Generic Name and Formulations:
Estradiol hemihydrate 2.5mg/g; topical emulsion.
Medicis Pharmaceuticals Corp
Indications for ESTRASORB:
Moderate-to-severe vasomotor symptoms of menopause.
Apply contents of 2 pouches (3.48g) onto legs (thigh and calf) daily each morning; use 1 pouch per leg. May taper or discontinue at 3–6 month intervals.
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.
Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Increased risk of cardiovascular events (eg, MI, stroke, VTE); discontinue if occurs. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Breast cancer. Risk of probable dementia in women >65yrs of age. Gallbladder disease. Bone disease associated with hypercalcemia. Visual abnormalities. 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, pancreatitis, sudden partial or complete vision loss, sudden onset of proptosis, diplopia, or migraine occurs. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Nursing mothers.
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). Avoid applying near sunscreen (increases estradiol absorption). May interefere with lab tests (eg, aPTT/PTT, thyroid, other binding proteins, cholesterol, glucose tolerance).
See full labeling. Endometrial disorder, infection, breast pain, headache, sinusitis, pruritus, nausea, vomiting, breakthrough bleeding.