
Profile
General Information
ORTHO-PREFEST is a single-tablet prescription hormone replacement therapy (HRT) indicated in women with an intact uterus for the treatment of moderate to severe vasomotor symptoms associated with menopause, treatment of vulvar and vaginal atrophy, and prevention of osteoporosis.
Clinical Results
Clinical trials tested post-menopausal women and found that ORTHO-PREFEST was safe and effective in reducing hot-flashes and providing relief from vaginal atrophy.
Side Effects
The most common side effects in clinical trials over a one-year period were headache and breast pain. These effects were rarely serious enough to cause women to discontinue treatment. Other side-effects experienced by patients during trials included back pain, fatigue, flu-like symptoms, abdominal pain, nausea, arthralgias (joint pain), dysmenorrhea (painful menstruation), vaginal bleeding, vaginitis, pharyngitis (inflammation of the throat), sinusitis and URIs (upper respiratory infections).
Warnings/Precautions
Estrogens have been associated with increased risks of serious
side-effects including thromboembolic disorders, cardiovascular
disease, and endometrial carcinoma in post-menopausal women.
Do not take this drug (or any estrogens) if you have a known or
suspected pregnancy, breast cancer, or estrogen-dependent
neoplasia. Also, do not take estrogens if you have undiagnosed
abnormal genital bleeding, active thrombophlebitis, or
thromboembolic disorders.
Women should consult their doctor before beginning hormone
replacement therapy.
Additional Information
Upon launch, the ORTHO-PREFEST will be co-promoted with Women
First HealthCare, a specialty health care company dedicated to
improving the health of midlife women.
For more information, please contact Nancy Casey of Women First
HealthCare, Inc., 858-509-3814, or visit the Women First
Healthcare, Inc. web site
www.womenfirst.com.
Approval Date: 1999-10-22
Company Name: Ortho-McNeil Pharmaceutical, RW Johnson