Drug Catalog - Product Detail
ESTRADIOL TRANSDERMAL SYSTEM PATCH PATCH 0.05MG/DAY 4
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-3350-99 | MYLAN | 4 | 0.05MG/24HR | TRANSDERMAL SYSTEM |
Generic Name
Substance Name
Product Type
Route
Application Number
Description
DESCRIPTION Estradiol Transdermal System Continuous Delivery (Once-Weekly) is designed to release estradiol continuously upon application to intact skin. Six (7.75 cm 2 , 11.625 cm 2 , 15.5 cm 2 , 18.6 cm 2 , 23.25 cm 2 and 31 cm 2 ) systems are available to provide nominal in vivo delivery of 0.025 mg, 0.0375 mg, 0.05 mg, 0.06 mg, 0.075 mg or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 7.75 cm 2 , 11.625 cm 2 , 15.5 cm 2 , 18.6 cm 2 , 23.25 cm 2 or 31 cm 2 , and contains 0.97 mg, 1.46 mg, 1.94 mg, 2.33 mg, 2.91 mg or 3.88 mg of estradiol USP respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17ß-diol. It has a molecular formula of C 18 H 24 0 2 and molecular weight of 272.39. The structural formula is: The Estradiol Transdermal System Continuous Delivery (Once-Weekly) comprises four layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a foam backing with adhesive layer, (2) a polyester film, and (3) an acrylate adhesive matrix containing estradiol USP. A protective liner (4) of siliconized polyester film is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system (propylene glycol, povidone, anhydrous colloidal silicon dioxide, pressure sensitive acrylic adhesive, copolymer foam, polyester film, and brown ink) are pharmacologically inactive. Structural formula Estradiol Patch
How Supplied
HOW SUPPLIED Estradiol Transdermal System, 0.025 mg/day Continuous Delivery (Once-Weekly), USP – each 7.75 cm 2 system contains 0.97 mg of estradiol USP NDC 0378-3349-99 Individual Carton of 4 systems Estradiol Transdermal System, 0.0375 mg/day Continuous Delivery (Once-Weekly), USP – each 11.625 cm 2 system contains 1.46 mg of estradiol USP NDC 0378-3360-99 Individual Carton of 4 systems Estradiol Transdermal System, 0.05 mg/day Continuous Delivery (Once-Weekly), USP – each 15.5 cm 2 system contains 1.94 mg of estradiol USP NDC 0378-3350-99 Individual Carton of 4 systems Estradiol Transdermal System, 0.06 mg/day Continuous Delivery (Once-Weekly), USP – each 18.6 cm 2 system contains 2.33 mg of estradiol USP NDC 0378-3361-99 Individual Carton of 4 systems Estradiol Transdermal System, 0.075 mg/day Continuous Delivery (Once-Weekly), USP – each 23.25 cm 2 system contains 2.91 mg of estradiol USP NDC 0378-3351-99 Individual Carton of 4 systems Estradiol Transdermal System, 0.1 mg/day Continuous Delivery (Once-Weekly), USP – each 31 cm 2 system contains 3.88 mg of estradiol USP NDC 0378-3352-99 Individual Carton of 4 systems Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Do not store unpouched. Apply immediately upon removal from the protective pouch. MYLAN PHARMACEUTICALS INC. Morgantown, WV 26505 REVISED AUGUST 2008 ETS:R16
Indications & Usage
INDICATIONS AND USAGE Estradiol Transdermal System Continuous Delivery (Once-Weekly), USP is indicated in the: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. 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. 3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4. 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 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 IU/day to 800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
Dosage and Administration
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 (7.75 cm 2 , 11.625 cm 2 , 15.5 cm 2 , 18.6 cm 2 , 23.25 cm 2 and 31 cm 2 ) Estradiol Transdermal Systems Continuous Delivery (Once-Weekly) are available. For the treatment of vasomotor symptoms, treatment should be initiated with the 7.75 cm 2 (0.025 mg/day) Estradiol Transdermal System Continuous Delivery (Once-Weekly) 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 Estradiol Transdermal System Continuous Delivery (Once-Weekly), especially in women with an intact uterus. Attempts to taper or discontinue the medication should be made at 3 month to 6 month intervals. In women who are not currently taking oral estrogens, treatment with Estradiol Transdermal System Continuous Delivery (Once-Weekly) can be initiated at once. In women who are currently taking oral estrogen, treatment with the Estradiol Transdermal System Continuous Delivery (Once-Weekly) can be initiated one week after withdrawal of oral therapy or sooner if symptoms reappear in less than one week. For the prevention of postmenopausal osteoporosis, the minimum dose that has been shown to be effective is the 7.75 cm 2 (0.025 mg/day) Estradiol Transdermal System Continuous Delivery (Once-Weekly). Response to therapy can be assessed by biochemical markers and measurement of bone mineral density. Application of the System The adhesive side of the Estradiol Transdermal System Continuous Delivery (Once-Weekly) should be placed on a clean, dry area of the lower abdomen or the upper quadrant of the buttock. The Estradiol Transdermal System Continuous Delivery (Once-Weekly) should not be applied to or near the breasts. The sites of application must be rotated, with an interval of at least one 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 Estradiol Transdermal System Continuous Delivery (Once-Weekly) 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.