Diclofenac sodium is a white to slightly yellow crystalline powder. Do not use combination therapy with Diclofenac Sodium Topical Gel and an oral NSAID unless the benefit outweighs the risk.The following adverse reactions are discussed in greater detail in other sections of the labeling:Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.During clinical development, 913 patients were exposed to diclofenac sodium topical gel in randomized, double-blind, multicenter, vehicle-controlled, parallel-group studies in osteoarthritis of the superficial joints of the extremities. In this same cohort, the incidence of death in the first year post-MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Antagonism between non-steroidal anti-inflammatory drugs and diuretics. Elevations in transaminases were seen more frequently in patients with osteoarthritis than in those with rheumatoid arthritis.Almost all meaningful elevations in transaminases were detected before patients became symptomatic. Keep diclofenac sodium topical gel, the dosing card, and all medicines out of the reach of childrenSee Medication Guide and Patient Instructions Inside of CartonWe comply with the HONcode standard for trustworthy health information - In this study, where patients were treated for up to 1 year with diclofenac sodium topical gel up to 32 g per day, application site dermatitis was observed in 11% of patients. (2.3) (Diclofenac Sodium Topical Gel should be measured onto the enclosed dosing card to the appropriate 2 g or 4 g designation. Monitor serum digoxin levels. Monitor these patients for signs of bleeding [The pharmacological activity of diclofenac sodium topical gel in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.Because serious GI bleeding, hepatotoxicity, and renal injury can occur without warning symptoms or signs, consider monitoring patients on long-term NSAID treatment with a CBC and a chemistry profile periodically [Patients should minimize or avoid exposure to natural or artificial sunlight on treated areas because studies in animals indicated topical diclofenac treatment resulted in an earlier onset of ultraviolet light induced skin tumors. Human and animal studies indicate that diclofenac crosses the placenta. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [Concomitant use of Diclofenac Sodium Topical Gel and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [Diclofenac Sodium Topical Gel is not a substitute for low dose aspirin for cardiovascular protection.Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [Status Post Coronary Artery Bypass Graft (CABG) SurgeryRisk Factors for GI Bleeding, Ulceration, and PerforationStrategies to Minimize the GI Risks in NSAID-treated patients:see Contraindications (4) and Warnings and Precautions (5.8)Adverse reactions observed in at least 1% of patients treated with diclofenac sodium topical gel:Table 1. Pharmacokinetic Parameters and Comparison of Diclofenac Sodium Topical Gel to Oral Diclofenac Sodium Tablets After Repeated AdministrationTable 4.
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