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PubMedDate not supplied

Interaction of naproxen with cholestyramine.

'In vitro' and 'in vivo' studies were used to determine the interaction of naproxen, an anti-inflammatory agent, and cholestyramine, a hypocholesterolemic substance. Cholestyramine shows a marked affinity for naproxen and the intensity of this is governed by the pH values. The maximum amount of naproxen adsorbed by the resin is close to 2.2 mM g-1. The pharmacokinetics of naproxen was studied in eight healthy volunteers after concurrent oral administration in a single dose of 250 mg of naproxen and 4 g of cholestyramine. The resin causes an important delay in the incorporation of naproxen into the systemic circulation, though no significant modifications are seen to take place in any other pharmacokinetic parameters of the drug.

Adsorption↗
PubMed1975

An open trial of naproxen in rheumatoid arthritis patients with significant esophageal, gastric, and duodenal lesions.

To confirm the reported lack of major gastrointestinal side effects of naproxen, we gave 58 patients with active rheumatoid arthritis and significant gastrointestinal disease therapeutic doses of naproxen while closely monitoring them for signs and symptoms of gastrointestinal dysfunction. All patients underwent upper gastrointestinal x-ray examinations at the start of the trail, and, when indicated, during the course of the study. Endoscopies were also performed when indicated. Forty patients had hiatus hernia and 35 had peptic ulcer (23 duodenal ulcer and 12 gastric ulcer). Twenty-six patients had a combination of hiatus hernia with either type of peptic ulcer. After 262 patient visits over a period of 52 weeks, 35 patients remained in the study, all having had more than six months of naproxen therapy in dosages ranging from 500 to 750 mg daily. In 33 of the 35, the response to naproxen had generally been good to excellent. Only seven patients dropped out of the trial because of complaints referable to side effects. There were no major related upper gastrointestinal side effects as monitored by continuing clinical evaluation, stool occult blood, comprehensive laboratory examination, and, where indicated, upper gastrointestinal x-ray studies. Approximately 70 per cent of the patients demonstrated efficacy on long-term naproxen therapy by subjective and objective parameters. Naproxen appears to be an efficacious and remarkably safe drug in the long-term therapy of rheumatoid arthritis, even in the presence of significant upper gastrointestinal symptomatology.

Anti-Inflammatory Agents↗
PubMed1984

Naproxen disposition in patients with alcoholic cirrhosis.

Chronic liver disease is known to alter the absorption and disposition of many drugs. To assess the influence of chronic alcoholic liver disease on the disposition of naproxen, we administered the drug both as a single dose and to steady state to 10 individuals with alcoholic cirrhosis and to 10 healthy controls. Plasma and serum samples collected after naproxen dosing were assayed for both total and (following equilibrium dialysis) unbound drug concentration. Clearance calculated based on both total and unbound naproxen concentration revealed no change in total plasma clearance of the drug at steady state but a marked reduction of approximately 60% in clearance based on unbound drug. Naproxen volume of distribution changed only minimally. Because clearance based on unbound drug concentration at a given dosing rate determines the plasma or blood free drug concentration, this concentration may increase significantly in patients with alcoholic liver disease given usual doses of naproxen. Unbound drug concentration is thought to determine the pharmacologic effect of a drug. We therefore recommend that naproxen dosing be reduced by at least half in patients with chronic alcoholic liver disease. In the absence of data to the contrary, this recommendation can be extended to individuals with other forms of hepatic disease.

Adult↗
PubMed1989

Pharmacokinetic properties and clinical efficacy of once-daily sustained-release naproxen.

The pharmacokinetics and clinical efficacy of a once-daily sustained-release formulation of naproxen (sodium salt) have been compared with those of conventional-release agents. In a single dose pharmacokinetic study, the rate of absorption of the sustained-release preparation was less than that of a conventional-release preparation but the extent of absorption was the same. As is the case with conventional-release naproxen, food decreased the rate but not the extent of absorption of the sustained-release formulation. On multiple dose administration for 7 days, the AUC and average concentrations of the sustained release preparation (1 g daily) were the same as those for conventional release preparations of naproxen sodium (250 mg four times daily) and naproxen free acid (500 mg daily). The conventional-release sodium salt was absorbed more quickly with no differences in bioavailability. A double-blind clinical comparison in patients with osteoarthritis showed the sustained-release preparation (1 g daily) to be equivalent in efficacy to conventional naproxen capsules (500 mg twice daily) but to have a significantly lower incidence of gastrointestinal side-effects. The results suggest that sustained-release naproxen sodium has potential for use as a once-daily treatment for inflammatory disease.

