Angeliq- Another choice for menopause therapy

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Company:

Berlex

Pharmacologic class:

Estrogen + progestin

Active ingredients:

Estradiol 1 mg, drospirenone 0.5 mg; tabs.

Indication:

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

Pharmacology:

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.

Clinical trials:

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 multidose bioequivalence study evaluated the equivalence of estradiol from a tablet containing drospirenone 2 mg and estradiol 1 mg relative to Estrace 1 mg. 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 1 mg yielded no diagnoses of endometrial hyperplasia in the Angeliq group.

Adults:

1 tab daily. Re-evaluate periodically.

Children:

Not applicable.

Contraindications:

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).

Precautions:

Use for shortest duration at lowest dose consistent with treatment goals and risks. Endometrial hyperplasia. Gallbladder disease. Hypercoagulability. Hypocalcemia. Familial hypercholesterolemia. 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 two weeks before surgery associated with thromboembolism. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. May aggravate asthma, diabetes, epilepsy, migraine, porphyria, systemic lupus erythematosus, hepatic hemangiomas. May interfere with lab tests (e.g., thyroid, prothrombin time, glucose tolerance, HDL/ LDL). Nursing mothers.

Interactions:

Consider monitoring serum potassium (especially during first cycle) with ACE inhibitors, angiotensin receptor blockers, nonsteroidal anti-inflammatory drugs, potassium-sparing diuretics, potassium supplements, heparin, others that may cause hyperkalemia. Thyroid re- placement therapy (may need dose adjustment). Estrogen may be antagonized by CYP3A4 inducers. Estrogen may be potentiated by CYP3A4 inhibitors.

Adverse reactions:

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.

How supplied:

Tabs—84.

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