Pentoxil (Pentoxifylline) - Summary

PENTOXIL SUMMARY

Pentoxil^® (Pentoxifylline Extended-release Tablets, USP) for oral administration contain 400 mg of the active drug and the following inactive ingredients: D&C Red No. 27 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, hypromellose USP, magnesium stearate NF, polyethylene glycol NF, polysorbate 80 NF, povidone USP, silicon dioxide NF and titanium dioxide USP, in an extended-release formulation.

Pentoxil^® (Pentoxifylline Extended-release Tablets, USP) is indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxil^® 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.

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NEWS HIGHLIGHTS

Published Studies Related to Pentoxil (Pentoxifylline)

Pentoxifylline decreases serum level of adhesion molecules in atherosclerosis patients. [2014]
with coronary artery disease (CAD)... CONCLUSION: Based on the results of our pilot study, administration of PTX in CAD

Pentoxifylline for intermittent claudication. [2012]
CONCLUSIONS: Given the generally poor quality of the published studies

Pentoxifylline improves nonalcoholic steatohepatitis: a randomized placebo-controlled trial. [2011.11]
CONCLUSION: PTX improved histological features of NASH compared to placebo. PTX was well tolerated in patients with NASH. Copyright (c) 2011 American Association for the Study of Liver Diseases.

Pentoxifylline decreases serum levels of tumor necrosis factor alpha, interleukin 6 and C-reactive protein in hemodialysis patients: results of a randomized double-blind, controlled clinical trial. [2011.10.03]
CONCLUSIONS: Pentoxifylline significantly decreased serum concentrations of TNF-alpha, IL-6 and CRP compared to placebo. Pentoxifylline could be a promising and useful strategy to reduce the systemic inflammation frequently observed in patients on HD.

Pentoxifylline (anti-tumor necrosis factor drug): effective adjuvant therapy in the control of ocular cicatricial pemphigoid. [2011.09]
PURPOSE: The detection of tumor necrosis factor-a (TNF-a) in conjunctiva affected by ocular cicatricial pemphigoid (OCP) may indicate that this cytokine plays an important role in its pathogenesis. The purpose of this randomized, controlled, comparative, blinded study was to evaluate the effectiveness of adding pentoxifylline as an anti-TNF-a drug to the well-documented therapy of steroids and cyclophosphamide in controlling OCP... CONCLUSIONS: The significantly increased level of serum TNF-a in OCP as compared to controls proves that TNF-a has an important role in the pathogenesis of this disease. The study illustrates that the addition of pentoxifylline to pulse steroid cyclophosphamide therapy is an effective, safe, and economical method in controlling OCP through directly reducing TNF-a levels, with long periods of remission as detected in our 18-month follow-up period.

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Clinical Trials Related to Pentoxil (Pentoxifylline)

Renal Effect of Pentoxyphylline in High Risk Patients Undergoing Angiography [Withdrawn]
The investigators will study 2 separate groups:

- Cardiology patients undergoing invasive coronary angiography +/- PCI (Percutaneous

coronary intervention).

- Patients undergoing CT examination with contrast medium. All patients will receive

intravenous (I. V) hydration for 8-12h before and 36 to 48 h after angiography with 0. 45% saline 100ml/h. All patients will receive oral N-acetyl cysteine 1200 mg twice daily, a day before, on the day of the angiography and for another 48 hours. In addition, patients will be assigned to receive oral pentoxyphylline (P group) or placebo

(C - control group) tablets 3 times a day one day before, on the day of the procedure and

for another 48 hours. Baseline Serum Creatinine (S. Cr) levels in will be taken before angiography and two days after angiography. Radio-contrast nephropathy is defined, in this study, as increase in serum ≥ 25 % of baseline after injection of the radio-contrast agent. Pentoxyfylline is an orally active haemorheological agent for the treatment of peripheral vascular disease, cerebrovascular disease and a number of other conditions involving a defective regional microcirculation. Pentoxyfylline acts primarily by increasing red blood cell deformability, by reducing blood viscosity and by decreasing the potential for platelet aggregation and thrombus formation (mechanism unclear). Pentoxyfylline has also proven to have a significant anti inflammatory effect as well as anti oxidant effect, mechanisms considered to be important patho-physiological causes of contrast induced nephropathy.

Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients [Recruiting]

Pentoxifylline/Nonalcoholic Steatohepatitis (NASH) Study: The Effect of Pentoxifylline on NASH [Completed]

Renoprotection by Pentoxifylline and Angiotensin Receptor Blocker in Chronic Kidney Disease (CKD) [Recruiting]
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial to investigate the renoprotective efficacy of combined pentoxifylline (PTX) and angiotensin receptor blockers (valsartan), compared with placebo and valsartan in 700 patients with Chronic Kidney Disease (CKD) stages 3 and 4. The effect on cardiovascular comorbidity will also be observed. The observation period will be 3 years. The primary endpoints consists of doubling of serum creatinine, end stage renal disease (ESRD), and death from any cause. The secondary endpoints include changes of microalbuminuria or proteinuria, serum and urinary levels of TNF-a(tumor necrosis factor-alpha ), MCP-1(monocyte chemotactic protein), TGF-beta1(transforming growth factor ), collagens III (amino terminal peptide of procollagen III) and IV, and fibronectin, urinary N-acetyl-beta-glucosaminidase, as well as serum fibrinogen and high-sensitive CRP(C reactive protein), and development of heart failure, nonfatal myocardial infarction, and stroke or transient ischemic attack.

Effects of Pentoxiphylline on Left Ventricular (LV) Systolic Function Indices and Circulating Biomarkers in Patients With Chronic Congestive Heart Failure (CHF) [Recruiting]
This is a prospective, double blinded randomized clinical study to evaluate the Effects of Pentoxifylline on left ventricular systolic function indices and circulating biomarkers in patients with chronic congestive heart failure. A few studies all focused in Africa have consistently shown marked beneficial effects of pentoxifylline in improvement of left ventricular size and systolic function along with marked decrease in biomarkers of heart failure and apoptosis markers on top of standard CHF therapy. Furthermore pentoxifylline was shown to have negligible effects on heart rate, blood pressure in those studies. Limitations of these studies are that they are largely single center originating in the African subcontinent and have never been tested in the North American population, particularly Caucasians. Despite major advances in medical therapy for congestive heart failure, it is still one of the leading causes of morbidity and mortality in North America. Most medications tested for improvement of Ejection Fraction with the exception of Beta-Blockers and Ace-Inhibitors have been associated with worsening mortality. Pentoxifylline is a medication that has negligible effects on myocardial oxygen consumption, yet promising effects on inflammatory markers seen in CHF with the possibility of improvement in LV systolic function and symptomology and may prove to be a useful addition for CHF patients. This would prove to be especially useful, particularly when associated with no major side effects.

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