Adolescent↗
PubMed1986

Pharmacokinetics of naproxen in elderly patients.

The pharmacokinetics of naproxen have been examined in 13 elderly patients (mean age 84.2 years) and in 9 younger patients (mean age 53.9 years) at the end of a 21 day course of therapy with naproxen 500 mg b.d. The mean pre-dose concentration on days 19, 20 and 21 was significantly higher in the elderly patients than in the controls (60.1 vs. 43.3 micrograms X ml-1). The AUC (0-24) was significantly higher in the elderly subjects only when normalized for body weight (9.1 vs. 5.4 micrograms X ml-1 X h kg-1 p less than or equal to 0.02). The AUC was significantly higher in the elderly group compared to the control group also in the normalized form. The apparent clearance of naproxen was reduced in the elderly compared to the control patients (315 vs. 628 ml X h-1). The percentage protein binding of naproxen was the same in both groups (99.8%) but the free concentration of naproxen was significantly higher in the elderly patients than in the control patients (141 vs. 89.8 ng X ml-1). Although there was no excess of side effects in the elderly patients it is suggested that when naproxen is given to elderly patients, therapy should be started at the lower end of the dosage range.

Adult↗
PubMed1994

Preoperative naproxen sodium reduces postoperative pain following arthroscopic knee surgery.

This study was undertaken to assess the efficacy of a single preoperative dose of naproxen sodium in reducing postoperative pain and length of day surgery stay in patients undergoing arthroscopic knee surgery. A randomized, double-blind clinical trial was carried out on 66 ASA I and ASA II patients scheduled for arthroscopic knee surgery. The treatment group (n = 26) received two capsules containing 275 mg of naproxen sodium each, and the control group (n = 40) received placebo. Preoperative and postoperative visual analogue pain scores, postoperative analgesic requirements in hospital as well as 24 hr after discharge, and length of day surgery stay were studied. There was a decrease in postoperative pain, both in hospital (naproxen 0.7 +/- 1.2 vs placebo 2.2 +/- 2.3) and at 24 hr after discharge (naproxen 0.8 +/- 1.9 vs placebo 3.8 +/- 3.2) (P = 0.0001). There was no difference in the need for in-hospital postoperative analgesics or in the time to discharge. However, there was a difference in the use of analgesics after discharge (naproxen group 30.4% vs placebo group 71.4%) (P < 0.01). The results of this study suggest that a single preoperative dose of 550 mg naproxen sodium is effective in reducing postoperative pain in arthroscopic knee surgery, both in the immediate postoperative period and for up to 24 hr after the completion of surgery.

Adult↗
PubMed2005

Restorative impact of rabeprazole on gastric mucus and mucin production impairment during naproxen administration: its potential clinical significance.

Rabeprazole augments gastric mucus and mucin production in humans. However, its potential restorative impact on gastric mucus and mucin production impairment, resulting from administration of naproxen, remained to be explored. Therefore, we measured the content of mucus and mucin in gastric juice (GJ) before and after administration of naproxen with rabeprazole or placebo. The study was approved by HSC at KUMC and conducted in 21 asymptomatic, H. pylori-negative volunteers in a double-blind, placebo-controlled, crossover design. The content of gastric mucus in GJ, after exhaustive dialysis and complete lyophilization, was assessed gravimetrically, whereas the content of mucin was measured after its purification with equilibrium density-gradient ultracentrifugation in CsC1. Gastric mucus secretion during administration of naproxen with placebo declined significantly both in basal (by 44%; P < 0.001) and in pentagastrin-stimulated (by 35%; P < 0.001) conditions. Coadministration of rabeprazole significantly restored the naproxen-induced impairment in mucus production in basal conditions (by 47%; P < 0.01) and by 22% during stimulation with pentagastrin. Gastric mucin secretion during naproxen/placebo administration also declined significantly in both basal (by 39%; P < 0.01) and stimulated (by 49%; P = 0.003) conditions. Rabeprazole also significantly restored the naproxen-induced decline of gastric mucin output during pentagastrin-stimulated conditions (by 67%; P = 0.003) and by 40% in basal conditions (P = 0.05). The restorative capacity of rabeprazole on the quantitative impairment of gastric mucus and mucin during administration of naproxen may translate into a clinical benefit of protection of the upper alimentary tract from NSAID-related mucosal injury.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed1987

