"March 7, 2013 -- An FDA panel voted to stop recommending calcitonin salmon for the treatment of osteoporosis in women who are at least five years past menopause.
The committee voted 12-9 against continued marketing of the drug, citing"...
Menostar (estradiol transdermal system) is indicated for the prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should be considered only for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.
The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
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. Response to therapy can be predicted by pre-treatment serum estradiol (see Table 3), and can be assessed during treatment by measuring biochemical markers of bone formation/resorption, and/or bone mineral density.
DOSAGE AND ADMINISTRATION
Menostar (estradiol transdermal system) 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. Response to therapy can be predicted by pre-treatment serum estradiol (see Table 3), and can be assessed during treatment by measuring biochemical markers of bone formation/resorption, and/or bone mineral density.
When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be used, to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. 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.
It is recommended that women who have a uterus and are treated with Menostar (estradiol transdermal system) receive a progestin for 14 days every 6 to 12 months and undergo an endometrial biopsy at yearly intervals or as clinically indicated. (See BOXED WARNINGS and WARNINGS).
Application of the System
The adhesive side of the Menostar (estradiol transdermal system) transdermal system should be placed on a clean, dry area of the lower abdomen. Menostar (estradiol transdermal system) should not be applied to or near the breasts. 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 and remove the transdermal system. Application to areas where sitting would dislodge the transdermal system should also be avoided. The transdermal system should be applied immediately after opening the pouch and removing the protective liner. The transdermal system should be pressed firmly in place with the fingers for about 10 seconds, making sure there is good contact, especially around the edges. If the transdermal system lifts, apply pressure to maintain adhesion. In the event that a transdermal system should fall off, a new transdermal system should be applied for the remainder of the 7-day dosing interval. 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 (estradiol transdermal system) has not been studied, and these activities may decrease the adhesion of the transdermal system and the delivery of estradiol.
Removal of the Transdermal System
Removal of the system should be done carefully and slowly to avoid irritation of the skin. Should any adhesive remain on the skin after removal of the system, allow the area to dry for 15 minutes. Then gently rubbing the area with an oil-based cream or lotion should remove the adhesive residue.
Used patches still contain some active hormones. Each patch should be carefully folded in half so that it sticks to itself before throwing it away.
Menostar (estradiol transdermal system), 14 mcg/day — each 3.25 cm²system contains 1 mg of estradiol USP
Individual Carton of 4 systems . . . . . . . . . . . . . . . NDC 50419-455-04
Do not store above 86°F (30°C). Do not store unpouched. Apply immediately upon removal from the protective pouch.
Manufactured by 3M Drug Delivery Systems, Northridge, CA 91324. Manufactured for: Bayer Healthcare Pharmaceuticals Inc., Wayne, NJ 07470. March 2007.
Last reviewed on RxList: 3/27/2009
This monograph has been modified to include the generic and brand name in many instances.
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