This risk may occur early in treatment and may increase with duration of use [Diclofenac Sodium Topical Gel, 1% is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [Gastrointestinal Bleeding, Ulceration, and PerforationNSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Read and follow these instructions carefully. Diclofenac sodium is a white to slightly yellow crystalline powder. In animal reproduction studies, no evidence of teratogenicity was observed in mice, rats, or rabbits given diclofenac during the period of organogenesis at doses up to approximately 5, 5, and 10 times, respectively, the maximum recommended topical dose of diclofenac sodium topical gel, despite the presence of maternal and fetal toxicity at these doses There are no studies on the effects of diclofenac sodium topical gel during labor or delivery. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [Of the total number of subjects treated with diclofenac sodium topical gel in clinical studies, 498 were 65 years of age and over.
If it is near the time of the next dose, skip the missed dose. Speak to your doctor about how drug interactions should be managed. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3-6 months, and in about 2%-4% of patients treated for one year. 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. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. Limit your time in the sun. Advertising revenue supports our not-for-profit mission.Check out these best-sellers and special offers on books and newsletters from Mayo Clinic. Select one or more newsletters to continue.
Meaningful elevations of ALT and/or AST occurred in about 4% of 3,700 patients and included marked elevations (greater than 8 times the ULN) in about 1% of the 3,700 patients.
Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. All rights reserved. Talk with the doctor. Diclofenac Emulgel, ketoprofen gel, piroxicam gel, and diclofenac plaster work reasonably well for strains and sprains. Read the Medication Guide and Patient Instructions for Use provided by your pharmacist before you start using diclofenac and each time you get a refill.
If you notice other effects not listed above, contact your doctor or pharmacist.Call your doctor for medical advice about side effects.
Non-serious Application Site Adverse Reactions (≥1% diclofenac sodium topical gel Patients) – Short-term Controlled TrialsTable 2: Clinically Significant Drug Interactions with DiclofenacACE Inhibitors, Angiotensin Receptor Blockers, and Beta-BlockersTable 3. Follow your doctor's orders or the directions on the label. Because cross-reactivity between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, diclofenac sodium topical gel is contraindicated in patients with this form of aspirin sensitivity [NSAIDs, including diclofenac, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. The following information includes only the average doses of this medicine. 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. The potential effects of diclofenac sodium topical gel on skin response to ultraviolet damage in humans are not known.Contact of diclofenac sodium topical gel with eyes and mucosa, although not studied, should be avoided. The median time to significant pain relief was 20 minutes for the ibuprofen/levomenthol and diclofenac gels but 25 minutes for ibuprofen gel. This medicine is not for long-term use.
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