Six-month multi-center study comparing nabumetone with naproxen in the treatment of osteoarthritis.

This six-month, double-blind, controlled, randomized, parallel study at 13 medical centers compared the safety and efficacy of nabumetone (1,000 mg taken at bedtime) with that of naproxen (250 mg twice daily) in the treatment of osteoarthritis in symptomatic adult outpatients. Five efficacy parameters were measured: patients' assessment of overall osteoarthritis activity and pain, physicians' assessment of overall osteoarthritis activity and pain, and physicians' assessment of pain with respect to a declined activity. All 489 patients who took medication were included in the evaluation of safety, and 455 patients (227 in the nabumetone group and 228 in the naproxen group) were evaluated for efficacy. Significant improvement in all five efficacy parameters occurred in both groups. No significant differences were found between the two groups at the end of the study in any of the five efficacy parameters. Twenty-three percent of nabumetone and 17 percent of naproxen patients withdrew from the study for lack of efficacy. At least one possible or probable treatment-related adverse experience was reported for 45 percent of nabumetone-treated patients and 42 percent of those given naproxen, and in 19 percent of the nabumetone-treated and 18 percent of the naproxen-treated patients these experiences were moderate or severe. However, only 7 percent of patients in each group withdrew from the study due to adverse experiences. Nabumetone and naproxen have comparable safety and efficacy, suggesting that a single, nighttime dose of nabumetone is a convenient, effective, and safe treatment for osteoarthritis.

Adult↗
PubMed1977

The treatment of dysmenorrhea with naproxen sodium: a report on two independent double-blind trials.

The efficacy of naproxen sodium (naproxen-Na) in dysmenorrhea has been established in two independent double-blind (placebo-controlled) studies. An initial dose of 550 mg. of naproxen-Na was followed by 275 mg. every six hours for a maximum of five days. Twenty patients were included in Study I (10 treated with naproxen-Na) and 23 patients in Study II (12 treated with naproxen-Na). Each patient received the medication during four dysmenorrheic episodes. Thus, a total of 172 treatment courses could be evaluated. A variety of efficacy criteria were measured: frequency of pill intake, changes in pain intensity, the degree of relief achieved by the medication, and need for additional analgesics. In both studies naproxen-Na was demonstrated to be superior to the placebo treatment with high statistical significance in each of these parameters.

Adult↗
PubMed1981

Naproxen sodium, aspirin, and placebo in primary dysmenorrhea. Reduction of pain and blood levels of prostaglandin F2-alpha metabolite.

In a double-blind, crossover study of 32 women with primary dysmenorrhea, the analgesic efficacy of naproxen sodium was compared to that of aspirin and placebo. The treatment started 1 to 5 days before the onset of menses and continued for 3 to 5 days. At the same time, a radioimmunoassay established concentrations of 13,14-dihydro-15-keto-prostaglandin F2-alpha, a prostaglandin F2-alpha metabolite (PGF-M) in blood samples obtained from before the treatment and on the first day of menses. In affording pain relief, naproxen sodium was superior to aspirin (p = 0.02) and placebo (p = 0.002); however, aspirin was not superior to placebo (p = 0.05). During naproxen sodium treatment, the patients' daily activities were less impaired than during both the aspirin and the placebo treatment courses. During naproxen sodium treatment, the mean blood PGF-M levels decreased by 73.5%, from a mean of 50.5 to 13.4 pg/ml; during aspirin treatment they decreased by 31.2%, from a mean of 44.2 to 30.4 pg/ml; during placebo treatment, an increase of 13.6% was observed, from a mean of 46.3 to 52.6 pg/ml. The PGF-M decrease during the naproxen sodium treatment was significantly more prominent than that during both aspirin and placebo treatments (p = 0.0001). Changes caused by aspirin treatment were significantly different from those occurring during the placebo treatment (p = 0.001). The study confirms that at the doses utilized in this study the analgesic properties of naproxen sodium are superior to those of the more conventional prostaglandin synthetase inhibitor, aspirin, and that pain relief is related to the inhibition of prostaglandin synthesis.

