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Additional comments from COM on mutagenicity evaluation. 10. The COM reviewed a number of publications where mutagenic effects in vitro had been specifically attributed to nanoparticulate titanium dioxide11 and zinc oxide12. However the COM noted inconsistency in the available mutagenicity data and in the information on the specification of the test materials used. It was therefore not able to conclude that any specific mutagenic activity had been documented which would not also be reported for studies using micrometre sized equivalents. The COM considered that specific information on particle size was required to assess mutagenicity studies undertaken with nanomaterials. Thus, there was insufficient information on titanium dioxide to allow an assessment of the agglomeration disagglomeration of particles in the vehicles used and it was not possible to conclude which particles had been tested. The COM agreed that it might be appropriate to support in-vitro mutagenicity tests with imaging data on particle sizes. The Committees agreed that particle size was a generic factor which should be considered with all in-vitro testing of nanomaterials.
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More recently, Hou et al. 2002 ; used the SCOTS technique to identify 46 genes that are up-regulated or uniquely expressed by MAA during growth in human macrophages. This analysis provided some insights into M. avium metabolism during intracellular growth. For example, both the tricarboxylic acid cycle and the glyoxalate shunt appeared to function during intracellular growth. The tricarboxylic acid cycle is the central metabolic pathway responsible for generation of CO2 , adenosine triphosphate, reduced nucleotides and precursors of several amino acids. The glyoxalate shunt functions to prevent loss of carbon molecules by bypassing the steps in which CO2 is generated. In other bacteria the kinds of carbon sources available affect the operation of these cycles with the glyoxalate shunt becoming operative when fatty acids are used as carbon sources. The glyoxalate shunt is not used exclusively but operates simultaneously with the tricarboxylic acid cycle Cronan & LaPorte 1996 ; . Expression of genes encoding several enzymes involved in biosynthetic pathways for amino acids and mycolic acids also appeared to be up-regulated during intracellular growth of MAA Hou et al. 2002 ; . In addition, genes encoding enzymes involved in mycobactin biosynthesis were up-regulated Hou et al. 2002 ; . Mycobactins are siderophores produced by mycobacteria to enable them to obtain iron, an essential nutrient for all organisms, but one which is not usually readily available to intracellular organisms. Another upregulated gene was a homologue of the M. tuberculosis narK3 gene Hou et al. 2002 ; . This gene codes for a nitrite extrusion protein. Excess nitrite is toxic to some mycobacteria. Several genes that code for proteins involved in regulation of gene expression were also up-regulated for expression during growth in macrophages. Finally, a number of genes encoding homologues to M. tuberculosis proteins that may be important in mycobacterial pathogenesis were also observed to be upregulated in MAA during growth in macrophages. These included genes belonging to two of the mce operons and two genes encoding PPE proteins Hou et al. 2002 ; . Certain mce proteins have been implicated in entry and intracellular survival Arruda et al. 1993; Graham & Clark-Curtiss 1999 ; , while PPE proteins have been postulated to participate in antigenic variation Cole et al. 1998 ; . Additional global gene expression analyses have targeted proteins. Honer zu Bentrup et al. 1999 ; and Sturgill-Koszycki et al. 1994 ; employed twodimensional gel electrophoresis to identify a protein, isocitrate lyase that is up-regulated for expression in MAA grown in mouse macrophages. Additional experiments are necessary to definitively prove that up-regulated proteins are essential for intracellular life. Moreover, there probably are additional proteins important to intracellular life which remain to be identified. Nevertheless, valuable information regarding MAA metabolism during intracellular growth has been obtained. Identification of additional upregulated genes will further enhance our understanding of MAA physiology in this environmental niche. Do all MAA strains express the same genes after phagocytosis by human macrophages? The MAA strain used for the SCOTS analyses was a serotype 4 strain isolated from an HIV-infected human. Do MAA strains that are able to infect humans express genes that are not expressed in strains that are not pathogenic in humans? Answers to these questions may provide better ways to assess the risks of infection by MAC-contaminated water supplies.
