Label Changes for:

Trental (pentoxifylline) Extended-Release Tablets

July 2012

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

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

 

 

PRECAUTIONS

General
  • At the first sign of anaphylactic/anaphylactoid reaction, TRENTAL must be discontinued
Drug Interactions
  • Postmarketing cases of increased anticoagulant activity have been reported in patients concomitantly treated with pentoxifylline and vitamin K antagonists. Monitoring of anticoagulant activity in these patients is recommended when pentoxifylline is introduced or the dose is changed.

ADVERSE REACTIONS

  • Cholestasis
  • Immune system disorders - anaphylactic reaction, anaphylactoid reaction, anaphylactic shock
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