Generic Name and Formulations:
Progesterone (micronized) 100mg, 200mg; caps; contains peanut oil.
Indications for PROMETRIUM:
To prevent endometrial hyperplasia in postmenopausal women with an intact uterus receiving conjugated estrogens. Secondary amenorrhea.
Endometrial hyperplasia prevention: 200mg once daily in the PM for 12 sequential days of each 28-day cycle. Amenorrhea: 400mg once daily in the PM for 10 days.
Undiagnosed vaginal bleeding. Breast carcinoma or history of. Active DVT, PE, arterial thromboembolic disease (eg, stroke, MI) or history of. Known liver dysfunction or disease. Peanut allergy. Pregnancy (Cat.B).
Cardiovascular disorders, probable dementia, and breast cancer for estrogen plus progestin therapy.
Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular disorders (eg, stroke, DVT, VTE); discontinue if occurs or suspected. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Increased risk of breast or ovarian cancer. Risk of probable dementia in women ≥65yrs of age. Conditions that may be aggravated by fluid retention. Discontinue pending exam if sudden loss of vision, proptosis, diplopia or migraine occurs. Permanently discontinue if exam reveal papilledema or retinal vascular lesions. Do initial and annual physical exam (include BP, PAP smear, mammogram). Monitor diabetics. Renal or hepatic dysfunction. Nursing mothers.
Headache, breast tenderness/pain/carcinoma, joint pain, depression, dizziness, abdominal bloating/pain, hot flashes, urinary problems, vaginal discharge, nausea, vomiting, worry, chest pain, diarrhea, night sweats, swelling of hands and feet, vaginal dryness, constipation, breast excisional biopsy, cholecysectomy.
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