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Conference on the Science and Policy of Performance-Enhancing Products Karl Friedl, Ph.D. Army Operational Medicine Research ; : It has taken 20 years just within the Department of Defense DoD ; studying one compound--caffeine--for the Institute of Medicine to issue recommendations on use of this substance. We cannot wait another 20 years for the next substance. A focused research agenda is needed to develop conclusions for the public. We cannot continue to throw out caveats for endless research. The public needs conclusions and recommendations. Dr. Strait DEA ; : Was HMB over represented in the meta-analysis? Dr. Nissen: Participant: I don't think HMB was over represented; the selected studies fit the criteria. Were the studies with the HMB mixture with arginine and lysine designed to rule out the possibility that the mitigation of wasting was simply due to improvement of energy balance--perhaps by the use of placebo or dietary controls? There were no dietary controls. We used the traditional dietary recall, which is not very sensitive. But there weren't any changes per se in dietary intake. One study was done institutionally and all the meals were eaten in the same dining hall. What about the placebo, was it balanced in energy? A proper placebo is tough anytime nitrogen is added to the diet. We used a combination of five nonessential amino acids, including alanine, serine, glutamic acid and dramamine.
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James F. Trotter, M.D., Associate Professor of Medicine in Department of Hepatology and Associate Medical Director of Liver Transplantation at UCHSC, gave an excellent presentation on "Pre-transplant PSC treatment". He specifically discussed the major symptoms; itching, cholangitis and weight loss. Dr. Trotter noted that itching is probably caused by accumulation of bile Dr. James Trotter acids in the skin, but observed that no single treatment is uniformly effective for all patients. Itching generally becomes worse at bedtime, tends to drive others e.g. spouses ; crazy, and tends to come and go over months ; . Dr. Trotter discussed the problem of cholangitis, which represents an infection in the bile tree, caused by stone or sludge build up blocking the bile tree, and then proceeded to discuss treatment options for cholangitis. Finally, Dr. Trotter addressed the problem of weight loss during end-stage PSC, and closed with some insightful observations on PSC. The audience was particularly struck by the concept of "hitting the wall". The following are some key points from Dr. Trotter's extremely thorough presentation: Itching Treatments keep skin moist esp. in Denver ; Neutrogeena best, expensive ; avoid narcotic pain pills topical put directly on skin ; hydrocortisone cream Sarna citrus body lotion Solarcaine spray lotion oatmeal bath ice pack Benadryl Atarax often recommended, rarely helpful Rifampin Interacts with some drugs ursodeoxycholic acid Urso, Actigall ; cholestyramine Questran ; tastes bad, stomach upset Marinol active component of "pot, " marijuana Ativan, Valium only for short-term treatment Revoa Phenobarbital other tanning booth, phototherapy hemodialysis with charcoal filter ?? Cholangitis Symptoms 3 and hydrea.
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Materials and methods: We have undertaken an experimental study in mouse embryos at 2-pronuclear stage, which were collected from 26 outbred CD-1 mice. The embryos were incubated in G1 medium under mineral oil and 5% CO2, at 37C. The embryos in the experimental group were placed 15 cm away from the electromagnetic field source, generated by a GSM device that has been called once for 90 s in every 20 min during the study. Two control groups were established: one was incubated in another incubator, in the same conditions except for lack of GSM device and the other located in the same incubator with the experiment group, but isolated in a steel container. Embryonic development was monitored in these groups for 3 days and blastomere counts were compared by 2-test. Statistical analysis was performed with SPSS Statistical Analysis Package. Results: The division cycle of the embryos up to compact morula stage was not affected and no statistical difference was detected between experimental and both control groups. The magnetic field tested with the duration of 3 days did not seem to interfere significantly with the normal proliferation rate of the embryos in vitro. Conclusions: These results suggest that the GSM device used in this regimen does not exert any harmful effect on early embryonic development for mice. However, different modalities of the device other than to be ringed i.e. speech mode and duration of experiment ; may have interactions on cell kinetics and proliferation effects, effects on genes, signal transduction effects and alterations in membrane structure and function, and biophysical and biochemical consequences. Multidisciplinary research is needed to determine whether there is any effect on structure and function and dilantin.
