Drug Catalog - Product Detail
ESTRADIOL TRANSDERMAL SYSTEM PATCH 0.0375MG/DAY 8
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-4643-26 | MYLAN | 8 | 0.0375MG/24HR | TRANSDERMAL SYSTEM |
PACKAGE FILES
Generic Name
ESTRADIOL
Substance Name
ESTRADIOL
Product Type
HUMAN PRESCRIPTION DRUG
Route
TRANSDERMAL
Application Number
ANDA201675
Description
11 DESCRIPTION Estradiol Transdermal System, USP (twice-weekly) contains estradiol hemihydrate in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system (twice-weekly) are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm 2 and contains estradiol, USP hemihydrate equivalent to 0.41, 0.62, 0.82, 1.23, or 1.64 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. The structural formula is: The molecular formula of estradiol hemihydrate is C 18 H 24 O 2 • ½ H 2 O. The molecular weight is 281.39. Meets USP Drug Release Test 4. Estradiol transdermal system (twice-weekly) is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film printed with brown ink, (2) an adhesive formulation containing estradiol, silicone adhesive, acrylic adhesive, dipropylene glycol, povidone and oleyl alcohol, and (3) an oversized slit polyester release liner which 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 are pharmacologically inactive. Estradiol Structrual Formula Transdermal Patch Cross Section
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Estradiol Transdermal System, USP (Twice-Weekly) is available as 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day or 0.1 mg/day of estradiol. Each strength is supplied in a Patient Calendar Pack containing 8 individually packaged systems. The 0.025 mg per day is available as a 2.5 cm 2 system containing estradiol, USP hemihydrate equivalent to 0.41 mg of estradiol, for nominal* delivery of 0.025 mg of estradiol per day. Each rectangular patch with rounded corners consists of an opaque, white to cream adhesive layer, matte film backing randomly printed with “Estradiol 0.025 mg/day” in brown ink, and a clear release liner. The patch is contained in a square, flat, notched, pouch. The pouch is imprinted with the lot number and expiration date. They are available as follows: NDC 0378-4644-26 carton containing 8 systems The 0.0375 mg per day is available as a 3.75 cm 2 system containing estradiol, USP hemihydrate equivalent to 0.62 mg of estradiol for nominal* delivery of 0.0375 mg of estradiol per day. Each rectangular patch with rounded corners consists of an opaque, white to cream adhesive layer, matte film backing randomly printed with “Estradiol 0.0375 mg/day” in brown ink, and a clear release liner. The patch is contained in a square, flat, notched, pouch. The pouch is imprinted with the lot number and expiration date. They are available as follows: NDC 0378-4643-26 carton containing 8 systems The 0.05 mg per day is available as a 5.0 cm 2 system containing estradiol, USP hemihydrate equivalent to 0.82 mg of estradiol for nominal* delivery of 0.05 mg of estradiol per day. Each rectangular patch with rounded corners consists of an opaque, white to cream adhesive layer, matte film backing randomly printed with “Estradiol 0.05 mg/day” in brown ink, and a clear release liner. The patch is contained in a square, flat, notched, pouch. The pouch is imprinted with the lot number and expiration date. They are available as follows: NDC 0378-4642-26 carton containing 8 systems The 0.075 mg per day is available as a 7.5 cm 2 system containing estradiol, USP hemihydrate equivalent to 1.23 mg of estradiol for nominal* delivery of 0.075 mg of estradiol per day. Each rectangular patch with rounded corners consists of an opaque, white to cream adhesive layer, matte film backing randomly printed with “Estradiol 0.075 mg/day” in brown ink, and a clear release liner. The patch is contained in a square, flat, notched, pouch. The pouch is imprinted with the lot number and expiration date. They are available as follows: NDC 0378-4641-26 carton containing 8 systems The 0.1 mg per day is available as a 10.0 cm 2 system containing estradiol, USP hemihydrate equivalent to 1.64 mg of estradiol for nominal* delivery of 0.1 mg of estradiol per day. Each rectangular patch with rounded corners consists of an opaque, white to cream adhesive layer, matte film backing randomly printed with “Estradiol 0.1 mg/day” in brown ink, and a clear release liner. The patch is contained in a square, flat, notched, pouch. The pouch is imprinted with the lot number and expiration date. They are available as follows: NDC 0378-4640-26 carton containing 8 systems [*see DESCRIPTION (11) ] 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] 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 sturdy child-proof container, and place this container in the trash. Used transdermal systems should not be flushed in the toilet.
