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PROMETRIUM® (progesterone, USP) Capsules
Clinical Information
PROMETRIUM® Capsules are indicated for use in the prevention of endometrial hyperplasia in non-hysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.
The PEPI (Postmenopausal Estrogen/Progestin Interventions) trial was a three-year multi-center, double-blind, placebo-controlled trial sponsored by the National Institutes of Health (NIH).
The PEPI trial included micronized progesterone 200 mg/day administered for 12 days/28 day cycle in combination with conjugated estrogens 0.625 mg/day as one of the five arms evaluated.
The PEPI trial demonstrated that micronized progesterone:
- Reduces a woman's risk of developing endometrial hyperplasia compared to estrogen taken alone;
- Does not appear to negate the positive effects of estrogen on HDL-C ("good cholesterol") levels;
- Is similarly effective to medroxyprogesterone (MPA) in providing endometrial protection; and
- thereby allowed for more favorable overall lipid profiles than MPA when examining these regimens compared to estrogen alone.
USE IN PATIENTS WITH KNOWN PEANUT ALLERGIES IS CONTRAINDICATED.
PROMETRIUM® Capsules should not be used in patients with known or suspected pregnancy, current or past history of thrombotic disorders, severe liver dysfunction or disease, or known or suspected malignancy of the breast or reproductive organs. Common adverse events resulting from the combination of PROMETRIUM® Capsules 200mg with conjugated estrogens in postmenopausal women were dizziness, breast tenderness, abdominal bloating, vaginal discharge, chest pain, and diarrhea. The most common ones associated with a 400mg dose (the usual dose for secondary amenorrhea) were dizziness, abdominal cramping, headache, and breast pain. Transient dizziness may occur in some patients; they should use caution when driving or operating machinery; a small percentage of women may experience extreme dizziness and/or drowsiness during initial therapy - for these women, bedtime dosing may be advised.
The Women's Health Initiative (WHI) reported increased risks of nonfatal myocardial infarction, strokes, invasive breast cancer, pulomary emboli and deep vein thrombosis in postmenopausal women during 5 years of combination therapy with conjugated equine estrogens (CEE) 0.625mg and medroxyprogesterone acetate (MPA) 2.5mg versus placebo. Lower dosages of CEE and MPA, and other formulations of estrogens, progestins, or androgens in combination or via different routes of administration, were not studied in the WHI. A parallel WHI study evaluating long-term use of estrogen alone is still ongoing. In the absence of comparable data and product-specific studies, the relevance of the WHI findings to other products has not been established. Until then, estrogens should be prescribed at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman.
Please see link below for complete safety and prescribing information.
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