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Mayxay M, Newton P, Yeung S, Pongvongsa T, Phompida S, Phetsouvanh R, White NJ. Short communication: An assessment of the use of malaria rapid tests by village health volunteers in rural Laos. Tropical Medicine and International Health. 9 3 ; : 325-9, 2004 Mar ; . Cost, Diagnosis, Laos, Malaria, Rapid malaria tests, Village health volunteers. Rapid malaria diagnosis, a key component of malaria control strategies, is hampered by the expense and training requirements of reliable microscopy. Rapid malaria antigen tests may improve the diagnosis of malaria in the rural tropics. After 1 h training 64 village health volunteers VHVs ; from rural Laos, with no previous laboratory experience, performed two malaria rapid diagnostic tests ParacheckPf and OptiMAL ; accurately. The reliability of six VHVs was assessed longitudinally, over 10 months with different frequencies of retraining. Compared with microscopy, error rates in dipstick interpretation were low 2% ; for both tests and were not associated with retraining frequency P 0.2 ; . Previously untrained Lao VHVs performed malaria rapid tests reliably with high sensitivity and specificity after minimal training and docusate.
Maria Hepel1, Indeewari Dela1, Jin Luo2 and Chuan-Jian Zhong3, 1 ; State University of New York at Potsdam, Potsdam, NY, 2 ; State University of New York at Binghamton, Binghamton, NY, 3 ; State Univerisity of New York at Binghamton, Binghamton, NY Considerable interest in utilizing methanol oxidation reaction in fuel cells has recently spurred a new wave of research to develop novel catalysts to drive this reaction. The main problem has been to diminish the ubiquitous poisoning effects inadvertently associated with Pt which is the main active component of most catalysts. In this work, we have investigated bifunctional metal catalysts, including PtRu, PtPd, PtAu, and PtFe, deposited on novel nanostructured substrate materials, such as the semiconducting transition metal oxides WO3-x, TiO2-x, etc. ; , in hopes of modifying the catalyst properties and providing new mechanistic paths for removal of CO poisoning intermediate. Special attention has been paid to surface diffusion of adsorbed CO and weak interactions of methanol with catalysts. The investigations were performed using AFM, EQCN, and point defect formation voltammetry. Various nanostructural and compositional options for enhancement of electrocatalytic effects in methanol oxidation reaction have been considered and they are discussed in details.
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Aspirin caffeine propoxyphene Darvon Compound-65 ; aspirin carisoprodol Soma Compound ; aspirin carisoprodol codeine Soma Compound with Codeine ; aspirin oxycodone Percodan ; baclofen Atrofen ; VA ; butorphanol Stadol NS ; carisoprodol Soma ; choline magnesium trisalicylate Trilisate ; VA ; codeine Codeine Sulfate ; codeine guaifenesin Robitussin AC ; cyclobenzaprine Flexeril ; diclofenac potassium Cataflem ; diclofenac sodium Voltaren ; diflunisal Dolobid ; ergoloid mesylates Ergot ; ergot caff bell alk phenobarb Cafergot P-B ; etodolac Lodine ; fenoprofen Nalfon ; flurbiprofen Ansaid ; hydromorphone Dilaudid ; ibuprofen Motrin ; VA ; indomethacin Indocin ; VA ; ketoprofen Orudis, Oruvail ; ketorolac Toradol ; levorphanol Levo-Dromoran ; meperidine Demerol ; methadone Dolophine ; methocarbamol Robaxin ; morphine Kadian ; nabumetone Relafen ; naltrexone ReVia ; naproxen Anaprox ; VA ; orphenadrine citrate Norflex ; oxaprozin Daypro ; oxycodone Roxicodone ; pentazocine acetaminophen Talacen ; pentazocine naloxone Talwin NX ; piroxicam Feldene ; propoxyphene Darvon ; salsalate Disalcid ; VA ; sulindac Clinoril ; tramadol Ultram ; Cafergot D.H.E. 45 Dantrium Duragesic Imitrex QL ; Kadian Maxalt QL ; Migranal MS Contin OxyContin QL ; Stadol NS QL ; Vioxx PAR ; Zomig QL ; Back to therapeutic class list RESPIRATORY albuterol Ventolin, Proventil ; aminophylline Panamin ; cromolyn inhaled Intal ; dyphylline Dilor ; epinephrine Epipen ; ipratropium inhaled Atrovent ; metaproterenol Alupent ; VA ; promethazine codeine Phenergan with Codeine ; theophylline Theo-Dur ; VA ; Accolate ST.
