Menostar Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
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.
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