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Howstuffworks "Zileuton: A Profile of an Antiasthmatic Drug" Zileuton is used to prevent the symptoms of asthma, such as wheezing and shortness of breath. Zileuton may increase the serious side effects and actions of midazolam, triazolam, alprazolam, nifedipine, isradipine, nicardipine, nifedipine, nimodipine, propranolol, theophylline, carbamazepine, phenytoin, tolbutamide, and cyclosporine. Zileuton may increase the actions of warfarin (a blood thinner) and increase the risk of bleeding. health.howstuffworks.com /define-zileuton.htm   (691 words)

Zileuton Drug Information, Professional   (Site not responding. Last check: 2007-11-06) Zileuton is a selective inhibitor of 5-lipoxygenase, which is the enzyme that catalyzes the formation of leukotrienes from arachidonic acid. Zileuton was not tumorigenic in male and female rats given doses of approximately four and six times, respectively, the systemic exposure achieved at the maximum recommended human daily oral dose. Zileuton was not mutagenic in multiple in vivo and in vitro assays; however, the livers and kidneys of female mice treated with zileuton showed a dose-related increase in DNA adduct formation. www.drugs.com /MMX/Zileuton.html   (1939 words)

zileuton - [Medication] Leukotrienes are substances in the body that are associated with the inflammation and constriction of airway muscles and the accumulation of fluid in the lungs, all of which occur during an asthma attack. Zileuton is in the FDA pregnancy category C. This means that it is not known whether zileuton will be harmful to an unborn baby. Symptoms of an overdose of zileuton are unknown. www.peacehealth.org /kbase/multum/d04103a1.htm   (1195 words)

News: Critical Therapeutics on Target to Submit NDA for Zileuton Controlled-Release Tablets in Third Quarter 2006. ... The pharmacokinetic studies were designed to evaluate whether the pharmacokinetic profile of zileuton CR tablets manufactured by Critical Therapeutics when compared with ZYFLO is similar to the pharmacokinetic profile of zileuton CR tablets previously manufactured by the third party when compared with ZYFLO. Critical Therapeutics must show relative bioavailability between the two zileuton CR formulations to enable it to bridge to the previous data generated from the original development of zileuton CR, including the results from the previous Phase III clinical trials. The studies were designed to assess the pharmacokinetics of zileuton CR in fed and fasted conditions and to enable a historical comparison of bioavailability to previously manufactured zileuton CR. www.genengnews.com /news/bnitem.aspx?name=1029503   (1126 words)

MedlinePlus Drug Information: Zileuton (Systemic)   (Site not responding. Last check: 2007-11-06) Zileuton (zye-LOO-ton) is used by patients with mild to moderate chronic asthma to decrease the symptoms of asthma and the number of acute asthma attacks. To work properly, zileuton must be taken every day at regularly spaced times, even if your asthma seems better. You may be taking other medicines for asthma along with zileuton. www.nlm.nih.gov /medlineplus/druginfo/uspdi/203040.html   (951 words)

Zileuton Improves Lung Function in Moderate to Severe Asthma Patients: Presented at CHEST   (Site not responding. Last check: 2007-11-06) Zileuton is approved for the treatment of chronic asthma. For each of 4 different measurements evaluated in the post hoc analysis there were 53 to 66 patients on zileuton and 61 to 68 patients on placebo who met the definition of moderate persistent asthma. There were between 43 and 65 patients on zileuton and between 35 and 68 patients on placebo who met the definition of severe persistent asthma for each of the 4 measurements. www.pslgroup.com /dg/25497e.htm   (452 words)

Rosacea News: Zileuton disappoints for acne relief, rosacea hopes dashed also ? Zileuton has been hyped and hoped as the first real breakthrough drug to treat rosacea in over a decade. Zyflo (Zileuton) was approved by the U.S. Food and Drug Administration (FDA) in 1996 for the treatment of asthma in patients 12 and older. The rosacea hope was that Zileuton's affect on inflammatory papules and pustules could be enjoyed by rosacea sufferers. rosacea.ii.net /news/2005/08/zileuton-disappoints-for-acne-relief.html   (474 words)

PharmaLive: FDA accepts New Drug Application for zileuton CR Zileuton CR is an investigational drug developed for the prevention and chronic treatment of asthma in adults and children 12 years of age and older. In its pivotal trials in adult asthma, zileuton was shown to bring the greatest benefit to those with the most severe disease. Zileuton is not intended for acute relief of asthma symptoms but chronic treatment with zileuton allows reduction of other therapies such as oral steroids which have undesirable side-effects. www.pharmalive.com /News/Index.cfm?articleid=383911   (531 words)

