1. For Treatment of Moderate to Severe Vasomotor Symptoms, Vulval and Vaginal Atrophy Associated with the Menopause, the Lowest Dose and Regimen that Will Control Symptoms Should be Chosen and Medication Should be Discontinued as Promptly as Possible.
Attempts to discontinue or taper medication should be made at 3-month to 6-month intervals.
The usual initial dosage range is 1 or 2 mg daily of estradiol adjusted as necessary to control presenting symptoms. The minimal effective dose for maintenance therapy should be determined by titration. Administration should be cyclic (e.g., 3 weeks on and 1 week off).
2. For Treatment of Female Hypoestrogenism Due to Hypogonadism, Castration, or Primary Ovarian Failure.
Treatment is usually initiated with a dose of 1 or 2 mg daily of estradiol, adjusted as necessary to control presenting symptoms; the minimal effective dose for maintenance therapy should be determined by titration.
3. For Treatment of Breast Cancer, for Palliation Only, in Appropriately Selected Women and Men With Metastatic Disease.
Suggested dosage is 10 mg three times daily for a period of at least three months.
4. For Treatment of Advanced Androgen-Dependant Carcinoma of the Prostrate, for Palliation Only.
Suggested dosage is 1 to 2 mg three times daily. The effectiveness of therapy can be judged by phosphatase determinations as well as by symptomatic improvement of the patient.
5. For Prevention of Osteoporosis.
Therapy with Innofem™ (Estradiol Tablets, USP) to prevent postmenopausal bone loss should be initiated as soon as possible after menopause. A daily dosage of 0.5 mg should be administered cyclically (e.g., 23 days on and 5 days off). The dosage may be adjusted if necessary to control concurrent menopausal symptoms. Discontinuation of estrogen replacement therapy may re-establish the natural rate of bone loss.