Pentoxifylline ER

Class
Vasoactive agents
Subclass
Nonselective phosphodiesterase inhibitors
Substance name
Pentoxifylline, oxpentifylline, PTXF ER
Brand names
Trental®
Common formulations
Tablet
Dosage and administration
Adults patients
Treatment
Intermittent claudication in patients with PAD
•
400 mg PO TID for at least 8 weeks
Cardiac sarcoidosis • Off-label
•
400 mg PO TID
Livedoid vasculopathy • Off-label
•
400 mg PO TID
MASLD • Off-label
•
400 mg PO TID for 3-12 months
Venous leg ulcer • Off-label
•
400 mg PO TID
Prevention
Prevention of osteoradionecrosis of the jaw, during head and neck radiotherapy • Off-label
•
400 mg PO BID for at least 1 week before and 4 weeks after invasive dental procedures
Other off-label uses
•
Treatment of osteoradionecrosis of the jaw
Indications for use
Labeled indications
Adults
•
Treatment of intermittent claudication in patients with PAD
Off-label indications
Adults
•
Treatment of cardiac sarcoidosis
•
Treatment of livedoid vasculopathy
•
Treatment of MASLD
•
Treatment of osteoradionecrosis of the jaw
•
Treatment of venous leg ulcer
•
Prevention of osteoradionecrosis of the jaw, in patients undergoing head and neck radiotherapy
Safety risks
Contraindications
Hypersensitivity to pentoxifylline or its components or other methylxanthines
•
Do not use pentoxifylline in patients with a history of hypersensitivity to pentoxifylline or its components or other methylxanthines, such as caffeine, theophylline, or theobromine.
Recent intracranial and/or retinal hemorrhage
Warnings and precautions
Anaphylaxis, anaphylactoid reactions
•
Maintain a high level of suspicion, as pentoxifylline has been associated with an increased risk for these adverse events.
Angina pectoris, hypotension, cardiac arrhythmias
•
Use caution in patients with coronary artery disease or cerebrovascular disease.
Bleeding
•
Use caution in patients with peptic ulcer disease, a recent surgery, or taking warfarin. Obtain frequent monitoring of PT in patients on warfarin. Monitor for bleeding, including hematocrit and/or hemoglobin measurements.
Specific populations
Renal impairment
CrCl ≥ 30 mL/min
•
Use acceptable. No dose adjustment required.
CrCl < 30 mL/min
•
Maximal dose of 400 mg. Do not exceed frequency of once daily.
Renal replacement therapy
Continuous renal replacement
•
No guidance available.
Intermittent hemodialysis
•
Administer the dose after dialysis session. Dose as in CrCl < 30 mL/min.
Peritoneal dialysis
•
Dose as in CrCl < 30 mL/min.
Hepatic impairment
Any severity
•
No dose adjustment required. Use with caution.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B1
•
Use only if benefits outweigh potential risks.
Breastfeeding
Do not use during breastfeeding.
Unknown drug levels in breastfed infants.
Adverse reactions
Common 1-10%
•
Nausea, vomiting
Uncommon < 1%
•
Angioedema, hypotension, peripheral edema, ↓ WBC count, angina pectoris, bloating, flatulence, belching, chest pain, seizure
Unknown frequency
•
Acute cholecystitis, anaphylactoid reactions, anaphylaxis, aplastic anemia, aseptic meningitis, bleeding, cardiac arrhythmias, retinal hemorrhage, auditory hallucinations, cholestasis, conjunctivitis, ↓ platelet count, hepatitis, ↑ liver enzymes, jaundice, laryngitis, pancytopenia, loss of appetite, purpura, blurred vision, confusion, ear pain, constipation, depression, dry mouth, anxiety, dyspnea, flu-like symptoms, hypersalivation, change in taste, malaise, throat pain, nasal congestion, nosebleed, pruritus, skin rash, weight gain, weight loss, tachycardia, urticaria, brittle nails
Interactions
Drug(s)
Check Interactions
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