pharmacopeia
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/api/v1/drug/pentoxifylline

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Unknown Cellular or Molecular Interaction.

Indications

Sourced from openFDA
  • Pentoxifylline extended-release tablets are indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxifylline can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease.

Contraindications

Sourced from openFDA
  • Pentoxifylline should not be used in patients with recent cerebral and/or retinal hemorrhage or in patients who have previously exhibited intolerance to this product or methylxanthines such as caffeine, theophylline, and theobromine.contraindicated

Dosage & administration

Sourced from openFDA

The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals. While the effect of pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration. Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline should be discontinued. 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.

Adverse reactions

Sourced from openFDA

Clinical trials were conducted using either extended-release pentoxifylline tablets for up to 60 weeks or immediate-release pentoxifylline capsules for up to 24 weeks. Dosage ranges in the tablet studies were 400 mg bid to tid and in the capsule studies, 200 to 400 mg tid. The table summarizes the incidence (in percent) of adverse reactions considered drug related, as well as the numbers of patients who received extended-release pentoxifylline tablets, immediate-release pentoxifylline capsules, or the corresponding placebos. The incidence of adverse reactions was higher in the capsule studies (where dose related increases were seen in digestive and nervous system side effects) than in the tablet studies. Studies with the capsule include domestic experience, whereas studies with the extended-release tablets were conducted outside the U.S. The table indicates that in the tablet studies few patients discontinued because of adverse effects.

Use in specific populations

Sourced from openFDA

Pregnancy Category C. Teratogenicity studies have been performed in rats and rabbits using oral doses up to 576 and 264 mg/kg, respectively. On a weight basis, these doses are 24 and 11 times the maximum recommended human daily dose (MRHD); on a body-surface-area basis, they are 4.2 and 3.5 times the MRHD. No evidence of fetal malformation was observed. Increased resorption was seen in rats of the 576 mg/kg group. There are no adequate and well controlled studies in pregnant women. Pentoxifylline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Overdosage

Sourced from openFDA

Overdosage with pentoxifylline has been reported in pediatric patients and adults. Symptoms appear to be dose related. A report from a poison control center on 44 patients taking overdoses of enteric-coated pentoxifylline extended-release tablets noted that symptoms usually occurred 4 to 5 hours after ingestion and lasted about 12 hours. The highest amount ingested was 80 mg/kg; flushing, hypotension, convulsions, somnolence, loss of consciousness, fever, and agitation occurred. All patients recovered. In addition to symptomatic treatment and gastric lavage, special attention must be given to supporting respiration, maintaining systemic blood pressure, and controlling convulsions. Activated charcoal has been used to absorb pentoxifylline in patients who have overdosed.

Approval history

Sourced from openFDA
  • Jul 8, 1997ANDAANDA074425Rising
  • Jul 9, 1997ANDAANDA074878Ani Pharms
  • Jun 9, 1999ANDAANDA075191Apotex

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
4,246 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Fatigue44711%
  2. 2Diarrhoea42910%
  3. 3Drug Ineffective3989.4%
  4. 4Dyspnoea3979.3%
  5. 5Fall3698.7%
  6. 6Dizziness3628.5%
  7. 7Nausea3598.5%
  8. 8Headache3498.2%
  9. 9Asthenia3448.1%
  10. 10Insomnia3428.1%
  11. 11Arthralgia3217.6%
  12. 12Pruritus2866.7%
  13. 13Vomiting2866.7%
  14. 14Sepsis2826.6%
  15. 15Decreased Appetite2796.6%

Literature

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Recent PubMed references pinned to Pentoxifylline as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

The 10 most recently updated of 197 ClinicalTrials.gov registrations naming Pentoxifylline as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Pentoxifylline work?
Mechanism-of-action class: Unknown Cellular or Molecular Interaction.
What is Pentoxifylline used for?
According to FDA labeling, Pentoxifylline carries indications including: Pentoxifylline extended-release tablets are indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxifylline can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Pentoxifylline?
Pentoxifylline is classified as Purine derivatives, Blood Viscosity Reducer, Unknown Cellular or Molecular Interaction, Decreased Blood Viscosity, Hematologic Activity Alteration.
What are the contraindications for Pentoxifylline?
Pentoxifylline labeling lists contraindications including: Pentoxifylline should not be used in patients with recent cerebral and/or retinal hemorrhage or in patients who have previously exhibited intolerance to this product or methylxanthines such as caffeine, theophylline, and theobromine.. Always consult the full prescribing information and a clinician.
Note. Data for pentoxifylline is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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