Generic name: norethindrone acetate and ethinyl estradiol
Dosage form: tablet
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Use of estrogen, alone or in combination with a progestin, should be limited to the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (e.g., 3 to 6 month intervals) to determine if treatment is still necessary (see BOXED WARNING and WARNINGS). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding. Patients should be evaluated for breast abnormalities in accordance with good clinical practice.
Patients should be started at the lowest dose.
JevantiqueTM therapy consists of a single tablet taken once daily.
1. For the Treatment of Moderate to Severe Vasomotor Symptoms associated with the menopause
JevantiqueTM should be given once daily for the treatment of moderate to severe vasomotor symptoms associated with the menopause. Patients should be reevaluated at 3 to 6 month intervals to determine if treatment is still necessary.
2. For Prevention of Postmenopausal Osteoporosis
When prescribing solely of the prevention of postmenopausal osteoporosis, JevantiqueTM should only be prescribed to postmenopausal women who are at significant risk of osteoporosis. Non-estrogen medications should be carefully considered. Risk factors for osteoporosis include low bone mineral density, low estrogen levels, family history of osteoporosis, previous fracture, small frame (low BMI), light skin color, smoking, and alcohol intake. Patients should be treated with the lowest effective dose. This dose should be periodically reassessed by the healthcare provider. Response to therapy can be assessed during treatment by measuring biochemical markers of bone formation/resorption, and/or bone mineral density.