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Premarin Cream
  • Professionals
  • FDA PI

Premarin Cream

Generic name:conjugated estrogens
Dosage form: vaginal cream
Drug classes:Estrogens, Miscellaneous vaginal agents

Medically reviewed by Drugs.com. Last updated on Oct 22, 2021.

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA

Estrogen-Alone Therapy

Endometrial Cancer

There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding[see Warnings and Precautions (5.3)].

Cardiovascular Disorders and Probable Dementia

Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia[see Warnings and Precautions (5.2, 5.4), and Clinical Studies (14.2, 14.3)].

The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo[see Warnings and Precautions (5.2), and Clinical Studies (14...