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Borderline elevations (i.e., less than 3 times the ULN [ULN = the upper limit of the normal range]) or greater elevations of transaminases occurred in about 15% of diclofenac-treated patients. Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Caution should be exercised in prescribing Voltaren with concomitant drugs that are known to be potentially hepatotoxic (e.g., antibiotics, anti-epileptics).As with other NSAIDs, anaphylactic reactions may occur both in patients with the aspirin triad and in patients without known sensitivity to NSAIDs or known prior exposure to Voltaren. There are no specific antidotes. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)This Medication Guide has been approved by the U.S. Food and Drug Administration.We comply with the HONcode standard for trustworthy health information - Almost all meaningful elevations in transaminases were detected before patients became symptomatic. And if you become pregnant while taking this drug, tell your doctor right away.This drug has not been shown to be safe or effective for treating GERD or erosive esophagitis in children younger than 1 year. Once a migraine has started, treatment is focused on managing the migraine symptoms. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events (see WARNINGS, GI Effects). However, there is usually a delay in the onset of absorption of 1 to 4.5 hours and a reduction in peak plasma levels of <20%.The apparent volume of distribution (V/F) of diclofenac sodium is 1.4 L/kg. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac. Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal) and vomiting. The effects of Voltaren on labor and delivery in pregnant women are unknown.It is not known whether this drug is excreted in human milk. Diarrhea 3. Voltaren is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).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, myocardial infarction, and stroke, which can be fatal. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.Carefully consider the potential benefits and risks of Voltaren      After observing the response to initial therapy with Voltaren, the dose and frequency should be adjusted to suit an individual patient’s needs. Diclofenac potassium for oral solution packets: 50 mg (1 packet) orally once Comments: This drug is not indicated for the prophylactic therapy of migraine or for use in cluster headaches; the safety and efficacy of a second dose has not been established. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed.Voltaren® (diclofenac sodium enteric-coated tablets)(See the end of this Medication Guide for a list of prescription NSAID medicines. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Our website services, content, and products are for informational purposes only.
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