Label Changes for:

Lotensin (benazepril)

May 2012

Changes have been made to the BOXED WARNING, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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

 

May 2012

BOXED WARNING

  • wording modified from previous BW

WARNINGS

Anaphylactoid and Possibly Related Reactions

Head and Neck Angioedema

  • Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks
Fetal Toxicity
Pregnancy category D
  • Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases ...

PRECAUTIONS

Information for Patients
  • Pregnancy: Female patients of childbearing age should be told about the consequences of exposure to Lotensin during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible
Drug Interactions
  • Lithium: Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors (including benazepril) during therapy with lithium. Monitor serum lithium levels when used concomitantly with Lotensin.
  • Other: The pharmacokinetics of benazepril are not affected by the following drugs: hydrochlorothiazide, furosemide, chlorthalidone, digoxin, propranolol, atenolol, nifedipine, amlodipine, naproxen, acetylsalicylic acid, or cimetidine. Likewise the administration of benazepril does not substantially affect the pharmacokinetics of these medications (cimetidine kinetics were not studied).
Pediatric Use
  • Neonates with a history of in utero exposure to Lotensin: If  oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function. Benazepril, which crosses the placenta, can theoretically be removed from the neonatal circulation by these means; there are occasional reports of benefit from these maneuvers with another ACE inhibitor, but experience is limited.
  • The long-term effects of benazepril on growth and development have not been studied. Infants below the age of 1 year should not be given Lotensin because of the risk of effects on kidney development.
ADVERSE REACTIONS
  • Other adverse experiences reported in controlled clinical trials (in less than 1% of benazepril patients or with less than 1% difference in incidence between benazepril or placebo treatment), and rarer events seen in post-marketing experience, include the following (in some, a causal relationship to drug use is uncertain):
  • Gastrointestinal:  added... nausea
  • Other: added... fatigue

 

 

November 2009

 

CONTRAINDICATIONS

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

 

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