Almost all meaningful elevations in transaminases were detected before patients became symptomatic. Abnormal tests occurred during the first 2 months of therapy with diclofenac in 42 of the 51 patients in all trials who developed marked transaminase elevations. In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month, and in some cases, the first 2 months of therapy, but can occur at any time during treatment with diclofenac.
Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure.
Some of these reported cases resulted in fatalities or liver transplantation. In a European retrospective population-based, case-controlled study, 10 cases of diclofenac associated drug-induced liver injury with current use compared with non-use of diclofenac were associated with a statistically significant 4-fold adjusted odds ratio of liver injury.
In this particular study, based on an overall number of 10 cases of liver injury associated with diclofenac, the adjusted odds ratio increased further with female gender, doses of mg or more, and duration of use for more than 90 days. Physicians should measure transaminases at baseline and periodically in patients receiving long-term therapy with diclofenac, because severe hepatotoxicity may develop without a prodrome of distinguishing symptoms. The optimum times for making the first and subsequent transaminase measurements are not known.
Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac. However, severe hepatic reactions can occur at any time during treatment with diclofenac.
Inform patients of the warning signs and symptoms of hepatotoxicity e. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur e. Patients taking angiotensin converting enzyme ACE inhibitors, thiazide diuretics, or loop diuretics may have impaired response to these therapies when taking NSAIDs [see Drug Interactions 7 ]. Use of diclofenac may blunt the CV effects of several therapeutic agents used to treat these medical conditions e. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion.
In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction, those taking diuretics and ACE-inhibitors or ARBs, and the elderly.
Hyperkalemia Increases in serum potassium concentration, including hyperkalemia, have been reported with use of NSAIDs, even in some patients without renal impairment. In patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state. Anaphylactoid Reactions Diclofenac has been associated with anaphylactic reactions in patients with and without known hypersensitivity to diclofenac and in patients with aspirin-sensitive asthma [see Contraindications 4 and Warnings and Precautions 5.
Seek emergency help if an anaphylactic reaction occurs. These serious events may occur without warning. Premature Closure of Fetal Ductus Arteriosus Diclofenac may cause premature closure of the fetal ductus arteriosus. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis. Co-morbid conditions such as coagulation disorders, concomitant use of warfarin, other anticoagulants, antiplatelet agents e. Monitor these patients for signs of bleeding [see Drug Interactions 7 ].
Laboratory Monitoring 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 [see Warnings and Precautions 5.
Sun Exposure 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 advised that if eye contact occurs, they should immediately wash out the eye with water or saline and consult a physician if irritation persists for more than an hour. Adverse Reactions The following adverse reactions are discussed in greater detail in other sections of the labeling: Diclofenac may also cause stomach or intestinal bleeding, which can be fatal.
These conditions can occur without warning while you are using Voltaren Gel, especially in older adults. Before taking this medicine Voltaren Gel can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease.
Even people without heart disease or risk factors could have a stroke or heart attack while using Voltaren Gel. Do not use this medicine just before or after heart bypass surgery coronary artery bypass graft, or CABG.
Voltaren Gel may also cause stomach or intestinal bleeding, which can be fatal. You should not use Voltaren Gel if you are allergic to diclofenac Voltaren, Cataflam, Flector, and others , or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.
To make sure Voltaren Gel is safe for you, tell your doctor if you have: Using Voltaren Gel during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether diclofenac topical passes into breast milk or if it could harm a nursing baby.
You should not breast-feed while using Voltaren Gel. Voltaren Gel is not approved for use by anyone younger than 18 years old. How should I use Voltaren Gel? Use Voltaren Gel exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger amounts or for longer than recommended. Use the lowest dose of Voltaren Gel that is effective in treating your condition.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Wash your hands after applying Voltaren Gel, unless you are treating the skin on your hands. Wait at least 10 minutes before dressing or wearing gloves. Wait at least 1 hour before you bathe or shower. Do not apply to an open skin wound, or on areas of infection, rash, or burn. Do not cover treated skin with a bandage or expose it to heat from a hot tub, heating pad, or sauna.
Heat or bandaging can increase the amount of diclofenac you absorb through your skin. To treat osteoarthritis pain with Voltaren Gel: This medicine is supplied with dosing cards that show you how much gel to use for a 2-gram dose or a 4-gram dose.
Squeeze the gel onto this card along the line for your dose. Use no more gel than will fit on the length of your dosing line.
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