Safety

Angeliq (drospirenone and estradiol) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

June 2015

Summary View

WARNINGS AND PRECAUTIONS

Hyperkalemia
  • Consider monitoring serum potassium concentrations during the first month of dosing in high-risk patients who take strong CYP3A4 inhibitors long-term and concomitantly. Strong CYP3A4 inhibitors include azole antifungals (for example, ketoconazole, itraconazole, voriconazole), human immunodeficiency virus (HIV)/hepatitis C virus (HCV) protease inhibitors (for example, indinavir, boceprevir), and clarithromycin.

 

February 2012 

Summary View 

CONTRAINDICATIONS

  • Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders 

WARNINGS and PRECAUTIONS

Hereditary Angioedema
  • Exogenous estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema.

 

Page Last Updated: 07/14/2015
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