Prempro is a combination oral tablet containing conjugated estrogens and medroxyprogesterone acetate (a progestin), used to treat moderate-to-severe hot flashes and vaginal changes of menopause and to help prevent postmenopausal osteoporosis in women with an intact uterus. The added progestin lowers the risk of endometrial cancer associated with estrogen-only therapy.
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Dr. Steve Malen, PharmD
Dr. Steven Blikstein, PharmD
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Prempro combines conjugated estrogens with medroxyprogesterone acetate in a single daily tablet (available in 0.3 mg/1.5 mg, 0.45 mg/1.5 mg, and 0.625 mg/2.5 mg or 0.625 mg/5 mg strengths). It is indicated for moderate-to-severe vasomotor symptoms (hot flashes) and moderate-to-severe vulvar/vaginal atrophy associated with menopause, and for prevention of postmenopausal osteoporosis, in women who have not had a hysterectomy. Because it already contains a progestin, Prempro provides endometrial protection against the cancer risk of unopposed estrogen. Prempro carries a boxed warning: estrogen-plus-progestin therapy should not be used to prevent cardiovascular disease or dementia, and studies (WHI) showed increased risks of heart attack, stroke, blood clots (DVT/PE), invasive breast cancer, and probable dementia in women 65 and older. Common side effects include headache, breast tenderness, bloating, nausea, and irregular vaginal bleeding or spotting, especially in the first few months. Prempro should not be used in women with undiagnosed abnormal vaginal bleeding, known or suspected breast cancer, active or history of blood clots or stroke/heart attack, active liver disease, or known/suspected pregnancy. Regular follow-up exams, including breast and pelvic exams, are recommended while on therapy.
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Boxed Warning: Estrogen-plus-progestin therapy should not be used to prevent cardiovascular disease or dementia. The Women's Health Initiative study found increased risks of heart attack, stroke, blood clots (deep vein thrombosis and pulmonary embolism), invasive breast cancer, and probable dementia in postmenopausal women 65 and older taking combined estrogen/progestin therapy.
Common side effects include headache, breast tenderness or enlargement, bloating, nausea, and irregular vaginal bleeding or spotting, which is most common during the first few months of therapy.
Dosing: Prempro is taken as one tablet daily, continuously, at the lowest effective dose for the shortest duration needed to manage symptoms. Because it combines estrogen with a progestin, no separate progestin is required for endometrial protection in women with a uterus.
Do not use if you have undiagnosed abnormal vaginal bleeding, known or suspected breast cancer or estrogen-dependent tumors, active or prior blood clots, a history of stroke or heart attack, active liver disease, or known/suspected pregnancy. Report new breast lumps, unusual vaginal bleeding, leg swelling or pain, chest pain, sudden severe headache, or vision changes to your provider promptly.