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ANGELIQ 0.5/1
Menopause and HRT
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Drug Name:

ANGELIQ 0.5/1 Rx

Generic Name and Formulations:
Drospirenone 0.5mg, estradiol 1mg; tabs.

Company:
Bayer Healthcare Pharmaceuticals Inc.

Therapeutic Use:

Indications for ANGELIQ 0.5/1:

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

Adult:

Swallow whole. Give continuously. Vasomotor symptoms: 0.25mg/0.5mg or 0.5mg/1mg tab once daily. Vulvar and vaginal atrophy: 0.5mg/1mg tab once daily.

Children:

Not applicable.

Contraindications:

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

Boxed Warning:

Cardiovascular disorders. Endometrial cancer and breast cancer. Probable dementia.

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 events (eg, MI, stroke, VTE); discontinue if occurs. 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. Increased risk of hyperkalemia or hyponatremia in high-risk patients. Gallbladder disease. Severe hypercalcemia in breast cancer or bone metastases. Visual abnormalities. History of hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, hypercalcemia, or retinal vascular lesions occur. Monitor thyroid function. Conditions aggravated by fluid retention. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical and repeat annually (include Pap smear, mammogram, and BP). Reevaluate periodically. Nursing mothers: not recommended.

See Also:

ANGELIQ 0.25/0.5

Pharmacological Class:

Progestin + estrogen.

Interactions:

Monitor serum K+ during 1st cycle with drugs that increase potassium (eg, ACEIs, ARBs, NSAIDs, K+-sparing diuretics, K+ supplements, heparin, aldosterone antagonists); consider monitoring in high-risk patients taking concomitant long-term strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, voriconazole, indinavir, boceprevir, clarithromycin). May be potentiated by CYP3A4 inhibitors (eg, azoles, verapamil, macrolides, diltiazem, grapefruit juice). May be antagonized by CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John’s wort). May be affected by pro­tease inhibitors, NNRTIs. Avoid alcohol. 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:

Abdominal pain, female genital tract bleeding, breast pain/discomfort, headache; thromboembolism, neoplasms.

Generic Availability:

NO

How Supplied:

Blister packs (28 tabs)—3


Data provided by MPR.

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