Bone disorders:
Indications for: CLIMARA PRO
Prevention of postmenopausal osteoporosis.
Limitations of Use:
Consider only for women at significant risk of osteoporosis and should carefully consider non-estrogen medications.
Adult Dosage:
Use lowest effective dose and for the shortest duration. Apply 1 patch once weekly to lower abdomen or upper buttock (avoid breasts, waistline); rotate application sites.
Children Dosage:
Not applicable.
CLIMARA PRO Contraindications:
Undiagnosed abnormal genital bleeding. Breast cancer or history of. Estrogen-dependent neoplasia. Active DVT, PE or history of. Active arterial thromboembolic disease or history of. Hepatic impairment or disease. Protein C, protein S, or antithrombin deficiency or other thrombophilic disorders.
Boxed Warning:
Endometrial and breast cancer. Cardiovascular disorders. Probable dementia.
CLIMARA PRO Warnings/Precautions:
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. Permanently discontinue if papilledema or retinal vascular lesions reveals on exam. History of hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, or hypercalcemia occurs. Monitor thyroid function. Monitor conditions that may predispose to fluid retention (eg, cardiac or renal impairment); discontinue if medically concerning fluid retention occurs. 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.
CLIMARA PRO Classification:
Estrogen + progestin.
CLIMARA PRO 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. 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).
Adverse Reactions:
Application site reactions, vaginal bleeding, breast pain, upper respiratory infection, back pain, depression, headache, flu syndrome, elevated BP.
How Supplied:
Patches—4
Menopause and HRT:
Indications for: CLIMARA PRO
Moderate to severe vasomotor symptoms of menopause.
Adult Dosage:
Use lowest effective dose and for the shortest duration. Apply 1 patch once weekly to lower abdomen or upper buttock (avoid breasts, waistline); rotate application sites.
Children Dosage:
Not applicable.
CLIMARA PRO Contraindications:
Undiagnosed abnormal genital bleeding. Breast cancer or history of. Estrogen-dependent neoplasia. Active DVT, PE or history of. Active arterial thromboembolic disease or history of. Hepatic impairment or disease. Protein C, protein S, or antithrombin deficiency or other thrombophilic disorders.
Boxed Warning:
Endometrial and breast cancer. Cardiovascular disorders. Probable dementia.
CLIMARA PRO Warnings/Precautions:
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. Permanently discontinue if papilledema or retinal vascular lesions reveals on exam. History of hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, or hypercalcemia occurs. Monitor thyroid function. Monitor conditions that may predispose to fluid retention (eg, cardiac or renal impairment); discontinue if medically concerning fluid retention occurs. 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.
CLIMARA PRO Classification:
Estrogen + progestin.
CLIMARA PRO 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. 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).
Adverse Reactions:
Application site reactions, vaginal bleeding, breast pain, upper respiratory infection, back pain, depression, headache, flu syndrome, elevated BP.
How Supplied:
Patches—4
