Rescue medication options that are consistent with the product labeling for sumatriptan/naproxen sodium (S/N) and that have been permitted in >or=1 clinical trial include the use of a second tablet of S/N, sumatriptan tablets (to a total daily dose of 200 mg), and naproxen sodium tablets (within the maximum limits recommended in the labeling). Sumatriptan subcutaneous (SC) injection might be especially useful as rescue medication mostly because of its rapid onset of activity.
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Slides from gastric antral biopsies of 50 patients with osteoarthritis taking NSAID were compared with slides from antral biopsies of 50 control cases matched for age, sex, and race. Semithin sections stained with toluidine blue were used.
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Twenty-six healthy volunteers participated (18 women and 8 men), aged 30 to 50 years. Gastric ulcers were present in 2 subjects receiving alendronate (8%), in 3 receiving naproxen (12%), and in 10 receiving both (38%) (P<.05 for the combination vs either drug alone).
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Heavy menstrual bleeding is an important cause of ill health in premenopausal women. Although surgery is often used as a treatment, a range of medical therapies are also available. Nonsteroidal anti-inflammatory drugs or prostaglandin synthetase inhibitors reduce prostaglandin levels which are elevated in women with excessive menstrual bleeding and also may have a beneficial effect on dysmenorrhoea.
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This study explored the utilization of a white-rot fungus (WRF), Phanerochaete chrysosporium, immobilized in wood chips, to remove carbamazepine and naproxen under non-sterile condition. The removal efficiencies for both pharmaceutically active compounds (PhACs) in artificially contaminated water were improved by 4% for naproxen and 30% for carbamazepine in seven days, compared to without wood chips. Although adsorption was crucial at the early stage, bioremoval was found to be the main removal mechanism for both PhACs. The extracellular enzymes played important roles in the naproxen removal, while the intracellular enzyme system was responsible for the carbamazepine removal. The increased of intracellular enzyme activity through the immobilization of WRF cells may contribute to the significantly enhanced removal efficiency for carbamazepine. In addition, the removal of naproxen or carbamazepine slightly increased when both compounds coexisted, compared to the system where the two pharmaceuticals existed separately. Based on the batch experimental results, a fixed-bed bioreactor packed with a mixture of WRF mycelia pellets and wood chips was developed and operated with the intermittent feeding and continuous aerating mode for 28 days under non-sterile condition, with naproxen and carbamazepine spiked into the influent at 1.0 mg L(-1). Almost complete removal of naproxen and 60-80% removal of carbamazepine were obtained in the first two weeks. However, the removal efficiencies for both compounds suddenly dropped to as low as less than 20% by the 14th day, possibly due to the contamination by other microorganisms in the reactor. After the addition of 8.25% sodium hypochlorite at the ratio of 1:100 (v/v) into the influent tank on both Day 20 and Day 25, a rapid recovery (higher than 95%) was achieved in the naproxen removal, by effectively inhibiting contamination in the reactor. In comparison, the same rebounding phenomenon was not observed for carbamazepine and this difference may be associated to the various enzyme-working systems. A longer hydraulic retention time (HRT) was conducive to improve the removal of both compounds.
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The effects of a commonly used non-steroid anti-inflammatory drug (naproxen) on zinc metabolism was studied in healthy volunteers. A significant increase in the urinary zinc excretion rate was found during treatment with naproxen, with a mean increase in the order of 35%. At the end of the treatment period the urinary zinc excretion fell towards normal, and after withdrawal of naproxen the urinary excretion rate became normal. During the treatment period the serum zinc concentration was virtually unchanged, being comparable to the initial and post-treatment values. The mechanism by which naproxen induces hyperzincuria is not known. Protein binding interaction or a direct renal action of naproxen implying a decrease in the maximum tubular reabsorption capacity (Tmax) would lead to an increase in zinc excretion. Prolonged studies in patients with rheumatoid arthritis, both untreated and treated with prostaglandin inhibitors, are needed however in order to evaluate the possibility of a zinc depletion.
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When pethidine was not used, 83% of the children in the naproxen group vs. 97% in the other two groups required rescue fentanyl (P < 0.05). The use of pethidine reduced the incidence of fentanyl requirement by 30% and the number of fentanyl doses by 50% (P < 0.001). It also equalized the effects of naproxen, paracetamol and the placebo making the pain model invalid for this kind of study. The drawback associated with better analgesia was a doubling of the incidence of PONV (P < 0.001).
