Climara Pro

— THERAPEUTIC CATEGORIES —
  • Bone disorders
  • Menopause and HRT

Climara Pro Generic Name & Formulations

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

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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