Vivelle-Dot (estradiol transdermal system) contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of Vivelle-Dot 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 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol...

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Vivelle-Dot is indicated for: Vivelle-Dot is an estrogen indicated for: • Treatment of moderate to severe vasomotor symptoms due to menopause • 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 vaginal atrophy, first consider the use of topical vaginal products. • Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure • Prevention of postmenopa...

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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 . Use estrogen-alone or in combination with a progestogen at the lowest effective dose and the shortest duration consistent with tr...

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Vivelle-Dot is contraindicated in women with any of the following conditions: • Undiagnosed abnormal genital bleeding . • Breast cancer or a history of breast cancer . • Estrogen-dependent neoplasia . • Active DVT, PE, or a history of these conditions . • Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions . • Known anaphylactic reaction, or angioedema, or hypersensitivity to Vivelle-Dot • Hepatic impairment or disease • Protein C, protein S, or ...

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• Estrogens increase the risk of gallbladder disease • Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs ( 5.5 , 5.6 , 5.9 , 5.10 ) • Monitor thyroid function in women on thyroid replacement therapy ( 5.11 , 5.18 ) 5.1 Cardiovascular Disorders Increased risks of stroke and DVT are reported with estrogen-alone therapy. Increased risks of PE, DVT, stroke, and MI are reported with estrogen plus progestin therapy. Immediately disco...

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In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4 such as St. John’s wort ( Hypericum perforatum ) preparations, phenobarbital, carbamazepine and rifampin may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as eryth...

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Vivelle-Dot is not indicated for use in pregnancy. There are no data with the use of Vivelle-Dot in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogen and progestins) before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defect...

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