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Label Changes for:

Accupril (quinapril hydrochloride) Tablets

October 2013

Changes have been made to the PRECAUTIONS sections of the safety label.

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

 

October 2013

PRECAUTIONS

Dual Blockade of the Renin-Angiotensin-Aldosterone System (RAS)
  • Avoid concomitant use of aliskiren with Accupril

 

 

September 2013

CONTRAINDICATIONS

  • Do not co-administer aliskiren with ACCUPRIL in patients with diabetes or in patients with renal impairment (GFR < 60 mL/min/1.73 m2)

WARNINGS

Anaphylactoid and Possibly Related Reactions
  • Patients taking concomitant mTOR inhibitor (e.g. temsirolimus) therapy may be at increased risk for angioedema.

PRECAUTIONS

Drug Interactions
  • Agents the inhibit mTOR: Patients taking concomitant mTOR inhibitor (e.g. temsirolimus) therapy may be at increased risk for angioedema.
Dual Blockade of the Renin-Angiotensin-Aldosterone System (RAS)

the following text was added/deleted:

  • Do not co-administer aliskiren with ACCUPRIL in patients with diabetes with renal impairment (GFR <60 mL/min/1.73 m2).

 

October 2011

 

PRECAUTIONS

Drug Interactions
  • Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase – 2 Inhibitors (COX-2 Inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised...

 

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