Zileuton (Systemic) - MayoClinic.com   (Site not responding. Last check: 2007-11-06) Zileuton passes into breast milk and may cause unwanted effects in nursing babies. Studies on this medicine have been done only in adult patients and there is no specific information comparing use of zileuton in children up to 12 years of age with use in other age groups. Check with your health care professional if more inhalations (puffs) than usual of an inhaled, short-acting bronchodilator are needed to relieve an acute attack or if more than the maximum number of puffs of the bronchodilator prescribed for a 24-hour period are needed. www.mayoclinic.com /health/drug-information/DR203040   (968 words)

News: Critical Therapeutics Completes Clinical Trial of Intravenous Zileuton in Patients with Asthma; Preliminary ... The Company is developing zileuton IV initially for use in patients who suffer acute exacerbations of asthma. The Phase I/II clinical trial of zileuton IV is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy in 60 patients. All patients participated in a three-day follow-up period post-infusion, primarily to assess the safety of zileuton IV. www.genengnews.com /news/bnitem.aspx?name=3667263   (775 words)

Zileuton   (Site not responding. Last check: 2007-11-06) (zileuton tablets) is the only FDA approved asthma treatment that inhibits the production of 5-lipoxygenase (5-LO), the main enzyme responsible for the production of leukotrienes, a family of inflammatory mediators that can trigger asthma symptoms, including inflammation, swelling, bronchoconstriction and mucus secretion. Zileuton CR is an investigational drug for the prevention and chronic treatment of asthma in adults and children 12 years of age and older. The trial was designed to evaluate safety, tolerability and pharmacokinetics of zileuton IV in patients with asthma. www.crtx.com /zileuton.html   (566 words)

Bronchial Dysplasia and Lung Cancer Prevention - National Cancer Institute Phase II Study of Zileuton for the Prevention of Lung Cancer in Patients with Bronchial Dysplasia (WSU-C-2405). Zileuton (Zyflo®) is a drug used to prevent asthma symptoms, and it is being studied in the prevention of cancer. This trial will study the effectiveness of zileuton in eliminating bronchial dysplasia in smokers and former smokers who are at high risk for lung cancer. www.cancer.gov /clinicaltrials/ft-WSU-C-2405   (304 words)

Clinical Pharmacology of Leukotriene Receptor Antagonists and 5-Lipoxygenase Inhibitors -- DRAZEN 157 (6): 233 -- ... Patients were treated with either placebo or zileuton at doses of 600 mg four times per day or 800 mg twice per day for 4 wk. Zileuton has been evaluated in both 13- and 26-wk studies (13, 14). Both zileuton and zafirlukast have been assessed for their effects on indices of airway inflammation. ajrccm.atsjournals.org /cgi/content/full/157/6/S233   (2652 words)

Zileuton: the first 5-lipoxygenase inhibitor for the treatment of asthma -- Wenzel and Kamada 30 (7): 858 -- The Annals ... OBJECTIVE: To introduce and review zileuton, an orally active 5-lipoxygenase inhibitor that represents the first of a new class of medications to be used in the treatment of asthma. DATA SYNTHESIS: Zileuton has shown the ability to attenuate induced bronchospasm, produce some degree of bronchodilation, and provide antiinflammatory or steroid-sparing effects with both single doses (800 mg) and chronic treatment (400 and 600 mg qid). Zileuton has been studied in patients requiring daily inhaled beta-adrenergic agonist treatment; however, data from pediatric populations and comparisons with other asthma medications are limited at this time. www.theannals.com /cgi/content/abstract/30/7/858   (466 words)

Zileuton Add-On Controls Severe Asthma as Well as Doubled Steroid Dose: Presented at ACAAI   (Site not responding. Last check: 2007-11-06) New findings suggest that adding zileuton has the same effect as doubling the corticosteroid dose, and for severe asthma may even work better. The experimental group received BPD at 200 mcg twice daily plus zileuton at either a low dose (400 mg) or a high dose (600 mg) 4 times daily. Zileuton was not found to have more frequent or more severe adverse events than high-dose BDP. www.pslgroup.com /dg/254aba.htm   (526 words)

