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Basic Drug Info
Drug Name:PREMARIN
Manufacturer:Wyeth Pharmaceuticals, Inc.
Other Info:

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



Clinical Trials:


Indications and Usage

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.
Symptoms -- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.

Hypogonadism -- Condition resulting from deficient gonadal functions, such as GAMETOGENESIS and the production of GONADAL STEROID HORMONES. It is characterized by delay in GROWTH, germ cell maturation, and development of secondary sex characteristics. Hypogonadism can be due to a deficiency of GONADOTROPINS (hypogonadotropic hypogonadism) or due to primary gonadal failure (hypergonadotropic hypogonadism).

Breast Carcinoma -- (brest KAN-ser) Cancer that forms in tissues of the breast, usually the ducts (tubes that carry milk to the nipple) and lobules (glands that make milk). It occurs in both men and women, although male breast cancer is rare.

Malignant neoplasm of breast -- A primary or metastatic malignant neoplasm involving the breast. The vast majority of cases are carcinomas arising from the breast parenchyma or the nipple. Malignant breast neoplasms occur more frequently in females than in males. -- 2003

Neoplasm Metastasis -- The transfer of a neoplasm from one organ or part of the body to another remote from the primary site.

Carcinoma -- A malignant neoplasm made up of epithelial cells tending to infiltrate the surrounding tissues and give rise to metastases. It is a histological type of neoplasm but is often wrongly used as a synonym for "cancer." (From Dorland, 27th ed)

Osteoporosis, Postmenopausal -- Metabolic disorder associated with fractures of the femoral neck, vertebrae, and distal forearm. It occurs commonly in women within 15-20 years after menopause, and is caused by factors associated with menopause including estrogen deficiency.

Osteoporosis -- Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.

Contraindications
PREMARIN therapy should not be used in individuals with any of the following conditions: Undiagnosed abnormal genital bleeding.Known, suspected, or history of cancer of the breast except in appropriately selected patients being treated for metastatic disease.Known or suspected estrogen-dependent neoplasia.Active deep vein thrombosis, pulmonary embolism or a history of these conditions.Active or recent (within the past year) arterial thromboembolic disease (for example, stroke, myocardial infarction).Liver dysfunction or disease.Known hypersensitivity to any of the ingredients in PREMARIN.Known or suspected pregnancy.
Malignant Neoplasms -- A term for diseases in which abnormal cells divide without control. Cancer cells can invade nearby tissues and can spread through the bloodstream and lymphatic system to other parts of the body.

Primary malignant neoplasm --

Neoplasm Metastasis -- The transfer of a neoplasm from one organ or part of the body to another remote from the primary site.

Deep Vein Thrombosis -- A blood clot (thrombus) in a deep vein in the thigh or leg.

Deep vein thrombosis of lower limb --

Pulmonary Embolism -- Blocking of the PULMONARY ARTERY or one of its branches by an EMBOLUS.

Thromboembolism -- Obstruction of a blood vessel (embolism) by a blood clot (THROMBUS) in the blood stream.

Arteriopathic disease -- An impairment of the structure or function of the blood vessels which carry blood away from the heart.

Cerebrovascular accident -- sudden neurologic impairment due to a cerebrovascular disorder, either an arterial occlusion or an intracranial hemorrhage.

Liver Dysfunction --

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings
See BOXED WARNINGS.

This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.