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Label Changes for:

Accupril (quinapril hydrochloride) Tablets

September 2015

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)  

September 2015

PRECAUTIONS

Hyperkalemia and potassium sparing diuretics
  • Risk factors … that raise serum potassium levels. Monitor serum potassium in such patients.
Drug Interactions
  • Coadministration of Accupril with potassium sparing diuretics, potassium supplements, potassium-containing salt substitutes or other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients.

 

May 2014

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

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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