Label Changes for:

Accuretic (quinapril hydrochloride/HCTZ) 10/12.5 mg, 20/12.5 mg, and 20/25 mg Tablets

September 2013

Changes have been made to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections of the safety label.

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

 

 

October 2013

PRECAUTIONS

Drug Interactions
  • Avoid concomitant use of aliskiren with Accuretic

 

September 2013

CONTRAINDICATIONS

  • Do not co-administer aliskiren with ACCURECTIC 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.
Drug Interactions
  • Agents the inhibit mTOR or DPP-IV: Patients taking concomitant mTOR inhibitor (e.g. temsirolimus) therapy may be at increased risk for angioedema.

PRECAUTIONS

Dual Blockade of the Renin-Angiotensin-Aldosterone System (RAS)
  • Do not co-administer aliskiren with ACCURETIC in patients with diabetes with renal impairment (GFR <60 mL/min/1.73 m2).
Drug Interactions
  • Non-steroidal Anti-inflammatory Drugs—the diuretic, natriuretic, and antihypertensive effects of thiazide diuretics may be reduced by concurrent administration of nonsteroidal anti-inflammatory agents.

 

October 2011

 

PRECAUTIONS

Drug Interactions

Other Agents

  • Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase – 2 Inhibitors (COX-2 Inhibitors): In patients who....

 

Hide
(web2)