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PubMed1995

Naproxen inhibits hepatic glycogenolysis induced by Ca(2+)-dependent agents.

1. The non-steroidal anti-inflammatory naproxen inhibited steady-state glycogenolysis stimulation caused by norepinephrine, phenylephrine (alpha 1-agonists) and methotrexate (not receptor mediated) in the isolated perfused rat liver. Stimulation of glycogenolysis caused by these agents is Ca(2+)-dependent. 2. Naproxen did not inhibit glycogenolysis stimulation caused by glucagon. 3. The action of naproxen depended on the extracellular Ca2+ concentration. At 0.25 mM extracellular Ca2+, the norepinephrine stimulated glycogenolysis was inhibited by 60% by 0.5 mM naproxen. At 3.5 mM Ca2+, inhibition was reduced to 25%. The inhibition degree correlated linearly with the extracellular Ca2+ concentration. 4. 45Ca2+ efflux stimulation caused by norepinephrine was not affected by naproxen, indicating that the mobilization of the intracellular Ca2+ pools was not significantly affected by naproxen. The initial increases in glycogenolysis caused by norepinephrine in the absence of extracellular Ca2+ (pre steady-state) were not affected by naproxen. These increases depend on intracellular Ca2+ mobilization. 5. It can be concluded that the action of naproxen is most probably related to the cytosolic Ca2+ concentration which, under steady-state conditions, depends on the extracellular one during the action of Ca(2+)-dependent glycogenolytic agents.

Animals↗
PubMedDate not supplied

Effects of age on the pharmacodynamics of naproxen in the rat.

The pharmacodynamics of naproxen were evaluated in 5- and 24-month-old male Fischer 344 rats. Plasma naproxen concentrations and thromboxane B2 (TxB2) concentrations were measured as a function of time after intravenous administration of 25 mg/kg naproxen. Age-dependent alterations in naproxen pharmacokinetics were attributed to significant reductions in free plasma clearance (CLfree) and free steady-state volume of distribution (VSSfree), suggesting a decline in metabolic activity and naproxen binding to tissue components in aged rats, respectively. The time course of TxB2 production as a function of unbound naproxen concentrations was described by a sigmoid Emax model. Age had no significant effect on the pharmacodynamic parameter Emax, the maximum percent inhibition of TxB2 formation. Age also had no statistically significant effect on EC50, the drug concentration producing 50% of the maximum effect, however, average EC50 values were 35% higher in the aged rats. The duration of TxB2 inhibition was unaffected by age, possibly owing to similar relative decreases in receptor sensitivity (increased EC50) and increases in free naproxen concentrations (decreased free clearance and volume of distribution). Alternatively, the age-related changes in pharmacokinetic parameters were not of sufficient magnitude to produce a significant change in drug response, naproxen, pharmacokinetics, pharmacodynamics, age, rats, thromboxane B2, nonsteroidal anti-inflammatory drugs.

Aging↗
PubMed2006

A multicenter, randomized, double-blind, active-comparator, placebo-controlled, parallel-group comparison of the incidence of endoscopic gastric and duodenal ulcer rates with valdecoxib or naproxen in healthy subjects aged 65 to 75 years.

