Pharmacokinetic Parameters and Comparison of VOLTAREN GEL to Oral Diclofenac Sodium Tablets After Repeated AdministrationTable . Voltaren Gel was administered at a dose of 2 g per hand, 4 times daily, on both hands (16 g per day). Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events Status Post Coronary Artery Bypass Graft (CABG) SurgeryRisk Factors for GI Bleeding, Ulceration, and PerforationStrategies to Minimize the GI Risks in NSAID-treated patientsAdverse reactions observed in at least 1% of patients treated with Voltaren GelACE Inhibitors, Angiotensin Receptor Blockers, and Beta-BlockersGastrointestinal Bleeding, Ulceration, and PerforationMedication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?Increased risk of a heart attack or stroke that can lead to deathDo not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG)".Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. Because cross-reactivity between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, VOLTAREN 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. • Patients with or without chronic asthma in whom asthma, angioedema, urticaria or acute rhinitis are precipitated by acetylsalicylic acid (aspirin) or other non- steroidal anti-inflammatory drugs (NSAIDs). Call your doctor for medical advice about side effects. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc. Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of Voltaren Gel at the first appearance of skin rash or any other sign of hypersensitivity. Updated In patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state.Diclofenac has been associated with anaphylactic reactions in patients with and without known hypersensitivity to diclofenac and in patients with aspirin-sensitive asthma Seek emergency help if an anaphylactic reaction occursA subpopulation of patients with asthma may have aspirin-sensitive asthma which may include chronic rhinosinusitis complicated by nasal polyps; severe, potentially fatal bronchospasm; and/or intolerance to aspirin and other NSAIDs. Not all pack sizes may be marketed. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.During concomitant use of Voltaren Gel with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects The concomitant use of diclofenac with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.During concomitant use of Voltaren Gel and digoxin, monitor serum digoxin levels.NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. It allows continued monitoring of the benefit/risk balance of the medicinal product. In the treatment of osteoarthritis, therapy should be reviewed after 4 weeks.After application, the hands should be washed unless they are the site being treated.Voltarol Emulgel is suitable for the transmission of ultrasound and may be used as a couplant in combination with ultrasound therapy. Diclofenac sodium is a white to slightly yellow crystalline powder. The dosing card is made of clear plastic.
Most postmarketing reports of fatal GI events occurred in elderly or debilitated patients.

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. Patients, families, or their caregivers should be informed of the following information before initiating therapy with VOLTAREN GEL and periodically during the course of ongoing therapy.Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their healthcare provider.