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| |  FDA Approves New Dose For Prometrium For Endometrial Hyperplasia Prevention MARIETTA, GA. -- October 19, 1999 -- The U.S. Food and Drug Administration (FDA) has approved for marketing a new 200-mg Prometrium® (progesterone, USP) Capsule strength. Prometrium Capsules is indicated for use with conjugated estrogens tablets for the prevention of endometrial hyperplasia (an overgrowth of cells in the uterine lining) in postmenopausal women who have not had a hysterectomy as well as for use in secondary amenorrhea. Prometrium, from Solvay Pharmaceuticals, Inc., is now available in two strengths, 200 mg and 100 mg. The 100-mg strength was approved for marketing by the FDA in December 1998. Plant-based Prometrium Capsules, synthesized from yam sources, is the only FDA-approved oral formulation of micronized (finely ground) progesterone. It is structurally identical to the endogenous (naturally occurring) progesterone found in a woman’s body. "Prometrium Capsules 200-mg strength offers dosing flexibility and added convenience for patients who are prescribed a 200-mg dose for the prevention of endometrial hyperplasia as well as those who require 400 mg for secondary amenorrhea," said Alan Altman, M.D., assistant clinical professor of Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School and Brigham and Women’s Hospital. "This is an especially significant consideration for older women taking multiple medications."
The Importance of Progesterone Progesterone is the female sex hormone responsible for changes in the uterine lining during the second half of the menstrual cycle. Like estrogen, progesterone production drops significantly when a woman reaches menopause. Progestogens (including progesterone and progestins) are recommended for women with a uterus who are on estrogen therapy to counteract the effects of estrogen on the uterine lining. Without progesterone, postmenopausal women taking estrogen may be at increased risk for endometrial hyperplasia. Doctors commonly prescribe a combination of estrogen and progesterone therapy for menopausal women who still have a uterus to help alleviate vasomotor symptoms like hot flashes, and prevent osteoporosis while still protecting the endometrium. According to Dr. Altman, "It is important for women to understand both why they need progesterone as part of their hormone replacement therapy and that not all progestogens have the same formulation or indications. To best meet patients’ needs, physicians should individualize therapy. The availability of a new 200-mg option with Prometrium (Progesterone, USP) Capsules can help physicians meet this goal."
Micronized Progesterone Shows Favorable Results In NIH Study The Postmenopausal Estrogen/Progestin Interventions (PEPI) trial, a three-year National Institutes of Health study, examined the effects of estrogen alone and in combination with both medroxyprogesterone acetate (MPA) and micronized progesterone (Prometrium Capsules). PEPI found that micronized progesterone, like MPA, significantly reduced a woman’s risk of developing endometrial hyperplasia when compared to estrogen taken alone. Additionally, micronized progesterone did not appear to negate the positive effects of estrogen on HDL-C ("good cholesterol") levels; and women taking the estrogen and Prometrium Capsules regimen experienced the highest increase in levels of "good cholesterol" compared to the estrogen and MPA regimens. Recommended dosing for Prometrium Capsules for use in hormone replacement therapy is 200 mg taken orally once a day, in the evening, for 12 sequential days per 28-day cycle. The suggested dose for Prometrium Capsules for the treatment of secondary amenorrhea is 400 mg taken orally once a day, in the evening, for 10 days.
Most Commonly Occurring Side Effects and Other Important Information Patients who may be allergic to peanuts, suffer from severe liver disease, or who have known or suspected breast cancer, or pregnancy should not take Prometrium Capsules. Common side effects of Prometrium Capsules are breast tenderness, dizziness, abdominal bloating, and vaginal discharge.
Related Link: Solvay Pharmaceuticals, Inc.
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