Monograph Details
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Ob/Gyn
> Menopause and HRT
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ANGELIQ |
| Manufacturer |
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Bayer Corp, Pharmaceutical Div. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Estrogen + progestin. |
| Generic Name |
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Estradiol 1mg, drospirenone 0.5mg; tabs. |
| Indications |
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In women with an intact uterus: moderate to severe vasomotor symptoms of menopause; moderate to severe vulvar and vaginal atrophy associated with menopause. |
| Children |
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Not applicable. |
| Adults |
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1 tab daily. Reevaluate periodically. |
| Contraindications |
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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 |
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Use for shortest duration and 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 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. |
| Interactions |
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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. |
| Adverse Reactions |
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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 |
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Tabs—84 |
| Additional Resources |
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• Related Prescribing Note |
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