Generic Name and Formulations:
Estradiol 0.05mg/day, 0.1mg/day; transdermal patch.
Novartis Pharmaceuticals Corp
Indications for ESTRADERM:
Moderate to severe vasomotor symptoms of menopause. Moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Hypoestrogenism. Osteoporosis prevention.
Initially one 0.05mg/day patch twice per week applied to trunk (avoid breasts, waistline). May be given continuously if patient does not have an intact uterus or cyclically (3 weeks on, 1 week off) in patients with intact uterus. Rotate application sites. Reevaluate periodically. Osteoporosis: supplement diet with calcium 1.5 g/day and Vitamin D 400–800IU/day.
Undiagnosed abnormal genital bleeding. Known, suspected or history of breast cancer. Known or suspected estrogen-dependent neoplasia. Active DVT, PE, or a history of these conditions. Active arterial thromboembolic disease (eg, stroke, MI), or a history of these conditions. Known liver impairment or disease. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Known or suspected pregnancy (Cat.X).
Family history of breast cancer. Coronary artery or cerebrovascular disease. Hepatic dysfunction. Conditions aggravated by fluid retention. Endometriosis. Gallbladder disease. Bone disease associated with hypercalcemia. Do initial complete physical and repeat annually (include BP, mammogram, and PAP smear). Discontinue if hypercalcemia or jaundice occurs. Hypertriglyceridemia. Hypothyroidism. Hypoparathyroidism. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangioma. Nursing mothers.
See literature. Increased risk of endometrial cancer or hyperplasia, gallbladder disease. Local irritation, fluid retention, breakthrough bleeding, weight or menstrual changes, mastodynia, nausea, abdominal cramps, headache, migraine, dizziness; anaphylactic reaction, angioedema (discontinue if occurs).
Hepatic (CYP1A2, CYP3A4).