DOSAGE AND ADMINISTRATION
Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer. It is recommended that women who have a uterus and are treated with Menostar receive a progestin for 14 days every 6 to 12 months and undergo an endometrial biopsy at yearly intervals or as clinically indicated in order to detect any endometrial stimulation which might require further clinical action. A women 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.
Prevention of Postmenopausal Osteoporosis
Menostar 14 mcg per day applied to a clean dry area of the lower abdomen once weekly.
Application of the Menostar Transdermal System
Site Selection
Application
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•Menostar should be applied immediately after opening the pouch and removing the protective liner.
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•Menostar should be pressed firmly in place with the fingers for at least 10 seconds, making sure there is good contact, especially around the edges.
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•If the system lifts, apply pressure to maintain adhesion.
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•In the event that a system should fall off reapply it to a different location. If the system cannot be reapplied, a new system should be applied for the remainder of the 7-day dosing interval.
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•Only one system should be worn at any one time during the 7-day dosing interval.
Swimming, bathing, or using a sauna while using Menostar has not been studied, and these activities may decrease the adhesion of the system and the delivery of estradiol.
Removal of the Menostar Transdermal System
DOSAGE FORMS AND STRENGTHS
Menostar (estradiol transdermal system) 14 mcg per day - each 3.25 cm2 system contains 1 mg of estradiol.
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HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
Menostar(estradiol transdermal system), 14 mcg per day — each 3.25 cm2 system contains 1 mg of estradiol USP
Individual Carton of 4 systems NDC 50419-455-04
Storage and Handling
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F°F and 86°F). Do not store above 86°F (30°C).
Do not store unpouched. Apply immediately upon removal from the protective pouch.
Used transdermal systems still contain active hormone. To discard, fold the sticky side of the transdermal system together, place it in a child-proof container, and place this container in the trash. Used transdermal systems should not be flushed in the toilet.
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