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PREMPRO® (conjugated estrogens/medroxyprogesterone acetate tablets)

Product Overview

Premarin

PREMPRO® (conjugated estrogens/medroxyprogesterone acetate tablets)

For additional product information, please visit www.prempro.com.



Indications and Usage

PREMPRO therapy is indicated in women who have a uterus for 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. 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.
    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.

Important Safety Information

WARNINGS
CARDIOVASCULAR AND OTHER RISKS


Estrogens plus progestins should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders and Dementia in the Prescribing Information.)

The estrogen plus progestin substudy of the Women's Health Initiative (WHI) reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg), relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders and Malignant neoplasms, Breast cancer in the Prescribing Information.)

The estrogen alone substudy of the WHI reported increased risks of stroke and DVT in postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1 years, respectively, of treatment with daily CE 0.625 mg, relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders in the Prescribing Information.)

The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE 0.625 mg combined with MPA 2.5 mg and during 5.2 years of treatment with daily CE 0.625 mg alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL STUDIES and WARNINGS, Dementia and PRECAUTIONS, Geriatric Use in the Prescribing Information.)

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

PREMPRO should not be used under any of the following conditions or circumstances: undiagnosed abnormal genital bleeding; known, suspected, or a history of breast cancer; known or suspected estrogen-dependent neoplasia; active venous thromboembolism or a history of this condition; active or recent arterial thromboembolism; liver dysfunction or disease; in patients with a known hypersensitivity to its ingredients; known or suspected pregnancy.

In a clinical trial, the most commonly reported (≥5%) adverse events for PREMPRO 0.45 mg/1.5 mg and PREMPRO 0.625 mg/2.5 mg that were statistically different than placebo were mastalgia, vaginal bleeding, vaginal moniliasis, leg cramps, dysmenorrhea, breast enlargement, and vaginitis. In a clinical trial, there was no difference in the commonly reported (≥5%) adverse events for women taking PREMPRO 0.3 mg/1.5 mg compared to those taking placebo.

Important: Wyeth received approval to produce PREMPRO 0.3mg/1.5 mg and PREMPRO 0.45mg/1.5 mg using a new manufacturing process, which included changes to inactive ingredients, beginning in September 2009. No changes were made to the active ingredients and the efficacy and safety profiles remain the same.

If you have a medical information inquiry about the reformulation, please call 1-800-934-5556 Monday through Friday, 8:30 AM - 6:30 PM EST.

Please see full Prescribing Information, including Boxed Warning.


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