Generic Name and Formulations:
Estradiol 0.05mg/day, 0.1mg/day; transdermal patch.
Novartis Pharmaceuticals Corp
Indications for VIVELLE:
Moderate to severe vasomotor symptoms of menopause. Vulvar or vaginal atrophy. Postmenopausal osteoporosis prevention. Hypoestrogenism.
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 full labeling. 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.
Undiagnosed abnormal genital bleeding. Known, suspected or history of breast cancer. Known or suspected estrogen-dependent neoplasia. Active DVT, PE or history of. Active arterial thromboembolic disease or history of. Hepatic impairment. Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders. Pregnancy (Cat.X).
Increased risk of cardiovascular disorders (eg, stroke, DVT). Endometrial or breast cancer. Risk of probable dementia in women >65yrs of age. Gallbladder disease. Bone disease associated with hypercalcemia. Visual abnormalities. Consider the addition of a progestin in patients with an intact uterus to avoid endometrial hyperplasia. History of hypertriglyceridemia. Hepatic impairment. Monitor thyroid function. Conditions aggravated by fluid retention. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Caution in asthma, diabetes, epilepsy, migraines, porphyria, SLE, hepatic hemangiomas. Do initial complete physical and repeat yearly (include Pap smear, mammogram, BP). Discontinue if jaundice, cardiac events, severe hypercalcemia or pancreatitis occurs. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Nursing mothers.
Antagonized by CYP3A4 inducers (eg, St. John's wort, phenobarbital, carbamazepine, rifampin). Potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir), grapefruit juice.
See full labeling. Headache, breast tenderness, local irritation, fluid retention, breakthrough bleeding, back pain, nasopharyngitis, influenza, mastodynia, nausea, abdominal cramps, migraine, weight changes, chloasma; increased risk of estrogen-dependent carcinoma, thromboembolism, stroke, dementia.