Zileuton   (Site not responding. Last check: 2007-11-06) The controlled-release formulation of zileuton that Critical Therapeutics is developing may be more convenient for patients as a result of its twice-a-day dosing regimen compared to the current four-times-a-day dosing regimen. Phase III clinical trials were previously conducted for this formulation in asthma and we expect to submit a New Drug Application (NDA) in the first half of 2006, based on safety and efficacy data generated from the two completed Phase III trials, a three-month efficacy trial, and a six-month safety and efficacy trial. ZYFLO is not indicated for use in the reversal of bronchospasm in acute asthma attacks. www.criticaltherapeutics.com /md_cdp.html   (585 words)

Rosacea News: zileuton reduces sebum production Background: Zileuton, a 5-lipoxygenase inhibitor, reduces the number of inflammatory lesions in moderate acne and inhibits the synthesis of sebaceous lipids. Methods: A 40-year-old female with mild disseminated sebaceous gland hyperplasia and seborrhea was treated with zileuton 4 x 600 mg/day over 2 weeks, was followed-up for 6 weeks after discontinuation of zileuton and was re-treated with low-dose isotretinoin 10 mg/2nd day over 5 weeks. Results: Under treatment with zileuton increased casual skin surface lipids were normalized and synthesis of facial sebum was decreased. rosacea.ii.net /news/2005/09/zileuton-reduces-sebum-production.html   (230 words)

Critical Therapeutics Presents Safety Data for Twice Daily, Controlled-Release Formulation of Zileuton at CHEST 2006 - ...   (Site not responding. Last check: 2007-11-06) Zileuton CR is a 5-lipoxygenase (5-LO) inhibitor designed to block the production of the 5-LO, an enzyme responsible for asthma symptoms. The objective was to compare the efficacy and safety of zileuton CR 1200 mg (n=206) with placebo (n=203). Patients enrolled in the zileuton CR arms had a mean baseline percent of predicted normal forced expiratory volume (FEV1) of 58.5%. www.forbes.com.cob-web.org:8888 /businesswire/feeds/businesswire/2006/10/25/businesswire20061025006262r1.html   (978 words)

Zileuton provided clinically relevant reductions in the need for rescue medication and oral corticosteroids compared to ...   (Site not responding. Last check: 2007-11-06) Zileuton provided clinically relevant reductions in the need for rescue medication and oral corticosteroids compared to placebo in moderate and severe asthmatics In an exploratory secondary analysis of patients in the high dose zileuton 600 mg QID group, patients were stratified by baseline (BL) percent predicted FEV1 into two subgroups of asthma severity: moderate (>60%-<80%) and severe ([less than or equal to] 60%). CLINICAL IMPLICATIONS: Zileuton, a 5-lipoyxgenase inhibitor approved for the treatment of chronic asthma, may reduce the need for beta-agonists and oral corticosteroids and improve other markers of asthma control, especially in severe asthmatics. www.findarticles.com /p/articles/mi_m0984/is_4_128/ai_n15787255   (350 words)

C&EN: COVERSTORY - CASE STUDY #1 - REVIVING AN OLD DRUG And in his dual quest, he is leveraging two strengths from his past: an intimate knowledge of zileuton and a good working experience with the pharmaceutical services firm Rhodia Pharma Solutions. When the drug was approved in 1996 as Zyflo, it became the only Food and Drug Administration-approved product that works by blocking the activity of 5-lipoxygenase, the main enzyme responsible for the formation of a family of lipids known as leukotrienes. CTI believes that zileuton's activity against a range of leukotrienes differentiates it from montelukast, the active ingredient in Singulair, a Merck drug that is the most frequently prescribed leukotriene receptor antagonist. pubs.acs.org /cen/coverstory/83/8314pharma2.html   (1088 words)

Peroxynitrite-Induced Nitrotyrosination of Proteins Is Blocked by Direct 5-Lipoxygenase Inhibitor Zileuton -- Coffey et ... LPS-treated AM were treated with or without zileuton (10 µM) in parallel for 16 h, and the cells were washed and stimulated with A23817 (1 µM) for 30 min at 37°C. The medium was then analyzed for LTB B, AM were incubated overnight, washed, and then stimulated with A23187 in the presence of zileuton. LPS-treated AM were treated with or without increasing concentrations of zileuton (0.1-50 µM) in parallel for 16 h, and then the cells were washed and stimulated with A23817 (1 µM) for 30 min at 37°C and the medium was analyzed for LTB jpet.aspetjournals.org /cgi/content/full/299/1/198   (4227 words)

