Monograph Details

Ob/Gyn > Menopause and HRT
OGEN
Manufacturer
Pfizer Labs
Legal Classification
Rx
Pharmacological Class
Estrogen.
Generic Name
Estrone sodium sulfate (as estropipate) 0.625mg, 1.25mg, 2.5mg; scored tabs.
Indications
Moderate to severe vasomotor symptoms of menopause. Atrophic vaginitis. Osteoporosis prevention. Hypoestrogenism.
Children
Not applicable.
Adults
Menopause: 0.625–5mg daily, given cyclically (3 weeks on, 1 week off). Osteoporosis prevention (begin therapy soon after menopause): 0.625mg daily, given cyclically (25 days of a 31-day cycle). Hypoestrogenism: 1.25–7.5mg daily for 3 weeks. Repeat course if withdrawal bleeding does not occur within 8–10 days after discontinuing. See literature. Reevaluate periodically.
Contraindications
Breast or estrogen-dependent carcinoma. Undiagnosed abnormal genital bleeding. Thromboembolic disorders. Thrombophlebitis. Pregnancy (Cat.X).
Precautions
Patients with an intact uterus should almost always receive a progestin to avoid endometrial hyperplasia. Cardiovascular disease. Hepatic dysfunction. Gallbladder disease. Conditions aggravated by fluid retention. Bone disease associated with hypercalcemia. Do initial complete physical and repeat annually (include BP, mammogram, and PAP smear). Discontinue if jaundice or hypertension occurs and at least 2 weeks before surgery associated with thromboembolism. Nursing mothers.
Adverse Reactions
See literature. GI upset, breakthrough bleeding, edema, weight changes, mastodynia, hypertension, intolerance to contact lenses.
How Supplied
Tabs—100
Additional Resources
Related Prescribing Note