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Climara Pro Generic Name & Formulations
Legal Class
Rx
General Description
Estradiol 0.045mg + levonorgestrel 0.015mg; per day; transdermal system.
Pharmacological Class
Estrogen + progestin.
How Supplied
Patches—4
Manufacturer
Climara Pro Indications
Indications
Prevention of postmenopausal osteoporosis.
Limitations of Use
Consider only for women at significant risk of osteoporosis and should carefully consider non-estrogen medications.
Climara Pro Dosage and Administration
Adult
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
Not applicable.
Climara Pro Contraindications
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.
Climara Pro Boxed Warnings
Boxed Warning
Endometrial and breast cancer. Cardiovascular disorders. Probable dementia.
Climara Pro Warnings/Precautions
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 Pharmacokinetics
See Literature
Climara Pro Interactions
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).
Climara Pro Adverse Reactions
Adverse Reactions
Application site reactions, vaginal bleeding, breast pain, upper respiratory infection, back pain, depression, headache, flu syndrome, elevated BP.
Climara Pro Clinical Trials
See Literature
Climara Pro Note
Not Applicable
Climara Pro Patient Counseling
See Literature
Climara Pro Generic Name & Formulations
Legal Class
Rx
General Description
Estradiol 0.045mg + levonorgestrel 0.015mg; per day; transdermal system.
Pharmacological Class
Estrogen + progestin.
How Supplied
Patches—4
Manufacturer
Climara Pro Indications
Indications
Moderate to severe vasomotor symptoms of menopause.
Climara Pro Dosage and Administration
Adult
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
Not applicable.
Climara Pro Contraindications
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.
Climara Pro Boxed Warnings
Boxed Warning
Endometrial and breast cancer. Cardiovascular disorders. Probable dementia.
Climara Pro Warnings/Precautions
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 Pharmacokinetics
See Literature
Climara Pro Interactions
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).
Climara Pro Adverse Reactions
Adverse Reactions
Application site reactions, vaginal bleeding, breast pain, upper respiratory infection, back pain, depression, headache, flu syndrome, elevated BP.
Climara Pro Clinical Trials
See Literature
Climara Pro Note
Not Applicable
Climara Pro Patient Counseling
See Literature
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