Benefits from Adding the 5-Lipoxygenase Inhibitor Zileuton to Conventional Therapy in Aspirin-intolerant Asthmatics -- ... for zileuton and 2.51 L (95% CI 2.26-2.76) for the placebo period. The concentration of zileuton in plasma was 4.5 µg/ml (95% CI 1.2-7.8) on the morning after the last dose of active drug. Zileuton inhibited aspirin-induced bronchoconstriction (Figure 5) when tested after 4 wk of treatment. ajrccm.atsjournals.org /cgi/content/full/157/4/1187   (4121 words)

Zileuton - Drugs & Vitamins - Drug Library - DrugDigest It helps to reduce recurring symptoms of asthma, but it is not for rapid relief of asthma attacks. It is important that you go on taking your medicine even when you do not have any asthma symptoms. Liver tests will need to be done on a regular basis while taking zileuton. www.drugdigest.org /DD/DVH/Uses/0,3915,710|Zileuton,00.html   (566 words)

warfarinfo A double-blind parallel randomised study was conducted to assess the effects of multiple oral doses of zileuton (600mg every 6 hours) or matching placebo on the steady-state pharmacokinetics and pharmacodynamics of warfarin titrated to a prothrombin time of 14 to 18 seconds in 24 healthy adult male volunteers. Coadministration of zileuton and warfarin had no effect on S-warfarin pharmacokinetics but statistically significantly increased mean R-warfarin plasma concentrations and decreased mean R-warfarin total oral plasma clearance compared with warfarin alone (by 15%). This stereoselective interaction was accompanied by an increase in mean morning (predose) and evening (12-hour postdose) prothrombin times from 17.5 to 19.8 seconds and 17.1 to 19.1 seconds, respectively; the corresponding changes in the placebo group were from 18.1 to 18.8 seconds and 17.3 to 17.5 seconds. www.warfarinfo.com /zileuton.htm   (337 words)

Zileuton (via CobWeb/3.1 planetlab1.netlab.uky.edu)   (Site not responding. Last check: 2007-11-06) Zileuton inhibits 5-lipoxygenase (5-LO), an enzyme that catalyzes the... Therapeutics Daily (subscription) (press release), PA -Zileuton CR is an investigational drug for the prevention and chronic treatment of asthma in adults and children 12 years of age and older. For any further understanding that could lead to the prevention, treatment, and/or cure of the disorders, we recommend that affected individuals seek the advice or counsel of his or her own personal physician(s). zileuton.diseasemap.com.cob-web.org:8888   (363 words)

Zileuton - Talk Medical · Zileuton is in the FDA pregnancy category C. This means that it is not known whether Zileuton will be harmful to an unborn baby. · Zileuton is not approved for use by children younger than 12 years of age. · Symptoms of an overdose of Zileuton are unknown. www.talkmedical.com /medications/6749/Zileuton   (923 words)

Zileuton provided significant improvement in pulmonary function compared to placebo in moderate and severe asthmatics ...   (Site not responding. Last check: 2007-11-06) METHODS: This was a randomized, placebo-controlled, double-blind, parallel, multicenter study of the safety and efficacy of zileuton in patients with asthma. RESULTS: Moderate and severe patients on zileuton experienced significant improvement in FEV1 and A.M. This difference was demonstrated as early as 30 minutes post-dose and was sustained throughout the duration of the study. CLINICAL IMPLICATIONS: Zileuton, a 5-lipoyxgenase inhibitor approved for chronic asthma, may improve pulmonary function via its mechanism of action in moderate and severe asthmatics. www.findarticles.com /p/articles/mi_m0984/is_4_128/ai_n15787254   (297 words)

MedlinePlus Drug Information: Zileuton Zileuton comes as a tablet to take by mouth. Zileuton controls asthma symptoms but does not cure them. Zileuton will not stop an acute attack that has already started. www.nlm.nih.gov /medlineplus/druginfo/medmaster/a697013.html   (584 words)

SkyePharma PLC :: Critical Therapeutics Files Controlled Release Formulation of Zileuton The new formulation only needs to be taken twice a day whereas Zyflo(R), the currently marketed version of zileuton, has the drawback of requiring dosing four times a day. SkyePharma developed a controlled-release formulation of zileuton, using its Geomatrix(TM) technology, for Abbott, which completed Phase III development in asthma with this product. CTI acquired the rights to zileuton from Abbott and since December 2003 SkyePharma has collaborated with CTI on the further development of this formulation. sev.prnewswire.com /biotechnology/20060801/NYTU10901082006-1.html   (584 words)

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