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MENOSTAR
Menopause and HRT
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Drug Name:

MENOSTAR Rx

Generic Name and Formulations:
Estradiol 14mcg/day; transdermal system.

Company:
Bayer Healthcare Pharmaceuticals Inc.

Therapeutic Use:

Indications for MENOSTAR:

Prevention of postmenopausal osteoporosis. Limitations of use: consider therapy only for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.

Adult:

Use lowest effective dose for shortest duration. Apply to clean, dry area of lower abdomen (avoid breasts, waistline). One patch (14mcg/day) once weekly. Rotate application sites.

Children:

Not applicable.

Contraindications:

Undiagnosed abnormal genital bleeding. Breast or other estrogen-dependent neoplasms. Thromboembolic disorders (eg, DVT, PE, stroke, MI). Protein C, protein S, or antithrombin deficiency, or other thrombophilias. Hepatic impairment or disease. Pregnancy.

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 events (eg, MI, stroke, VTE); discontinue if occurs. 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. Severe hypercalcemia in breast cancer or bone metastases. 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. ESRD on hemodialysis. Do initial complete physical and repeat annually (include Pap smear, mammogram, and BP). Reevaluate periodically. Nursing mothers: not recommended.

Pharmacological Class:

Estrogen.

Interactions:

May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). May be antagonized CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John's wort). 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:

Upper respiratory tract infections, pain, arthralgia, leukorrhea, local irritation; thromboembolism, neoplasms.

How Supplied:

Transdermal systems—4

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