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Diclofenac: Patients
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Diclofenac Potassium, like other NSAIDs, can cause GI discomfort and, rarely, more serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative signs or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up (see WARNINGS: Gastrointestinal Effects: Risk of Ulceration, Bleeding, and Perforation).
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Diclofenac has been found to increase the blood pressure in patients with Shy-Drager syndrome (autonomous hypotension) often seen in diabetic patients. Currently, this use is highly investigational and cannot be recommended as routine treatment.
Carefully consider the potential benefits and risks of Diclofenac Potassium tablets and other treatment options before deciding to use Diclofenac Potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
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ALLERGIC REACTIONS: As with other nonsteroidal anti-inflammatory drugs, allergic reactions including anaphylaxis, have been reported with Diclofenac. Specific allergic manifestations consisting of swelling of eyelids, lips, pharynx and larynx, urticaria, asthma, and bronchospasm, sometimes with a concomitant fall in blood pressure (severe at times) have been observed in clinical trials and/or the foreign marketing experience with Diclofenac. Anaphylaxis has been reported rarely from foreign sources; in U.S. clinical trials with Diclofenac in over 6000 patients, 1 case of anaphylaxis was reported. In controlled clinical trials, allergic reactions have been observed at an incidence of 0.5%. These reactions can occur without prior exposure to the drug.
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Following the identification of increased risks of heart attacks with the selective COX-2 inhibitor rofecoxib in 2004, attention has focused on all the other members of the NSAIDs group, including Diclofenac. Research results are mixed with a meta-analysis of papers and reports up to April 2006 suggesting a relative increased rate of heart disease of 1.63 compared to non users.[2] Professor Peter Weissberg, Medical Director of the British Heart Foundation said, "However, the increased risk is small and many patients with chronic debilitating pain may well feel that this small risk is worth taking to relieve their symptoms". Only Aspirin was found not to increase the risk of heart disease... this is known to have a higher rate of gastric ulceration than Diclofenac.
ANTICOAGULANTS: While studies have not shown Diclofenac to interact with anticoagulants of the warfarin type, caution should be exercised, nonetheless, since interactions have been seen with other NSAIDs. Because prostaglandins play an important role in hemostasis, and NSAIDs affect platelet function as well, concurrent therapy with all NSAIDs, including Diclofenac, and warfarin requires close monitoring of patients to be certain that no change in their anticoagulant dosage is required.
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