Label Changes for:

Lotrel (amlodipine besylate/benazepril hydrochloride) capsules

October 2009

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) -- October 2009

CONTRAINDICATIONS

  • Lotrel is 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, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy.
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