Indications & Usage
1 INDICATIONS AND USAGE Estradiol transdermal system (twice-weekly) is indicated for: Estradiol transdermal system (twice-weekly) is an estrogen indicated for: • Treatment of moderate to severe vasomotor symptoms due to menopause ( 1.1 ) • Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause ( 1.2 ) Limitations of Use When prescribing solely for the treatment of moderate to severe vaginal atrophy, first consider the use of topical vaginal products. • Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure ( 1.3 ) • Prevention of postmenopausal osteoporosis ( 1.4 ) Limitations of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis. 1.1 Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause 1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Due to Menopause Limitations of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, first consider the use of topical vaginal products. 1.3 Treatment of Hypoestrogenism Due to Hypogonadism, Castration, or Primary Ovarian Failure 1.4 Prevention of Postmenopausal Osteoporosis Limitations of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, consider addition of a progestogen to reduce the risk of endometrial cancer. Generally, a woman without a uterus does not need to use a progestogen in addition to her estrogen therapy. In some cases, however, hysterectomized women who have a history of endometriosis may need a progestogen [see Warnings and Precautions (5.2 , 5.14) ] . Use estrogen-alone or in combination with a progestogen at the lowest effective dose and the shortest duration consistent with treatment goals and risks for the individual woman. Reevaluate postmenopausal women periodically as clinically appropriate to determine whether treatment is still necessary. • Start therapy with estradiol transdermal system (twice-weekly) 0.0375 mg/day applied to the skin twice weekly for the treatment of moderate to severe vasomotor symptoms due to menopause or moderate to severe symptoms of vulvar and vaginal atrophy symptoms due to menopause. Dosage adjustment should be guided by the clinical response ( 2.1 , 2.2 , 2.3 ) • Start therapy with estradiol transdermal system (twice-weekly) 0.025 mg/day for the prevention of postmenopausal osteoporosis ( 2.4 ) • Place estradiol transdermal system (twice-weekly) on a clean, dry area of the lower abdomen or buttocks. Do not apply estradiol transdermal system (twice-weekly) to the breasts ( 2.5 ) 2.1 Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause Start therapy with estradiol transdermal system (twice-weekly) 0.0375 mg per day applied to the skin twice weekly. Make dosage adjustments based on the clinical response. Initiate estradiol transdermal system (twice-weekly) at once in a woman not currently taking oral estrogens or in a woman switching from another estradiol transdermal therapy. In women who are currently taking oral estrogens, initiate treatment with estradiol transdermal system (twice-weekly) 1 week after withdrawal of oral hormone therapy, or sooner if menopausal symptoms reappear in less than 1 week. Attempts to taper or discontinue estradiol transdermal system (twice-weekly) at 3 to 6-month intervals. Give estradiol transdermal system (twice-weekly) continuously in a woman who does not have an intact uterus. In a woman with an intact uterus, give estradiol transdermal system (twice-weekly) on a cyclic schedule (for example, 3 weeks on estradiol transdermal system (twice-weekly) followed by 1 week off estradiol transdermal system (twice-weekly)). 2.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Due to Menopause Start therapy with estradiol transdermal system (twice-weekly) 0.0375 mg per day applied to the skin twice weekly. Dosage adjustment should be guided by the clinical response. Attempts to taper or discontinue estradiol transdermal system (twice-weekly) at 3 to 6-month intervals. In women not currently taking oral estrogens or in women switching from another estradiol transdermal therapy, treatment with estradiol transdermal system (twice-weekly) may be initiated at once. In women who are currently taking oral estrogens, initiate treatment with estradiol transdermal system (twice-weekly) 1 week after withdrawal of oral hormone therapy, or sooner if menopausal symptoms reappear in less than 1 week. Give estradiol transdermal system (twice-weekly) continuously in a woman who does not have an intact uterus. In a woman with an intact uterus, give estradiol transdermal system (twice-weekly) on a cyclic schedule (for example, 3 weeks on estradiol transdermal system (twice-weekly) followed by 1 week off estradiol transdermal system (twice-weekly)). 2.3 Hypoestrogenism Due to Hypogonadism, Castration, or Primary Ovarian Failure 2.4 Prevention of Postmenopausal Osteoporosis Start therapy with estradiol transdermal system (twice-weekly) 0.025 mg per day applied to the skin twice weekly. In women not currently taking oral estrogens or in women switching from another estradiol transdermal therapy, treatment with estradiol transdermal system (twice-weekly) may be initiated at once. In women who are currently taking oral estrogens, initiate treatment with estradiol transdermal system (twice-weekly) 1 week after withdrawal of oral hormone therapy, or sooner if menopausal symptoms reappear in less than 1 week. Estradiol transdermal system (twice-weekly) may be given continuously in a woman who does not have an intact uterus. In a woman with an intact uterus, estradiol transdermal system (twice-weekly) may be given on a cyclic schedule (for example, 3 weeks on estradiol transdermal system (twice-weekly) followed by 1 week off estradiol transdermal system (twice-weekly)). 2.5 Application Instructions Place the adhesive side of estradiol transdermal system (twice-weekly) on a clean, dry area of the trunk of the body (including the abdomen or buttocks). Do not apply estradiol transdermal system (twice-weekly) to the breasts. Replace estradiol transdermal system (twice-weekly) twice weekly. Rotate the sites of application, with an interval of at least 1 week allowed between applications to a particular site. Select an area that is not oily, damaged, or irritated. Avoid the waistline, since tight clothing may rub the system off. Apply the system immediately after opening the pouch and removing the oversized protective liner. Press the system 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 event that a system falls off, reapply the same system or apply a new system to another location. In either case, continue the original treatment schedule. If a woman has forgotten to apply estradiol transdermal system (twice-weekly), have her apply a new system as soon as possible. Apply the new system on the original treatment schedule. The interruption of treatment in women taking estradiol transdermal system (twice-weekly) might increase the likelihood of breakthrough bleeding, spotting and recurrence of symptoms.