Label Changes for:
Lotensin (benazepril hydrochloride) Tablets
May 2008
Changes have been made to the 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 2008
| The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. |
Sections Modified
PRECAUTIONS
- Drug Interactions
- Lithium
- Anti-diabetics
- Carcinogenesis, Mutagenesis, Impairment of Fertility
ADVERSE REACTIONS
- Other
- Frequent Urination
- The following adverse events of unknown frequency have been reported during post-marketing use of benazepril: small bowel angioedema, anaphylactoid reactions, hyperkalemia, agranulocytosis, and neutropenia.
Label approved 05/29/2008 is not available on Drugs@FDA
For current prescribing information, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682.
