Safety

Trental (pentoxifylline) Extended-Release Tablets

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

January 2016

Summary View

DRUG INTERACTIONS

  • Bleeding has been reported in patients treated with Trental with or without concomitant NSAIDs, anticoagulants, or platelet aggregation inhibitors. Increased prothrombin time has 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. Concomitant administration of Trental and theophylline-containing drugs leads to increased theophylline levels and theophylline toxicity in some individuals. Monitor theophylline levels when starting Trental or changing dose. Concomitant administration of strong CYP1A2 inhibitors (including e.g. ciprofloxacin or fluvoxamine) may increase the exposure to pentoxifylline)… Concomitant administration with cimetidine is reported to increase the average steady state plasma concentration of pentoxifylline (~25%) and the Metabolite I (~30%).

 

February 2015

Summary View

PRECAUTIONS

Drug Interaction
  • Concomitant administration of strong CYP1A2 inhibitors (including e.g. ciprofloxacin or fluvoxamine) may increase the exposure to pentoxifylline.

 

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 

 

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