Naproxen and naproxen sodium are used to relieve mild to moderately severe pain. Conventional (immediate-release) and delayed-release (enteric-coated) tablets and suspension formulations of naproxen or naproxen sodium are used for anti-inflammatory and analgesic effects in the symptomatic treatment of rheumatoid arthritis, osteoarthritis, juvenile rheumatoid arthritis, and ankylosing spondylitis. Conventional (immediate-release) tablets and suspension formulations of naproxen or naproxen sodium also are used for the symptomatic treatment of tendinitis, bursitis, acute gout, pain, and primary dysmenorrhea. Suspension formulations of naproxen are preferred for the management of juvenile arthritis since this formulation provides maximum dosage flexibility. Because of the delayed-release properties of enteric-coated naproxen tablets, this formulation is not recommended for the management of acute pain. Extended-release naproxen sodium tablets are used for the symptomatic treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis, acute gout, mild to moderately severe pain, and primary dysmenorrhea. (Naproxen 250 mg is approximately equivalent to naproxen sodium 275 mg.) Naproxen sodium also may be used for self-medication for anti-inflammatory and analgesic effects to provide temporary relief of minor aches and pains, including those associated with arthritis, and of dysmenorrhea and for its antipyretic effect to reduce fever.
The potential benefits and risks of naproxen therapy as well as alternative therapies should be considered prior to initiating naproxen therapy. The lowest possible effective dosage and shortest duration of therapy consistent with treatment goals of the patient should be employed.
Naproxen and naproxen sodium are used for anti-inflammatory and analgesic effects in the symptomatic treatment of rheumatoid arthritis, osteoarthritis, juvenile rheumatoid arthritis, and ankylosing spondylitis. Naproxen also is used in fixed combination with esomeprazole magnesium for the symptomatic treatment of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis in patients at risk of developing gastric ulcers associated with NSAIA therapy. For information on the combined use of naproxen and esomeprazole,
Rheumatoid Arthritis, Juvenile Arthritis, and Osteoarthritis
When used in the treatment of rheumatoid arthritis or juvenile rheumatoid arthritis, naproxen has relieved pain and stiffness, reduced swelling, and improved mobility and grip strength. In the treatment of osteoarthritis, naproxen has relieved pain and stiffness and improved knee joint function. Naproxen appears to be only palliative in these conditions and has not been shown to permanently arrest or reverse the underlying disease process. Naproxen sodium also may be used for self-medication to provide temporary relief of minor aches and pains associated with arthritis.
Most clinical evaluations of naproxen in the management of rheumatoid arthritis or osteoarthritis have shown that the anti-inflammatory and analgesic effects of usual dosages of naproxen are greater than those of placebo and about equal to those of usual dosages of salicylates, indomethacin, fenoprofen, or ibuprofen. The results of a study in patients with osteoarthritis suggested that naproxen (500 mg twice daily) was less effective than tolmetin (800 mg twice daily) in some measures of pain relief, although improvements in functional ability did not differ. In controlled studies in patients with juvenile rheumatoid arthritis, the anti-inflammatory and analgesic effects of usual dosages of naproxen were comparable to those of usual dosages of aspirin, indomethacin, or piroxicam. Patient response to oral NSAIAs is variable; patients who do not respond to or cannot tolerate one NSAIA might be successfully treated with a different agent. However, NSAIAs are generally contraindicated in patients in whom sensitivity reactions (e.g., urticaria, bronchospasm, severe rhinitis) are precipitated by aspirin or other NSAIAs.
(See Cautions: Precautions and Contraindications.)
In the management of rheumatoid arthritis in adults, NSAIAs may be useful for initial symptomatic treatment; however, NSAIAs do not alter the course of the disease or prevent joint destruction. Disease modifying antirheumatic drugs (DMARDs) (e.g., azathioprine, cyclosporine, etanercept, oral or injectable gold compounds, hydroxychloroquine, infliximab, leflunomide, methotrexate, minocycline, penicillamine, sulfasalazine) have the potential to reduce or prevent joint damage, preserve joint integrity and function, and reduce total health care costs, and all patients with rheumatoid arthritis are candidates for DMARD therapy. DMARDs should be initiated early in the disease course and should not be delayed beyond 3 months in patients with active disease (i.e., ongoing joint pain, substantial morning stiffness, fatigue, active synovitis, persistent elevation of erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP], radiographic evidence of joint damage) despite an adequate regimen of NSAIAs. NSAIA therapy may be continued in conjunction with DMARD therapy or, depending on patient response, may be discontinued. For further information on the treatment of rheumatoid arthritis,
The manufacturers state that naproxen and its salt may be used safely in conjunction with gold compounds and/or corticosteroids in the treatment of rheumatoid arthritis. The manufacturers state that combined use of naproxen or its salt and corticosteroids has not resulted in greater improvement than with steroids alone, although addition of naproxen or its salt to a regimen of gold compounds has resulted in greater improvement than with gold salts alone.
