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The pharmacokinetics, efficacy, and safety of intravenous (iv) itraconazole (2 days at 400 mg/day, 12 days at 200 mg/day), followed by 12 weeks of oral capsules (400 mg/day) were studied in 31 immunocompromised patients with pulmonary invasive aspergillosis. All patients received iv itraconazole (median duration, 14 days), and 26 then received oral itraconazole (median duration, 78.5 days). After receiving iv itraconazole, concentrations increased rapidly, with trough plasma levels ⩾250 ng/mL in 91% of patients and in all patients by day 7. Concentrations ⩾500 ng/mL were observed in 64% of patients by day 2. Mean trough concentrations after 2 and 14 days were 670 and 850 ng/mL, respectively. Therapeutic levels were maintained after switching to oral capsules. A complete or partial response was seen at the last on-treatment assessment in 15 (48%) of 31 patients, with 6 (19%) showing stable disease. Itraconazole was well tolerated, with no unexpected effects. Overall iv/oral itraconazole was ...
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It has been reported that the protein expression and mRNA level of hepatic cytochrome P450 (CYP) 3A1/2 increased in a rat model of diabetes mellitus induced by streptozotocin (DMIS rats). From this thesis, it has been obtained that 7-hydroxyitraconazole, a main metabolite of itraconazole, was formed via hepatic CYP3A1/2 in rats, and the protein expression of intestinal CYP3A subfamily was comparable between control and DMIS rats. The fungal infection was common in older patients with diabetes mellitus. Thus, itraconazole was chosen using DMIS rats as an animal model in the present thesis. After the intravenous administration of itraconazole, the AUC 0−24 hs of both itracoanzole and 7-hydroxyitracoanzole were comparable between control and DMIS rats. This could have been supported by comparable hepatic CLints for the disappearance of itraconazole and in the formation of 7-hydroxyitraconazole and comparable free fractions of itraconazole in rat plasma between two groups of rats. After the oral ...
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WebMD provides information about interactions between Xanax oral and selected-benzodiazepines-itraconazole-ketoconazole.. Original Article from The New England Journal of Medicine - Posaconazole vs.In the fluconazole or itraconazole group,. or itraconazole Fluconazole A.Itraconazole Compared With Fluconazole to Prevent Infections in Patients Undergoing Peripheral Stem Cell or Bone Marrow Transplantation.. Itraconazole is a relatively well-tolerated drug (although not as well tolerated as fluconazole or voriconazole) and the range of adverse effects it produces is.Includes Diflucan side effects, interactions and indications.Fluconazole is found in human breast milk at concentrations similar to plasma.Sporanox (itraconazole) Capsules and Sporanox Oral Solution should not be used interchangeably.. Itraconazole is used to treat infections caused by fungus, which can invade any part.Compare head-to-head ratings, side effects, warnings, dosages.Detailed View: Safety Labeling Changes Approved By FDA ...
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The analysis required 200 µL of plasma and involved a rapid, simple solid-phase extraction with an Oasis HLB cartridge, which resulted in recoveries of 87-92% for itraconazole and 91-94% for hydroxyitraconazole. The lower limit of quantification for itraconazole and hydroxyitraconazole was 5 ng/mL each. Intra- and interday coefficients of variation for itraconazole and hydroxyitraconazole were less than 11.3% and 12.2%, respectively, and accuracies were within 11.7% and 4.5% over the linear range, respectively. Although the steady-state plasma concentrations of itraconazole and hydroxyitraconazole ranged from 506 to 2482 ng/mL and from 766 to 2444 ng/mL, respectively, after a two-day loading dose of 400 mg/day intravenous itraconazole followed by the administration of 200 mg/day itraconazole oral solution, calibration curves of itraconazole and hydroxyitraconazole showed positive linearity in a concentration range of 5-2500 and 50-2500 ng/mL, respectively.. ...
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A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B...
ClinicalTrials.gov summary of A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis
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Itraconazole inhibits angiogenesis and tumor growth in non-small cell lung cancer. | Medic Debate
The antiangiogenic agent bevacizumab has been approved for the treatment of non-small cell lung cancer (NSCLC), although the survival benefit associated with this agent is marginal, and toxicities and cost are substantial. A recent screen for selective inhibitors of endothelial cell proliferation identified the oral antifungal drug itraconazole as a novel agent with potential antiangiogenic activity. In this article, we define and characterize the antiangiogenic and anticancer activities of itraconazole in relevant preclinical models of angiogenesis and lung cancer. Itraconazole consistently showed potent, specific, and dose-dependent inhibition of endothelial cell proliferation, migration, and tube formation in response to both VEGF- and basic fibroblast growth factor-mediated angiogenic stimulation. In vivo, using primary xenograft models of human NSCLC, oral itraconazole showed single-agent growth-inhibitory activity associated with induction of tumor hypoxia-inducible factor 1 alpha ...
