CLIMARA PRO Rx
Generic Name and Formulations:
Estradiol 0.045mg + levonorgestrel 0.015mg; per day; transdermal system.
Indications for CLIMARA PRO:
Moderate-to-severe vasomotor symptoms of menopause in women with an intact uterus. Postmenopausal osteoporosis prevention.
Apply 1 patch once weekly to lower abdomen or upper buttock (avoid breasts, waistline); rotate application sites.
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 or disease. Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders. Pregnancy.
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 annually (include Pap smear, mammogram, BP). Reevaluate periodically. 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). Concomitant thyroid replacement; may need to increase thyroid dose. Levonorgestrel may be affected by CYP3A, CYP2E and CYP2C inhibitors or inducers. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).
Estrogen + progestin.
Application site reactions, vaginal bleeding, breast pain, upper respiratory infection, back pain, depression, headache, flu syndrome, elevated BP.
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