Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. Increased risks of DVT, PE, stroke, MI, and invasive breast cancer reported in postmenopausal women (50-79 yrs of age) on estrogen plus progestin therapy. Increased risk of probable dementia reported in postmenopausal women ≥65 yrs of age on estrogen plus progestin therapy. Progestins with estrogens should be prescribed at the lowest effective dose and for the shortest duration consistent with treatment goals and risks.
View FDA-Approved Full Prescribing Information for Prometrium
Prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tabs. For use in secondary amenorrhea.
Prevention in Nonhysterectomized Postmenopausal Women Receiving Conjugated Estrogens Tabs:
200mg qhs for 12 days sequentially per 28-day cycle
In patients w/ difficulty swallowing caps, take w/ a glass of water while in standing position
Cap: 100mg, 200mg
Hypersensitivity to peanuts. Undiagnosed abnormal genital bleeding, known/suspected/history of breast cancer, active or history of DVT/PE, active or history of arterial thromboembolic disease (eg, stroke, MI), known liver dysfunction or disease, known or suspected pregnancy.
Caution in patients with risk factors for arterial vascular disease and/or VTE. If feasible, d/c at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization. Increased risk of endometrial cancer reported with the use of unopposed estrogen therapy in women with a uterus. Rule out malignancy in all cases of undiagnosed persistent or recurring abnormal genital bleeding. Adding a progestin to estrogen therapy in women with a uterus reported to reduce risk of endometrial hyperplasia. May increase risk of ovarian cancer. Retinal vascular thrombosis reported; d/c therapy pending examination if there is sudden partial or complete loss of vision, or if there is sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, d/c permanently. May cause fluid retention; caution with cardiac/renal dysfunction. May impair physical/mental abilities. May affect certain endocrine, hepatic, and blood components in lab tests.
Headache, breast tenderness, joint pain, depression, dizziness, abdominal bloating, hot flashes, urinary problems, abdominal pain, vaginal discharge, N/V, worry, chest pain, diarrhea, breast pain.
PREGNANCY AND LACTATION
Category B, caution in nursing.
MECHANISM OF ACTION
Progestogen; chemically identical to progesterone of ovarian origin.
Absorption: Administration of different doses resulted in different pharmacokinetic parameters. Distribution: Plasma protein binding (96-99%); found in breast milk. Metabolism: Liver to pregnanediols and pregnanolones, and sulfate/glucuronide conjugation; intestine via reduction, dehydroxylation, and epimerization. Elimination: Bile, urine, feces.
Assess for drug hypersensitivity, peanut allergy, undiagnosed abnormal genital bleeding, known/suspected/history of breast cancer, active/history of DVT/PE, active/history of arterial thromboembolic disease, and any other conditions where treatment is contraindicated or cautioned.
Monitor for signs/symptoms of cardiovascular disorders, breast cancer, endometrial cancer, ovarian cancer, dementia, visual abnormalities, fluid retention, and other adverse reactions. Perform annual breast exam; schedule mammography based on age, risk factors, and prior mammogram results. In cases of undiagnosed, persistent, or recurrent vaginal bleeding in women with uterus, perform adequate diagnostic measures (eg, endometrial sampling) to rule out malignancies.
Inform that the drug contains peanut oil and should not be used if allergic to peanuts. Inform that medication may increase chances for heart attack, stroke, visual loss/blindness, and blood clots. Advise to contact physician if breast lumps, unusual vaginal bleeding, dizziness or faintness, changes in speech, severe headaches, chest pain, SOB, leg pain, visual changes, or vomiting occurs. Advise to have yearly breast examinations by a physician and to perform monthly breast self-examinations.
25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from excessive moisture.
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