BACKGROUND: Compared with nonselective NSAIDs, cyclooxygenase (COX)-2-selective inhibitors have been associated with a lower incidence of gastroduodenal ulcers (in short-term endoscopic studies) and ulcer complications (in long-term trials). OBJECTIVE: The aim of this study was to compare the effects of valdecoxib 20 mg BID and naproxen 500 mg BID, administered for 6.5 days, on the upper gastrointestinal (UGI) mucosa of healthy older subjects (aged 65-75 years) as assessed by UGI endoscopy. METHODS: In this multicenter, double-blind, active-comparator, placebo-controlled, parallel-group study, eligible subjects who were free of NSAID or COX-2-selective inhibitor use for 2 weeks and who had normal UGI mucosa (mucosal grading score of 0, based on endoscopic evaluation of both the stomach and duodenum) were randomized. Serologic testing for Helicobacter pylori antibodies was conducted at baseline. No antiulcer medications were permitted. The primary end point was the incidence of gastroduodenal ulcers (gastric or duodenal mucosal grading score of 7, as indicated by any lesion with unequivocal depth > or =3 mm in diameter) after 6.5 days of blinded treatment with valdecoxib, naproxen, or placebo. Secondary end points were incidence of gastric ulcers, duodenal ulcers, and gastroduodenal erosions/ulcers, and the incidence of > or =11 gastroduodenal erosions/ulcers. All documented adverse events were self-reported by subjects or were observed by investigators. RESULTS: Sixty-one patients were randomized to receive valdecoxib, 60 to naproxen, and 60 to placebo. Mean (SD) subject age was 68.8 (3.25) years in the valdecoxib group, 68.6 (2.76) years in the naproxen group, and 68.6 (3.14) years in the placebo group (P = NS). In the valdecoxib and naproxen groups, 47.5% and 58.3% of subjects were female, respectively, compared with 56.7% of the placebo group (P = NS). Valdecoxib and placebo were associated with significantly lower incidences of gastroduodenal ulcers than naproxen (1.6% [1 gastroduodenal ulcer/61 patients] and 1.7% [1/59], respectively, vs 22.0% [13/59]; P < 0.001). Compared with naproxen, both valdecoxib and placebo were associated with significantly lower incidences of gastric (1.6% [1/61] and 1.7% [1/59] vs 15.3% [9/59]; both, P < 0.03) and duodenal ulcers (0% [0/61] and 0% [0/59] vs 8.5% [5/59]; both,P < 0.03). In all cases, the incidence of ulcers with valdecoxib was not significantly different from placebo. Results were similar for any erosions/ulcers, and when analyzed by H pylori status. The number of adverse events was low in each group. CONCLUSION: In these healthy older subjects (aged 65-75 years), valdecoxib 20 mg BID was associated with a significantly lower rate of gastroduodenal, gastric, and duodenal ulcers than naproxen 500 mg BID, even after 6.5 days of therapy.

Aged↗
PubMed1986

Differential response by adolescents to naproxen sodium therapy for spasmodic and congestive dysmenorrhea.

The purpose of this study was to determine whether adolescents with "spasmodic" dysmenorrhea (SD) versus "congestive" dysmenorrhea (CD) respond differently to naproxen sodium therapy. Forty-five females ages 12-18 years were pretested and randomly assigned in a double-blind fashion to one of five treatment regimens of various dosages of naproxen sodium and placebo. Subjects were posttested at one, two, and three months. Subjects with initial Menstrual Symptom Questionnaire (MSQ) scores of greater than or equal to 76 were classified as SD (n = 28) and those with scores of less than or equal to 75 were classified as CD (n = 17). Subjects with SD had a significant (p less than or equal to 0.05) reduction in MSQ scores after the first month of naproxen sodium therapy. By the second month, the degree of reduction was associated with a loading dose of 550 mg of naproxen sodium. Subjects with CD had a dose-related (p less than or equal to 0.05) response to naproxen sodium therapy that appeared to be influenced by other factors. At the first month follow-up, greater post menarchal age and parents' education were associated with increased symptom relief following naproxen sodium therapy (p less than or equal to 0.05). At the second month, CD subjects with increased life crisis events and lower self-concepts had more severe symptoms following naproxen sodium therapy (p less than 0.05). Our subjects with SD symptoms had a greater response to naproxen sodium therapy than those with CD symptoms.

Adolescent↗
PubMed2006

Binding of naproxen and amitriptyline to bovine serum albumin: biophysical aspects.

Binding of the drugs naproxen (which is an anti-inflammatory) and amitriptyline (which is an anti-depressant) to bovine serum albumin (BSA) has been studied using isothermal titration calorimetry (ITC), in combination with fluorescence and circular dichroism spectroscopies. Naproxen is observed to bind more strongly to BSA than amitriptyline. The temperature-dependent ITC results indicate the interaction of one molecule of naproxen with more than one protein molecule. On the other hand, amitriptyline binds to BSA with a reaction stoichiometry that varies from 1:1.2 to 1:2.9. The van't Hoff enthalpy, which is calculated from the temperature dependence of the binding constant, agrees well with the calorimetric enthalpy in the case of naproxen binding to BSA, indicating adherence to a two-state binding process. However, their disagreement in the case of amitriptyline indicates conformational changes in the protein upon ligand binding, as well as with the rise in temperature. The spectroscopic results did not suggest appreciable conformational changes as a result of binding; hence, the discrepancy could be attributed to the temperature-induced conformational changes. With increases in the ionic strength, a reduction in the binding affinity of naproxen to BSA is observed. This suggests the prevailing electrostatic interactions in the complexation process. The preponderance of the hydrophobic interactions in the binding of amitriptyline to BSA is indicated by the absence of any dependence of the ionic strength. A predominance of electrostatic interactions in the case of naproxen binding to BSA and that of hydrophobic interactions in the case of amitriptyline binding to BSA is further strengthened by the results of the binding experiments performed in the presence of ionic and nonionic surfactants. The binding parameters indicate that Triton X-100 blocks the hydrophobic binding sites on BSA, thereby altering the binding affinity of amitriptyline toward BSA. A partial overlap of the binding sites for these drugs is indicated by the binding parameters obtained in the titration of naproxen to the amitriptyline-BSA complex and vice versa. Thus, the results provide a quantitative understanding of the binding of naproxen and amitriptyline to BSA, which is important in understanding their effect as therapeutic agents individually and in combination therapy.

