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Zyflo CR (Zileuton) - Summary

 
 



ZYFLO CR SUMMARY

Zileuton is an orally active inhibitor of 5-lipoxygenase, the enzyme that catalyzes the formation of leukotrienes from arachidonic acid.

ZYFLO CR is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older.

ZYFLO CR is not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with ZYFLO CR can be continued during acute exacerbations of asthma.


See all Zyflo CR indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Zyflo CR (Zileuton)

Early Exposure to Dogs, Farm Animals Reduces Childhood Asthma
Source: Medscape Allergy & Clinical Immunology Headlines [2016.05.20]
Could exposure to dogs at an early age help prevent asthma in children?
Evidence-Based Medicine

Strategy for depleting immune cells implicated in asthma-associated inflammation
Source: Respiratory / Asthma News From Medical News Today [2016.05.20]
Patients with asthma have chronic lung inflammation that results in sporadic narrowing of the airways and difficulty breathing.

New data show that tiotropium helps children with their asthma symptoms by improving lung function in comparison to placebo
Source: Respiratory / Asthma News From Medical News Today [2016.05.18]
New data from the Phase III VivaTinA-asthma® study show that when used as an add-on to maintenance asthma therapy (inhaled corticosteroid, ICS, or ICS plus another maintenance therapy)...

Capitalizing on a teachable moment motivates parents of kids with asthma to quit smoking
Source: Alcohol / Addiction / Illegal Drugs News From Medical News Today [2016.05.17]
Parents who smoke are more likely to quit smoking after receiving motivational smoking cessation counseling following a "teachable moment" (TM) such as witnessing their child experience an asthma...

Is a written asthma action plan for children necessary?
Source: Respiratory / Asthma News From Medical News Today [2016.05.16]
Parents of children with asthma need ongoing education and guidance on this chronic condition and how to prevent and manage symptoms, but does a written asthma action plan improve outcomes more than...

more news >>

Published Studies Related to Zyflo CR (Zileuton)

Randomized trial of zileuton for treatment of COPD exacerbations requiring hospitalization. [2011.02]
RATIONALE: Leukotrienes have been implicated in the pathogenesis of acute exacerbations of COPD, but leukotriene modifiers have not been studied as a possible therapy for exacerbations. OBJECTIVE: We sought to test the safety and efficacy of adding oral zileuton (a 5-lipoxygenase inhibitor) to usual treatment for acute exacerbations of COPD requiring hospitalization... CONCLUSIONS: While oral zileuton during COPD exacerbations that require hospital admission is safe and reduces urinary LTE(4) levels, we found no evidence suggesting that this intervention shortened hospital stay, with the limitation that our sample size may have been insufficient to detect a modest but potentially meaningful clinical improvement.

Randomized trial of zileuton for treatment of COPD exacerbations requiring hospitalization. [2011]
requiring hospitalization... CONCLUSIONS: While oral zileuton during COPD exacerbations that require

Efficacy of zileuton controlled-release tablets administered twice daily in the treatment of moderate persistent asthma: a 3-month randomized controlled study. [2007.08]
BACKGROUND: A controlled-release (CR) formulation of zileuton was developed to simplify administration from 600 mg 4 times daily (Zyflo) to 1,200 mg twice daily. OBJECTIVE: To evaluate the efficacy of zileuton CR, two 600-mg tablets twice daily, compared with placebo... CONCLUSIONS: Treatment with zileuton CR, 1,200 mg twice daily, resulted in a significant improvement in asthma control, and the safety and efficacy profile was similar to that observed with zileuton IR, 600 mg 4 times daily (Zyflo).

Zileuton added to low-dose inhaled beclomethasone for the treatment of moderate to severe persistent asthma. [2007.06]
OBJECTIVE: To assess the therapeutic effects of oral zileuton tablets combined with low-dose beclomethasone compared to doubling the dose of beclomethasone, in improving lung function and reducing asthma symptoms... CONCLUSIONS: The addition of a 5-LO inhibitor added to low-dose beclomethasone may be an alternative to higher-doses of ICS in patients unable to achieve sufficient asthma control on low-dose ICS therapy.

The safety and efficacy of zileuton controlled-release tablets as adjunctive therapy to usual care in the treatment of moderate persistent asthma: a 6-month randomized controlled study. [2007.05]
This study was conducted to assess the safety and efficacy of zileuton controlled release [CR] 1,200 mg BID added to usual care (UC) in 926 patients with moderate asthma (619 patients randomized to zileuton CR and 307 to placebo). Sustained improvements in AM and PM peak expiratory flow (PEF) were observed in the zileuton CR group compared to placebo.

more studies >>

Clinical Trials Related to Zyflo CR (Zileuton)

Evaluating the Safety of Zileuton (Zyflo�) in Combination With Dasatinib (Sprycel�) in Chronic Myelogenous Leukemia [Recruiting]
Prospective nonrandomized phase I study The purpose of this study is to determine safety and efficacy of zileuton when added to dasatinib in patients with chronic myelogenous leukemia (CML).

Safety of Zileuton (Zyflo) in Combination With Imatinib Mesylate (Gleevec) in CML. [Terminated]
The leukemic stem cells (LSCs) are cells that self- renew and give rise to leukemia. Eradication of LSC is required for cure. In chronic myelogenous leukemia (CML) LSCs are not eradicated by imatinib (Gleevec) alone. Recent discovery by Dr. Shaoguang Li at University of Massachusetts indicates that the LSCs can be targeted by a new drug zileuton (Chen et al. Nature Genetics 2009; 41: 783-792). Zileuton (approved for asthma) will be tested in a combination with Gleevec. This combination has not been used previously to treat leukemia. This is a Phase I study. The goal of this research is to evaluate the safety of the standard anti-cancer drug imatinib and experimental drug zileuton.

Aspirin and Zileuton and Biomarker Expression in Nasal Tissue of Current Smokers [Not yet recruiting]
This randomized phase II trial studies the effects of aspirin and zileuton on genes related to tobacco use in current smokers. Smokers are at increased risk for developing lung and other cancers. Aspirin and zileuton may interfere with genes related to tobacco use and may be useful in preventing lung cancer in current smokers.

Trial of Zileuton CR in Children and Adults With Sickle Cell Disease [Completed]
The purpose of this research study is to test the safety of Zileuton and see what effects (good and bad) it has on you, other children and adults with Sickle Cell Disease (SCD). The investigators also want to see how Zileuton is handled by your body at different doses. Zileuton is a drug that is approved by the Food and Drug Administration (FDA) for the treatment of asthma for people age 12 and older. The FDA has not approved Zileuton for the treatment of SCD, so it is being studied as an investigational drug for SCD through an application to the FDA. In asthma patients, Zileuton helps by reducing inflammation. This study will see if Zileuton helps to reduce inflammation associated with SCD.

Zileuton With or Without Celecoxib As Chemopreventive Agents in Smokers [Completed]
The goal of this clinical research study is to learn how zileuton alone or the combination of zileuton and celecoxib may affect certain chemicals in the body that may be linked with a risk for smoking-related lung disease. These effects will be measured by a urine test

more trials >>

Reports of Suspected Zyflo CR (Zileuton) Side Effects

Palpitations (3)Drug Ineffective (2)Death (2)Product Quality Issue (2)Alanine Aminotransferase Increased (2)Aspartate Aminotransferase Increased (2)Blood Bilirubin Increased (1)Hypersensitivity (1)Pyrexia (1)Fatigue (1)more >>


Page last updated: 2016-05-20

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