Label Changes for:
Ionamin (Phentermine Resin) Capsules
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
- 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.