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Oropharyngeal candidiasis is a frequent infection in cancer patients who receive cytotoxic drugs. In this study, the efficacy, safety and tolerance of fluconazole and itraconazole were compared in non-neutropenic cancer patients with oropharyngeal candidiasis. Of 279 patients who were randomised between the two treatment groups, 252 patients were considered to be eligible (126 in each group). The clinical cure rate was 74% for fluconazole and 62% for itraconazole (P=0.04, 95% Confidence Interval (CI): 0.5-23.3%). The mycological cure rate was 80% for fluconazole and 68% for itraconazole (P=0.03, 95% CI: 1.2-22.6%). The safety and tolerance profile of both drugs were comparable. This study has shown that in patients with cancer and oropharyngeal candidiasis, fluconazole has a significantly better clinical and mycological cure rate compared with itraconazole ...
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Adverse cutaneous reactions to itraconazole are known to be quite rare. We report a case of maculopapular reaction caused by itraconazole. On the 7th day of itraconazole therapy for hand onychomycosis, in a 39-year-old woman pruritus...
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Itraconazole has a broader spectrum of activity than fluconazole (but not as broad as voriconazole or posaconazole). In particular, it is active against Aspergillus, which fluconazole is not. It is also licensed for use in blastomycosis, sporotrichosis, histoplasmosis, and onychomycosis. Itraconazole is over 99% protein-bound and has virtually no penetration into cerebrospinal fluid. Therefore, it should never be used to treat meningitis or other central nervous system infections. According to the Johns Hopkins Abx Guide, it has negligible CSF penetration, however treatment has been successful for cryptococcal and coccidioidal meningitis.. It is also prescribed for systemic infections, such as aspergillosis, candidiasis, and cryptococcosis, where other antifungal drugs are inappropriate or ineffective.. Itraconazole has also recently been explored as an anticancer agent for patients with basal cell carcinoma, non-small cell lung cancer, and prostate cancer. For example, in a phase II study ...
Influence of albumin on itraconazole and ketoconazole antifungal activity: results of a dynamic in vitro study. | Antimicrobial...
The relevance of intense protein binding to the antifungal activity of azole compounds is still a matter of debate. The influence of albumin on the antimicrobial activity of ketoconazole and itraconazole, which exhibit very strong plasma protein binding (99 and 99.8%), was evaluated in vitro. Candida albicans was exposed to continuously changing azole concentrations corresponding to drug levels in serum following an oral dose of 200 mg. Total as well as free drug levels in serum were simulated. The incubation medium was free of proteins or contained 4% human serum albumin. Itraconazole levels reflecting free drug concentrations in humans did not reduce the growth rate of C. albicans, as compared with controls (difference in the log CFU per milliliter at 12 h, 0.03 +/- 0.09), whereas total drug levels were as active in the presence of 4% albumin (mean difference, -0.61) as in its absence (-0.75). The same was true for ketoconazole, except that free drug levels were also active (-1.21 versus -1.39 ...
Evaluation of Antifungal Prophylaxis on Graft-versus-host Disease (GVHD) Patients - Full Text View - ClinicalTrials.gov
Eligible patients who provided an informed consent form will be administered itraconazole oral solution (200mg bid initially, swash and swallow) in either an in patient or outpatient setting. Treatment can be initiated at the same time of or within 10 days after starting systemic immunosuppressive therapy.. Itraconazole oral solution dose can be adjusted according to the liver function test: 1) in case of - AST/ALT level 5-10 times UNL or bilirubin/ALP level 2-5 times UNL, itraconazole dose can be reduced to half (i.e. itraconazole 200mg po once daily or 100mg bid); 2) in case of - AST/ALT level , 10 times UNL or bilirubin/ALP level , 5 times UNL, itraconazole can be stopped.. GVHD treatment can be given per centers policy: With respect to acute GVHD, prednisone (1-2mg/Kg/day) oral or iv can be given on top of calcineurin inhibitor (CNI) GVHD prophylaxis. For chronic GVHD, various type of frontline regimen can be permitted including CNI+prednisone (PD), PD alone, CNI+PD+mycophenolate mofetil ...
