"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.
Climara (estradiol transdermal) is indicated in the:
- 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 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.
DOSAGE AND ADMINISTRATION
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 for 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 if 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.
Patients should be started at the lowest dose. Six (6.5, 9.375, 12.5, 15, 18.75 and 25 cm²) Climara (estradiol transdermal) systems are available. For the treatment of vasomotor symptoms, treatment should be initiated with the 6.5 cm² (0.025 mg/day) Climara (estradiol transdermal) system applied to the skin once weekly. The dose should be adjusted as necessary to control symptoms. Clinical responses (relief of symptoms) at the lowest effective dose should be the guide for establishing administration of the Climara (estradiol transdermal) system, especially in women with an intact uterus. Attempts to taper or discontinue the medication should be made at 3- to 6-month intervals. In women who are not currently taking oral estrogens, treatment with the Climara (estradiol transdermal) system can be initiated at once. In women who are currently taking oral estrogen, treatment with the Climara (estradiol transdermal) system can be initiated 1-week after withdrawal of oral therapy or sooner if symptoms reappear in less than 1-week. For the prevention of postmenopausal osteoporosis, the minimum dose that has been shown to be effective is the 6.5 cm² (0.025 mg/day) Climara (estradiol transdermal) system. Response to therapy can be assessed by biochemical markers and measurement of bone mineral density.
Application of the System
The adhesive side of the Climara (estradiol transdermal) system should be placed on a clean, dry area of the lower abdomen or the upper quadrant of the buttock. The Climara (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 system. Application to areas where sitting would dislodge the system should also be avoided. 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 fingers for about 10 seconds, making sure there is good contact, especially around the edges. If the system lifts, apply pressure to maintain adhesion. In the event that a system should fall off, a new 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 the Climara (estradiol transdermal) system has not been studied, and these activities may decrease the adhesion of the system and the delivery of estradiol.
Removal of the 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.
Climara (estradiol transdermal system), 0.025 mg/day — each 6.5 cm² system contains 2 mg of estradiol USP
Individual Carton of 4 systems………………NDC 50419-454-04
Climara (estradiol transdermal system), 0.0375 mg/day — each 9.375 cm² system contains 2.85 mg of estradiol USP
Individual Carton of 4 systems………………NDC 50419-456-04
Climara (estradiol transdermal system), 0.05 mg/day — each 12.5 cm² system contains 3.8 mg of estradiol USP
Individual Carton of 4 systems………………NDC 50419-451-04
Climara (estradiol transdermal system), 0.06 mg/day — each 15 cm² system contains 4.55 mg of estradiol USP
Individual Carton of 4 systems……………….NDC 50419-459-04
Climara (estradiol transdermal system), 0.075 mg/day — each 18.75 cm² system contains 5.7 mg of estradiol USP
Individual Carton of 4 systems……………… NDC 50419-453-04
Climara (estradiol transdermal system), 0.1 mg/day — each 25 cm² system contains 7.6 mg of estradiol USP
Individual Carton of 4 systems……………….NDC 50419-452-04
Do not store above 86°F (30°C). Do not store unpouched. Apply immediately upon removal from the protective pouch.
Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470. Manufactured by: 3M Drug Delivery Systems, Northridge, CA 93124. FDA revision date: 1/3/2008
Last reviewed on RxList: 10/2/2008
This monograph has been modified to include the generic and brand name in many instances.
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