Activities of Daily Living↗
PubMed1988

Hepatic and renal tolerability of long-term naproxen treatment in patients with rheumatoid arthritis.

Clinical and laboratory assessments of hepatic and renal function in rheumatoid arthritis (RA) patients who received naproxen for up to 6 months during two randomized, double-blind studies comparing naproxen 375 mg twice daily (n = 286) with naproxen 750 mg twice daily (n = 300) were analyzed. Patient groups were segregated by dosage, duration of treatment, and age at entry (less than 65 years v greater than or equal to 65 years), and laboratory measurements of SGOT, SGPT, serum creatinine (Scr), and BUN were examined. Records of individual patients with clinically meaningful abnormalities in laboratory tests or adverse events of hepatic or renal origin were examined in detail. Over the duration of these studies, there were no clinically meaningful changes in mean laboratory values or differences in occurrences of abnormal values among the different patient groups. In both dosage groups, pretreatment incidences of clinically meaningful abnormalities in laboratory tests were similar to those in serial observations during treatment. Six patients who received naproxen 375 mg twice daily and four patients who received naproxen 750 mg twice daily had a hepatic or renal clinical event or distinctly abnormal laboratory value, but only three of these withdrew because of these problems. Occasional transient abnormalities of conventional laboratory tests of hepatic and renal function occurred in some patients during naproxen treatment. Such abnormalities called for careful patient monitoring but generally did not warrant immediate drug withdrawal.

Adult↗
PubMed1980

Severe, primary dysmenorrhea treated with naproxen. A prospective, double-blind, crossover investigation.

26 women aged 15-45 with severe, primary dysmenorrhea were treated with naproxen (NAPROSYN, SYNTEX) and placebo during 2 x 2 consecutive menstrual cycles in a randomized, double-blind crossover study. The dosage of naproxen was 500 mg (2 tablets) initially, followed by 250 mg as needed, with a maximum of 1250 mg daily. In most cases medication started at the first sign of menstrual distress. 80 per cent of the women preferred naproxen to placebo. The number of tablets taken during each menstruation fell from a mean of 17.8 in the placebo period to 5.1 in the naproxen period. Likewise, additional analgesics fell from 7.1 to 1.6 and hours of bed rest from 16.4 to 1.2. Total number of days of sick leave per two menstruations decreased from 40 to 7. These differences are statistically significant (P < 0.001). The side effects were mild. CNS or gastrointestinal side effects were not seen. Naproxen changed the amount of bleeding in 12 and delayed bleeding in three. Two developed acne, which however gradually diminished during the next five bleeding periods treated with naproxen. The influence of prostaglandin synthetase inhibitors on the ovarian production of steroids is discussed.

Acne Vulgaris↗
PubMedDate not supplied

Efficacy and safety of etodolac and naproxen in patients with osteoarthritis of the knee: a double-blind, placebo-controlled study.

A multicenter, parallel-group, double-blind, randomized, outpatient study compared the efficacy and safety of etodolac versus naproxen in patients with osteoarthritis of the knee. After a washout period free of nonsteroidal anti-inflammatory drugs, 254 patients self-administered etodolac 400 mg (n = 86), naproxen 500 mg (n = 82), or placebo (n = 86) twice daily for 4 weeks. Compliance exceeded 90% in all three groups. Primary efficacy variables improved progressively from baseline in all three groups. The extent of improvement was greater in the etodolac and naproxen groups than in the placebo group (P < or = 0.003), except with respect to target joint tenderness (P = 0.028, etodolac vs placebo; P = 0.013, naproxen vs placebo). There were no statistical differences between active treatment groups (P > 0.1). At end point, twice as many patients responded in the etodolac (59%) and naproxen groups (51%) than in the placebo group (26%; P < or = 0.01). There were no significant between-group differences in the numbers of patients who had an adverse experience, a serious adverse experience, or an adverse experience leading to study discontinuation; there were also no significant between-group differences in the distribution of adverse experiences. There were no unexpected clinical or laboratory experiences. Etodolac 400 mg twice daily was as effective and safe as naproxen 500 mg twice daily and both were superior to placebo in the management of osteoarthritis of the knee.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1992

