Label Changes for:

Ionamin (Phentermine Resin) Capsules

December 2012

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2012

 

ADVERSE REACTIONS

Drug Interactions
  • In a single-dose study comparing the exposures after oral administration of a combination capsule of 15 mg Phentermine and 92 mg Topiramate to the exposures after oral administration of a 15 mg Phentermine capsule or a 92 mg Topiramate capsule, there is no significant Topiramate exposure change in the presence of phentermine. However in the presence of Topiramate, phentermine Cmax and AUC increase 13% and 42%, respectively.

 

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