Premarin Warnings & Precautions

Drug Library
Premarin - Warnings & Precautions [Conjugated Estrogens]

A postmenopausal woman without a uterus who requires estrogen should receive estrogen-alone therapy and should not be exposed unnecessarily to progestins. All postmenopausal women should receive yearly breast exams by a healthcare provider and perform monthly breast self-examinations. In addition, mammography examinations should be scheduled based on patient age and risk factors.

3. Dementia.

In a study of women 65 years of age and older (a randomized controlled sub-study of the Women's Health Initiative, the Women's Health Initiative Memory Study; n= 4,532, 54% older than 70), those treated with PREMPRO (0.625 mg, conjugated equine estrogen, plus 2.5 mg medroxyprogesterone acetate) were reported to have a two-fold increase in the risk of developing probable dementia. After an average follow-up of 4 years, the absolute risk of probable dementia was 45 per 10,000 woman-years in the PREMPRO group and 22 per 10,000 woman-years in the placebo group. It is unknown whether these findings apply to younger postmenopausal women.

The estrogen-alone sub-study of the Women's Health Initiative Memory Study is currently ongoing. No data are available. It is unknown whether these findings apply to estrogen alone therapy.

4. Gallbladder Disease.

A 2-to 4-fold increase in the risk of gallbladder disease requiring surgery in postmenopausal women receiving estrogens has been reported.

5. Hypercalcemia.

Estrogen administration may lead to severe hypercalcemia in patients with breast cancer and bone metastases. If hypercalcemia occurs, use of the drug should be stopped and appropriate measures taken to reduce the serum calcium level.

6. Visual abnormalities.

Retinal vascular thrombosis has been reported in patients receiving estrogens. Discontinue medication pending examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, estrogens should be discontinued.