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U.S. Department of Health and Human Services

Safety

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Prinivil (lisinopril) Tablets

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

 

February 2013

Summary View

 

CONTRAINDICATIONS

  • Do not co-administer aliskiren with Prinivil in patients with diabetes
 

PRECAUTIONS

Drug Interactions
  • 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 Prinivil and other agents that affect the RAAS. Do not co-administer aliskiren with Prinivil in patients with diabetes. Avoid use of aliskiren with Prinivil in patients with renal impairment (GFR <60 ml/min).

 

November 2011 

Summary View

 

PRECAUTIONS

  • Dual blockade of the renin-angiotensin-aldosterone system: Dual blockade of the renin-angiotensin-aldosterone system is associated with increased risk of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure). Closely monitor blood pressure, renal function and electrolytes in patients.

PATIENT PACKAGE INSERT

What should I tell my doctor before taking?

Especially tell your doctor if you are taking:

  • other medicines to reduce blood pressure

 

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