Label Changes for:
Dilacor XR (diltiazem hydrochloride) extended release capsules
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2011
- (section revised) In a ten-subject randomized, open label, 4-way cross-over study, coadministration of diltiazem (120 mg twice daily diltiazem SR for 2 weeks) with a single 20 mg dose of lovastatin resulted in 3- to 4-fold higher mean lovastatin AUC and Cmax values compared with lovastatin alone. In the same study, there was no significant change in 20 mg single dose pravastatin AUC and Cmax during diltiazem coadministration.