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CLIMARA
Menopause and HRT
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Drug Name:

CLIMARA Rx

Generic Name and Formulations:
Estradiol 0.025mg/day, 0.0375mg/day, 0.05mg/day, 0.06mg/day, 0.075mg/day, 0.1mg/day; transdermal patch.

Company:
Bayer Healthcare Pharmaceuticals Inc.

Therapeutic Use:

Indications for CLIMARA:

Moderate-to-severe vasomotor symptoms of menopause. Vulvar or vaginal atrophy. Postmenopausal osteoporosis prevention. Hypoestrogenism.

Adult:

Use lowest effective dose for shortest duration. Apply 1 patch once weekly to lower abdomen or upper buttock (avoid breasts, waistline); rotate application sites. Hypoestrogenism: see full labeling. Other uses: initially one 0.025mg/day patch. Give cyclically (3 weeks on, 1 week off).

Children:

Not applicable.

Contraindications:

Undiagnosed abnormal genital bleeding. Known, suspected or history of breast cancer. Known or suspected estrogen-dependent neoplasia. Active DVT, PE or history of. Active arterial thromboembolic disease or history of. Known hepatic impairment or disease. Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders. Pregnancy.

Boxed Warning:

Endometrial and breast cancer. Cardiovascular disorders. Probable dementia.

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. History of hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, hypercalcemia, or retinal vascular lesions occur. Monitor thyroid function. Conditions aggravated by fluid retention. 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. Nursing mothers.

Pharmacological Class:

Estrogen.

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).

Adverse Reactions:

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

How Supplied:

Patches—4


Data provided by MPR.

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