains a mixture of conjugated estrogens, which are a mixture of sodium estrone sulfate and sodium equilin sulfate and other components including sodium sulfate conjugates, 17 ?-dihydroequilin, 17 ?-estradiol, and 17 ?-dihydroequilin.
PREMARIN 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg tablets also contain the following inactive ingredients: calcium phosphate tribasic, hydroxypropyl cellulose, microcrystalline cellulose, powdered cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sucrose and titanium dioxide.
The tablets come in different strengths and each strength tablet is a different color.
The color ingredients are: — 0.3 mg tablet (green color): D&C Yellow No. 10 and FD&C Blue No. 2.
— 0.45 mg tablet (blue color): FD&C Blue No. 2.
— 0.625 mg tablet (maroon color): FD&C Blue No. 2 and FD&C Red No. 40.
— 0.9 mg tablet (white color): D&C Red No.
30 and D&C Red No. 7.
— 1.25 mg tablet (yellow color): black iron oxide, D&C Yellow No. 10, and FD&C Yellow No. 6.
The appearance of these tablets is a trademark of Wyeth Pharmaceuticals.Store at Controlled Room Temperature 20° – 25°C (68° – 77°F). This product's label may have been updated.
For current package insert and further product information, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556.Wyeth® Wyeth Pharmaceuticals Inc.Philadelphia, PA 19101W10405C023ET01Rev 05/08
PREMARIN therapy is indicated in the: Treatment of moderate to severe vasomotor symptoms due to menopause.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.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 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 medications are not considered to be appropriate. (See 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.