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U.S. Department of Health and Human Services

Safety

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Accupril (quinapril hydrochloride) Tablets

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

 

May 2014

Summary View

CONTRAINDICATIONS

  • Do not co-administer ACCUPRIL with aliskiren in patients with diabetes....added

DRUG INTERACTIONS
 

  • ...added... Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors.

 

October 2013

Summary View

PRECAUTIONS

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

 

 

September 2013

Summary View

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

Summary View

 

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...