Climara

— 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 Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Estradiol 0.025mg/day, 0.0375mg/day, 0.05mg/day, 0.06mg/day, 0.075mg/day, 0.1mg/day; transdermal patch.

    Pharmacological Class

    Estrogen.

    How Supplied

    Patches—4

    Manufacturer

    Bayer Corporation

    Generic Availability

    YES

    Mechanism of Action

    Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. 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.

    Climara 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 Dosage and Administration

    Adult

    Use lowest effective dose for shortest duration. Apply 1 patch to lower abdomen or upper buttock (avoid breasts, waistline); rotate application sites. Initially one 0.025mg/day patch once weekly; adjust dose based on clinical response. 

    Children

    Not applicable.

    Climara Contraindications

    Contraindications

    Undiagnosed abnormal genital bleeding. Breast cancer or history of. Estrogen-dependent neoplasia. Active DVT, PE, or history of. Active arterial thromboembolic disease (eg, stroke, MI), or history of. Hepatic impairment or disease. Protein C, protein S, or antithrombin deficiency or other thrombophilic disorders.

    Climara Boxed Warnings

    Boxed Warning

    Endometrial and breast cancer. Cardiovascular disorders. Probable dementia.

    Climara Warnings/Precautions

    Warnings/Precautions

    Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). 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. Increased risk of 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 Pharmacokinetics

    Absorption

    Average peak estradiol concentrations: ~100 pg/mL (with 25cm2 patch).

    Distribution

    Estrogens are widely distributed and are largely bound to SHBG and albumin.

    Metabolism

    Hepatic.

    Elimination

    Renal. 

    Climara 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. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).

    Climara Adverse Reactions

    Adverse Reactions

    Breast pain, upper respiratory tract infections, headache, abdominal pain, edema, local irritation, breakthrough bleeding, elevated BP, intolerance to contact lenses.

    Climara Clinical Trials

    See Literature

    Climara Note

    Not Applicable

    Climara Patient Counseling

    See Literature

    Climara Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Estradiol 0.025mg/day, 0.0375mg/day, 0.05mg/day, 0.06mg/day, 0.075mg/day, 0.1mg/day; transdermal patch.

    Pharmacological Class

    Estrogen.

    How Supplied

    Patches—4

    Manufacturer

    Bayer Corporation

    Generic Availability

    YES

    Mechanism of Action

    Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. 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.

    Climara Indications

    Indications

    Moderate to severe vasomotor symptoms of menopause. Moderate to severe vulvar or vaginal atrophy due to menopause. Hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.

    Limitations of Use

    For vulvar and vaginal atrophy: first consider topical vaginal products. 

    Climara Dosage and Administration

    Adult

    Use lowest effective dose for shortest duration. Apply 1 patch to lower abdomen or upper buttock (avoid breasts, waistline); rotate application sites. Initially one 0.025mg/day patch once weekly; adjust dose based on clinical response. For vasomotor, vulvar/vaginal atrophy symptoms: attempt to taper or discontinue at 3–6 month intervals.

    Children

    Not applicable.

    Climara Contraindications

    Contraindications

    Undiagnosed abnormal genital bleeding. Breast cancer or history of. Estrogen-dependent neoplasia. Active DVT, PE, or history of. Active arterial thromboembolic disease (eg, stroke, MI), or history of. Hepatic impairment or disease. Protein C, protein S, or antithrombin deficiency or other thrombophilic disorders.

    Climara Boxed Warnings

    Boxed Warning

    Endometrial and breast cancer. Cardiovascular disorders. Probable dementia.

    Climara Warnings/Precautions

    Warnings/Precautions

    Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). 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. Increased risk of 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 Pharmacokinetics

    Absorption

    Average peak estradiol concentrations: ~100 pg/mL (with 25cm2 patch).

    Distribution

    Estrogens are widely distributed and are largely bound to SHBG and albumin.

    Metabolism

    Hepatic.

    Elimination

    Renal. 

    Climara 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. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).

    Climara Adverse Reactions

    Adverse Reactions

    Breast pain, upper respiratory tract infections, headache, abdominal pain, edema, local irritation, breakthrough bleeding, elevated BP, intolerance to contact lenses.

    Climara Clinical Trials

    See Literature

    Climara Note

    Not Applicable

    Climara Patient Counseling

    See Literature

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