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Winston and colleagues data and conclusions (1) should remind us of the problems encountered in the design and reporting of trials of antifungal agents (2). First, it is unclear why blinding of the 2 agents studied was technologically impossible. Second, even though a multivariable analysis that included graft-versus-host disease showed that itraconazole was still associated with fewer fungal infections than fluconazole, the randomization process could have easily stratified patients by donor type, related versus unrelated, at enrollment. Third, the authors did not mention what percentage of patients in both groups were treated empirically with amphotericin B for suspected fungal infection. Fourth, antifungal prophylactic measures used during the preparative regimens of chemoradiation therapy, such as topical mucosal antifungal agents, were not listed, nor were the prophylactic measures used after day 100 following transplantation. Fifth, the study was designed to show that itraconazole was ...
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ABSTRACT. The present study deals with the formulation and evaluation of egg albumin based delayed release microspheres of itraconazole, which is drug of choice for systemic fungal infections. The study was undertaken in order to achieve the best possible drug-polymer (egg albumin) ratio to get delayed drug release using natural biodegradable polymer. The preparation of microsphere was done by using heat denaturation technique. The prepared microspheres were evaluated on various parameters like the size, morphology, micromeritic properties, percent drug entrapment, in-vitro dissolution studies and the scanning electron microscopy (SEM).The in vitro dissolution studies were carried out for 10 hrs. at pH 6.8 which showed that the drug release for the batch EA4 (drug: polymer ratio - 1:4) was 87.02 ± 5.89 after 10 hrs. The hypothesis of this research work i.e delayed drug release using natural biodegradable polymer was well supported by results of its evaluation.. Keywords: Itraconazole, egg ...
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Itraconazole showed no evidence of carcinogenicity potential in mice treated orally for 23 months at dosage levels up to 80 mg/kg/day (approximately 10x the maximum recommended human dose [MRHD]). Male rats treated with 25 mg/kg/day (3.1x RHD) had a slightly increased incidence of soft tissue sarcoma. These sarcomas may have been a consequence of hypercholesterolemia, which is a response of rats, but not dogs or humans, to chronic itraconazole administration. Female rats treated with 50 mg/kg/day (6.25x MRHD) had an increased incidence of squamous cell carcinoma of the lung (2/50) as compared to the untreated group. Although the occurrence of squamous cell carcinoma in the lung is extremely uncommon in untreated rats, the increase in this study was not statistically significant. Hydroxypropyl-β-cyclodextrin (HP-β-CD), the solubilizing excipient used in SPORANOX® Oral Solution, was found to produce pancreatic exocrine hyperplasia and neoplasia when administered orally to rats at doses of 500, ...
DSpace at EWHA: Success rate and risk factors for failure of empirical antifungal therapy with itraconazole in patients with...
Success rate and risk factors for failure of empirical antifungal therapy with itraconazole in patients with hematological malignancies: a multicenter, prospective, open-label, observational study in Korea. ...
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Abnormal angiogenesis is implicated in a number of human diseases and endothelial growth inhibition represents a common approach in tumor therapy. Recently itraconazole, frequently used in humans as antifungal drug, which blocks the biosynthesis of cholesterol, has been found to be antiangiogenic in primary umbilical vein endothelial cells. However, the exact antiangiogenic mechanisms remain largely unknown. In this paper, we studied the effect of itraconazole in human dermal microvascular endothelial cells (HMEC-1), an immortalized cell line to study adult angiogenesis. A 50% reduction of microtubule formation was observed after itraconazole treatment which was partially rescued by cholesterol addition. We found that itraconazole inhibits angiogenesis markers such as VEGF, AAMP and e-NOS. mTOR and ERK1/2 phosphorylation as well as the expression of Gli1, one of the main controllers of the Shh pathway, were also inhibited by itraconazole. Cholesterol addition did not completely rescue inhibition ...
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A Randomized Phase II Study of Itraconazole and Pemetrexed in Patients With Previously Treated Non-Squamous Non-Small Cell Lung...
Itraconazole is a strong CYP3A4 inhibitor and may increase plasma concentrations of drugs metabolized by this pathway. Coadministration of cisapride, midazolam, pimozide, quinidine, lovastatin, simvastatin, triazolam, dofetilide, or levacetylmethadol (levomethadyl) with itraconazole is contraindicated. Patients who take any of these medications and who are not able to change to an alternative medication will be excluded. Lists including medications and substances known or with the potential to interact with the CYP3A4 isoenzymes are provided in Section 7.1 ...
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