"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
Estraderm® (estradiol transdermal system) is indicated in:
- Treatment of moderate to severe vasomotor symptoms associated with the menopause.
- Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
- Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.
- Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risks 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 1500 mg/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.
DOSAGE AND ADMINISTRATION
The adhesive side of the Estraderm (estradiol transdermal) system should be placed on a clean, dry area of the skin on the trunk of the body (including the buttocks and abdomen). The site selected should be one that is not exposed to sunlight. Estraderm (estradiol transdermal) should not be applied to the breasts. The Estraderm (estradiol transdermal) system should be replaced twice weekly. 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, especially around the edges. In the unlikely event that a system should fall off, the same system may be reapplied. If necessary, a new system may be applied. In either case, the original treatment schedule should be continued.
Initiation of Therapy
When estrogen is prescribed for a postmenopausal woman with a uterus, progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen alone or in combination with a progestin, should be with the lowest effective dose and the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (e.g. 3-month to 6-month intervals) to determine whether treatment is still necessary (See BOXED WARNINGS 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.
Estraderm (estradiol transdermal) is currently available in two dosage forms – 0.05 mg and 0.1 mg. Patients should be started at the lowest dose. The lowest effective dose of Estraderm (estradiol transdermal) has not been determined.
For treatment of moderate to severe vasomotor symptoms or moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause, initiate therapy with Estraderm (estradiol transdermal) 0.05 applied to the skin twice weekly.
Prophylactic therapy with Estraderm (estradiol transdermal) to prevent postmenopausal bone loss should be initiated with the 0.05 mg/day dosage as soon as possible after menopause. The dosage may be adjusted if necessary. Discontinuation of estrogen therapy may reestablish bone loss at a rate comparable to the immediate postmenopausal period.
In women not currently taking oral estrogens, treatment with Estraderm (estradiol transdermal) may be initiated at once. In women who are currently taking oral estrogen, treatment with Estraderm (estradiol transdermal) should be initiated 1 week after withdrawal of oral hormone therapy, or sooner if menopausal symptoms reappear in less than 1 week.
Estraderm (estradiol transdermal) therapy may be given continuously in patients who do not have an intact uterus. In those patients with an intact uterus, Estraderm (estradiol transdermal) may be given on a cyclic schedule (e.g., 3 weeks on drug followed by 1 week off drug).
Estraderm estradiol transdermal system 0.05 mg/day – each 10 cm² system contains 4 mg of estradiol USP for nominal* delivery of 0.05 mg of estradiol per day.
Patient Calendar Pack of 8 Systems...........................NDC
Carton of 6 Patient Calendar Packs of 8 Systems.........NDC 0083-2310-62
Carton of 1 Patient Calendar Pack of 24 Systems.........NDC 0083-2310-24
Estraderm estradiol transdermal system 0.1 mg/day – each 20 cm² system contains 8 mg of estradiol USP for nominal* delivery of 0.1 mg of estradiol per day. Patient Calendar
Pack of 8 Systems ...................................................NDC
Carton of 6 Patient Calendar Packs of 8 Systems.........NDC 0083-2320-62
Carton of 1 Patient Calendar Pack of 24 Systems.........NDC 0083-2320-24
Do not store above 30°C (86°F).
Do not store unpouched. Apply immediately upon removal from the protective pouch.
REV: JUNE 2004. Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936. FDA revision date: 12/17/2004
Last reviewed on RxList: 2/3/2009
This monograph has been modified to include the generic and brand name in many instances.
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