Minimal occurrence of abdominal bloating

Similar incidence of abdominal bloating vs placebo in estrogen-primed, postmenopausal women taking PROMETRIUM® 400 mg/day[1]

Low occurrence of emotional instability and irritability

Low incidence of irritability in estrogen-primed, postmenopausal women taking PROMETRIUM® 400 mg/day[1]

Proven safety profile

Common adverse events[1] (Percentage of patients reporting)

Common adverse events[1] (Percentage of patients reporting)

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]

The most common adverse events reported at a rate greater than placebo in a clinical trial by postmenopausal women receiving conjugated estrogens 0.625 mg daily plus cyclic PROMETRIUM® 200 mg capsules were: headache, breast tenderness, depression, dizziness, abdominal bloating, chest pain, and diarrhea.[1]

The most common adverse events reported at a rate greater than placebo in a clinical trial by postmenopausal women receiving PROMETRIUM® 400 mg capsules were: dizziness, abdominal pain, headache, breast pain, musculoskeletal pain, and viral 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.

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Reference:
1. PROMETRIUM® [package insert]. Marietta, Ga: Solvay Pharmaceuticals, Inc.; 2009.