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MENOSTAR
Menopause and HRT
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Drug Name:

MENOSTAR Rx

Generic Name and Formulations:
Estradiol 0.014mg/day; transdermal patch.

Company:
Bayer Healthcare Pharmaceuticals Inc.

Therapeutic Use:

Indications for MENOSTAR:

Postmenopausal osteoporosis prevention. 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 once weekly. Rotate application sites.

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. Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders. Pregnancy (Cat.X).

Warnings/Precautions:

Not for prevention of cardiovascular disease. Increased risk of cardiovascular disorders (eg, stroke, DVT, VTE); discontinue if occurs or suspected. 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. Consider the addition of a progestin in patients with an intact uterus to avoid endometrial hyperplasia. 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 yearly (include Pap smear, mammogram, BP). Reevaluate periodically. Nursing mothers.

Interactions:

Antagonized by CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John’s Wort). Potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, 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).

Pharmacological Class:

Estrogen.

Adverse Reactions:

See full labeling. Upper respiratory tract infections, pain, arthralgia, leukorrhea, local irritation; elevated BP, hypercalcemia, thromboembolic disorders, gallbladder disease, endometrial cancer or hyperplasia.

How Supplied:

Patches—4

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