| 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.[2]
The most common adverse events reported in patients receiving varying dosages of PROMETRIUM® (100 mg/day to
400 mg/day) were: dizziness, breast pain, headache, abdominal pain, chest pain, and diarrhea.[2]
Transient dizziness may occur in some patients; they should use caution when driving or operating machinery; for these women, bedtime dosing may be advised.[2]
PATIENTS WHO ARE ALLERGIC TO PEANUTS SHOULD NOT USE PROMETRIUM® CAPSULES.[2]
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. 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.[2]
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.[2]
References:
1. IMS Health. 2006/2007 Prescription Data; PROMETRIUM® #1 prescribed single entity progestogen. 2. PROMETRIUM® [package insert]. Marietta, Ga: Solvay Pharmaceuticals, Inc.; 2004.
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