Company:

Berlex

Estrogen+ progestin

Estradiol 1mg, drospirenone 0.5mg; tabs.

In women with an intact uterus: moderate to severe vasomotor symptoms of menopause; moderate to severe vulvar and vaginal atrophy associated with menopause.

Angeliq combines the estrogen, estradiol, with the progestin, drospirenone, to treat moderate to severe symptoms of menopause. If this product is being used solely for the symptoms of genital atrophy, the use of topical vaginal products should be considered.

Bioequivalency studies comparing the estrogen component of Angeliq to that of a currently-marketed product, Estrace (estradiol tablets, from Warner Chilcott), were conducted in order to provide support for the treatment of vasomotor symptoms and vaginal and vulvar atrophy. A multi-dose bioequivalence study evaluated the equivalence of estradiol from a tablet containing drospirenone 2mg and estradiol 1mg relative to Estrace 1mg. The combination product met the criteria for bioequivalence to Estrace.

Several large studies were conducted to establish the safety and efficacy of Angeliq in providing endometrial protection along with an acceptable bleeding profile. A one-year study involving 227 women given Angeliq and 226 women given estradiol 1mg yielded no diagnoses of endometrial hyperplasia in the Angeliq group.

1 tab daily. Reevaluate periodically.

Not applicable.

Breast or estrogen-dependent carcinoma. Thromboembolic disorders. Undiagnosed abnormal genital bleeding. Renal or adrenal insufficiency. Liver dysfunction or disease. Other conditions that may predispose to hyperkalemia. Pregnancy (Cat.X).

Use for shortest duration and lowest dose consistent with treatment goals and risks. Endometrial hyperplasia. Gallbladder disease. Hypercoagulability. Hypocalcemia. Familial hypercholesterol-emia. Bone disease associated with hypercalcemia. Do initial complete physical (include BP, mammogram, PAP smear) and repeat annually. Conditions aggravated by fluid retention. Discontinue if visual disturbances or jaundice occurs and during immobilization, or at least 2 weeks before surgery associated with thromboembolism. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. May aggravate asthma, diabetes, epilepsy, migraine, porphyria, SLE, hepatic hemangiomas. May interfere with lab tests (eg, thyroid, PT, glucose tolerance, HDL-C/LDL-C). Nursing mothers.

Consider monitoring serum potassium (esp during 1st cycle) with ACEIs, ARBs, NSAIDs, K+-sparing diuretics, K+-supplements, heparin, others that may cause hyperkalemia. Thyroid replacement therapy (may need dose adjustment). Estrogen may be antagonized by CYP3A4 inducers. Estrogen may be potentiated by CYP3A4 inhibitors.

See literature. Increased risk of hyponatremia, gallbladder disease, thromboembolic disorders, dementia, breast and ovarian cancer. GI upset/pain, irregular bleeding, headache, edema, hypertension, mastodynia, chloasma, others.

Tabs—84

1/4/07