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Important Safety Information
WARNINGS
ENDOMETRIAL CANCER
Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. (See WARNINGS, Malignant neoplasms, Endometrial cancer in the Prescribing Information.)
CARDIOVASCULAR AND OTHER RISKS
Estrogens with or without 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 alone substudy of the Women’s Health Initiative (WHI) reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1 years, respectively, of treatment with daily oral conjugated estrogens (CE 0.625 mg), relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders in the Prescribing Information.)
The estrogen plus progestin substudy of WHI reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and DVT in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily 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 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 5.2 years of treatment with daily CE 0.625 mg alone and during 4 years of treatment with daily CE 0.625 mg combined with MPA 2.5 mg, 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.
PREMARIN is indicated in the treatment of moderate to severe vasomotor symptoms due to menopause, the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, and the prevention of postmenopausal osteoporosis.
PREMPRO is indicated in women who have a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause, the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, and the prevention of postmenopausal osteoporosis.
PREMARIN Vaginal Cream is indicated in the treatment of atrophic vaginitis and kraurosis vulvae and the treatment of moderate to severe dyspareunia, a symptom 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. 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.
PREMARIN, PREMPRO, and PREMARIN Vaginal Cream 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 their ingredients; known or suspected pregnancy.
In a clinical trial, the most commonly reported (≥5%) adverse events for PREMARIN that were statistically different than placebo included vaginal moniliasis, vaginitis, vaginal bleeding, dysmenorrhea, and leg cramps. In a clinical trial, the most commonly reported (≥5%) adverse events for PREMPRO 0.45 mg/1.5 mg and 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. In a prospective, randomized, placebo-controlled, double-blind study, the most common adverse reactions (≥5%) for PREMARIN Vaginal Cream are headache, infection, abdominal pain, back pain, accidental injury, and vaginitis.
Please see Prescribing Information, including Boxed Warning, for PREMARIN, PREMPRO, and PREMARIN Vaginal Cream.
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