Label Changes for:

Horizant (Gabapentin Enacarbil) Extended-Release Tablets

December 2012

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

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

 

WARNINGS AND PRECAUTIONS

Somnolence/Sedation and Dizziness
  • During the 12-week, controlled study in patients with PHN, somnolence was reported in 10% of patients treated with 1,200 mg of HORIZANT per day compared with 8% of patients receiving placebo…
Discontinuation of Horizant
  • In patients with PHN receiving HORIZANT twice daily, the dose should be reduced to once daily for 1 week prior to discontinuation to minimize the potential of withdrawal seizure

 

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