Label Changes for:
Accuretic (quinapril hydrochloride/HCTZ) 10/12.5 mg, 20/12.5 mg, and 20/25 mg Tablets
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)
- Avoid concomitant use of aliskiren with Accuretic
- Do not co-administer aliskiren with ACCURECTIC in patients with diabetes or in patients with renal impairment (GFR < 60 mL/min/1.73 m2).
Anaphylactoid and Possibly Related Reactions
- Patients taking concomitant mTOR inhibitor (e.g. temsirolimus) therapy may be at increased risk for angioedema.
- Agents the inhibit mTOR or DPP-IV: 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)
- Do not co-administer aliskiren with ACCURETIC in patients with diabetes with renal impairment (GFR <60 mL/min/1.73 m2).
- 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.
- Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase – 2 Inhibitors (COX-2 Inhibitors): In patients who....