Label Changes for:

Zestril (lisinopril) Tablets

August 2011

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) – August 2011 

 

 

Altace (ramipril) Tablets

Avapro (irbesartan) Tablets

Zestoretic (lisinopril and hydrochlorothiazide) Tablets

Zestril (lisinopril) Tablets

 

Avapro (irbesartan) Tablets

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 renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including irbesartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving irbesartan and NSAID therapy.
  • The antihypertensive effect of angiotensin II receptor antagonists, including irbesartan, may be attenuated by NSAIDs

 

Zestoretic (lisinopril and hydrochlorothiazide) Tablets

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 renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including lisinopril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving lisinopril and NSAID therapy.
  • The antihypertensive effect of ACE inhibitors, including lisinopril, may be attenuated by NSAIDs.

 

Altace (ramipril) Tablets

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 renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including ramipril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving ramipril and NSAID therapy.
  • The antihypertensive effect of ACE inhibitors, including ramipril, may be attenuated by NSAIDs.
Other
  • Neither ramipril nor its metabolites have been found to interact with food, digoxin, antacid, furosemide, cimetidine, indomethacin, and simvastatin. The co-administration of ramipril and warfarin did not adversely affect the anticoagulation effects of the latter drug. Additionally, co-administration of ramipril with phenprocoumon did not affect minimum phenprocoumon levels or interfere with the patients’ state of anticoagulation.

 

Zestril (lisinopril) Tablets

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 renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including lisinopril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving lisinopril and NSAID therapy.
  • The antihypertensive effect of ACE inhibitors, including lisinopril, may be attenuated by NSAIDs.

 

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