Inhibition of endothelial cell prostaglandin H synthase gene expression by naproxen.

Naproxen is a potent anti-inflammatory drug whose action is attributed to inhibition of prostaglandin biosynthesis. In view of our recent discovery that aspirin and sodium salicylate are capable of reducing cellular levels of prostaglandin H (PGH) synthase mRNA, we have evaluated the effect of naproxen on PGH synthase protein and mRNA levels in cultured human umbilical vein endothelial cells (HUVEC). PGH synthase mRNA levels were quantified by a competitive polymerase chain reaction (PCR) assay; protein was assessed by Western blotting. Naproxen decreased the PGH synthase protein level in HUVEC in a concentration-dependent manner. It abolished entirely the 70 kDa PGH synthase subunit at 5 micrograms/ml. It appears more effective in blocking interleukin-1 inducible PGH synthase levels. Naproxen also inhibited the synthase mRNA level in a concentration-dependent manner; levels were reduced by 33% at 5 micrograms/ml and 60% at 30 micrograms/ml naproxen. These results indicate that naproxen, like the salicylates, inhibits PGH synthase levels in cultured endothelial cells either by inhibiting transcription of the PGH synthase gene or by destabilizing its messenger RNA.

Cells, Cultured↗
PubMed1996

Pain relief during and following outpatient curettage and hysterosalpingography: a double blind study to compare the efficacy and safety of tramadol versus naproxen. Cobra Research Group.

OBJECTIVE: To compare the analgetic efficacy and side-effects of Naproxen and Tramadol following the outpatient VABRA aspiration or hysterosalpingography. SETTING: Ninety-one patients from the gynaecology clinics of two university hospitals and one municipal-teaching hospital. DESIGN: Multicentre double blind randomized clinical trial. Computerised randomisation, stratification per-centre. METHODS: Semiquantitative assessment of the two drugs was performed by the patient and the gynaecologist using a 1- to 6-point scale. Pain, stress and well-being was scored by the patient using the visual analog scale (VAS) and the verbal description scale (VDS), ranging from 0 (good) to 100 (bad). Side-effects during the first 24 h postoperatively were recorded by the patient in a diary. RESULTS: The analgetic efficacy (pain, stress and well-being) of Naproxen and Tramadol was identical. Subjective assessment by the patient and the doctor also revealed no differences between Naproxen and Tramadol. Side-effects of Tramadol, however, were significantly more severe than those of Naproxen and this phenomenon was responsible for a lower ability to proceed with normal activities in the Tramadol group. CONCLUSION: Tramadol is a good alternative for Naproxen at outpatient VABRA or HSG procedures when Naproxen is contra-indicated.

Adult↗
PubMed2006

The effects of G-CSF and naproxen sodium on the serum TGF-beta1 level and fracture healing in rat tibias.

Local and systemic release of transforming growth factor beta 1 (TGF-beta1) is known to increase during the process of fracture healing and this cytokine stimulates bone healing. The majority of the non steroidal anti inflammatory drugs (NSAIDs) inhibit fracture healing. Granulocyte colony stimulating factor (G-CSF) is a hematopoietic growth factor that stimulates bone marrow. In this study, the effects of the NSAID naproxen sodium, G-CSF, and both of them in combination on the TGF-beta1 serum level in rats with tibia fractures were measured and fracture healing was evaluated by histopathologic and radiologic examination. The TGF-beta1 serum levels obtained on day one (24 h after fracture but before administration of naproxen or G-CSF) were found to be similar in all of the five groups (p > 0.05). At the end of the first week, TGF-beta1 levels were significantly lower in naproxen-treated rats than those of the other groups excluding control (p = 0.002). Similar changes in TGF-beta1 levels were found at the end of the second and fourth weeks. TGF-beta1 levels were significantly higher in G-CSF-treated rats at the end of the first, second and fourth weeks (p < 0.05). Fracture healing scores measured with histopathological and radiological methods were higher in G-CSF-treated rats than in naproxen-treated ones. When both naproxen and G-CSF were given, the scores resumed to normal. The results point to the negative effect of naproxen sodium on fracture healing is due to its decreasing effect on the level of TGF-beta1, which may be a new possible mechanism. Moreover, this negative effect can be inhibited by the use of G-CSF.