2 anti-craving drug, naltrexone helps women quit smoking - dec 5, 2006 medindia, the study randomly assigned 110 adult smokers to receive two months of naltrexone brand name revia ; or inactive placebo pills in combination with six anti-craving drug helps women quit smoking - dec 3, 2006 macleans, andrea king of the university of chicago and her colleagues randomly assigned 110 adult smokers to receive two months of naltrexone brand name revia ; or in the spirit of giving - dec 21, 2006 branford news, revia munch stops by once in awhile, and so does leota fletcher, and joyce rogers stops by quite frequently, and recently gary and michelle cannon stopped as seasonal drinking increases, closet alcoholics find hope in new and lamictal.
Approximately 3 million cardiac catheterizations are performed each year, of which at least half are for diagnostic purposes with no intervention performed. A significant percentage of these patients have negative or near normal test results. We have been in need of a non-invasive, reliable test for coronary artery disease. Technologic advances in multidetector CT have made coronary CT angiography a reality, one which is non-invasive, as well as less expensive and less time consuming than conventional angiography. The high negative predictive value of coronary CTA makes this an excellent tool for a wide range of patients. The introduction of 16-slice multidetector CT scanners has made coronary CT angiography possible, and the new GE 64-slice scanner at Frankford-Torresdale has decreased scan time and reduced motion artifact. With a rapid scan of the entire heart utilizing slices of 0.625 mm thickness, we are now able to achieve nearly motion-free images of the coronary arteries. This is aided by ECG gating, in which the images used for interpretation are taken from the point in the cardiac cycle during which cardiac motion is minimized. The images are then transferred to a 3D workstation, where multiplanar reformatted imaging is performed.
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Post-marketing Experience Data collected from post-marketing use of REVIA show that most events usually occur early in the course of drug therapy and are transient. It is not always possible to distinguish these occurrences from those signs and symptoms that may result from a withdrawal syndrome. Events that have been reported include anorexia, asthenia, chest pain, fatigue, headache, hot flushes, malaise, changes in blood pressure, agitation, dizziness, hyperkinesia, nausea, vomiting, tremor, abdominal pain, diarrhoea, elevations in liver enzymes or bilirubin, hepatic function abnormalities or hepatitis, palpitations, myalgia, anxiety, confusion, euphoria, hallucinations, insomnia, nervousness, somnolence, abnormal thinking, dyspnoea, rash, increased sweating, and vision abnormalities. Depression, suicide, attempted suicide and suicidal ideation have been reported in the postmarketing experience with REVIA naltrexone hydrochloride ; used in the treatment of opioid dependence. No causal relationship has been demonstrated. In the literature, endogenous opioids have been theorised to contribute to a variety of conditions. In some individuals the use of opioid antagonists has been associated with a change in baseline levels of some hypothalamic, pituitary, adrenal or gonadal hormones. The clinical significance of such changes is not fully understood. Laboratory Tests: With the exception of liver test abnormalities see PRECAUTIONS ; , results of laboratory tests, like adverse reaction reports, have not shown consistent patterns of abnormalities that can be attributed to treatment with REVIA. Idiopathic thrombocytopenic purpura was reported in one patient who may have been sensitised to REVIA in a previous course of treatment with REVIA. The condition cleared without sequelae after discontinuation of REVIA and corticosteroid treatment and imodium and Revia online.
