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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 associated with menopause.

Adult:

Use lowest effective dose for shortest duration. 1 tab daily. Reevaluate periodically.

Children:

Not applicable.

Contraindications:

Undiagnosed abnormal uterine bleeding. Known, suspected or history of breast cancer. Known or suspected estrogen-dependent neoplasia. Active DVT, PE or history of. Active arterial thromboembolic disease or history of. Renal or hepatic impairment. Adrenal insufficiency. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Pregnancy.

Warnings/Precautions:

Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular disorders (eg, stroke, MI, DVT, VTE); discontinue if occurs or suspected. Manage risk factors for CVD and VTE appropriately. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Hyperkalemia or risk thereof. Endometrial, breast, or ovarian cancer. Risk of probable dementia in women ≥65yrs of age. Gallbladder disease. Bone disease associated hypercalcemia. Visual abnormalities. Hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, loss of vision, or hypercalcemia occurs. Hypothyroidism. Conditions aggravated by fluid retention (eg, cardiac or renal impairment). Hypoparathyroidism. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical (include BP, mammogram, PAP smear) and repeat annually. Nursing mothers.

Interactions:

Monitor serum K+ during 1st cycle with drugs that increase potassium (eg, ACE inhibitors, 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 antagonized by CYP3A4 inducers (eg, carbamazepine, phenytoin, rifampin, St. John's wort). May be affected by pro­tease inhibitors, NNRTIs. Avoid alcohol. Thyroid replacement therapy (may need dose adjustment). May interfere with lab tests (eg, PT, thyroid, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding proteins).

See Also:

ANGELIQ 0.25/0.5

Pharmacological Class:

Progestin + estrogen.

Adverse Reactions:

See full labeling. GI or abdominal pain, genital bleeding, breast pain/discomfort, headache, vaginal yeast infection, nausea, diarrhea, peripheral edema; thromboembolic disorders, hyperkalemia, dementia, gallbladder disease, hyponatremia.

Generic Availability:

NO

How Supplied:

Tabs—3 blister packs (28 tabs each)

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