Climara Pro

— THERAPEUTIC CATEGORIES —
  • Bone disorders
  • Menopause and HRT
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • 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

    Bayer Corporation

    Generic Availability

    NO

    Mechanism of Action

    Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH), and FSH, through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women. Levonorgestrel inhibits gonadotropin production resulting in retardation of follicular growth and inhibition of ovulation.

    Climara Pro Indications

    Indications

    Prevention of postmenopausal osteoporosis.

    Limitations of Use

    First consider non-estrogen medications. Consider therapy only for women at significant risk of osteoporosis.

    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

    Cardiovascular disorders. Probable dementia. Breast and endometrial cancer.

    Climara Pro Warnings/Precautions

    Warnings/Precautions

    Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular disorders (eg, stroke, MI, PE, DVT); 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

    Absorption

    Mean time to maximum concentrations in serum: ~2 to 2.5 days. Steady-state concentration: ~35.7 pg/mL (estradiol); 166 pg/mL (levonorgestrel).

    Distribution

    Estrogens are widely distributed and are largely bound to SHBG and albumin. Levonorgestrel in serum is bound to both SHBG and albumin.

    Metabolism

    Hepatic.

    Elimination

    Renal. Half-life: 3 ± 0.67 hours (estradiol); 28 ± 6.4 hours (levonorgestrel).

    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

    Bayer Corporation

    Generic Availability

    NO

    Mechanism of Action

    Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH), and FSH, through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women. Levonorgestrel inhibits gonadotropin production resulting in retardation of follicular growth and inhibition of ovulation.

    Climara Pro Indications

    Indications

    Moderate to severe vasomotor symptoms due to 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. Attempt to discontinue at 3–6 month intervals.

    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

    Cardiovascular disorders. Probable dementia. Breast and endometrial cancer.

    Climara Pro Warnings/Precautions

    Warnings/Precautions

    Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular disorders (eg, stroke, MI, PE, DVT); 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

    Absorption

    Mean time to maximum concentrations in serum: ~2 to 2.5 days. Steady-state concentration: ~35.7 pg/mL (estradiol); 166 pg/mL (levonorgestrel).

    Distribution

    Estrogens are widely distributed and are largely bound to SHBG and albumin. Levonorgestrel in serum is bound to both SHBG and albumin.

    Metabolism

    Hepatic.

    Elimination

    Renal. Half-life: 3 ± 0.67 hours (estradiol); 28 ± 6.4 hours (levonorgestrel).

    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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