Menostar

— THERAPEUTIC CATEGORIES —
  • Bone disorders

Menostar Generic Name & Formulations

General Description

Estradiol 14mcg/day; transdermal system.

Pharmacological Class

Estrogen.

How Supplied

Transdermal systems—4

Manufacturer

Generic Availability

NO

Mechanism of Action

Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and follicle stimulating hormone (FSH) through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women.

Menostar Indications

Indications

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.

Menostar Dosage and Administration

Adult

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

Not applicable.

Menostar Contraindications

Contraindications

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

Menostar Boxed Warnings

Boxed Warning

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

Menostar 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. Severe hypercalcemia in breast cancer or bone metastases. Visual abnormalities. Permanently discontinue if papilledema or retinal vascular lesions reveals on exam. Pre-existing hypertriglyceridemia. History of cholestatic jaundice. Discontinue if cholestatic jaundice, pancreatitis, or hypercalcemia occurs. 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 Pharmacokinetics

Distribution

Estrogens are widely distributed in the body and largely bound to SHBG and albumin.

Metabolism

Hepatic.

Elimination

Renal.

Menostar Interactions

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).

Menostar Adverse Reactions

Adverse Reactions

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

Menostar Clinical Trials

See Literature

Menostar Note

Not Applicable

Menostar Patient Counseling

See Literature