Amitriptyline↗
PubMed1990

Coadministration of naproxen and low-dose methotrexate in patients with rheumatoid arthritis.

Fifteen patients (30 to 78 years of age) with diagnoses of rheumatoid arthritis were administered oral and intravenous methotrexate (15 mg), alone or with concomitant naproxen (1000 mg/day). Serial blood samples and urine were collected for 24 hours after the dose of methotrexate and were assayed for methotrexate by a specific radioenzymatic method. In twelve patients who completed the study, methotrexate systemic clearance was not statistically different with naproxen (103.3 +/- 35.0 ml/min) versus without naproxen (113.4 +/- 48.3 ml/min; p = 0.37). Oral clearance of methotrexate was not statistically different with naproxen (161.7 +/- 55.0 ml/min) versus without naproxen (176.7 +/- 68.3 ml/min; p = 0.14). Likewise, there was not a significant difference in methotrexate renal clearance or plasma protein binding with or without naproxen. No toxicity was observed when patients received methotrexate alone or with naproxen. This study indicates that concomitant naproxen does not abruptly alter the disposition of low-dose methotrexate in patients with rheumatoid arthritis who have normal renal function.

Absorption↗
PubMed1997

Drug-targeting to the kidney: renal delivery and degradation of a naproxen-lysozyme conjugate in vivo.

A renal-specific controlled release of an active drug may enable a reduction of the required dose and may provide a reduction of extra-renal toxicity. To achieve renal specific targeting of the NSAID naproxen, the low-molecular-weight protein (LMWP) lysozyme was employed as carrier since it is mainly taken up and catabolized in the proximal tubules of the kidney. A conjugate was synthesized with an average coupling degree of 2 mol naproxen per 1 mol lysozyme in which the drug was directly coupled to the protein via a peptide bond. First, we investigated whether naproxen conjugation affects the renal disposition of lysozyme. As native lysozyme, the conjugate was predominantly and rapidly (within 20 min) taken up by the kidney. The subsequent decrease in renal content reflecting the renal degradation of the conjugated lysozyme molecules appeared also to be similar to that of native lysozyme with a half life of four hours. Second, the effect of lysozyme conjugation on the body distribution of naproxen was studied. An important observation with regard to the aimed reduction in extra-renal side effects was that no detectable amounts of free naproxen were present in the plasma after administration of conjugate. Conjugation of naproxen to lysozyme resulted in a pronounced (70-fold) increase of naproxen accumulation in the kidney. In agreement with the protein disposition study, the conjugate was rapidly taken up by the kidney and subsequently degraded. In conclusion, renal selective targeting of the NSAID naproxen can be obtained by conjugation with the LMWP lysozyme. This concept of drug delivery to the kidney has the potential to improve drug efficacy and safety.

Animals↗
PubMed2003

Gastroduodenal tolerability of lumiracoxib vs placebo and naproxen: a pilot endoscopic study in healthy male subjects.

