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Angeliq 0.5/1 Generic Name & Formulations
Legal Class
Rx
General Description
Drospirenone 0.5mg, estradiol 1mg; tabs.
Pharmacological Class
Progestin + estrogen.
See Also
How Supplied
Blister packs (28 tabs)—3
Manufacturer
Generic Availability
NO
Angeliq 0.5/1 Indications
Indications
In women with an intact uterus: moderate to severe vasomotor symptoms of menopause; moderate to severe vulvar and vaginal atrophy due to menopause.
Angeliq 0.5/1 Dosage and Administration
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.
Angeliq 0.5/1 Contraindications
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.
Angeliq 0.5/1 Boxed Warnings
Boxed Warning
Cardiovascular disorders. Endometrial cancer and breast cancer. Probable dementia.
Angeliq 0.5/1 Warnings/Precautions
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.
Angeliq 0.5/1 Pharmacokinetics
See Literature
Angeliq 0.5/1 Interactions
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).
Angeliq 0.5/1 Adverse Reactions
Adverse Reactions
Abdominal pain, female genital tract bleeding, breast pain/discomfort, headache; thromboembolism, neoplasms.
Angeliq 0.5/1 Clinical Trials
See Literature
Angeliq 0.5/1 Note
Not Applicable
Angeliq 0.5/1 Patient Counseling
See Literature