Animals↗
PubMed2004

Treatment of painful temporomandibular joints with a cyclooxygenase-2 inhibitor: a randomized placebo-controlled comparison of celecoxib to naproxen.

To compare the efficacy and adverse effects of celecoxib, a cyclooxygenase-2 (COX-2) inhibitor, with naproxen, a non-steroidal anti-inflammatory drug, and placebo in the treatment of painful temporomandibular joints (TMJs). In this randomized, double-blind, placebo-controlled trial, 68 subjects with painful TMJs secondary to disc-displacement with reduction, received celecoxib 100 mg twice a day; naproxen, 500 mg twice a day; or placebo for 6 weeks. Subjects were evaluated with standard measures of efficacy: pain intensity measured by visual analogue scale, maximal comfortable mandibular opening, and quality of life (SF-36), at baseline (1 week after discontinuing previous analgesic therapy) and again after 6 weeks of drug treatment. Naproxen significantly reduced the symptoms of painful temporomandibular joint disc-displacement (TMJ DD) with reduction as determined by most efficacy measures. Significant improvement in pain intensity occurred within 3 weeks of treatment, and was sustained throughout the 6-week study. Clinically significant improvement in mandibular range of motion was observed for naproxen compared to celecoxib and placebo. Celecoxib showed slightly better pain reduction than placebo, but was not significantly effective for temporomandibular disorder pain. Celecoxib and naproxen were well tolerated, with similar number of reported adverse effects. Dual COX-1 and COX-2 inhibition with naproxen was demonstrated to be effective for the treatment of painful TMJs, as seen by significant improvement in clinical signs and symptoms of TMJ DD with reduction compared to celecoxib and placebo. Inhibition of both COX isozymes is needed to achieve effective analgesia for this type of musculoskeletal pain.

Adult↗
PubMed2003

Naproxen, clenbuterol and insulin administration ameliorates cancer cachexia and reduce tumor growth in Walker 256 tumor-bearing rats.

Cancer cachexia is characterized by anorexia and intense peripheral catabolism. We examine the potential benefits of combination of different anabolic agents such as insulin and clenbuterol associated to prostaglandin synthesis inhibitor (naproxen) on tumor growth, cachexia and renal function in Walker 256 tumor-bearing rats (WK). Groups were separated into WK, and WK with naproxen (WK N) or naproxen plus clenbuterol (WK NCb) or naproxen plus clenbuterol plus insulin (WK NCbI). Treatment begins at the 4th day after tumor inoculation, at the 14th day they were killed, glycemia, lacticidemia, glycogen content from liver, soleus and gastrocnemius muscles, tumor mass, body weight and kidney function were determined. Glycemia and glycogen content were reduced and lacticidemia increased in WK (p<0.05) as compared to control rats. The glycogen content recovered in all treated groups. Tumor weight was significantly reduced by the different treatments. At the 14th weight change (carcass-initial body weight) in the control increased by 38% and in the WK -2%. Naproxen treatment (WK N) induced an increased by 14%. The inclusion of clenbuterol (WK NCb) and insulin (WK NCbI) by 38 and 41%, respectively. Mean glomerular filtration rate (GFR) increased in the WK (p<0.05) as compared to control, but in the WK NCb the GFR was similar to control. Our results suggest that naproxen is able to reduce tumor growth and its association with insulin and clenbuterol induce mass weight gain and recovery energy fuel.

Adrenergic beta-Agonists↗