BACKGROUND: Lumiracoxib (Prexige) is a cyclooxygenase-2 (COX-2) selective inhibitor. AIM: To compare the gastroduodenal tolerability of lumiracoxib with placebo and naproxen in a randomized, parallel-group, double-blind study. METHODS: : Sixty-five healthy male subjects were randomized to receive 8 days' dosing with lumiracoxib 200 mg twice daily (b.d.) (n = 21), placebo (n = 22) or naproxen 500 mg b.d. (n = 22). Endoscopic evaluations of gastric and duodenal mucosae were conducted at baseline and after 8 days' dosing. Serum was assayed for ex-vivo concentrations of thromboxane B2 (TxB2) to determine cyclooxygenase-1 (COX-1) inhibitory activity. RESULTS: Sixty subjects (20 per group) completed the study. No gastroduodenal erosions were observed in subjects receiving lumiracoxib. Thirteen subjects receiving naproxen developed duodenal erosions. At the gastric site, one subject in each of the naproxen and placebo groups had erosions; one subject receiving naproxen also developed a small asymptomatic gastric ulcer. Gastrointestinal adverse events accounted for 42.3% of all adverse events, occurring in 3/21, 4/22 and 6/22 of the lumiracoxib, placebo and naproxen groups, respectively. TxB2 levels were similar for patients receiving placebo or lumiracoxib, but were reduced by > 95% in patients receiving naproxen, compared with placebo. CONCLUSIONS: Multiple doses of lumiracoxib resulted in gastroduodenal tolerability similar to placebo and superior to naproxen.

Adolescent↗
PubMed2004

Risks of clinically significant upper gastrointestinal events with etodolac and naproxen: a historical cohort analysis.

BACKGROUND AND AIMS: Etodolac is a generic nonsteroidal anti-inflammatory drug (NSAID). Previous in vitro studies have shown that etodolac is a selective inhibitor of cyclooxygenase (COX)-2 with selectivity in between that of other COX-2 inhibitors such as celecoxib and rofecoxib. However, there are no outcomes data assessing clinically significant upper gastrointestinal (CSUGI) events with etodolac. METHODS: A historical cohort study was performed at the Dallas Veterans Affairs Medical Center in which 16,286 veteran patients (5596 patient-years) received etodolac or naproxen during a 3-year period without concurrent use of other ulcerogenic drugs other than low-dose aspirin. The primary outcome was the CSUGI event rate of the etodolac and naproxen groups without concomitant low-dose aspirin. RESULTS: The incidence of CSUGI events was .78% and .24% for naproxen and etodolac, respectively. In the NSAID-naive subset, the incidence of CSUGI events was .99% and .24% for naproxen and etodolac, respectively. Compared with naproxen, etodolac was associated with a reduction in upper gastrointestinal events, corresponding to an odds ratio of .39 (95% confidence interval, .20-.76; P = .006). Concomitantly used low-dose aspirin increased event rates with naproxen 2-fold and etodolac 9-fold. Hence, there was no significant difference in gastrointestinal event rates between etodolac and naproxen when low-dose aspirin was taken concomitantly. CONCLUSIONS: Etodolac is a generic COX-2 selective inhibitor that reduces CSUGI events compared with the nonselective NSAID naproxen. However, concomitant use of low-dose aspirin negates the gastrointestinal safety advantages of etodolac.

Adult↗
PubMed2002

An in-vivo study on placental transfer of naproxen in early human pregnancy.

BACKGROUND: Naproxen is one of the most common non-steroidal anti-inflammatory drugs used by women of reproductive age. Naproxen is known to be teratogenic in animals. The aim of this study was to investigate the placental transfer of naproxen in the first trimester of human pregnancy, and to determine the amount of the drug in different embryonic compartments. METHODS: Twenty-eight patients who requested surgical termination of pregnancy in the first trimester were given two oral 500 mg doses of naproxen before the surgical procedure. Four biological samples, maternal venous blood, coelomic fluid, amniotic fluid and fetal tissue, were collected from each patient for drug analyses by high performance liquid chromatography. RESULTS: Naproxen was detected in all samples. The mean (+/- SD) concentrations were 69.5 +/- 12.2 microg/ml, 6.4 +/- 2.4 microg/g, 1.85 +/- 1.03 microg/ml and 0.14 +/- 0.11 microg/ml in maternal serum, fetal tissue, coelomic fluid and amniotic fluid respectively. The mean amniotic fluid/maternal drug ratio and fetal/maternal drug ratio were 0.002 (range 0.0005-0.0064) and 0.092 (range 0.022-0.155) respectively. There was a positive correlation between the fetal drug concentration (r = 0.59, P = 0.001), amniotic fluid drug concentration (r = 0.47, P = 0.013), amniotic fluid/maternal ratio (r = 0.536, P = 0.003) and fetal/maternal ratio (r = 0.72, P < 0.001) with advancing gestational age. CONCLUSIONS: Although naproxen can cross the placenta readily in the first trimester of human pregnancy, only a small amount was present in fetal tissues. Since there is no information on whether this small amount of naproxen would be teratogenic or not, women of reproductive age who are taking naproxen regularly should be warned of the possible fetal side-effects.

