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Label Changes for:

Atacand (candesartan cilexetil) Tablets

February 2016

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

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

February 2016

WARNINGS AND PRECAUTIONS

Hyperkalemia
  • Concomitant use of ATACAND with drugs that may increase potassium levels may increase the risk of hyperkalemia [see Drug Interactions (7)]. Monitor serum potassium periodically

DRUG INTERACTIONS

Agents Increasing Serum Potassium Other drugs that affect serum potassium
  • Coadministration of ATACAND 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.
Lithium
  • Increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium

 

February 2015

DRUG INTERACTIONS

Lithium
  • Increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including Atacand.  

April 2013

CONTRAINDICATIONS

  • Atacand is contraindicated in patients who are hypersensitive to candesartan. Do not administer Aliskiren with Atacand in patients with diabetes.

WARNINGS AND PRECAUTIONS

Hypotension
  • Atacand can cause symptomatic hypotension. Symptomatic hypotension is most likely to occur in patients who have been volume and/or salt depleted as a result of prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting…
  • In the CHARM-Added program, where candesartan or placebo was given in addition to ACE inhibitors, hypotension was reported in 22.6% of patients treated with Atacand versus 13.8% treated with placebo.
Impaired Renal Function
  • In the CHARM-Added program, where candesartan or placebo was given in addition to ACE inhibitors, the incidence of abnormal renal function (e.g.,creatinine increase) was 15% in patients treated with Atacand versus 9% in patients treated with placebo
Hyperkalemia
  • In the CHARM-Added program where candesartan or placebo was given in addition to ACE inhibitors, the incidence of hyperkalemia was 9.5% in patients treated with Atacand versus 3.5% in patients treated with placebo. 

ADVERSE REACTIONS

Postmarketing Experience
  • Immunologic: Angioedema

USE IN SPECIFIC POPULATIONS

Patient Information - Who should not take Atacand?
  • are diabetic and taking Aliskiren

 

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