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Product Information
PROMETRIUM® Capsules were the first FDA-approved oral formulation of micronized progesterone and represent an exciting option in oral progestogen therapy. Because it is micronized (finely ground) and suspended in peanut oil, the progesterone is better absorbed by the body. Patients who are allergic to peanuts should not take PROMETRIUM® Capsules.
PROMETRIUM® Capsules is indicated for use in the prevention of endometrial hyperplasia in non-hysterectomized postmenopausal women who are receiving conjugated estrogens tablets. PROMETRIUM® Capsules is also indicated for use in secondary amenorrhea.
Progesterone is taken in conjunction with estrogen during hormone therapy to counter estrogen's proliferative effect on the endometrium and to reduce the risk of endometrial hyperplasia.
Prior to PROMETRIUM® Capsules, micronized progesterone was available only through select pharmacies and mail-order companies offering "compounded" progesterone, which can vary in potency and consistency from batch to batch.
PROMETRIUM® Capsules is structurally identical to the progesterone naturally produced in a woman's body. The progesterone in PROMETRIUM® Capsules is synthesized from yams.
Important Safety Information
Contraindications
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
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.
Cardiovascular and Other Risks
The Women's Health Initiative (WHI) reported increased risks of nonfatal myocardial infarction, strokes, invasive breast cancer, pulmonary emboli and deep vein thrombosis in postmenopausal women during five 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.
PROMETRIUM® is available by prescription only. Ask your doctor if PROMETRIUM® is right for you.
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