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.
Published Studies Related to Pentoxil (Pentoxifylline)
Pentoxifylline for intermittent claudication. 
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.
Pentoxifylline for renoprotection in diabetic nephropathy: the PREDIAN study. Rationale and basal results. [2011.09]
STATEMENTS OF THE PROBLEM: Diabetic nephropathy (DN) is the main cause of end-stage renal disease (ESRD). Renin-angiotensin system (RAS) blockade is the standard of care; however, a significant proportion of patients progress to ESRD. Pentoxifylline (PTF) possesses properties suggesting potential renoprotective efficacy. The aim of the Pentoxifylline for Renoprotection in Diabetic Nephropathy (PREDIAN) study is to test the efficacy of PTF addition to RAS blockade on the progression of DN. Here we report the study design and the baseline patient characteristics... CONCLUSIONS: The PREDIAN study will provide evidence on the renoprotective benefit of PTF in addition to interventions of proven efficacy (RAS blockade) in DN. Copyright (c) 2011 Elsevier Inc. All rights reserved.
Clinical Trials Related to Pentoxil (Pentoxifylline)
Pentoxifylline/Nonalcoholic Steatohepatitis (NASH) Study: The Effect of Pentoxifylline on NASH [Recruiting]
Renal Effect of Pentoxyphylline in High Risk Patients Undergoing Angiography [Not yet recruiting]
The investigators will study 2 separate groups:
- Cardiology patients undergoing invasive coronary angiography +/- PCI (Percutaneous
- 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.
Prevention of Capsular Contracture Using Trental and Vitamin E [Recruiting]
The main purpose of this research study is to determine if the use of Trental and Vitamin E
compared to Placebo (an inactive substance) will decrease the incidence and severity of
contractures (shrinking and or hardening of tissue surrounding the implant) associated with
breast implant reconstruction following radiation treatment. Another goal is to find out
the impact that Trental and Vitamin E compared to Placebo may have on implant loss or need
for surgical intervention in the setting of chest wall radiation after reconstruction. In
addition, the investigators want to evaluate the patient's sense of well being and quality
Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients [Recruiting]
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.