Label Changes for:

Rozerem (ramelteon) Tablets

November 2010

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) – November 2010

PRECAUTION

Drug Interactions
  • Donepezil increases systemic exposure of ramelteon; patients should be closely monitored when ramelteon is co administered with donepezil.
  • Doxepin increases systemic exposure of ramelteon; patients should be closely monitored when ramelteon is co administered with doxepin.
     

 

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