Label Changes for:

Lotensin HCT (benazepril/hydrochlorothiazide) tablets

November 2009

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

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

CONTRAINDICATIONS

  • Lotensin is also contraindicated in patients with a history of angioedema with or without previous ACE inhibitor treatment.

ADVERSE REACTIONS

Skin
  • Erythema multiforme including Steven-Johnson syndrome, exfoliative dermatitis, including toxic epidermal necrolysis
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