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U.S. Department of Health and Human Services

Safety

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Trental (pentoxifylline) Extended-Release Tablets

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

 

April 2014

Summary View

PRECAUTIONS 

General

  • added .....In patients with hepatic or renal impairment, the exposure to pentoxifylline and/or active metabolites is increased. The consequences of the increase in drug exposure are not known (please see Pharmacokinetics and Metabolism and DOSAGE AND ADMINISTRATION).”

Drug Interactions

  • added ..... TRENTAL has been used concurrently with antihypertensive drugs, beta blockers, digitalis, diuretics, and antiarrhythmics, without observed problems

NOTE: in the DOSAGE AND ADMINISTRATION section, the following language was added: “In patients with severe renal impairment (creatinine clearance below 30 ml/min) reduce dose to 400 mg once a day. Dosing information cannot be provided for patients with hepatic impairment. 

 

July 2012

Summary View

 

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