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.
