Uses
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Inflammatory Diseases
Diclofenac sodium and diclofenac potassium are used orally for anti-inflammatory and analgesic effects in the symptomatic treatment of acute and chronic rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, and other inflammatory conditions.
Diclofenac sodium in fixed combination with misoprostol is used orally for anti-inflammatory activity and analgesic effects in the symptomatic treatment of rheumatoid arthritis and osteoarthritis in patients at high risk of developing NSAIA-induced gastric or duodenal ulcers and in patients at high risk of developing complications from these ulcers.
Diclofenac sodium 1% gel (Voltaren gel) is used topically for the symptomatic treatment of osteoarthritis-related joint pain. The gel is used for joints amenable to topical therapy (e.g., hands, knees); the gel has not been evaluated for use on joints of the spine, hip, or shoulder.
The potential benefits and risks of diclofenac therapy as well as alternative therapies should be considered prior to initiating diclofenac therapy. The lowest possible effective dosage and shortest duration of therapy consistent with treatment goals of the patient should be employed.
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Rheumatoid Arthritis and Osteoarthritis
When used in the symptomatic treatment of rheumatoid arthritis, oral diclofenac has relieved pain and stiffness; reduced swelling, tenderness, and the number of joints involved; and improved mobility and grip strength. In the symptomatic treatment of osteoarthritis, diclofenac has relieved pain and stiffness, improved knee joint function, and increased range of motion and functional activity. Diclofenac appears to be only palliative in these conditions and has not been shown to permanently arrest or reverse the underlying disease process.
Most clinical studies have shown that the anti-inflammatory and analgesic effects of usual oral dosages of diclofenac sodium in the management of rheumatoid arthritis or osteoarthritis are greater than those of placebo and about equal to those of usual dosages of salicylates, diflunisal, ibuprofen, indomethacin, ketoprofen, mefenamic acid, naproxen, phenylbutazone (no longer commercially available in the US), piroxicam, or sulindac. In controlled clinical studies of 3 months' duration in patients with rheumatoid arthritis or osteoarthritis, diclofenac sodium dosages of 100-200 mg daily, given as delayed-release (enteric-coated) tablets, were as effective as 2.4-4.8 g of aspirin daily, 500 mg of naproxen daily, or 2.4 g of ibuprofen daily. 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., abatacept, adalimumab, anakinra, etanercept, hydroxychloroquine, infliximab, leflunomide, methotrexate, minocycline, rituximab, sulfasalazine) have the potential to reduce or prevent joint damage and to preserve joint integrity and function. DMARDs are used in conjunction with anti-inflammatory agents (i.e., NSAIAs, intra-articular and oral glucocorticoids) and physical and occupational therapies for the management of rheumatoid arthritis. DMARD therapy should be initiated early in the disease course to prevent irreversible joint damage. (For further information on the treatment of rheumatoid arthritis, including considerations in selecting a DMARD regimen, .) Diclofenac has been used concomitantly with gold compounds, antimalarials, penicillamine, acetaminophen, and/or corticosteroids. Use of diclofenac with aspirin is not recommended, because the risk of serious adverse GI events may be increased and the pharmacokinetics of one or both of these drugs may be altered.
(See Drug Interactions: Nonsteroidal Anti-inflammatory Agents.) When used for the symptomatic treatment of osteoarthritis of the hand or knee, diclofenac sodium 1% gel has been more effective than vehicle (placebo) in relieving pain; however, results of clinical trials evaluating the formulation suggest that its analgesic effects may be modest.
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Ankylosing Spondylitis
In the symptomatic treatment of ankylosing spondylitis, oral diclofenac appears to provide relief of spinal pain, tenderness and/or spasm, morning stiffness, and pain at rest (including night pain) and to improve motion, posture, chest expansion, and spinal mobility. The anti-inflammatory and analgesic effects of usual dosages of diclofenac in the management of ankylosing spondylitis are about equal to those of usual dosages of indomethacin or sulindac. In a controlled clinical study in patients with ankylosing spondylitis, diclofenac sodium dosages of 75-125 mg daily, given as delayed-release (enteric-coated) tablets, were as effective as indomethacin 75-125 mg daily.
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Juvenile Arthritis
Diclofenac has been used orally with good results in a number of children for the management of juvenile rheumatoid arthritis. Results of these studies suggest that usual dosages of the drug are more effective than placebo and at least as effective as usual dosages of salicylates, naproxen, or tolmetin in decreasing the number of painful, swollen, and tender joints. Further studies are needed to evaluate the efficacy and safety of diclofenac in the management of juvenile rheumatoid arthritis.
(See Cautions: Pediatric Precautions.)
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Other Inflammatory Conditions
Oral diclofenac has been effective in a limited number of patients for the symptomatic relief of acute gouty arthritis. The drug does not appear to correct hyperuricemia but has been used instead for its anti-inflammatory and analgesic effects to relieve pain, joint tenderness, and swelling associated with this condition.
