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U.S. Department of Health and Human Services

Safety

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Amlodipine besylate/ Benazepril hydrochloride capsule

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2009

 

Summary View

 

CONTRAINDICATIONS (reworded)

  • Amlodipine besylate and benazapril hydrochloride combination capsules are contraindicated in patients with a history of angioedema, with or without previous ACE inhibitor treatment, or patients who are hypersensitive to benazepril, to any other ACE inhibitor, or to amlodipine.

PRECAUTIONS

Drug Interactions
  • Gold: Nitritoid reactions (symptoms include facial flushing, nausea, vomitingand hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy.