COMBIPATCH 0.05/0.25mg Rx
Generic Name and Formulations:
Estradiol 0.05mg + norethindrone acetate 0.25mg; per day; transdermal system.
Indications for COMBIPATCH 0.05/0.25mg:
In women with an intact uterus: moderate-to-severe vasomotor symptoms of menopause, vulvar and vaginal atrophy, hypoestrogenism.
Use lowest effective dose for shortest duration. Apply to smooth, clean, dry area of lower abdomen (avoid breasts, waistline). Continuous combined regimen: 1 CombiPatch twice weekly for 28-day cycle; repeat. Continuous sequential regimen (use with 0.05mg/day estrogen patch): Use estrogen-only patch for first 14 days of cycle, then 1 CombiPatch twice-weekly for second 14 days of 28-day cycle; repeat. Rotate application site. Reevaluate at 3–6 month intervals to assess need.
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. Known hepatic impairment. Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders. Pregnancy.
Endometrial and breast cancer. Cardiovascular disorders. Probable dementia.
Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular disorders (eg, stroke, DVT, VTE); 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. Endometrial, breast, or ovarian cancer. Risk of probable dementia in women ≥65yrs of age. Gallbladder disease. Bone disease associated with hypercalcemia. Visual abnormalities. History of hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, hypercalcemia, or retinal vascular lesions occur. Monitor thyroid function. Conditions aggravated by fluid retention. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical and repeat yearly (include Pap smear, mammogram, BP). Reevaluate periodically. Nursing mothers.
Estrogen + progestin.
May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). May be antagonized CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John's wort). 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).
See full labeling. Headache, breast pain, dysmenorrhea, menstrual disorder, back pain, asthenia, respiratory disorders, application site reactions; elevated BP, hypercalcemia, thromboembolic disorders, gallbladder disease.
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