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Rat renal mesangial cells possess morphological and functional features of smooth muscle cells in culture, such as intracellular myosin filaments, A II receptors and a contractile response to A II. Furthermore, they represent the main glomerular site of PGE2 synthesis. In the presence of A II (50 nM), their PGE2 production rate was significantly increased, this effect being potentiated by arachidonic acid (3 micrograms/ml). After a prior inhibition of arachidonic acid metabolism by cyclooxygenase inhibitors (indomethacin 1 microM or naproxen 0.02 microM) or by a cyclo- and lipoxygenase inhibitor (phenidone 670 microM), the percentage of cells contracting in response to various A II concentrations (10 pM to 10 nM) was significantly enhanced as compared to the basal conditions. On the contrary, the percentage of cells presenting a contractile response to A II in the presence of exogenous PGE2 (50 ng/ml) or of arachidonic acid (3 micrograms/ml) was significantly decreased. These modifications were not related to some changes in the A II receptor properties of the cells, i.e. the number of receptor sites and their affinity constant. The data demonstrate that the contractile response of glomerular mesangial cells is modulated by the PGE2 content of their incubation medium. Since their own PGE2 production rate is enhanced in the presence of A II, this cellular response may represent a local regulatory mechanism of their contractile properties.
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The cardiovascular safety of nonsteroidal antiinflammatory drugs (NSAIDs) may be influenced by interactions with antiplatelet doses of aspirin. We sought to quantitate precisely the propensity of commonly consumed NSAIDs—ibuprofen, naproxen, and celecoxib—to cause a drug-drug interaction with aspirin in vivo by measuring the target engagement of aspirin directly by MS. We developed a novel assay of cyclooxygenase-1 (COX-1) acetylation in platelets isolated from volunteers who were administered aspirin and used conventional and microfluidic assays to evaluate platelet function. Although ibuprofen, naproxen, and celecoxib all had the potential to compete with the access of aspirin to the substrate binding channel of COX-1 in vitro, exposure of volunteers to a single therapeutic dose of each NSAID followed by 325 mg aspirin revealed a potent drug-drug interaction between ibuprofen and aspirin and between naproxen and aspirin but not between celecoxib and aspirin. The imprecision of estimates of aspirin consumption and the differential impact on the ability of aspirin to inactivate platelet COX-1 will confound head-to-head comparisons of distinct NSAIDs in ongoing clinical studies designed to measure their cardiovascular risk.
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Thirty healthy patients with bilaterally impacted mandibular third molars were included in this randomized, cross-over, double-blind, placebo-controlled study. Patients were assigned randomly to 1 of 3 surgery groups and received postoperatively 1,200 mg oxaprozin, 550 mg naproxen sodium, or a placebo. Postoperative edema was measured with ultrasonography performed before and after surgery. Trismus was measured by comparison of preoperative and postoperative maximum interincisal mouth opening measurements by caliper. Pain was assessed by a visual analog scale (VAS) and by recording the number of rescue analgesic pills taken.
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Non-steroidal anti-inflammatory drugs (NSAD) are among the most commonly used medications. Many of them, such as ibuprofen, naproxen and aspirin, are widely advertised in the media and available without prescription. NSADs have anti-inflammatory effects, and some of them (aspirin, ibuprofen) are also antipyretic. The basic mechanism of their action is based on the inhibition of the enzyme cascade in the metabolism of arachidonid acid - cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2) - and as a result inhibition of prostaglandin production. The undesirable side-effects of NSADs are primarily a direct result of the anti-inflammatory mechanism, and increase proportionally with the dosage. The article presents undesirable side-effects in the digestive system, the kidneys, and elsewhere. In conclusions the author point to the need for caution in using drugs of this kind.
Binding equilibria of 12 nonsteroidal, anti-inflammatory substances, salicylic acid, diflunisal, phenylbutazone, azapropazone, fenbufen, biphenylacetic acid, naproxen, flurbiprofen, ibuprofin, diclofenac, indomethacin, and benoxaprofen, to defatted human serum albumin has been investigated at 37 degrees, pH 7.4, in a sodium phosphate buffer, 66 mM, by means of equilibrium dialysis and, in case of salicylic acid, by dialysis rate determinations. Cobinding of each of these drugs with monoacetyl-4,4'-diaminodiphenyl sulfone, warfarin, and diazepam has been studied by measuring dialysis rates of the last-mentioned ligands. Cobinding of each drug with bilirubin was investigated by two techniques, equilibrium dialysis against albumin with and without bilirubin, and by measuring rates of oxidation of free bilirubin with hydrogen peroxide and peroxidase. Results were analyzed in quantitative terms. The use of a site-oriented description versus a stoichiometric analysis is discussed. The stoichiometric description is preferred for the following reasons: (a) Simple relations exist between the percentage of bound drug at low drug concentrations and the first stoichiometric binding constant. (b) The stoichiometric description does not imply that preformed binding sites are present in the albumin molecule. (c) A quantitative, stoichiometric analysis of multiple cobinding of two ligands is possible.
