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Vivelle-dot Generic Name & Formulations
Legal Class
Rx
General Description
Estradiol 0.025mg/day, 0.0375mg/day, 0.05mg/day, 0.075mg/day, 0.1mg/day; transdermal system.
Pharmacological Class
Estrogen.
See Also
How Supplied
Patches—8, 24
Manufacturer
Generic Availability
YES
Vivelle-dot Indications
Indications
Moderate to severe vasomotor symptoms of menopause. Vulvar or vaginal atrophy due to menopause. Postmenopausal osteoporosis prevention. Hypoestrogenism.
Vivelle-dot Dosage and Administration
Adult
Apply to clean, dry, intact skin (not to breasts or waist) on lower abdomen; rotate application sites. Use lowest effective dose for shortest duration. 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.
Children
Not established.
Vivelle-dot Contraindications
Contraindications
Undiagnosed abnormal genital bleeding. Arterial thromboembolic disorders (eg, DVT, PE, stroke, MI). Protein C, protein S, or antithrombin deficiency or other thrombophilias. Breast or other estrogen-dependent neoplasms. Hepatic impairment or disease.
Vivelle-dot Boxed Warnings
Boxed Warning
Endometrial cancer. Cardiovascular disorders. Probable dementia. Breast cancer.
Vivelle-dot Warnings/Precautions
Warnings/Precautions
Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular disorders (eg, stroke, DVT); discontinue if occurs or suspected. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Increased risk of breast or ovarian cancer. Risk of probable dementia in women ≥65yrs of age. Gallbladder disease. Bone disease associated with hypercalcemia. Visual abnormalities. Pre-existing hypertriglyceridemia. History of cholestatic jaundice. Discontinue if cholestatic jaundice, pancreatitis, hypercalcemia, or retinal vascular lesions occur. Monitor thyroid function. Monitor conditions aggravated by fluid retention (eg, cardiac or renal impairment); discontinue if medically concerning fluid retention. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical and repeat annually (include Pap smear, mammogram, BP). Reevaluate periodically. Pregnancy: not indicated. Nursing mothers.
Vivelle-dot Pharmacokinetics
See Literature
Vivelle-dot Interactions
Interactions
May be antagonized by CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John’s wort). May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, and grapefruit juice). Concomitant thyroid replacement; may need to increase thyroid dose. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).
Vivelle-dot Adverse Reactions
Adverse Reactions
Headache, local reactions (eg, erythema, pruritus, rash), back pain, irregular vaginal bleeding, spotting, breast tenderness, nasopharyngitis, sinusitis, upper RTI, depression; thromboembolism, neoplasms, anaphylaxis.
Vivelle-dot Clinical Trials
See Literature
Vivelle-dot Note
Not Applicable
Vivelle-dot Patient Counseling
See Literature
