Menopause and HRT:

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 Dosage:

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

Children Dosage:

Not applicable.

MENOSTAR Contraindications:

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

Boxed Warning:

Endometrial cancer. Cardiovascular disorders. Probable dementia. Breast cancer.

MENOSTAR 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); 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. Severe hypercalcemia in breast cancer or bone metastases. Visual abnormalities. Pre-existing hypertriglyceridemia. History of cholestatic jaundice. Discontinue if cholestatic jaundice, pancreatitis, hypercalcemia, or retinal vascular lesions occur. Monitor thyroid function. Monitor conditions aggravated by fluid retention (eg, cardiac or renal impairment); discontinue if medically concerning 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. Pregnancy: not indicated. Nursing mothers: not recommended.

MENOSTAR Classification:


MENOSTAR 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, anaphylaxis.

Generic Drug Availability:


How Supplied:

Transdermal systems—4