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A single-blind two-week comparison of benorylate and naproxen tablets was carried out in 85 patients with painful osteoarthritis. The degree of discomfort, pain at rest and on movement, joint stiffness and difficulty using affected joints all improved during the study with no significant difference between the treatments. Both patients' and observers' assessment of overall improvement favoured benorylate although the difference was not statistically significant. The majority had disease of weight-bearing joints for which Benoral was significantly more effective. Both drugs were well tolerated.
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Ankylosing spondylitis (AS) is a chronic inflammatory disease of unknown cause, characterized by sacroiliitis and spondylitis. Methotrexate (MTX), a widely used disease-modifying antirheumatic drug (DMARD), is effective for rheumatoid arthritis (RA), and so might work for AS. This is an update of a Cochrane review first published in 2004, and previously updated in 2006.
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Enzymic experiment: Soybean lipoxygenase (SLO), substrate (benzo[a] pyrene) and other component react in the enzymic system and the reaction product are detected by spectrophotometry. At the same time, in vitro detect of benzo (a) pyrene-DNA adducts with a UV spectrophotometer and HPLC. Cellular experiment: After HBE cells exposure to different poison (B[a]P 4, 8, 16, 32, 64, 128µmol/L, AA-861, naproxen or α- naphthoflavone 0.1, 1, 10 µmol/L) for 24 hours, the effect of benzo (a) -pyrene on cell survival rate were assessed by reductions of tetrazolium dye (MTT) and flow cytometry in cultured HBE cells, and the protein expressions of 5-lipoxygenase in the cells are tested by western-blot, and the DNA damages by the single cell gel electrophoresis. And then, the effect of the specific inhibitor of 5-lipoxygenase (AA-861) on 5-lipoxygenase protein expression and DNA damage in the cells are detected.
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Used drugs--naproxen (50 mg/kg b.w.), cimetidine (50 mg/kg b.w.) and N-acetylcysteine (300 mg/kg b.w.) were administered in two doses (first 30 minutes before exposure to toluene, second six hours after first dose). After exposure to toluene (2 hours in each of 3 consecutive days) was followed up reactivity of tracheal and lung smooth muscle to histamine in "in vitro" conditions. The studied substances were not administered in the control group of animals.
The aim of this work was to study at what extent mixtures of drug substances and oppositely charged surfactants form catanionic aggregates and to apply these as a means of obtaining prolonged drug release from a gel. The properties of traditional catanionic mixtures are relatively well known, but only recently we found that not only traditional surfactants form these mixtures, but also structurally more complex surface active drug compounds. In this study, several different compositions of catanionic mixtures were studied visually, by cryogenic transmission electron microscopy (cryo-TEM) and rheologically using a Bohlin VOR Rheometer. Some of the catanionic vesicle and micelle phases were incorporated in and released from gels using the USP paddle method. The drug compounds investigated were lidocaine, ibuprofen, naproxen, alprenolol, propranolol, and orphenadrine. Of the six drug molecules used in this study, five, both positively and negatively charged, were capable of forming catanionic vesicles and/or micelles with oppositely charged surfactants. The drug release studies show that catanionic drug surfactant mixtures are beneficial for obtaining prolonged release from gels, as the drug release using catanionic vesicles and micelles was prolonged between 10 and 100 times compared to the release of pure drug substance from the gel.
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The effect of indomethacin and naproxen on collagen metabolism was studied in arthritic animals after an injection of [3H]-proline, both the specific and total radioactivity of [3H]-hydroxyproline being determined in skin collagen fractions and in urine. It was found that collagen synthesis and conversion of soluble to insoluble collagen are diminished, accompanied by an increased collagen degradation in untreated arthritic animals. Administration of indomethacin and naproxen to arthritic animals accelerated the synthesis of collagen and conversion soluble to insoluble collagen and inhibited the catabolism of collagen.
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From December 2007 to December 2008, water samples were collected monthly (n=12) from an upstream point, the effluent, four downstream points of the WWTP, and at the point where the river merges with the lake, and the concentrations of ibuprofen, naproxen, bezafibrate, diclofenac, and ketoprofen were determined. The analytical methodology involved solid-phase extraction of the target compounds from water samples followed by liquid chromatography coupled with tandem mass spectrometry for compound separation and detection.
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[structure: see text] A facile synthesis of a cholic acid derived dendritic structure labeled with nine naproxens and a single anthracene is reported. This multichromophoric, novel dendritic construct acts as an efficient molecular light harvester.
