Label Changes for:

Azor (amlodipine/olmesartan medoxomil) 5/20 mg, 5/40 mg, 10/20 mg and 10/40 mg Tablets

September 2012

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

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

 

 

November 2012

  • Exforge (amlodipine/valsartan) Tablets
  • Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) Tablets

 

 

September 2012 

  • Accupril (quinapril hydrochloride) 5 mg, 10 mg, 20 mg and 40 mg Tablets
  • Accuretic (quinapril HCL/hydrochlorothiazide) 10/12.5 mg, 20/12.5 mg and 20/25 mg Tablets
  • Avapro (irbesartan) 75 mg, 150 mg, and 300 mg tablets
  • Azor (amlodipine/olmesartan medoxomil) 5/20 mg, 5/40 mg, 10/20 mg and 10/40 mg Tablets
  • Benicar (olmesartan medoxomil) 5 mg 20 mg and 40 mg Tablets
  • Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) 20/12.5 mg, 40/12.5 mg and 40/25 mg Tablets
  • Cozaar (losartan potassium) 25 mg, 50 mg and 100 mg Tablets
  • Hyzaar (losartan potassium/HCTZ) 50/12.5 mg, 100/25 mg, and 100/12.5 mg Tablets
  • Lotensin (benazepril HCl) 5 mg, 10 mg 20 mg and 40 mg Tablets
  • Lotensin HCT (benazepril HCl and hydrochlorothiazide) 5/6.25 mg, 10/12.5 mg 20/12.5 mg and 20/25 mg Tablets
  • Mavik (trandolapril) 1 mg, 2 mg and 4 mg Tablets
  • Tarka (trandolapril/verapamil hydrochloride) 2/180 mg, 1/240 mg, and 4/240 mg Tablets
  • Teveten (eprosartan mesylate) 400 mg and 600 mg Tablets
  • Teveten HCT (eprosartan mesylate hydrochlorothiazide) 600/12.5 mg and 600/25 mg Tablets
  • Tribenzor (olmesartan medoxomil amlodipine/hydrochlorothiazide) 20/5/12.5 mg, 40/5/12.5 mg, 40/5/25 mg 40/10/12.5 and 40/10/25 mg Tablets
  • Uniretic (moexipril hydrochloride/hydrochlorothiazide) 7.5/12.5 mg, 15/12.5 mg and 15/25 mg Tablets
  • Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets
  • Vasotec (enalapril maleate) 2.5 mg, 5 mg, 10 mg, and 20 mg Tablets
  • Univasc (moexipril hydrochloride) 7.5 mg and 15 mg Tablets

 

 


To view current Prescribing Information, enter drug name in Drugs@FDA


 

 

CONTRAINDICATIONS

  • Do not co-administer aliskiren with xxxx in patients with diabetes (see PRECAUTIONS, Drug Interactions).

PRECAUTIONS

Drug Interactions

Dual Blockade of the Renin-Angiotensin System (RAS)

  • Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Closely monitor blood pressure, renal function and electrolytes in patients on xxxx and other agents that affect the RAS. Do not co-administer aliskiren with xxxx in patients with diabetes. Avoid use of aliskiren with xxxx in patients with renal impairment (GFR <60ml/min).

 

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