Amniotic Fluid↗
PubMed1980

Bioavailability of naproxen sodium and its relationship to clinical analgesic effects.

1 In the first of a series of trials with naproxen sodium it was shown that patients achieved significantly earlier and higher plasma levels of naproxen when naproxen sodium was administered. 2 In a second study comparing naproxen with naproxen sodium in patients with post-partum pain, pain intensity was consistently lower for the group receiving naproxen sodium. However, statistically significant differences were not seen until 4 to 5 h after medication. 3 A final study documented that a more frequent dosage schedule of every 6 h led to clearly higher plasma levels than those achieved with an every 8 h regimen; plasma levels did not plateau. Doses up to 1,375 mg/day were well tolerated. 4 In conclusion, naproxen sodium appears to be an improved form of naproxen for use as a analgesic agent.

Analgesia↗
PubMed1984

Naproxen pharmacokinetics in the elderly.

While naproxen pharmacokinetics appear to be altered in the presence of both diminished renal and hepatic function, the degree to which naproxen disposition might be influenced in the elderly by concurrent alteration in these functions is not obvious. Total plasma clearance/bioavailability (CL/F) of naproxen after a single 375 mg oral dose was found to be less in a group of 10 healthy men between 66 and 81 years of age than in 10 healthy men between 22 and 39 years (0.318 +/- 0.078, 0.416 +/- 0.061 l/h). At steady state (375 mg, 12 hourly), however, CL/F was statistically indistinguishable between the two groups. The fraction of naproxen unbound to plasma protein was doubled in elderly subjects, both at peak and trough drug concentrations. The lowered protein binding tended to obscure a 50% decrement in the intrinsic clearance of naproxen in the elderly as estimated by unbound clearance/bioavailability (213 +/- 64, 396 +/- 155 l/h). As a result, mean steady-state plasma concentrations of naproxen were indistinguishable between the elderly and young (64.2 +/- 8.5, 58.2 +/- 8.1 mg/l) but the elderly generated twice the mean steady-state unbound plasma drug concentration (0.157 +/- 0.039, 0.0859 +/- 0.0212 mg/l). Since it is the unbound drug concentration which appears in general to relate more closely to pharmacological and toxic effect, it may be advisable to reduce naproxen doses by half in the elderly, pending plasma drug concentration-response studies in this age group. If a similar perturbation with age occurs in benoxaprofen protein binding as was observed with naproxen, benoxaprofen intrinsic clearance in the elderly might be only one quarter of that in younger individuals; a factor which may contribute to the toxicity of this drug in the elderly.

Adult↗
PubMed2004

The gastrointestinal tolerability of the LOX/COX inhibitor, licofelone, is similar to placebo and superior to naproxen therapy in healthy volunteers: results from a randomized, controlled trial.

OBJECTIVES: Concerns exist over the safety of conventional nonsteroidal antiinflammatory drugs (NSAIDs) and selective cyclooxygenase (COX)-2 inhibitors. In experimental models, licofelone, a competitive inhibitor of 5-lipoxygenase (5-LOX) and COX-1/-2, has been shown to have good gastrointestinal and general tolerability and analgesic and antiinflammatory properties. The aim of the present endoscopy trial was to investigate the gastroduodenal tolerability of licofelone compared to placebo and naproxen in healthy volunteers. METHODS: In this randomized, parallel-group trial, healthy volunteers received licofelone 200 mg b.i.d. (n = 30), licofelone 400 mg b.i.d. (n = 30), naproxen 500 mg b.i.d. (n = 30), or placebo (n = 31). Tolerability was assessed by gastro/duodenoscopy following 4 wk of treatment. Laboratory parameters and the incidence of ulcers and adverse events were recorded. RESULTS: Ulcers were observed in 20% of the naproxen-treated volunteers, compared with 0% of those receiving licofelone 200 mg, licofelone 400 mg, and placebo (p= 0.024). Posttreatment mean gastric Lanza scores were similar for volunteers who received placebo or either dose of licofelone, while Lanza scores were significantly worse following naproxen therapy (p < 0.00001). The gastric mucosa was normal in 93%, 89%, and 90% of volunteers who received licofelone 200 mg, licofelone 400 mg, or placebo, respectively, compared with 37% of volunteers receiving naproxen. The incidence of adverse events did not differ significantly between licofelone 200 mg or naproxen therapy. No clinically relevant changes in laboratory parameters were observed with licofelone or naproxen therapy. CONCLUSIONS: The results from this trial indicate that licofelone has a potential gastrointestinal safety advantage over conventional NSAID therapy, as licofelone was associated with significantly superior gastric tolerability and a lower incidence of ulcers compared with naproxen in healthy volunteers. Further trials will be required to investigate the safety and efficacy of licofelone in the treatment of diseases such as osteoarthritis.

