Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- Concomitant administration of strong CYP1A2 inhibitors (including e.g. ciprofloxacin or fluvoxamine) may increase the exposure to pentoxifylline.
- 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).”
- 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.
- At the first sign of anaphylactic/anaphylactoid reaction, TRENTAL must be discontinued
- 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.
- Immune system disorders - anaphylactic reaction, anaphylactoid reaction, anaphylactic shock