Prinzide (lisinopril hydrochlorothiazide) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2013
- Do not co-administer aliskiren with Prinzide in patients with diabetes
- Dual blockade of the renin-angiotensin-aldosterone system (RAAS) with angiotensin receptor blockers, ACE inhibitors, or direct renin inhibitors (such as aliskiren) is associated with increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Closely monitor blood pressure, renal function and electrolytes in patients on Prinzide and other agents that affect the RAAS. Do not co-administer aliskiren with Prinzide in patients with diabetes. Avoid use of aliskiren with Prinzide in patients with renal impairment (GFR <60 ml/min).