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It is the second decade of controversy regarding the cardiovascular effects of cyclo-oxygenase-2 (COX-2) inhibitors. At this time, celecoxib is the only available COX-2-specific inhibitor for treatment of pain and inflammation. Therefore, the present study was designed primarily to determine the impact of celecoxib on cholesterol handling (uptake via scavenger receptors and efflux from the cells) and foam cell formation in human THP-1 macrophages, followed by comparison to rofecoxib and other non-steroidal anti-inflammatory drugs (NSAIDs). THP-1 human macrophages and peripheral blood mononuclear cells were incubated with: celecoxib, rofecoxib, naproxen (at 5, 10, 25 µM) and acetaminophen (0.5 mM, 1 mM)±oxidized low-density lipoprotein (oxLDL, 25 µg/mL). Scavenger receptors: CD36, LOX-1, SR-A1, and CXCL16 and cholesterol efflux proteins: ATP-binding cassette transporter (ABC) A1 and G1, and 27-hydroxylase were detected. The adhesion of monocytes to cultured endothelial cells with/ without COX-2 inhibitors/NSAIDs was also analyzed. The presence of celecoxib and rofecoxib (at high concentrations) significantly decreased expression of 27-hydroxylase and ABCA1, interfering with normal cholesterol outflow from macrophages. Acetaminophen and the non-specific COX inhibitor naproxen had no significant effect on these proteins. Only celecoxib had a profound effect on the class B scavenger receptor CD36 and the class E receptor LOX1. We demonstrate that in contrast to celecoxib, rofecoxib and naproxen increased adhesive properties of monocytes to endothelial cells. This work might contribute to our understanding of multiple mechanisms underlying elevated cardiovascular risk upon the use of COX-2 inhibitors and uncover new possibilities to enhance the safety profile of existing COX-2 inhibitors.
The mesangial cells of the glomerulus, the proximal tubular cells and the interstitial fibroblasts are the first choice targets for renal drug delivery since they play a pivotal role in many disease processes in the kidney. In the present review, only targeting to the proximal tubular cell is addressed because only this has been studied extensively. Two approaches of drug delivery to the proximal tubular cell have been studied up to now, the prodrug/softdrug and low-molecular-weight protein (LMPWP) approach. Most research on tubular specific drug delivery has focused on the development of amino-acid prodrugs that, after delivery, require activation by more or less kidney-selective enzymes. Large differences in renal selectivity are found. For some prodrugs, a rapid removal of the released drug from the kidney explained the low renal selectivity whereas for others, cleavage in non-target tissue and insufficient transport across the cell to the enzyme site seemed mainly responsible. The LMWP approach is based on drug attachment to a protein (<30 kD) that is freely filtered through the glomerulus and after accumulation is selectively catabolized in the lysosomes of the proximal tubular cell. Using LMWPs as drug carriers, a higher renal selectivity can be attained and a broader range of drugs can be attached while the rate of drug release can also be manipulated. The studies with captopril-lysozyme and naproxen-lysozyme clearly showed that targeting resulted in a higher renal selectivity and that drugs delivered into and regenerated in the proximal tubular cell exert renal selective pharmacological activity. Further testing will provide more definite data on the added value of this delivery technology.
The effect of pH variation on complexation and solubilization of naproxen (pK(a) 4.2) with natural betaCyclodextrin (betaCyD) and various neutral, cationic and anionic betaCyD-derivatives has been investigated. The combined effect of pH variation and hydrophilic polymer addition on CyD solubilizing and complexing efficiency has also been determined. Phase-solubility analysis in buffered aqueous solutions (pH from 1.1 to 6.5) was used to study the interaction of the drug with each CyD, in the presence or not of the water-soluble polymer. A clear influence of the substituent type was observed, the methylderivative being the most efficient agent; on the contrary, unexpectedly, no influence of the CyD charge in the interaction with the ionizable drug was detected. As expected, total drug solubility increased with increasing pH; however, the solubility increment with respect to drug alone obtained by CyD complexation progressively decreased, with a parallel reduction of the complex stability, attributed to the reduced affinity of charged drug for the hydrophobic CyD cavity. The addition of the polymer in part counterbalanced the destabilizing effect obtained with increasing pH, by improving the CyD complexation power towards naproxen. In particular, the presence of PVP allowed an increase of the complex stability constant with hydroxypropyl betaCyD up to 60% with respect to the corresponding drug-CyD binary system. Therefore, the combined strategy of pH control and polymer addition to the CyD complexing medium can be successfully exploited to improve naproxen solubilization and reduce the amount of CyD needed. The construction of theoretical drug solubility curves as a function of pH for any given CyD and polymer concentration enables selection of the best experimental conditions for obtaining the desired drug solubility value.