PROMETRIUM® (progesterone, USP) Capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets, as well as for treatment of secondary amenorrhea.[1]
The most common adverse events reported in postmenopausal women receiving PROMETRIUM® 200 mg were: breast tenderness, dizziness, abdominal bloating, vaginal discharge, chest pain, and diarrhea.[1]
The most common adverse events reported in postmenopausal women receiving PROMETRIUM® 400 mg were: headache, dizziness, breast pain, musculoskeletal pain, and viral infection.[1]
PREGNANCY CATEGORY B
PROMETRIUM® is contraindicated in patients with known or suspected pregnancy.[1]
PATIENTS WHO ARE ALLERGIC TO PEANUTS SHOULD NOT USE PROMETRIUM® CAPSULES.[1]
PROMETRIUM® is contraindicated for patients with any of the following conditions: known hypersensitivity to any of its ingredients; undiagnosed abnormal genital bleeding; known, suspected, or history of cancer of the breast; active deep vein thrombosis, pulmonary embolism, or history of these conditions; active or recent (within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction); liver dysfunction or disease; or known or suspected pregnancy.[1]
Progestins and estrogens should not be used for the prevention of cardiovascular disease. The Women’s Health Initiative reported an increased risk of myocardial infarction, stroke, breast cancer, pulmonary emboli, and deep venous thrombosis in postmenopausal women (ages 50–79) receiving oral conjugated equine estrogens (0.625 mg/day) in combination with medroxyprogesterone acetate (2.5 mg/day) compared to placebo.[1] While products marketed by Solvay Pharmaceuticals, Inc., were not studied in the WHI, in the absence of conclusive data, a conservative view would assume the risks to be similar.
The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during four years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.[1]
Reference:
1. PROMETRIUM® [package insert]. Marietta, Ga: Solvay Pharmaceuticals, Inc.; 2004. |
