during long-term administration, the dose of naproxen may be adjusted up or down depending on the clinical response of the patient. a lower daily dose may suffice for long-term administration. the morning and evening doses do not have to be equal in size and the administration of the drug more frequently than twice daily is not necessary. the morning and evening doses do not have to be equal in size and administration of the drug more frequently than twice daily does not generally make a difference in response. in patients who tolerate lower doses well, the dose may be increased to naproxen 1500 mg/day for limited periods of up to 6 months when a higher level of anti-inflammatory/analgesic activity is required. when treating such patients with naproxen 1500 mg/day, the physician should observe sufficient increased clinical benefits to offset the potential increased risk. 2.3 polyarticular juvenile idiopathic arthritis naproxen solid-oral dosage forms may not allow for the flexible dose titration needed in pediatric patients with polyarticular juvenile idiopathic arthritis. a liquid formulation may be more appropriate for weight-based dosing and due to the need for dose flexibility in children. in pediatric patients, doses of 5 mg/kg/day produced plasma levels of naproxen similar to those seen in adults taking 500 mg of naproxen [ see clinical pharmacology (12)]. the recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses. dosing with naproxen tablets is not appropriate for children weighing less than 50 kilograms. 2.4 management of pain, primary dysmenorrhea, and acute tendonitis and bursitis the recommended starting dose of naproxen sodium tablets is 550 mg followed by 550 mg every 12 hours or 275 mg every 6 to 8 hours as required. the initial total daily dose should not exceed 1375 mg of naproxen sodium. thereafter, the total daily dose should not exceed 1100 mg of naproxen sodium. because the sodium salt of naproxen is more rapidly absorbed, naproxen sodium tablets are recommended for the management of acute painful conditions when prompt onset of pain relief is desired. 2.5 acute gout naproxen sodium tablets may also be used at a starting dose of 825 mg followed by 275 mg every 8 hours. 2.6 non-interchangeability with other formulations of naproxen different dose strengths and formulations (e.g., tablets, suspension) of naproxen are not interchangeable. this difference should be taken into consideration when changing strengths or formulations.

rmulations of naproxen 375 mg twice a day (750 mg a day) vs 750 mg twice a day (1500 mg/day), 9 patients in the 750 mg group terminated prematurely because of adverse events. nineteen patients in the 1500 mg group terminated prematurely because of adverse events. most of these adverse events were gastrointestinal events. in clinical studies in patients with rheumatoid arthritis, osteoarthritis, and polyarticular juvenile idiopathic arthritis, naproxen has been shown to be comparable to aspirin and indomethacin in controlling the aforementioned measures of disease activity, but the frequency and severity of the milder gastrointestinal adverse effects (nausea, dyspepsia, heartburn) and nervous system adverse effects (tinnitus, dizziness, lightheadedness) were less in naproxen-treated patients than in those treated with aspirin or indomethacin. in patients with ankylosing spondylitis, naproxen has been shown to decrease night pain, morning stiffness and pain at rest. in double-blind studies the drug was shown to be as effective as aspirin, but with fewer side effects. in patients with acute gout, a favorable response to naproxen was shown by significant clearing of inflammatory changes (e.g., decrease in swelling, heat) within 24 to 48 hours, as well as by relief of pain and tenderness. naproxen has been studied in patients with mild to moderate pain secondary to postoperative, orthopedic, postpartum episiotomy and uterine contraction pain and dysmenorrhea. onset of pain relief can begin within 1 hour in patients taking naproxen and within 30 minutes in patients taking naproxen sodium. analgesic effect was shown by such measures as reduction of pain intensity scores, increase in pain relief scores, decrease in numbers of patients requiring additional analgesic medication, and delay in time to remedication. the analgesic effect has been found to last for up to 12 hours. naproxen may be used safely in combination with gold salts and/or corticosteroids; however, in controlled clinical trials, when added to the regimen of patients receiving corticosteroids, it did not appear to cause greater improvement over that seen with corticosteroids alone. whether naproxen has a “steroid-sparing” effect has not been adequately studied. when added to the regimen of patients receiving gold salts, naproxen did result in greater improvement. its use in combination with salicylates is not recommended because there is evidence that aspirin increases the rate of excretion of naproxen and data are inadequate to demonstrate that naproxen and aspirin produce greater improvement over that achieved with aspirin alone. in addition, as with other nsaids, the combination may result in higher frequency of adverse events than demonstrated for either product alone. in 51cr blood loss and gastroscopy studies with normal volunteers, daily administration of 1100 mg of naproxen sodium has been demonstrated to cause statistically significantly less gastric bleeding and erosion than 3250 mg of aspirin.