Use of naproxen or its salt with aspirin is not recommended by the manufacturers. There is inadequate proof that the combination is more efficacious than either drug alone, and the potential for adverse reactions may be increased.
(See Drug Interactions: Nonsteroidal Anti-inflammatory Agents.)
When used in patients with ankylosing spondylitis, naproxen has relieved night pain, morning stiffness, and pain at rest. In a limited number of controlled studies, the anti-inflammatory and analgesic effects of usual dosages of naproxen in the symptomatic treatment of ankylosing spondylitis were greater than those of placebo and comparable to those of usual dosages of aspirin or phenylbutazone (no longer commercially available in the US).
Other Inflammatory Conditions
Naproxen has been used effectively to relieve pain, fever, redness, swelling, and tenderness in patients with acute gouty arthritis.
When used in the treatment of acute painful shoulder, the anti-inflammatory and analgesic effects of naproxen sodium are greater than those of placebo and about equal to those of indomethacin. When used in the treatment of tendinitis and bursitis, the anti-inflammatory and analgesic effects of usual dosages of naproxen sodium are comparable to those of usual dosages of oxyphenbutazone (no longer commercially available in the US).
Naproxen and its salt are used to relieve postoperative pain (including that associated with dental surgery), postpartum pain, primary dysmenorrhea, pain following insertion of an intrauterine contraceptive device, orthopedic pain, headache (including migraine), and visceral pain associated with cancer. Naproxen sodium also may be used for self-medication to provide temporary relief of minor aches and pains associated with the common cold, headache, toothache, muscular aches, and backache.
There are few published studies comparing the effectiveness of naproxen and its salt with other analgesics in the relief of nonarthritic pain. In one study, a single 275-mg oral dose of naproxen sodium was as effective as a single 650-mg oral dose of aspirin in the relief of postpartum uterine pain. In another study, when used to relieve postoperative or orthopedic pain, 550 mg of oral naproxen sodium followed by 275 mg every 6 hours was at least as effective as 650 mg of acetaminophen orally every 6 hours or 50 mg of pentazocine orally every 6 hours; in this study, the onset of action appeared to be more rapid for naproxen sodium than for acetaminophen or pentazocine. In another study of patients with postoperative pain, the analgesic effects of 550 mg of oral naproxen sodium and 60 mg of oral codeine sulfate were additive (the combination was more effective than either drug alone).
Some experts state that an NSAIA (e.g., naproxen or its salt) is a reasonable first-line therapy for mild to moderate migraine attacks or for severe attacks that have responded in the past to similar NSAIAs or non-opiate analgesics. When used for prophylaxis of migraine headache, naproxen and its salt appear to have a modest effect on headache frequency, intensity, and/or duration. For further information on management and classification of migraine headache and on efficacy of concomitant naproxen sodium and sumatriptan therapy,
When used to relieve dysmenorrhea, including that which develops after insertion of an intrauterine contraceptive device, an oral dosage of 500 mg of naproxen or 550 mg of naproxen sodium followed by 250 mg of naproxen or 275 mg of naproxen sodium every 6 hours, respectively, has been reported to be more effective than placebo or aspirin (650 mg 4 times daily). In a placebo-controlled study of women with primary menorrhagia or menorrhagia associated with intrauterine contraceptive devices, administration of naproxen (750 mg daily for the first 2 days of menstrual bleeding followed by 500 mg daily thereafter for up to 7 days) resulted in a reduction of blood loss.In one controlled study in patients with postpartum pain, a single oral dose of 550 mg of naproxen sodium appeared to provide greater pain relief after 4 and 5 hours than 500 mg of naproxen; however, there was no difference in onset of analgesia. Naproxen sodium also may be used for self-medication to provide temporary relief of manifestations of dysmenorrhea (e.g., menstrual cramps).
Naproxen sodium has been used in adults for self-medication as an antipyretic. The drug also has been used as an antipyretic in children; one study indicates that a single oral dose of naproxen (2.5 or 7.5 mg/kg) was at least as effective as a single oral dose of aspirin (15 mg/kg) in the reduction of fever in children. The results of one study suggested that the combination of naproxen sodium and ampicillin was more effective than ampicillin alone in alleviating fever, dyspnea, and coughing associated with acute respiratory infections in children.
Naproxen has been used in the symptomatic management of osteitis deformans (Paget's disease of bone) and Bartter's syndrome.
Results from a large, prospective, population-based cohort study in geriatric individuals indicate a lower prevalence of Alzheimer's disease among patients who received an NSAIA for 2 years or longer. Similar findings have been reported from some other, but not all, observational studies.