Oral diclofenac also has been used for the symptomatic treatment of acute painful shoulder (bursitis and/or tendinitis), sciatic pain, backache, myositis, and radiohumeral bursitis (radiohumeral epicondylitis, tennis elbow). The drug has been injected locally (a parenteral dosage form currently is not commercially available in the US) for the relief of myofascial pain in a limited number of patients with fibrositis, but additional study is necessary.
Oral or topical diclofenac has been used for the symptomatic treatment of infusion-related superficial thrombophlebitis. In a controlled clinical trial in a limited number of patients, symptoms of thrombophlebitis improved in 60% of patients receiving diclofenac either orally (75 mg every 12 hours) or topically (as a gel applied to affected area every 8 hours) for 48 hours compared with 20% of those receiving placebo.
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Pain
Diclofenac potassium is used orally for symptomatic relief of postoperative pain (including that associated with orthopedic, gynecologic, and oral surgery) and orthopedic pain (including musculoskeletal sprains and traumatic joint distortions). Diclofenac epolamine transdermal system is used for symptomatic relief of acute pain due to minor strains, sprains, and contusions.
The potential benefits and risks of diclofenac therapy as well as alternative therapies should be considered prior to initiating diclofenac therapy. The lowest possible effective dosage and shortest duration of therapy consistent with treatment goals of the patient should be employed.
In patients with dental extraction or gynecologic surgery pain, single oral 50- and 100-mg doses of diclofenac potassium have been reported to be as effective as single 650-mg doses of aspirin; the duration of diclofenac potassium's analgesic effect appears to be longer than that of aspirin. When used to relieve postoperative orthopedic surgery pain, 50- or 100-mg doses of diclofenac potassium followed by 50 mg every 8 hours were as effective as 550 mg of naproxen sodium followed by 275 mg every 8 hours. When used to relieve orthopedic pain, 150 mg of diclofenac potassium daily was more effective than placebo and at least as effective as 1.2 g of ibuprofen daily or 20 mg of piroxicam daily.
Diclofenac sodium also has been used orally for symptomatic relief of postoperative (including that associated with dental surgery), postpartum, and orthopedic (including musculoskeletal strains or sprains) pain, and visceral pain associated with cancer. Because of the relatively slow onset of action of delayed-release (enteric-coated) or extended-release tablets of diclofenac sodium, other more rapid-acting NSAIAs (e.g., diclofenac potassium) may be preferred when prompt relief of acute pain is required. Diclofenac also has been used parenterally (a parenteral dosage form is currently not commercially available in the US) for the relief of acute biliary or renal colic , and for relief of postoperative pain (including that associated with gynecologic and orthopedic surgery).
When used to relieve mild to moderate acute pain, single oral diclofenac sodium doses of 50-150 mg have been more effective than placebo and at least as effective as usual analgesic doses of other NSAIAs or mild opiate analgesics. Diclofenac sodium dosages of 75-150 mg daily have been as effective as aspirin dosages of 0.9-2.7 g daily or ibuprofen dosages of 1.2 g daily. In patients with oral surgery pain, 50-mg doses of diclofenac sodium have been reported to be as effective as 100-mg doses of pentazocine.
Efficacy of diclofenac epolamine transdermal system for the management of pain in patients with minor strains, sprains, and contusions has been demonstrated in 2 of 4 clinical studies. In one of these studies, diclofenac epolamine transdermal system (applied twice daily for 2 weeks) was more effective than a placebo transdermal system in relieving pain due to an acute minor sports injury.
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Dysmenorrhea
Diclofenac potassium is used orally in the management of primary dysmenorrhea. In patients with primary dysmenorrhea, NSAIAs may relieve pain and reduce the frequency and severity of uterine contractions, possibly as a result of inhibition of prostaglandin synthesis.
The potential benefits and risks of diclofenac therapy as well as alternative therapies should be considered prior to initiating diclofenac therapy. The lowest possible effective dosage and shortest duration of therapy consistent with treatment goals of the patient should be employed.
When used to relieve primary dysmenorrhea, 50- or 100-mg doses of diclofenac potassium followed by 50 mg every 8 hours were as effective as 550 mg of naproxen sodium followed by 275 mg every 8 hours.
Diclofenac sodium as delayed-release (enteric-coated) tablets also has been used for the symptomatic relief of dysmenorrhea. When used to relieve dysmenorrhea, diclofenac sodium (delayed-release [enteric-coated]) dosages of 50-150 mg daily were more effective than placebo and as effective as naproxen dosages of 250-1250 mg daily.
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Other Uses
Oral diclofenac sodium has been used for its antipyretic effect in the management of fever, usually associated with infection. In one study, the antipyretic effect of usual dosages of diclofenac sodium as delayed-release (enteric-coated) tablets was about equal to that of usual dosages of aspirin. The drug, however, should not be used routinely as an antipyretic because of its potential adverse effects.
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.
Diclofenac sodium also is used topically as an ophthalmic solution for the treatment of postoperative ocular inflammation in patients undergoing cataract extraction.
For use of diclofenac sodium in the topical treatment of actinic keratoses, see Diclofenac Sodium 84:92.