Updated Each gram of gel contains 30 mg of diclofenac sodium. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X.If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Diclofenac Sodium Gel should not be applied to open skin wounds, infections, or exfoliative dermatitis. Of the 211 patients treated with Diclofenac Sodium Gel, 172 (82%) experienced AEs involving skin and the application site compared to 160 (75%) vehicle-treated patients. No long-term patient follow-ups, after the 30-day assessments, were performed for the detection of recurrence.Diclofenac Sodium Gel is contraindicated in patients with a known hypersensitivity to diclofenac, benzyl alcohol, polyethylene glycol monomethyl ether 350 and/or hyaluronate sodium.As with other NSAIDs, anaphylactoid reactions may occur in patients without prior exposure to diclofenac. Serum concentrations of diclofenac were, on average, at or below 20 ng/mL. Of the 423 patients evaluable for safety in adequate and well-controlled trials, 211 were treated with Diclofenac Sodium Gel drug product and 212 were treated with a vehicle gel. Forced diuresis may theoretically be beneficial because the drug is excreted in the urine. * Based on body surface area and assuming 10% bioavailability following topical application of 2 g Diclofenac Sodium Gel per day (1 mg/kg diclofenac sodium). Diclofenac sodium is a white to slightly yellow crystalline powder. Ratio of area under the plasma concentration time curve from 48-72 hrs (AUC48-72 hrs) of Diclofenac gel in tube and AUC48-72 hrs of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic The recommended duration of therapy is from 60 days to 90 days. It is to be smoothed onto the affected skin gently. Two of these phenolic metabolites are biologically active, however to a much smaller extent than diclofenac. Forced diuresis may theoretically be beneficial because the drug is excreted in the urine. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The chemical name for diclofenac sodium is:Diclofenac sodium has a molecular weight of 318.13.The CAS number is CAS-15307-79-6. No long-term patient follow-ups, after the 30-day assessments, were performed for the detection of recurrence. Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Diclofenac Sodium Gel, 3%, contains the active ingredient, diclofenac sodium, in a clear, transparent, colorless to slightly yellow gel base. Diclofenac Sodium Gel is indicated for the topical treatment of actinic keratoses (AK). Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke. Patients were excluded from participation for reasons of known or suspected hypersensitivity to any diclofenac sodium gel ingredient, pregnancy, allergies to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), or other dermatological conditions which might affect the absorption of the study medication. 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