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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]
IMPORTANT SAFETY INFORMATION
Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. The Women’s Health Initiative (WHI) study reported increased risks of stroke, deep vein thrombosis (DVT), pulmonary embolism, myocardial infarction, and invasive breast cancer in postmenopausal women (ages 50–79 years) during 5.6 years of treatment with daily conjugated estrogens 0.625 mg combined with medroxyprogesterone acetate (MPA) 2.5 mg relative to placebo. The WHI Memory Study, an ancillary study of WHI, reported an increased risk of probable dementia in postmenopausal women 65 years of age or older.[1]
PROMETRIUM® is contraindicated for patients with any of the following conditions: known hypersensitivity to its ingredients; undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; active deep vein thrombosis, pulmonary embolism or history of these conditions; active arterial thromboembolic disease (i.e. stroke, myocardial infarction) or a history of these conditions; known liver disease or dysfunction; known or suspected pregnancy.[1]
PROMETRIUM® is contraindicated in patients with known or suspected pregnancy.[1]
Pregnancy Category B
PATIENTS WHO ARE ALLERGIC TO PEANUTS SHOULD NOT USE PROMETRIUM® CAPSULES.[1]
Common side effects reported in patients taking PROMETRIUM® included headaches, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting, hair loss, fluid retention, and vaginal yeast infection.[1]
You are encouraged to report suspected adverse reactions. Please contact Solvay Pharmaceuticals, Inc. at 1-800-241-1643 or the FDA at www.fda.gov/medwatch or by calling 1-800-FDA-1088.
Please click here for the PROMETRIUM® Full Prescribing Information.
Reference:
1. PROMETRIUM® [package insert]. Marietta, Ga: Solvay Pharmaceuticals, Inc.; 2009.