Label Changes for:
Cardizem CD (diltiazem hydrochloride) Capsules and Tablets Cardizem LA (diltiazem hydrochloride) Extended-Release Tablets
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)
