Monograph Details
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Ob/Gyn
> Menopause and HRT
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VIVELLE |
| Manufacturer |
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Novartis Pharmaceuticals Corp |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Estrogen. |
| Generic Name |
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Estradiol 0.05mg/day, 0.1mg/day; transdermal patch. |
| Also |
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• VIVELLE-DOT
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| Indications |
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Moderate to severe vasomotor symptoms of menopause. Vulvar or vaginal atrophy. Postmenopausal osteoporosis prevention. Hypoestrogenism. |
| Children |
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Not recommended. |
| Adults |
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Apply to clean, dry, intact skin (not to breasts or waist); rotate application sites. Apply Vivelle to trunk, Vivelle-Dot to lower abdomen. Menopause: Initially one 0.0375mg/day patch twice weekly. Osteoporosis: initially one 0.025mg/day patch twice weekly. Hypoestrogenism: see literature. With intact uterus: usually give cyclically (3 weeks on, 1 week off); without uterus: may give continuously. Transferring from oral estrogens: apply 1st patch up to 1 week after last oral dose. Adjust after at least 1 month. Reevaluate periodically. |
| Contraindications |
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Undiagnosed abnormal genital bleeding. Thrombophlebitis. Thromboembolic disorders. Breast or estrogen-dependent carcinoma. Hepatic dysfunction. Pregnancy (Cat.X). |
| Precautions |
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Patients with an intact uterus should almost always receive a progestin to avoid endometrial hyperplasia. Familial hyperlipoproteinemia. History of breast cancer. Hepatic insufficiency. Conditions aggravated by fluid retention. Endometriosis. Gallbladder disease. Bone disease associated with hypercalcemia. Do initial complete physical and repeat yearly (include Pap smear, mammogram, BP). Discontinue if jaundice occurs and during immobilization, or 2 weeks before surgery associated with increased risk of thromboembolism. Nursing mothers. |
| Adverse Reactions |
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See literature. Headache, local irritation, fluid retention, breakthrough bleeding, mastodynia, nausea, abdominal cramps, migraine, weight changes, chloasma, back pain; increased risk of estrogen-dependent carcinoma, thromboembolism. |
| How Supplied |
Vivelle—8
Vivelle-Dot—8, 24 |
| Additional Resources |
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• Related Prescribing Note |
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