Acetates↗
PubMed1991

Inhibition of alveolar bone loss in beagles with the NSAID naproxen.

The non-steroidal anti-inflammatory drug(NSAID) naproxen was studied in 11 beagle dogs over a 13-month period to determine its effect on the progression of periodontitis. Following a 6-month pretreatment period, 5 dogs received naproxen daily at a dosage of 2.0 mg/kg for 1 month, then 0.2 mg/kg for 6 months. Six control dogs received a gelatin capsule daily as placebo. Standardized radiographs were used to measure the rate of bone loss during the pretreatment and treatment periods. In the control dogs, the rate of bone loss was seen to increase during the treatment period although the increase was not statistically significant. In dogs treated daily with naproxen, the rate of bone loss in the treatment period was significantly less at 4 months of treatment; however, at 7 months the difference, though lower than pretreatment rate, was not significant. When the percent change in rate of bone loss during the overall 7-month treatment period was compared with pretreatment rate, the control dogs demonstrated a 38% increase in rate of bone loss during the treatment period contrasting with a 61% decrease in bone loss rate in naproxen-treated dogs. The data indicate that the non-steroidal anti-inflammatory drug naproxen can significantly inhibit alveolar bone loss in beagles. At 4 months of treatment the rate of bone loss in the naproxen-treated dogs was significantly less than pretreatment, but at 7 months of treatment the rate was no longer statistically significantly less than baseline. This probably reflects a dose response to naproxen treatment for, after 30 days of the treatment period, the naproxen dosage was reduced 10-fold due to tolerance by the beagle.

Alveolar Bone Loss↗
PubMed2003

Naproxen 500 mg bid versus acetaminophen 1000 mg qid: effect on swelling and other acute postoperative events after bilateral third molar surgery.

A controlled, randomized, double-blind crossover study, in which the patients acted as their own controls, was carried out to test the efficacy of naproxen 500 mg x 2 versus acetaminophen 1000 mg x 4 for 3 days on the postoperative course following third molar surgery. Acetaminophen reduced the mean swelling on the 3rd postoperative day by 22.4% (p = 0.023) compared to that after naproxen. On the 6th postoperative day, there was 20.9% less mean swelling with naproxen (p = 0.44), although the total swelling measurements were much less than those measured on the 3rd postoperative day. Summed pain intensity (SUMPI3.5-11) on the day of surgery revealed no statistically significant difference between the acetaminophen or naproxen regimen with the exception of 0.5 hours (p = 0.002) and 1 hour (p = 0.009) after first medication when acetaminophen gave less pain than naproxen. Since the drug regimens were different, summed PI for the first acetaminophen dose interval (SUMPI3.5-6) and the first naproxen dose interval (SUMPI3.5-9) was calculated. There was a tendency toward a statistically significant difference in favor of acetaminophen for SUMPI3.5-6 (p = 0.055) but no statistically significant difference (p = 0.41) between the treatments with respect to SUMPI3.5-9. Naproxen was statistically superior (p < or = 0.002) to acetaminophen at 08:00, 12:00, and 16:00 hours on the 1st postoperative day and at 08:00 hours on the 2nd postoperative day, when the pain intensity level was lower than that on the day of surgery. A 3-day acetaminophen regimen reduces acute postoperative swelling better than naproxen on the 3rd postoperative day after third molar surgery but not on the 6th postoperative day when the total swelling is less.

Acetaminophen↗
PubMedDate not supplied

Celecoxib is as efficacious as naproxen in the management of acute shoulder pain.