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Antabuse is a registered trademark of Odyssey Pharmaceuticals, Inc. ReVia is a registered trademark of the DuPont Merck Pharmaceutical Company; Campral is a registered trademark of Merck Sant s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany Source: O'Connor PG, et al. N Engl J Med. 1998; 338: 592-602.
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NARCOTIC ANTAGONISTS NALTREXONE HCL TABS COX 2 NSAIDS NSAID - PPI COX 2 INHIBITORS - HIGHLY SELECTIVE PREVACID NAPRA-PAC CELEBREX CAPS The FDA has issued a Public Approved without PA for patients 60 years old or over. Patients under 60 can use a preferred proton pump inhibitor with any preferred generic NSAID to achieve similar reductions in GI bleeding risk to that seen with the COX-II agents. Approvals for Mobic will be granted for other requests based on failure of at least one generic NSAID from at least 3 different NSAID Health Advisory warning of classes as described in the COX-II PA form. High risk GI bleeding patients must fail on adequate trials of safer agents non-NSAID Cox-2 ; for GI tract, such as acetaminophen. the potential for increased cardiovascular risk & GI bleeding with Celebrex use. Dosing limits will be set at a maximum of 200 mg once daily for PA requests or for patients over 60 without PA. Use PA Form # 10310 REVIA TABS Use PA Form # 20420 Will only be approved for side effects experienced with generic that are not described in the literature as occurring with the brand version.
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Source: Company research, store checks, trade interviews, Euromonitor estimates Table 49 Retail Sales of Vitamins by Type: % Value Growth 1998-2003 % current value growth 2002 03 Vitamins - Multivitamins - Single vitamins -- Vitamin A -- Vitamin B -- Vitamin C -- Vitamin D -- Vitamin E -- Other single vitamins 3.9 2.8 4.9 CAGR 15.3 14.9 15.7 TOTAL 103.9 100.6 107.3.
Table of Contents SR group, the severity of reported adverse events was also lower. We have incorporated this proprietary SR formulation into the Contrave tablet for our Phase III clinical trials. Planned Mechanistic Study. As part of the exploration of the putative effect of Contrave on food craving, we plan to initiate a study utilizing functional magnetic resonance imaging, or fMRI. This technique is a brain imaging technology that permits the regional localization and quantification of changes in neuronal activation. Based on emerging literature demonstrating that the brain's basic reward mechanisms are activated when exposed to individualized food cues picture, image, smell, etc. ; , we believe the potential exists to demonstrate such a regional activation in select brain centers with select food cues, and in turn, the ability of Contrave to reduce this activation relative to placebo. The constituents of Contrave have been shown individually to be effective in attenuating craving-associated behaviors bupropion in smoking under the brand name Zyban, and naltrexone in alcoholism and opioid drug addiction under the brand names Vivitrol, Trexan and Revua ; . Our proposed study would be conducted in a randomized, double-blind fashion at an academic neuroimaging center. Under current plans, patients receiving either Contrave or placebo will receive an fMRI at baseline and at study termination at week eight. It is anticipated that this study, to the extent that it substantiates our hypothesis, may be useful in positioning Contrave as a treatment that reduces the craving-based consumption of select high calorie foods among obese individuals. Empatic Empatic is a fixed dose combination of zonisamide SR and bupropion SR. The combination of zonisamide and bupropion, in our screening model, suggested a synergistic increase in POMC neuronal firing, indicating that this drug combination would enhance satiety and energy expenditure. We have also validated this synergy in rodent models of obesity. Based on the strength of these results and the unique mechanism of action of Empatic, we selected this product combination to complement our Contrave clinical development program. We hold an exclusive license to an issued U.S. patent covering the Empatic composition and methods of use in obesity, and we have filed additional patents covering various compositions, methods of use and formulations. Zonisamide IR was approved in the United States in 2000 for the adjunctive treatment of partial seizures, a form of epilepsy. It is marketed under the brand name Zonegran by Eisai Inc., which acquired the rights to the product from Elan Pharmaceuticals in 2004. Zonegran became available in generic form in the United States in 2005, and at its peak produced approximately 7 