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)
[Effect of pentoxifylline on the evolution of diabetic nephropathy] [2009.05.30]
CONCLUSIONS: PXF treatment caused regression and prevented the progression of renal damage. Thus, PXF should be used in the preventive treatment of DN. These results showed that inflammation and pro-inflammatory cytokines are related to the progression of diabetic nephropathy.
Pentoxifylline versus prednisolone for severe alcoholic hepatitis: a randomized controlled trial. [2009.04.07]
AIM: To compare the efficacy of pentoxifylline and prednisolone in the treatment of severe alcoholic hepatitis, and to evaluate the role of different liver function scores in predicting prognosis... CONCLUSION: Reduced mortality, improved risk-benefit profile and renoprotective effects of pentoxifylline compared with prednisolone suggest that pentoxifylline is superior to prednisolone for treatment of severe alcoholic hepatitis.
Preoperative oral pentoxifylline for management of cytokine reactions in cardiac surgery. [2009.04]
BACKGROUND: Cardiopulmonary bypass may lead to many inflammatory responses that may cause myocardial dysfunction after open heart surgery. We aimed to investigate the effect of preoperative pentoxifylline treatment to reduce the occurrence of cardiopulmonary bypass-induced inflammatory response... CONCLUSIONS: We conclude that pretreatment with oral pentoxifylline before cardiac surgery inhibits proinflammatory cytokine release caused by cardiopulmonary bypass and has some beneficial effects in protecting the myocardium during the cardioplegic arrest period in open-heart surgery, without affecting postoperative hemodynamics.
Effect of pentoxifylline on GFR decline in CKD: a pilot, double-blind, randomized, placebo-controlled trial. [2009.04]
BACKGROUND: Pentoxifylline is a nonspecific phosphodiesterase inhibitor with anti-inflammatory properties. It reduces proteinuria in patients with glomerular disease, although its impact on glomerular filtration rate (GFR) is unknown. We hypothesized that pentoxifylline would slow the estimated GFR decrease in patients with chronic kidney disease at high risk of progression... CONCLUSIONS: Pentoxifylline may slow the estimated GFR decrease in high-risk patients. This may be independent of its antiproteinuric properties and warrants further investigation.
Effect of intravenous pentoxifylline in inflammatory response in patients undergoing nephrolithotomy. [2009.02]
PURPOSE: To determine the potential efficacy of intravenous (IV) infusion of pentoxifylline (PTX) before nephrolithotomy on attenuating plasma level of the tumor necrosis factor (TNF)-alpha and interleukin (IL)-1, and to investigate whether it prevents postoperative pain... CONCLUSIONS: An infusion of IV PTX that is administered preoperatively could be applied to reduce inflammatory changes and pain intensity in patients undergoing nephrolithotomy; it causes no serious side effects.
Clinical Trials Related to Pentoxil (Pentoxifylline)
Clinical Trial of Pentoxifylline in Patient With Cirrhosis [Completed]
In patients with cirrhosis and liver failure, pro-inflammatory cytokines (TNF alpha) might be
responsible of severe complications and death. Thus, the prevention of cytokine production
should prevent complications and mortality.
The aim of this study is to study the 2 months survival rate in patients with severe
cirrhosis (Child-Pugh C) with pentoxifylline - an inhibitor of cytokine production. The 6
month mortality, the proportion of transplanted patients, the occurrence of complications
(bacterial infection, renal failure, hepatic encephalopathy and gastrointestinal bleeding),
plasma cytokine levels and fibrotest - a marker of fibrosis - will be also studied. This is a
multicenter double blind randomized trial with a placebo.
All adult patients with severe cirrhosis might be randomized after written consent. Patients
with severe carcinoma, intolerance or contraindication to pentoxifylline will not be
included. Patients receive either pentoxifylline or placebo 3 times a day for 6 months. Three
hundred and forty two patients are necessary to decrease mortality rate by 50% at 2 months in
a beta risk of 10% and an alpha risk of 5%. Patients will be seen every month.
Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS [Completed]
To determine whether pentoxifylline lowers tumor necrosis factor (TNF) levels in AIDS
patients. Pentoxifylline decreases tumor necrosis factor (TNF), and therefore should decrease
such TNF-intensified events as cachexia, enhanced HIV expression, and inhibition of
zidovudine (AZT) activity.
Study of Daily Pentoxifylline as a Rescue Treatment in Duchenne Muscular Dystrophy [Completed]
The purpose of this study is to see if male children with Duchenne muscular dystrophy (DMD)
have changes in strength when given the drug Pentoxifylline as a rescue treatment. A total of
64 subjects are expected to participate through all other centers of the Cooperative
International Neuromuscular Research Group (CINRG) worldwide.
The primary purpose of this study is to see whether the addition of pentoxifylline to a
steroid regimen is effective in treating deteriorating muscle strength by comparing the
muscle strength of PTX treated subjects and placebo treated subjects.
Pilot Study of Pentoxifylline for Hepatopulmonary Syndrome [Terminated]
The Hepatopulmonary syndrome (HPS) results from intrapulmonary microvascular dilatation that
impairs arterial oxygenation in the setting of cirrhosis or portal hypertension. As many as
10-20% of cirrhotics being evaluated for orthotopic liver transplantation (OLT) have advanced
HPS and mortality is greater in those with HPS than in those without HPS. Currently, OLT is
the only effective treatment, although post-operative mortality in HPS is increased relative
to cirrhotic patients without HPS, with a one-year survival of between 68-80 %. Therefore, an
effective medical therapy for advanced HPS could improve both pre-operative and
post-operative mortality.
Recent work in experimental models of HPS has revealed that both nitric oxide
synthase-derived nitric oxide and heme oxygenase-derived carbon monoxide cause intrapulmonary
vasodilatation. These alterations appear to be driven in part by TNF-α modulation of
pulmonary blood flow and intravascular monocyte accumulation. Pentoxifylline is a nonspecific
phosphodiesterase inhibitor with inhibitory effects on TNF-α and has recently been shown to
be beneficial in patients with severe alcoholic hepatitis where TNF-α overproduction
contributes to liver injury. In experimental HPS, pentoxifylline administration also
decreases the severity of oxygenation abnormalities. However, pentoxifylline therapy has been
associated with dose limiting side effects in patients with liver disease and the
tolerability of pentoxifylline in cirrhotic patients with advanced HPS is unknown.
Therefore, this open label single arm clinical trial was designed to evaluate the efficacy
and tolerability of 8 weeks of pentoxifylline in cirrhotic patients with advanced HPS being
considered for OLT.
Pentoxifylline/Nonalcoholic Steatohepatitis (NASH) Study: The Effect of Pentoxifylline on NASH [Recruiting]
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