Label Changes for:

Tiazac (diltiazem hydrochloride) Extended Release Capsules

November 2010

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) – November 2010

 

 

PRECAUTIONS

Drug Interactions
  • Clonidine:Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concurrently with diltiazem. Monitor heart rate in patients receiving concomitant diltiazem and clonidine.
  • Statins: Diltiazem is an inhibitor of CYP3A4 and has been shown to increase significantly the AUC of some statins...

ADVERSE REACTIONS

Other
  • Acute generalized exanthematous pustulosis
  • Photosensitivity (including lichenoid keratosis and hyperpigmentation at sun-exposed skin areas)

 

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