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