million in annual sales, according to IMS Health. The precise mechanism of zonisamide is unknown; however, it is believed that zonisamide has a number of pharmacologic mechanisms including sodium-channel modulation and enhancement of dopamine and serotonin neurotransmission. Zonisamide, given alone, has also shown weight loss in prior clinical trials conducted at Duke University, or Duke. We have developed a proprietary SR formulation of zonisamide in order to improve its tolerability. Controlling the release of zonisamide via our novel SR formulation reduces the C max while retaining a similar AUC to zonisamide IR. In a single-dose, double-blind, crossover Phase I clinical trial the zonisamide SR formulation that we have chosen to take forward suggested an improved side effect profile compared to the IR form. Our initial Phase II clinical trial of Empatic used an IR formulation of zonisamide. Our more recent Phase IIb clinical trial of Empatic utilized our proprietary zonisamide SR formulation. In commercial form, if approved, zonisamide SR and bupropion SR would be paired in a single tablet given orally twice a day. Scientific Rationale Like Contrave, Empatic employs bupropion to increase alpha-MSH secretion via POMC stimulation. The second component in Empatic, zonisamide, has been shown in our research to synergistically increase the firing rate of POMC neurons by up to eightfold in the presence of bupropion. However, we also believe that zonisamide may have one or more additional effects. Within the hypothalamus, a set of neurons acts in a reciprocal way to POMC. These are referred to as the Neuropeptide Y Agouti-related peptide, or NPY AgRP, neurons. Stimulation of NPY AgRP neurons results in the release of AgRP, which competes with alpha-MSH for access to the MC-4 receptor. Binding of AgRP at the MC-4 receptor results in an increase in appetite and energy conservation, which tends to counteract the weight loss promoting activity of alphaMSH. The pharmacology of zonisamide has been hypothesized to also inhibit.
The prevalence of bipolar disorder may be higher than previously estimated. In this study, the Mood Disorder Questionnaire MDQ ; a validated screening tool for bipolar disorders ; was sent to a sample of more than 125, 000 adults in the United States. Results of the survey showed an adjusted prevalence rate of 3.7% [Hirschfeld et al, 2003a]. Only about one fifth of the respondents who screened positive on the MDQ reported that they had previously received a diagnosis of bipolar disorder; 31% of these individuals were diagnosed with unipolar depression. Nearly half 49% ; of the respondents had not received a diagnosis of either unipolar depression or bipolar disorder in the community [Hirschfeld et al, 2003a]. These findings are broadly consistent with epidemiologic studies Kessler et al, 1997] and a recent US patient survey that found 69% of individuals had been misdiagnosed, most frequently as having unipolar depression. Thirty-five percent of the patients were symptomatic for more than 10 years before being accurately diagnosed [Hirschfeld et al, 2003b]. References.
In his 1990 ; study, James Price claims that the Tiberian cantillation system i.e., the cantillation system used in what most consider to be the best Medieval biblical manuscripts ; can be formalized as a self-contained, computerimplementable, context-free accentual grammar. Context-free grammars are sets of rewrite rules, like the classic sentence structure rule, S NP VP "a sentence consists of a noun phrase followed by a verb phrase" ; , which are often used to describe the syntax of a language. Although Price's study does much to systematize and elucidate the structure of the Tiberian cantillation system, he never actually offers a full set of such rules; that is, he never offers a full context-free accentual grammar Goerwitz 1994 ; . Why? Because doing so, at least in the way he envisions the task, is simply not possible. To illustrate why it is not possible to create such a grammar, let us examine the case of one particularly difficult accent, revia. Evia is a disjunctive accent, somewhat like a comma in most modern Latin-based orthographies. Rdvia divides clauses marked by . ifha, zaqef, and segolta--which denote even stronger t . breaks somewhat like a semicolon ; . 4evia can be repeated as many times in a verse as necessary. Revia, however, cannot follow itself too closely. If fewer than three words intervene between one revia and the next, the last revia turns into pa. a or, depending on syllable structure, into the variant form yetiv ; , unless st this pa. a would land within two words of the next tevir or zarqa, in which case st.
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