Generic name: ESTRADIOL 0.025mg in 1d
Dosage form: transdermal film, extended release
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Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should be considered to reduce the risk of endometrial cancer. A woman without a uterus does not need a progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin [see Warnings and Precautions (5.2, 5.14)].
Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.
Treatment of Moderate to Severe Vasomotor Symptoms
Start therapy with MINIVELLE 0.0375 mg per day applied to the skin twice weekly. Dosage adjustment should be guided by the clinical response.
Therapy should be started at the lowest effective dose and the shortest duration consistent with the treatment goals. Attempts to taper or discontinue the medication should be made at 3 to 6 month intervals.
2.2 Prevention of Postmenopausal Osteoporosis
Start therapy with MINIVELLE 0.025 mg per day applied to the skin twice weekly. The dose may be adjusted as necessary.
Patch Application Instructions
The adhesive side of MINIVELLE should be placed on a clean, dry area on the lower abdomen (below the umbilicus) or buttocks. MINIVELLE should not be applied to the breasts.
MINIVELLE should be replaced twice weekly (every 3-4 days).
The sites of application must be rotated, with an interval of at least 1 week allowed between applications to a particular site.
The area selected should not be oily, damaged, or irritated. The waistline should be avoided, since tight clothing may rub the system off. The system should be applied immediately after opening the pouch and removing the protective liner. The system should be pressed firmly in place with the palm of the hand for about 10 seconds, making sure there is good contact with the skin, especially around the edges. In the event that a system should fall off, the same system may be reapplied. If the same system cannot be reapplied, a new system should be applied to another location. If a woman has forgotten to apply a patch, she should apply a new patch as soon as possible. In either case, the original treatment schedule should be continued. The interruption of treatment in women taking MINIVELLE might increase the likelihood of breakthrough bleeding, spotting and recurrence of symptoms.