This study compared the analgesic efficacy and safety of the cyclo-oxygenase-2 specific inhibitor celecoxib with the non-specific non-steroidal anti-inflammatory drug, naproxen, in patients with acute shoulder pain. Adult patients with shoulder pain, onset within the previous 14 days and shoulder pain of > or = 40 mm on a 100 mm visual analogue scale (VAS), were treated with oral doses of celecoxib or naproxen for 14 days and followed by a visit at day 42 in a double-blind, randomized study. The primary efficacy assessment was change in maximum pain at rest on a 100 mm VAS at day 14 compared with baseline. In addition, secondary efficacy pain and functional assessments were analysed at baseline, day 14 and day 42. A total of 202 patients were included in the trial (99 celecoxib 400 mg/day; 103 naproxen 1 g/day). The difference in change from baseline at day 14 in maximum pain at rest was not statistically significant between the two treatment groups, but was numerically higher for celecoxib than for naproxen (-47.9 +/- 2.5 versus -42.3 +/- 2.5, respectively). According to the limits of the 95% confidence interval of the difference between groups (-12.52; 1.38), celecoxib appeared to be at least as effective as naproxen. All secondary efficacy measures followed the same pattern, showing similarity between the two treatments with a trend in favour of celecoxib. The incidences of adverse events were similar for both groups. Fewer patients experienced epigastric pain with celecoxib (seven patients versus 14 with naproxen). This adverse event led to discontinuation in two patients receiving celecoxib and five receiving naproxen. Celecoxib 400 mg/day was at least as effective as naproxen 1 g/day in managing pain in this condition.

Acute Disease↗
PubMed1988

Clinical evaluation of a new controlled-release formulation of naproxen in osteoarthritis and rheumatoid arthritis. Canadian Multicentre Study Group.

A two-part multi-centre study was carried out to assess the efficacy and tolerability of a new controlled-release (CR) naproxen tablet in the treatment of osteoarthritis and rheumatoid arthritis. Patients already receiving naproxen on a regular basis were first enrolled in a 6-week randomized double-blind trial comparing the controlled-release tablet (750 mg or 1000 mg once-a-day) to the standard marketed tablet (375 mg or 500 mg twice-a-day). At the end of this phase, patients in both treatment groups were eligible to enter the long-term phase involving 28 weeks of open-label treatment with controlled-release naproxen at the previously established dose level (750 mg or 1000 mg once-a-day). A total of 404 patients entered the initial double-blind phase, 320 of whom continued into the open-label phase. Twenty-nine (14%) naproxen patients and 23 (11%) naproxen CR patients were withdrawn prematurely from the double-blind phase, 87 (27%) patients from the open-label phase. Parameters of efficacy and tolerability were evaluated at base-line, during the double-blind phase (after 3 and 6 weeks of treatment), and during the open-label phase (after 20 and 34 weeks of treatment). The entire study population showed significant improvements in overall disease activity and severity of pain, but with no statistically or clinically significant differences between the two treatment groups; nor were there significant differences among treatments in incidence of adverse events. The patients treated with naproxen CR for an additional 28 weeks showed either no change or continued improvement in arthritic symptoms and no signs of toxicity. It was concluded that, in osteoarthritis and rheumatoid arthritis patients, once-a-day controlled-release naproxen tablets can be substituted for standard naproxen tablets without loss of efficacy or tolerability.

Adult↗
PubMed1995

The pharmacokinetic and pharmacodynamic interactions between the 5-lipoxygenase inhibitor zileuton and the cyclo-oxygenase inhibitor naproxen in human volunteers.

The potential pharmacokinetic and pharmacodynamic interactions between zileuton, a 5-lipoxygenase inhibitor, and naproxen, a nonsteroidal anti-inflammatory drug that acts as a cyclo-oxygenase inhibitor, have been investigated in 24 healthy volunteers. Coadministration of these 2 drugs had no effect upon the plasma concentration-time curves of either zileuton (800mg) or naproxen (500mg) when compared with each drug administered alone. Both naproxen plasma concentrations during the elimination phase and area under the plasma concentration-time curve values were statistically significantly raised upon coadministration with zileuton, when compared with naproxen alone. However, these differences in these 2 values were sufficiently small to be of no clinical significance. There is no evidence that the combination of zileuton and naproxen had an effect on leukotriene B4 levels that was different from the inhibitory effect of zileuton alone, or had an effect on serum thromboxane B2 levels that was different from the effect of naproxen alone. Moreover, inhibition of the 5-lipoxygenase pathway by zileuton did not appear to aggravate the gastrointestinal adverse events commonly associated with naproxen administration. It is concluded that zileuton and naproxen may be coadministered with minimal risk of a clinically significant interaction.

Administration, Oral↗