Angeliq 0.5/1

  • Menopause and HRT

Angeliq 0.5/1 Generic Name & Formulations

General Description

Drospirenone 0.5mg, estradiol 1mg; tabs.

Pharmacological Class

Progestin + estrogen.

See Also

How Supplied

Blister packs (28 tabs)—3


Generic Availability


Angeliq 0.5/1 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


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.


Not applicable.

Angeliq 0.5/1 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


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


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